I have written several articles on the coronavirus and on masks and healthcare issues. A series of links have been provided at the bottom of this article for your convenience. This article will, however address a different aspect of the virus or on healthcare issues in general. Links are provided for Dr. Fauci as well.

Table of Contents

-Why Not Vaccine Alternatives?

-Safety Concerns

-Is the Vaccine Safe?

–Why do reactions to vaccines differ and what do they tell us?

-Scientists say COVID-19 booster shots aren’t needed yet—here’s why

-Vaccines are highly unlikely to cause side effects long after getting the shot

–COVID Vaccine Mandates Are Coming

-SHAPIRO: When Does The COVID-19 Panic End?

–What is a breakthrough infection? 6 questions answered about catching COVID-19 after vaccination

-People who already had COVID-19 should still get vaccinated, scientists urge

-Why kids are still waiting for their COVID-19 vaccines

-Who qualifies for a coronavirus booster shot? Why it’s still unclear.

-Decades-old SARS virus infection triggers potent response to COVID vaccines

-COVID vaccines protect against Delta, but their effectiveness wanes

-Evidence mounts that people with breakthrough infections can spread Delta easily

-What full FDA approval of Pfizer’s vaccine means for the course of the pandemic

-Why the CDC and FDA only approved booster shots for some Americans

-Pregnant and Unvaccinated: Delta’s Deadly Toll

-COVID Vaccines Show No Signs of Harming Fertility or Sexual Function

-COVID super-immunity: one of the pandemic’s great puzzles

-Should you mix and match COVID-19 vaccines? Experts weigh in.

-Why the CDC and FDA only approved booster shots for some Americans

-What COVID vaccines for young kids could mean for the pandemic

-What to expect with COVID-19 vaccines for kids ages 5 to 11

-Why scientists worldwide are watching UK COVID infections

-Biden Vaccine Mandate For Private Employers: Everything You Need To Know

-The Daily Wire Challenges Biden Administration Vaccine Mandate

-Why kids under 5 still can’t get a COVID-19 vaccine

-Long-COVID symptoms less likely in vaccinated people, Israeli data say

-Why is it so hard to compensate people for serious vaccine side effects?

-Boost now? Boost later? Tricky calculation for a 4th coronavirus shot.

-FDA authorizes COVID-19 vaccines for kids under five

-Some Vaccines Last a Lifetime. Here’s Why Covid-19 Shots Don’t.

–Multiple COVID infections can lead to chronic health issues. Here’s what to know.

-It’s good to feel bad after your COVID shot

Why Not Vaccine Alternatives?

Why the government and medical globalists attack lifesaving hydroxychloroquine and ivermectin. The worldwide suppression of hydroxychloroquine and now ivermectin, even at the direct cost of lives, is so inexplicable that before describing the situation further, it may help to answer the question, “Why is it so necessary for the establishment to suppress inexpensive, easily available treatments for COVID-19?” The answer is this: If effective treatments are already available, the FDA cannot issue Emergency USE Authorization (EUAs), allowing the FDA to skip its usual safety and effectiveness studies to push expensive, highly remunerative drugs and vaccines down the pipeline as experiments to be inflicted upon the population.

If they cannot issue EUAs, which exempt drugs and vaccines from going through the usual FDA multi-year approval process, they cannot create Warp Speed or any other process aimed at giving the drug companies government help in slamming through their new, expensive, and dangerously experimental drugs and vaccines.

The EUA statute permitting a Warp Speed approach explicitly states, “For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition.”

In short, any existing lifesaving drugs must be shot down, and people must be allowed to die so drug companies and their big investors like Bill Gates and their supporters like Anthony Fauci can gain more wealth, self-aggrandizement, and power.

(Update 1/22/2022)

Is the Vaccine Safe?

I have discussed the subject of vaccines for the coronavirus in brief. I will discuss this subject matter more in depth. I feel this is a good time to do so, since we are getting closer to the roll out of these vaccines. Typically it takes 2 to 3 years for a vaccine to be introduced for a new outbreak, if one comes out at all. We still do not have a vaccine for HIV, though we do have excellent therapeutics out. The diagnosis is no longer a death sentence. The flu vaccine has to be updated yearly due to mutations and new strains of the virus appearing. The coronavirus is an insidious virus, not only is it easily spread, it is quite lethal for certain high risk individuals. I have discussed the cornavirus thoroughly in a previous article on entitled “The Coronavirus Exposed”, so I won’t rehash that information. President Trump to speed up the creation of the vaccine has set up a task force called Warp Speed. He has authorized large amounts of funds and also has set up the production of the vaccine even before it has been thoroughly tested. As a result several pharmaceutical companies are doing final stages of testing.

While the president does have a lot of power, he is not a super hero like Dr. Strange. He can’t make events happen by the power of his mind. The companies that are working on these vaccines are reputable companies. They are being closely monitored by not only the US but the rest of the world as well. They are not going to do anything to jeopardize people’s health. Their are countless lawyers waiting for possible lawsuits from this vaccine. These companies know that. I also take exception with the news media, politicians and celebrities casting doubt on the safety of these vaccines, simply for political reasons. They are jeopardizing people’s health by doing so. I will get my vaccination shot as soon as it is available. I also get my yearly flu shot. I am an ICU nurse, so my situation is somewhat different. I can’t hide from the virus.

To allay these fears, I have included some more information on the development of the vaccine.

A vaccine to prevent coronavirus disease 2019 (COVID-19) is perhaps the best hope for ending the pandemic. Currently, there is no vaccine to prevent infection with the COVID-19 virus, but researchers are racing to create one.

Coronavirus vaccine research

Coronaviruses are a family of viruses that cause illnesses such as the common cold, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). COVID-19 is caused by a virus that’s closely related to the one that causes SARS. For this reason, scientists named the new virus SARS-CoV-2.

While vaccine development can take years, researchers aren’t starting from scratch to develop a COVID-19 vaccine. Past research on SARS and MERS vaccines has identified potential approaches.

Coronaviruses have a spike-like structure on their surface called an S protein. (The spikes create the corona-like, or crown-like, appearance that gives the viruses their name.) The S protein attaches to the surface of human cells. A vaccine that targets this protein would prevent it from binding to human cells and stop the virus from reproducing.

Coronavirus vaccine challenges

Past research on vaccines for coronaviruses has also identified some challenges to developing a COVID-19 vaccine, including:

• Ensuring vaccine safety. Several vaccines for SARS have been tested in animals. Most of the vaccines improved the animals’ survival but didn’t prevent infection. Some vaccines also caused complications, such as lung damage. A COVID-19 vaccine will need to be thoroughly tested to make sure it’s safe for humans.
• Providing long-term protection. After infection with coronaviruses, re-infection with the same virus — though usually mild and only happening in a fraction of people — is possible after a period of months or years. An effective COVID-19 vaccine will need to provide people with long-term infection protection.
• Protecting older people. People older than age 50 are at higher risk of severe COVID-19. But older people usually don’t respond to vaccines as well as younger people. An ideal COVID-19 vaccine would work well for this age group.

Pathways to develop and produce a COVID-19 vaccine

Global health authorities and vaccine developers are currently partnering to support the technology needed to produce vaccines. Some approaches have been used before to create vaccines, but some are still quite new.

Live vaccines

Live vaccines use a weakened (attenuated) form of the germ that causes a disease. This kind of vaccine prompts an immune response without causing disease. The term attenuated means that the vaccine’s ability to cause disease has been reduced.

Live vaccines are used to protect against measles, mumps, rubella, smallpox and chickenpox. As a result, the infrastructure is in place to develop these kinds of vaccines.

However, live virus vaccines often need extensive safety testing. Some live viruses can be transmitted to a person who isn’t immunized. This is a concern for people who have weakened immune systems.

Inactivated vaccines

Inactivated vaccines use a killed (inactive) version of the germ that causes a disease. This kind of vaccine causes an immune response but not infection. Inactivated vaccines are used to prevent the flu, hepatitis A and rabies.

However, inactivated vaccines may not provide protection that’s as strong as that produced by live vaccines. This type of vaccine often requires multiple doses, followed by booster doses, to provide long-term immunity. Producing these types of vaccines might require the handling of large amounts of the infectious virus.

Genetically engineered vaccines

This type of vaccine uses genetically engineered RNA or DNA that has instructions for making copies of the S protein. These copies prompt an immune response to the virus. With this approach, no infectious virus needs to be handled. While genetically engineered vaccines are in the works, none has been licensed for human use.

The vaccine development timeline

The development of vaccines can take years. This is especially true when the vaccines involve new technologies that haven’t been tested for safety or adapted to allow for mass production.

Why does it take so long? First, a vaccine is tested in animals to see if it works and if it’s safe. This testing must follow strict lab guidelines and generally takes three to six months. The manufacturing of vaccines also must follow quality and safety practices.

Next comes testing in humans. Small phase I clinical trials evaluate the safety of the vaccine in a small group. During phase II, the formulation and doses of the vaccine are established to prove the vaccine’s effectiveness in a larger gropu. Finally, during phase III, the safety and efficacy of a vaccine need to be demonstrated in an even larger group of people.

Because of the seriousness of the COVID-19 pandemic, vaccine regulators might fast-track some of these steps. But it’s unlikely that a COVID-19 vaccine will become available sooner than six months after clinical trials start. Realistically, a vaccine will take 12 to 18 months or longer to develop and test in human clinical trials. And we don’t know yet whether an effective vaccine is possible for this virus.

If a vaccine is approved, it will take time to produce, distribute and administer to the global population. Because people have no immunity to the COVID-19 virus, it’s likely that two vaccinations will be needed, three to four weeks apart. People would likely start to achieve immunity to the COVID-19 virus one to two weeks after the second vaccination.

A lot of work remains. Still, the number of pharmaceutical companies, governments and other agencies working on a COVID-19 vaccine is cause for hope.

Biologically, a vaccine against the COVID-19 virus is unlikely to offer complete protection. Logistically, manufacturers will have to make hundreds of millions of doses while relying, perhaps, on technology never before used in vaccines and competing for basic supplies such as glass vials. Then the federal government will have to allocate doses, perhaps through a patchwork of state and local health departments with no existing infrastructure for vaccinating adults at scale. The Centers for Disease Control and Prevention, which has led vaccine distribution efforts in the past, has been strikingly absent in discussions so far—a worrying sign that the leadership failures that have characterized the American pandemic could also hamper this process. To complicate it all, 20 percent of Americans already say they will refuse to get a COVID-19 vaccine, and with another 31 percent unsure, reaching herd immunity could be that much more difficult.

Vaccines are, in essence, a way to activate the immune system without disease. They can be made with weakened viruses, inactivated viruses, the proteins from a virus, a viral protein grafted onto an innocuous virus, or even just the mRNA that encodes a viral protein. Getting exposed to a vaccine is a bit like having survived the disease once, without the drawbacks. A lot remains unknown about the long-term immune response to COVID-19, but, as my colleague Derek Thompson has explained, there are good reasons to believe getting COVID-19 will protect against future infections in some way. Vaccine-induced immunity, though, tends to be weaker than immunity that arises after an infection. Vaccines are typically given as a shot straight into a muscle. Once your body recognizes the foreign invader, it mounts an immune response by, for example, producing long-lasting antibodies that circulate in the blood.

Below I have included as of August 10, the progress of the three leading pharmaceutical companies.

Moderna

Where is it now? The start of Moderna’s Phase 3 trial of its mRNA-1273 vaccine was announced just last week. It will involve 30,000 adults at 89 clinical research sites around the country. It is the first Phase 3 trial begun under Operation Warp Speed, according to the National Institutes of Health.Phase 2 was started in May.Trial results: So far, only Phase 1 results have been released. Those early results showed the vaccine brought about an immune response, which is what researchers wanted to see. The higher the dose, the higher the immune response was in the people who got it.How safe is it? More than half of participants had side effects, including fatigue, chills, headache, muscle pain and pain at the injection site. These are considered normal side effects for a vaccine. The higher the dose, the worse the side effects. The Phase 3 trial will use the middle dose.Who is developing it? Moderna, a biotech based in Cambridge, Massachusetts, developed the vaccine with help from the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health.

Pfizer

Where is it now? Pfizer has more than one vaccine candidate, being developed together with the German company BioNTech. It has moved into a combined Phase 2/3 trial, also started last week, with one of them, BNT162b2. That’s being carried out at about 120 sites worldwide, including 39 US states and Argentina, Brazil and Germany.When will we have it? If the trial is successful, Pfizer and BioNTech have said they are on track to seek regulatory review as early as October. If it gets emergency authorization from the FDA, as many as 100 million doses may be available by the end of the year, and about 1.3 billion by the end of 2021.The US Department of Health and Human Services and Department of Defense last month announced a $1.95 billion agreement with Pfizer to produce 100 million doses of the vaccine. The deal also allows the US government to acquire an additional 500 million doses.Trial results: In the combined Phase 1/2 trial, both vaccines brought about an immune response and produced antibodies, a “double-arm” approach that the companies hope will be more effective and provide longer protection. So far, only one has moved on to more advanced trials. Almost 120 people participated.How safe is it? Preliminary data from the Phase 1/2 trial showed “a favorable overall tolerability profile” for the vaccine, Pfizer said in a news release, “with generally mild to moderate” side effects that lasted one to two days, “such as fever, fatigue and chills and no serious adverse events.”

Novavax

Where is it now? Maryland-based biotechNovavax hopes to have its vaccine in Phase 3 trials next month.Trial results: Novavax released data from its Phase 1 trial Tuesday involving 131 participants. After two doses of the vaccine, participants had levels of antibodies that can fight off the virus that were four times higher, on average, than those developed by people who have recovered from Covid-19.The vaccine also brought about a response by immune cells, according to an analysis of 16 randomly selected volunteers.How safe is it? Of the 106 people who got the vaccine, and not a placebo, five had severe side effects, including muscle pain, nausea and joint pain, and one had a mild fever. The side effects lasted two days or less, on average.

A fourth Company has recently come on board,

Janssen Pharmaceutical Company of Johnson and Johnson

A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.

The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational vaccine (also known as Ad.26.COV2.S) and is leading the clinical trial as regulatory sponsor. Janssen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are funding the trial.

U.S. and international trial sites part of the NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial. The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.

“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia,” said NIAID Director Anthony S. Fauci, M.D. “It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose.”

The Janssen vaccine candidate is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells. Adenoviruses are a group of viruses that cause the common cold. However, the adenovirus vector used in the vaccine candidate has been modified so that it can no longer replicate in humans and cause disease. Janssen uses the same vector in the first dose of its prime-boost vaccine regimen against Ebola virus disease (Ad26.ZEBOV and MVA-BN-Filo) that was recently granted marketing authorization by the European Commission.

Why do reactions to vaccines differ and what do they tell us?

(Updated 7/15/2021)

But not everyone experiences side effects after a COVID-19 vaccine. Some feel fine after both doses. Scientists don’t really know why, says Sujan Shresta, an immunologist at the Center for Infectious Disease and Vaccine Research at the La Jolla Institute for Immunology, in California. “But it’s not a surprise that each person mounts the immune response differently.”

Several factors can contribute to this wide variation. Women, for example, typically have stronger immune reactions than men, which may be part of what makes them more prone to suffering from side effects from the shots.

“We all have our own individualized immune system,” says John Wherry, director of the institute for immunology at the University of Pennsylvania, in Philadelphia. “It’s almost like our own immune fingerprint that’s driven by genetics, gender, diet, our environment, and even our life history, which are the things our immune system has been exposed to in the past and has been trained to respond to over the years.”

Even if you don’t have an unpleasant reaction, the vaccines are still doing their job, because the real work of the immune system—and of the vaccines—takes place during the second, or adaptive, phase of the immune response. During this phase, the spike protein generated via the vaccine trains the B-cells to produce antibodies that match the virus, and the T-cells to seek-and-destroy infected cells. But it takes days to weeks to provide this long-lasting protection against the virus.

This is also the reason why people often have more rigorous reactions to the second shot. Three weeks after the first shot, the immune system has already been primed, and the B-cells and T-cells are ready to fight. When the second shot is delivered, both the innate and adaptive systems respond.

Still, we don’t really know if having a serious response to the vaccines is a measure of the strength of the immune system. We also don’t know if it means that someone who doesn’t have a strong innate response will be more vulnerable to COVID or more resistant. “We really don’t have any data in the field on this—whether a person with strong side effects would have a more severe COVID infection and vice versa,” says Wherry.

Women experience more side effects

In a February study that looked at the data from the first 13.7 million COVID-19 vaccine recipients, the Centers for Disease Control and Prevention found that nearly 80 percent of the people reporting reactions were female, even though only 61.2 percent of the injections had been given to women. In a similar vein, the CDC reported that all anaphylactic reactions to the Moderna shot have been in women; 44 of the 47 people who’ve had these reactions to the Pfizer injection were female.

The majority of people who have experienced the severe blood clotting issues with the J & J vaccine, and also the AstraZeneca vaccine in Europe and the United Kingdom, have been women. “There has been speculation about hormones playing a role—which is always the first culprit that’s looked at when you see a major sex difference,” says Penn’s Wherry.

Several other factors may also contribute to this gender imbalance. Women also seem to have a more robust immune system, both in their innate responses and in their adaptive immune reactions. “Females mount a stronger antibody response than males but it’s a double-edged sword because this is why women have more auto immune disease than men,” says Shresta of the La Jolla Institute for Immunology.

Other studies have shown that a woman’s response to half a dose of the influenza vaccine was the same as men’s full dose, so females might not need full doses of the COVID-19 vaccines. “We have this idea that one size fits all, but this may be part of what’s contributing to the higher rate of reactions among women,” says Rosemary Morgan, a scientist specializing in gender research at the Johns Hopkins Bloomberg School of Public Health. “There is also a behavioral component—women are more likely to visit the doctor and to be more proactive about reporting unpleasant symptoms.”

Side effects versus adverse events

“But side effects and adverse events—which often get conflated—are not the same,” says Wherry. “Side effects are pretty common—occurring maybe 50 to 70 percent of the time. But adverse events are rare and unexpected, like the clotting disorders.”

Immediately after injection, about two to five people per million experience anaphylaxis, a severe allergic reaction that causes a dramatic drop in blood pressure and difficulty breathing. But even this is easily treatable with an EpiPen and antihistamines, which is why everyone is asked to stick around for 15 minutes after their COVID-19 shots.

The blood clots associated with the Johnson & Johnson vaccines, that have occurred within six to 13 days of receiving the shot, can be dangerous and even life threatening. But the incidence is quite low; there are only 23 confirmed cases out of 8.4 million doses of the vaccine.

“This is very rare,” says Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital and a professor of pediatrics at Harvard Medical School. “The risk of getting COVID and possibly dying is much higher than getting blood clots from the vaccines.”

Are we noting all the adverse effects?

There is some worry that there may be other adverse effects that have gone largely unreported.

The three COVID-19 vaccines that have been authorized in the United States have been tested on tens of thousands of people in clinical trials, and manufacturers were required to follow up with at least half the vaccine recipients for two months or more after they received both shots. But now that more than 116 million Americans have been fully vaccinated, rare side effects that don’t show up in smaller human clinical trials can emerge—which is why surveillance systems are important.

Here in the U.S., we have a patchwork of systems: the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink, and the CDC’s new phone-based tracking program, v-safe.

All of these have limitations, including that “someone has to suspect these health outcomes are related to vaccination and go to the trouble of filling out the form,” says Katherine Yih, a biologist and epidemiologist at Harvard Medical School, specializing in infectious diseases, immunization, and vaccine safety monitoring. “We have a vigorous surveillance system in place. But we can’t be sure it’s picking up everything.”

What’s more, these incidents only show correlation. In other words, if someone died or had a stroke after getting vaccinated, physicians don’t know if it was triggered by the shot. Only further study can reveal that.

The swift identification of the rare blood clotting disorder related to the J & J vaccine was reassuring. Initially, six cases were reported, prompting the FDA and the CDC to temporarily halt its use. When the CDC’s Advisory Committee on Immunization Practices met in late April to determine the vaccine’s fate, 15 cases had been detected out of seven million people who had the shot. “The discovery of that association with the J & J vaccine—which is very rare—is a real demonstration of how good our safety program is,” says the Mayo Clinic’s Jacobson.” At this point in the pandemic, a risk of less than three per million should not enter into our calculus of how to proceed.”

Heart problems after vaccinations are very rare—and often resolve quickly

New CDC data on myocarditis after a second dose of an mRNA vaccine suggests that the benefits still vastly outweigh the risks.

The teenager arrived at the Oregon Health & Science University Hospital in late April with chest pains that had started suddenly. An MRI showed myocarditis: a swelling of the heart muscle. It’s something doctors at the Portland hospital see in young people a handful of times a year, says Judith Guzman-Cottrill, a pediatric infectious disease physician.

But the timing caught her attention: Just a few days before his symptoms started, the boy had received his second dose of Pfizer’s COVID-19 vaccine. A couple weeks later, Guzman-Cottrill received a call from a colleague in Atlanta who told her about a similar patient with myocarditis that started two days after his second Pfizer shot. The same day, she got news via email of two more such cases in Connecticut.

“Myocarditis in itself is not something so extremely rare that we thought this must be a new illness or new disease,” she says. “But when I heard about what was at that point four new cases—all healthy boys who developed chest pain, I thought, this seems almost too much to be coincidence.”

As of June 11, the U.S. Centers for Disease Control and Prevention has recorded 323 confirmed cases of myocarditis and pericarditis, a related condition, among people ages 12 to 29, mostly documented within a week after each patient had received one of the mRNA COVID-19 vaccines made by Pfizer-BioNTech and Moderna. That figure, announced this week by the CDC’s Advisory Committee on Immunization Practices, revises the previous count to include data from children ages 12 to 15, a group that gained authorization to get the Pfizer vaccine in May.

So far, post-vaccination myocarditis has been most commonly reported among people in their late teens and early 20s, according to the committee’s report. The condition is more likely to occur after the second dose, and it happens more often in boys and young men than in girls and women.

Overall, rates of post-vaccination myocarditis and pericarditis are higher than rates normally seen from other causes, Tom Shimabukuro, of the CDC’s COVID-19 Vaccine Task Force, said during the June 23 committee meeting announcing the results. But cases are still infrequent, and the vast majority of patients have responded quickly to treatment.

“This is still a rare event,” Shimabukuro said. “Reassuringly, the available outcome data indicate that patients recover from symptoms and do well.”

What is myocarditis?

When young people develop myocarditis or pericarditis (inflammation of the lining around the heart), the cause is often a viral infection. Enteroviruses such as hand-foot-and-mouth disease are among the most common triggers, and those infections are most common in the summertime, says Jeremy Asnes, chief of pediatric cardiology at the Yale School of Medicine in New Haven, Connecticut. There is also evidence of myocarditis after smallpox vaccination.

To get a handle on the apparent uptick of myocarditis in teenagers back in April, Guzman-Cottrill and colleagues took a detailed look at the experiences of seven healthy boys, ages 14 to 19, who sought care for chest pain in April or May. For all of them, symptoms began within four days after receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine. Testing confirmed myocarditis or pericarditis. All seven recovered quickly, and three received common pain relievers such as ibuprofen as their only treatment, the team reported in a paper this month.

Those findings echoed several other case reports from the U.S. and Israel, which have suggested that post-vaccination myocarditis happens most often in younger people, especially men, says Matthew Oster, a pediatric cardiologist and epidemiologist at Children’s Healthcare of Atlanta and a member of the CDC’s COVID-19 Vaccine Task Force, who spoke at the ACIP meeting. Across those reports, cases have generally been mild, and recovery tends to be relatively rapid, with hospital discharge in two to four days instead of six, as is common with more traditional cases.

“It seems to disappear more quickly than typical myocarditis,” Oster said at the meeting. “I’m optimistic about that.”

The new data are consistent with that previous evidence. Of the 323 confirmed cases so far, 309 were hospitalized, Shimabukuro said. Among those, 295 have been discharged and 218 have recovered from all symptoms. Nine remain hospitalized and two are in the ICU. Most reports of myocarditis came within the first few days after vaccination, especially after the second dose. Cases peak in people in their late teens and early 20s and taper off after age 50.

The CDC’s numbers are also in line with what doctors report seeing in their own institutions. At his hospital in New Haven, Asnes says, his team has cared for 10 patients with post-vaccination myocarditis under age 21 and about the same number over 21. Stuart Berger, a pediatric cardiologist at the Northwestern University Feinberg School of Medicine in Chicago, says his group has seen six cases of confirmed myocarditis, mostly in boys ages 16 and up. All have been mild and included chest pain that went away quickly.

“This has been the experience that that the CDC has described,” says Berger, who is also a spokesperson for the American Academic of Pediatrics. “And it has been the experience that our colleagues and other institutions have described.”

Detecting rare side effects

Using data from the Vaccine Adverse Event Reporting System (VAERS), which allows anyone to report any potential issue related to vaccines, and the Vaccine Safety Datalink, which uses electronic health data from nine health care organizations around the country, the ACIP team calculated a rate of 12.6 cases of myocarditis or pericarditis per million within 21 days after the second dose of any mRNA vaccine in people ages 12 to 39.

The CDC continues to investigate reports submitted to VAERS, and Shimabukuro cautioned against focusing too much on the estimated case rate to guide decision-making in clinical settings. But in interviews, experts say the risk appears to be low compared to the number of vaccines administered.

As of June 22, more than three million 16- and 17-year-olds had received at least one dose of a vaccine in the U.S., and more than four million 12- to 15-year-olds had begun vaccination. “That denominator is very reassuring to me,” says Guzman-Cottrill, whose 16- and 13-year-olds have been vaccinated, including one with an autoimmune condition.

Rates of myocarditis have not been exploding, she adds, even as vaccine numbers grow. “Our emergency rooms are not filled with teenagers with chest pain.”

Link between vaccines and myocarditis

Scientists still don’t know how the vaccine might be causing myocarditis. One leading theory, Oster said, involves a cytokine response—the reaction of inflammatory molecules that rally immune cells to fight. That could explain why the condition appears so quickly after vaccination when it happens. Clinical trials have shown elevated rates of side effects such as fever, muscle aches, chills, and fatigue in young people compared with older adults, and those symptoms are caused by inflammation, Guzman-Cottrill says. So, it would make sense for myocarditis to be another inflammatory response at the most severe end.

The mechanism after vaccination is different from what happens in reaction to enteroviruses, Asnes adds. Instead of the direct invasion of a virus into the heart tissue, it’s the immune system itself that affects the heart after vaccination.

“There must be some cross-reactivity in some patients between their immune response to the vaccine and their heart muscles,” he says.

Facilities have taken different approaches to treating post-vaccination myocarditis, ranging from over-the-counter pain medication to intravenous medications and steroids. More clarity on mechanisms, as well as long-term follow-up studies, should help clarify the best treatment strategies. Further study may also explain why the condition is more common among males and how long recovery should be expected to take. Guzman-Cottrill plans to rescan her seven patients in August, three months after their initial diagnosis.

Given the latest numbers and the still-real risk of severe complications from COVID-19 among young people, including multisystem inflammatory syndrome, experts continue to recommend vaccination for teenagers.

“In the patients in this age group that we saw who were adversely affected by COVID, there were some very severe cases, so I still think that vaccination is appropriate,” Asnes says. “Like with any new therapy, we have to keep our eyes open. And that’s what we’re doing.

The Associated Press recently reported that about 1.3 million people in France made vaccine appointments in one day following new government mandates. President Emmanuel Macron announced that people in France would soon need special passes showing either their vaccination status or negative COVID-19 test results to go to restaurants and malls, or to ride in planes and trains. He also said vaccines would become mandatory for all healthcare workers in the fall. To many people, these measures will sound draconian. But after an initial surge in vaccinations, the rate slowed down in the summer, so that right now only 41 percent of France’s population has been fully vaccinated. That’s well below the rate needed for herd immunity at a time when dangerous variants are threatening to extend the pandemic. We’re in a similar pickle in the U.S., where just 48 percent of the population is fully vaccinated and rates for new appointments have also been dropping. So far, U.S. officials have chosen to use the carrot rather than the stick, with federal and state leaders offering prizes big and small to encourage vaccination. The question on everyone’s lips is whether vaccines will become mandatory here, too, though odds are that would happen at the level of states and businesses rather than the feds. Intriguingly, a June survey by the nonprofit Kaiser Family Foundation found that half the respondents think U.S. employers should require their workers to get vaccinated—even though most people don’t want their own employer to make shots mandatory. Underpinning the kerfuffle is the complex tangle of reasons why people remain unvaccinated. According to that Kaiser survey, 53 percent of respondents in the U.S. think the COVID-19 vaccine is too new and are worried about side effects. But the survey also found that workers whose employers offered paid time off to get vaccinated and recover from side effects were much more likely to report getting at least one dose of the vaccine. These results further underscore how much social equity, and not just hesitancy, will play a role in ending the pandemic.

A smaller but still alarming number of people—26 percent—say they are skipping the COVID-19 shot because they don’t trust vaccines in general. That’s especially troubling when one of the brightest spots of the pandemic has been the rise in mRNA technology. The two mRNA vaccines currently in use continue to prove safe and effective, and that’s driving development of mRNA shots for a host of other diseases. Moderna has already started human clinical trials for an mRNA flu vaccine. And as Stacey Colino reports for us, promising clinical trials are underway for mRNA vaccines that can help beat back especially dire forms of cancer, including pancreatic cancer and melanoma. It’s tragic to think that heightened distrust of vaccines stoked during this pandemic might prevent people from taking advantage of future life-saving options. It’s equally tragic that people who may want vaccines can’t get them because they don’t have the necessary support systems. Vaccine mandates may well be in our future in the U.S., and I sincerely hope the people making them take all these factors into account and craft policies that ensure vaccines are seen as safe, reliable, and accessible to all.

More information on vaccines can be found in my two part article entitled “The Coronavirus Exposed. ” I discussed more in depth vaccines and other aspects of the virus.

Scientists say COVID-19 booster shots aren’t needed yet—here’s why

(Update 7/19/2021)

For the fully vaccinated, the Pfizer shot generates an immune response that could last years and is protective against severe disease and death.

The past week has been a wild ride for fully vaccinated Americans seeking clarity on whether they will need COVID-19 booster shots—either now or in the future, particularly as more contagious variants emerge.

On July 8, Pfizer and BioNTech announced they planned to seek emergency authorization for a booster dose of their vaccine, saying that their data shows their vaccine’s efficacy is waning and that a booster “may be needed within six to 12 months after full vaccination.” Pfizer representatives later met with U.S. officials to press their case for emergency authorization of a third dose.

U.S. regulators, however, have pushed back on Pfizer’s claims. In a joint statement, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention said that Americans who have been fully vaccinated “do not need a booster shot at this time,” emphasizing that the vaccines remain highly effective against severe disease and death.

A spokesperson from the Department of Health and Human Services tells National Geographic that regulators are taking all data into consideration—including those from research labs, clinical trials, and pharmaceutical companies like Pfizer. “We appreciate the information they shared, and officials continue to engage in a science-based rigorous process to consider whether, when, or for whom a booster might be necessary.”

In fact, contrary to Pfizer’s study, new laboratory data has emerged suggesting that the Pfizer vaccine offers protection that could last for years. So what exactly is going on? Here’s a look at what the data shows about how long immunity lasts among the fully vaccinated—and what scientists want to know before they recommend giving anyone another dose.

Antibodies aren’t everything

First, a quick primer on the body’s immune response. It typically has two phases: Innate immunity is the first line of defense, immediately generating a general immune response that can destroy foreign substances or germs. Then the adaptive immune system—which targets specific bacteria and viruses—kicks in to make antibodies to shield against that pathogen in the short and long term.

It does so with the help of T cells and B cells, two types of white blood cells. As E. John Wherry, director of the Institute for Immunology at the University of Pennsylvania, puts it, T cells “are kind of the orchestrators of these complex immune responses.” They nurture the B cells, which mature and transform into plasma cells with one mission: “They are antibody factories,” Wherry says.

But studies have shown that the levels of neutralizing antibodies generated by the COVID vaccines do decline over time. In its statement last week, Pfizer said that a third dose of its vaccine elicits an antibody response five to 10 times higher than after two doses. Pfizer has not released its data, however; a spokesperson told National Geographic that the company is preparing it for publication.

Wherry says that there’s no doubt that the presence of neutralizing antibodies is critically important—but that they’re not everything.

Jane O’Halloran, assistant professor of medicine at Washington University School of Medicine in St. Louis, Missouri, agrees, pointing out that scientists expect to see a decline in antibody levels. “If you had high levels of antibodies to every pathogen that you come across, your blood would be sludge,” she says.

So it’s not about the quantity of the antibodies. It’s about their quality—making sure that the antibodies present are actually doing the job and that your body has the tools to quickly create them when they’re needed.

Training camps of the immune system

O’Halloran was part of a research team that set out to investigate whether the vaccines are indeed preparing the body to fight COVID-19 over the long haul. In their study, they took samples from lymph nodes—which contain B and T cells—of 14 healthy adults who received the Pfizer vaccine.

When the B and T white blood cells respond to a disease and interact with one another, they create something known as germinal centers—essentially training camps for the immune system. Found in the lymph nodes, the germinal centers are where plasma cells learn how to make antibodies that will be most effective in fighting a pathogen.

The germinal centers also produce memory cells that can stick around for a longer time and help the body mount an immune response if it encounters the virus or bacterium again later in life. Unlike antibodies, memory cells can’t “see” a virus until it infects cells in part of the body. When that happens, however, they jump into action and eliminate the infection.

In late June, O’Halloran and her team at the Washington University School of Medicine researchers published their study in the journal Nature showing that germinal centers were still forming in participants for up to 15 weeks after vaccination. Although that might not seem like a long time, O’Halloran says the idea is that those germinal centers “are potentially producing these long-lived memory cells that we need to give long-term immunity.” The study’s lead author Ali Ellebedy told National Institutes of Health director Francis Collins that the germinal center response is so robust that he believes it could last for years.

“This gives us insight that the body is doing what it’s supposed to be doing,” O’Halloran says. Wherry, who wasn’t involved with the study, agrees. “Now we know for sure that’s happening really robustly with these vaccines,” he says.

But the study provides a fairly small dataset, particularly when compared to the abundant studies measuring antibody levels. That’s because studies like this one are much harder and take longer—meaning fewer researchers have been able to take them on.

“Sometimes the easy bit to measure is not the thing that gives us the best window into what’s going on in the body,” O’Halloran says.

O’Halloran also points out the study only speaks to the durability of the Pfizer shot. Some observers have extrapolated that Moderna’s vaccine may have similar durability since it relies on the same mRNA technology. But for that and the Johnson & Johnson vaccine, O’Halloran says, you’ll have to look to how they’re performing in the real world.

Reassuring real-world data

Another argument Pfizer has made for booster shots has pointed to real-world data out of Israel showing that the efficacy of its vaccine declines six months after full vaccination. On July 5, Israel’s Ministry of Health said that it has observed a “marked decline” in the vaccine’s efficacy to 64 percent in preventing both infection and symptomatic illness.

There’s also some indication that protections are waning among the immunocompromised, leading Israel to begin administering a third jab to transplant patients. (Here’s why COVID-19 vaccines are so complex for immunocompromised people.)

Wherry says that the dramatic decline in efficacy in Israel can be attributed in part to the country’s robust COVID-19 testing program. “They test everybody all the time,” he says. “They’re picking up asymptomatic infections.”

He points out that Israel’s data shows the vaccine remains 93 percent effective in preventing serious illness and hospitalization. This suggests that, while the vaccines may no longer be producing the robust levels of antibodies that shield people entirely from infection, the long-term memory response is still kicking in and preventing the infection from spreading.

Public health data elsewhere would seem to back that up: Earlier this month, CDC director Rochelle Walensky said that more than 99 percent of the U.S. deaths from COVID-19 in June were among unvaccinated people. O’Halloran says that’s really the point of getting vaccinated.

“At no point have the vaccines been said to 100 percent prevent infection,” O’Halloran says. “The most important thing is their impact on severe disease and death.”

Critically, the Pfizer, Moderna, and Johnson & Johnson vaccines have all been shown to be effective against Delta and other variants of concern. Of course, that could change or new variants could arise that evade the vaccines’ protections. But O’Halloran points out that booster shots aren’t really the best way to deal with the threat of variants.

“The best way to do that is to get everybody vaccinated once rather than finessing the potential incremental benefit you might from a booster vaccine in one group when you have a whole other group of people who aren’t vaccinated at all,” O’Halloran says.

What the data doesn’t show

While the existing data does offer reassurance that the vaccines remain protective—and booster shots aren’t needed—scientists and regulators alike point to the need for more academic studies to untangle exactly how the immune system is responding to the COVID-19 vaccines.

“I think what we’re going to see, over the next six months or so, a lot of studies outlining what those other components of the immune response look like in both healthy people and in some of our vulnerable populations,” Wherry says. “We really just need a lot more information on multiple layers of the immune response to vaccination.”

It’s also important to keep an eye on public-health data, particularly the rate of hospitalizations and deaths among vaccinated people. Wherry says that, ideally, states will be able to pinpoint when those who are infected were first vaccinated to help identify when immunity seems to be waning.

The HHS spokesperson says regulators are monitoring all this new data as well. “The administration is prepared for booster doses if and when the science demonstrates that they are needed, and any recommendation by CDC and FDA would come after their thorough review process.”

All the same, Wherry says it can’t hurt to be prepared for the time when boosters are needed. “Right now you can have confidence that, if you’re fully vaccinated, your chances of getting severely ill from COVID are extremely low in the U.S.”

Vaccines are highly unlikely to cause side effects long after getting the shot

(Update 7/25/2021)

Science shows that even the most serious side effects for any vaccine, including COVID-19, occur within just a few weeks.

Seven months after the U.S. began administering COVID-19 vaccines, the latest figures from the nonprofit Kaiser Family Foundation’s ongoing tracking poll show that 10 percent of adults are still nervous about the vaccine and want to “wait and see” how others fare before rolling up their sleeves. Young adults ages 18 to 29 and Black and Hispanic people are some of the most likely to voice this sentiment.

The main two reasons cited for this hesitancy are that the vaccines are “too new” and that they may trigger unexpected or life-threatening side effects, perhaps even months or years later. It’s true that reports of new side effects can sometimes take months to emerge as a vaccine goes from populations of thousands in clinical trials to millions in the real world, encountering natural variations in human responses along the way. But more than a hundred million Americans have already passed that point in their vaccinations and the first participants in the clinical trials are now beyond a year.

So far, incidents of severe side effects for the coronavirus vaccines such as Guillain-Barré Syndrome and heart inflammation are very rare, and they were discovered quickly because they were on official lists of potential problems to watch for. What’s more, all these and other side effects appear soon after someone has taken the vaccine, suggesting that people don’t need to worry about delayed long-term reactions.

This picture fits with the modern history of vaccinations, which shows that most new immunizations have been incredibly safe, and even the most severe effects have reared their ugly heads right away.

“Side-effects nearly always occur within a couple of weeks of a person being vaccinated,” says John Grabenstein, director of scientific communication for the Immunization Action Coalition. He adds that the longest time before a side effect appeared for any type of shot has been six weeks.

“The concerns that something will spring up later with the COVID-19 vaccines are not impossible, but based on what we know, they aren’t likely,” adds Miles Braun, adjunct professor of medicine at the Georgetown University School of Medicine and the former director of the division of epidemiology at the U.S. Food and Drug Administration.

A key reason for this limited window of side effects is the short time all vaccines stay in the body, says Onyema Ogbuagu, an infectious diseases specialist at Yale Medicine and a principal investigator of the Pfizer-BioNTech COVID-19 vaccine trial. Unlike medicines that people take every day or week, vaccines are generally administered once or a handful of times over a lifetime. The mRNA molecules used in the Pfizer and Moderna vaccines are especially fragile, he notes, so “they are out of your body in a day or so.”

The vaccines subsequently get to work stimulating the immune system so it can memorize the virus’s blueprint and mount a quick response if it encounters the real thing later. “This process is completed within about six weeks,” says Inci Yildirim, a vaccinologist and pediatric infectious diseases specialist at Yale Medicine. That’s why serious adverse effects that might be triggered by the process emerge within this time frame, after which everything is put on a shelf in the body’s library of known pathogens, Yildirim says.

Historically, vaccine side-effects appear right away

A stroll through vaccine history confirms that even the most damaging side effects have indeed taken place within a six-week window.

After the initial Salk polio vaccine was introduced in 1955, it became clear that some of the first batches inadvertently contained live polio viruses and not the weakened form intended to be in the shot. Within weeks, this mistake resulted in some polio infections and, in a few cases, eventual death. The “Cutter incident,” named after the manufacturing labs with the biggest mishaps, prompted more stringent government regulations. Today, polio vaccines are monitored to make sure the virus is completely inactivated in shots given to children.

In 1976, rare cases of the nerve disorder Guillain- Barré Syndrome emerged some two to three weeks after people began receiving an egg-based inactivated flu vaccine against a dangerous strain of H1N1 swine flu. Scientists eventually determined the effect occurred in one to two people per million shots. Guillain- Barré is a treatable disease, but with flu season winding down that year, the vaccination effort was soon abandoned.

This same condition was recently tied to the Johnson & Johnson COVID-19 vaccine, with a hundred preliminary reports after approximately 12.5 million doses were administered, according to the FDA. In these cases, the syndrome emerged some two weeks after vaccination, primarily in men over 50.

In 2008, seven to 10 days after receiving a shot combining the measles, mumps, and rubella vaccine (MMR) with one for chicken pox (varicella), some babies developed febrile seizures. These seizure cases occurred in one child per 2,300 vaccine doses, which is why the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices currently recommends most children get the two shots separately.

Within weeks of receiving the yellow fever vaccine, a very small number of people develop inflammation of the brain (encephalitis), swelling of the spinal cord covering (meningitis), Guillain-Barré Syndrome, or a multiple-organ system dysfunction called viscerotropic disease. Travelers to places where this fatal disease is endemic are still urged to get the vaccine, although the CDC recommends people over 60 weigh the risks and benefits with their healthcare provider.

The rare exception to adverse events occurring within the six-week timetable is the dengue fever vaccine, Dengavaxia, which the Philippine government approved for use in their children in 2016. When people are infected with the dengue virus, their first bout of this disease is fairly mild. But when they get infected a second time, with a different strain, the reaction can be much more severe and, in some cases, fatal.

As some experts predicted, the vaccine—made from inactivated viruses—acted like a first infection, meaning many kids subsequently bitten by a dengue virus-carrying mosquito fared worse than if they hadn’t been inoculated. In 2019, the FDA approved the vaccine, but only for children in dengue-infested U.S. territories who had a laboratory-confirmed prior case of the disease.

So, no vaccine has caused chronic conditions to emerge years or decades later, says Robert Jacobson, medical director of the population health science programat the Mayo Clinic. “Study after study have looked for this with all sorts of vaccines, and have not found it to be the case,” he says.

For example, a 2016 meta-analysis examined 23 studies for evidence that common childhood vaccines like MMR or haemophilus influenza B might somehow cause childhood diabetes; it found no connection. To test the concern that vaccinations might bring on autoimmune conditions such as multiple sclerosis in adults, a 2017 review evaluated nine common vaccines, including tetanus, human papillomavirus, and seasonal flu. It found that cases of MS did not rise as a result of widespread vaccine use.

Monitoring for COVID-19 is even more extensive

With COVID-19, regulators have added several extra pairs of eyes to watch for adverse events and report them as quickly as possible.

“For all vaccines there is a phase four,” Yildirim says, that involves extensive monitoring after a vaccine completes its phase-three clinical trial and is granted FDA approval. This monitoring primarily happens via the Vaccine Adverse Reporting System (VAERS), where any individual or physician can fill out a form flagging potential side effects. Scientists then evaluate whether any reported effects occur beyond what is generally expected in the population.

Massive computer power is put to use for the second leg of the stool, the Vaccine Safety Datalink. This program is a collaboration between the CDC and nine large healthcare providers, the majority of which are part of the Kaiser Permanente system. One aspect of this program is a rapid cycle analysis, which tracks the records of millions of participants’ patients immediately after a new vaccine is administered.

“This analysis is done weekly. If there are signals [of an adverse event] we see it quickly,” says Nicola Klein, director of Kaiser Permanente’s vaccine study center in Oakland, California, who is leading the analysis for COVID-19. The Datalink program flagged the febrile seizures with the MMRV vaccine, information that was brought to the public within months, Klein says.

New for COVID-19, the CDC developed the V-safe app; once downloaded, vaccine recipients are asked by text messages and web surveys about any adverse events. Other programs involve long-term care facilities and large insurers tasked with flagging issues emerging in their patient populations.

“The breadth of vaccine safety surveillance systems means the limitations of one approach are offset by the strengths of others, making the combination quite robust,” says Grabenstein, of the Immunization Action Coalition.

What side effects have been flagged for COVID-19 shots?

Experts begin this robust monitoring process with a ready list of potential side effects. “These conditions are selected based on what was seen in clinical trials (even if they weren’t statistically significant there), those caused by the disease itself, and what has appeared in prior vaccines,” says Frank DeStefano, director of the CDC’s Immunization Safety Office.

For the COVID-19 vaccines, these “events of special interest,” which number nearly two dozen, include arthritis, narcolepsy, encephalitis, and stroke.

Also on this list: the blood clotting condition thrombosis. Klein says this was added after the issue emerged with the AstraZeneca vaccine in Europe, since the Johnson & Johnson shot authorized in the U.S. employs a similar adenovirus vector technology. Soon after, regulators saw the effect in a minute number of young women who got the Johnson & Johnson shot, with clots appearing by the second week after their vaccinations.

Guillain-Barré was always on the watch list, since it previously appeared with other vaccines. Similarly, the heart inflammations myocarditis and pericarditis, which have occurred several days after vaccination in a tiny fraction of young men getting the mRNA vaccines, was already on the list.

Of course, experts say they also watch for the unexpected. Grabenstein recalls the time in 2004 when he led a smallpox vaccination effort for the U.S. Army. Several servicemembers quickly developed myocarditis, even though this condition had not appeared during the smallpox inoculation efforts in the 1940s and ‘50s. “The best explanation is that earlier vaccines were given to infants, while we were inoculating 20-year-olds,” he says.

With so many coronavirus vaccines administered in so short a time, it has actually been easier to spot incredibly rare adverse events, Yildirim says. The Johnson & Johnson events were flagged within months of the vaccine’s authorization—which shows that the system is working. “We don’t like to hear about side effects, but the fact that we hear about them is a good sign because this means they are being identified,” she says.

And DeStefano feels confident that severe adverse events shouldn’t start appearing for the vaccines authorized late last year. “We have systems looking for delayed effects,” he says. “But our experience from other vaccines shows that late-arriving effects from the COVID-19 vaccines are unlikely.”

COVID Vaccine Mandates Are Coming

(Updated 7/31/2021)

1. COVID Vaccine Mandates Are Coming   On Monday, for the first time, a federal agency, as well as multiple state and private organizations announced they would require proof of vaccination for employees and customers.   Daily Wire’s Ian Haworth told Morning Wire, “Historically in the US, vaccine mandates have been very rare on a national level.”   Federal Level   On Monday, the U.S. Department of Veterans Affairs (VA) became the first federal agency to require its employees to be vaccinated. The VA secretary said it was taking this “necessary” step to “keep the Veterans it serves safe,” and that each employee will have eight weeks to be fully vaccinated.

State Level

On Monday, Governor Gavin Newsom’s (D-CA) office announced that all state employees and health care workers must show proof of vaccination or get tested often, starting in August. The office cited the “pandemic of the unvaccinated” as a justification.   New York City expanded its vaccine requirement to cover its 340,000 city workers — such as teachers and police officers — in addition to health workers.   There are multiple groups and organizations who are pushing for mandatory vaccinations. More than 50 medical groups, including the American Medical Association have called for all health care workers to be vaccinated, while the San Francisco Bar Owner Alliance announced that the 500 bars it represents will demand that customers show proof of vaccination or a negative test.

What’s Driving The Push?   Those pushing vaccine mandates are looking at the spread of the Delta variant and what they see as “stagnating” vaccine rates, and say they are trying to react.    Critics are arguing that mandating COVID-19 vaccines is an unprecedented infringement of Americans’ rights, with many pointing out that the vaccine has still yet to be fully approved by the U.S. Food and Drug Administration.   Many Republican leaders acted to preempt this move in recent months. Montana made it illegal to discriminate based on vaccine status, while Alabama prevented schools and universities from requiring vaccines.   Governor Ron DeSantis (R-FL) was one of the first to block vaccine requirements, signing legislation back in May which outlawed vaccine passports. DeSantis was outspoken on this topic in March, also pointing out that mandates have “huge privacy implications.”   In March, Desantis said, “We are not going to have you provide proof of this just to be able to live your life normally.”   CDC Confusion   The U.S. Centers for Disease Control and Prevention (CDC) reversed their indoor mask policy, saying that fully vaccinated people should now wear masks while indoors in COVID “hot spots.”   Federal health officials say that fully vaccinated people could still pose a risk to others.

SHAPIRO: When Does The COVID-19 Panic End?

(Update 8/1/2021)

Two weeks to slow the spread.

That was the original rationale for the lockdowns, masking and social distancing: Prevent transmission of the coronavirus so that Americans could be assured that we would not overwhelm hospital capacity, causing needless death.

Wait until a vaccine is available.

That was the next goal post: an admonition to continue to take precautions to avoid spreading the coronavirus until a vaccine could be developed. Despite the warnings of COVID-19 pessimists that a vaccine would take years to develop, despite the unjustified alarmism of figures like Vice President Kamala Harris that the Trump administration would skew the vaccine protocols to achieve political ends, vaccines were miraculously developed.

Wait until every adult has a chance to get the vaccine.

That was the final rationale for caution. And as states began to tranche out vaccines by the millions, every person above the age of 12 in the United States was given the opportunity to get vaccinated. As of today, over 90% of adults over the age of 65 — the most at-risk population in the United States — have been vaccinated, and more than 70% of all Americans over age 18 have been vaccinated as well.

And yet.

We are told that we are experiencing a massive COVID-19 crisis. We have been told that the vaccinated must mask up again; that the unvaccinated should be barred from public establishments; that children must be masked in school. We have been told that America faces doom and death on a daily basis and that we’re seeing a crisis akin to the last wave of the coronavirus in January. We’re masking up and checking vaccine cards in Washington, D.C., in San Francisco, in Los Angeles, in New York.

The statistics simply do not bear this out. According to the seven-day rolling average as calculated by The New York Times, fewer than 400 Americans per day are dying of COVID-19; at the height of the pandemic, well over 3,000 were. In Washington, D.C. (total population: 692,000), that number is 0; in San Francisco County (total population: 875,000), that number is 0; in Los Angeles County (total population: 10 million), that number is 9; in New York City (total population: 8.4 million), that number is 3.

The current delta variant spike has resulted in a massive case count, particularly in Florida, but deaths are not following cases — and if the United States follows the pattern of the United Kingdom and the Netherlands, we’re likely to see the case count begin to crater in the next few weeks. Those who are vaccinated are not dying of COVID-19; their death rate is minuscule. Those who are unvaccinated have chosen not to vaccinate; they are independent adults capable of determining their own approach to risk and reward.

All of which requires us to ask the question: When are we done?

When are we done telling children to mask up to protect adults who don’t want to vaccinate? When are we done telling businesses to close up or bar customers based on vaccination status? When are we done with mask mandates (data suggests that mask mandates are ineffective, even if masking is sometimes useful), with evidence-free social distancing rules (six feet is pure conjecture), with the ever-vacillating, Delphic pronouncements of Dr. Anthony Fauci? We have hit the goal posts; every adult now has the capacity to protect himself. There are no other realistic goal posts: Zero COVID-19 cases was never a realistic goal.

When is the job of government done?

And yet.

Our public health “experts” continue to promote more and more outrageous restrictions. This week, National Institutes of Health Director Francis Collins went so far as to recommend that vaccinated parents mask up in their own homes around their own children. There is no limiting principle to this, no end goal. There is only a bureaucratic and political elite unwilling to treat citizens as adults, recognize their own limitations and leave us all the hell alone.

And if we accept that, we deserve nothing less than subjection to their paternalistic control.

What is a breakthrough infection? 6 questions answered about catching COVID-19 after vaccination

(Update 8/2/2021)

If you’ve been fully vaccinated against COVID-19, maybe you figured you no longer need to worry about contracting the coronavirus. But along with the rising number of new COVID-19 cases globally and growing concern about highly transmissible strains like the delta variant come reports of fully vaccinated people testing positive for COVID-19.

Members of the New York Yankees, U.S. Olympic gymnast Kara Eaker and U.K. health secretary Sajid Javid are some of those diagnosed with what is called a “breakthrough infection.”

As scary as the term may sound, the bottom line is that the existing COVID-19 vaccines are still very good at preventing symptomatic infections, and breakthrough infections happen very rarely. But just how common and how dangerous are they? Here’s a guide to what you need to know.

What is ‘breakthrough infection?’

No vaccine is 100% effective. Dr. Jonas Salk’s polio vaccine was 80%-90% effective in preventing paralytic disease. Even for the gold standard measles vaccine, the efficacy was 94% among a highly vaccinated population during large outbreaks.

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Comparably, clinical trials found the mRNA vaccines from Pfizer and Moderna were 94%–95% effective at preventing symptomatic COVID-19 – much more protective than initially hoped.

A quick reminder: A vaccine efficacy of 95% does not mean that the shot protects 95% of people while the other 5% will contract the virus. Vaccine efficacy is a measure of relative risk – you need to compare a group of vaccinated people to a group of unvaccinated people under the same exposure conditions. So consider a three-month study period during which 100 out of 10,000 unvaccinated people got COVID-19. You’d expect five vaccinated people to get sick during that same time. That’s 5% of the 100 unvaccinated people who fell ill, not 5% of the whole group of 10,000.

When people get infected after vaccination, scientists call these cases “breakthrough” infections because the virus broke through the protective barrier the vaccine provides.

How common is COVID-19 infection in the fully vaccinated?

Breakthrough infections are a little more frequent than previously expected and are probably increasing because of growing dominance of the delta variant. But infections in vaccinated people are still very rare and usually cause mild or no symptoms.

For instance, 46 U.S. states and territories voluntarily reported 10,262 breakthrough infections to the U.S. Centers for Disease Control and Prevention between Jan. 1 and April 30, 2021. By comparison, there were 11.8 million COVID-19 diagnoses in total during the same period.

Beginning May 1, 2021, the CDC stopped monitoring vaccine breakthrough cases unless they resulted in hospitalization or death. Through July 19, 2021, there were 5,914 patients with COVID-19 vaccine breakthrough infections who were hospitalized or died in the U.S., out of more than 159 million people fully vaccinated nationwide.

One study between Dec. 15, 2020, and March 31, 2021, that included 258,716 veterans who received two doses of the Pfizer or Moderna vaccine, counted 410 who got breakthrough infections – that’s 0.16% of the total. Similarly, a study in New York noted 86 cases of COVID-19 breakthrough infections between Feb. 1 and April 30, 2021, among 126,367 people who were fully vaccinated, mostly with mRNA vaccines. This accounts for 1.2% of total COVID-19 cases and 0.07% of the fully vaccinated population.

How serious is a COVID-19 breakthrough infection?

The CDC defines a vaccine breakthrough infection as one in which a nasal swab can detect the SARS-CoV-2 RNA or protein more than 14 days after a person has completed the full recommended doses of an FDA-authorized COVID-19 vaccine.

Note that a breakthrough infection doesn’t necessarily mean the person feels sick – and in fact, 27% of breakthrough cases reported to the CDC were asymptomatic. Only 10% of the breakthrough-infected people were known to be hospitalized (some for reasons other than COVID-19), and 2% died. For comparison, during the spring of 2020 when vaccines were not yet available, over 6% of confirmed infections were fatal.

In a study at U.S. military treatment facilities, none of the breakthrough infections led to hospitalization. In another study, after just one dose of Pfizer vaccine the vaccinated people who tested positive for COVID-19 had a quarter less virus in their bodies than those who were unvaccinated and tested positive.

What makes a breakthrough infection more likely?

Nationwide, on average more than 5% of COVID-19 tests are coming back positive; in Alabama, Mississippi and Oklahoma, the positivity rate is above 30%. Lots of coronavirus circulating in a community pushes the chance of breakthrough infections higher.

The likelihood is greater in situations of close contact, such as in a cramped working space, party, restaurant or stadium. Breakthrough infections are also more likely among health care workers who are in frequent contact with infected patients.

For reasons that are unclear, nationwide CDC data found that women account for 63% of breakthrough infections. Some smaller studies identified women as the majority of breakthrough cases as well.

Vaccines trigger a less robust immune response among older people, and the chances of a breakthrough infection get higher with increasing age. Among the breakthrough cases tracked by the CDC, 75% occurred in patients age 65 and older.

Being immunocompromised or having underlying conditions such as high blood pressure, diabetes, heart disease, chronic kidney and lung diseases and cancer increase the chances of breakthrough infections and can lead to severe COVID-19. For example, fully vaccinated organ transplant recipients were 82 times more likely to get a breakthrough infection and had a 485-fold higher risk of hospitalization and death after a breakthrough infection compared with the vaccinated general population in one study.

How do variants like delta change things?

Researchers developed today’s vaccines to ward off earlier strains of the SARS-CoV-2 virus. Since then new variants have emerged, many of which are better at dodging the antibodies produced by the currently authorized vaccines. While existing vaccines are still very effective against these variants for preventing hospitalization, they are less effective than against previous variants.

Two doses of the mRNA vaccines were only 79% effective at preventing symptomatic disease with delta, compared with 89% effective in the case of the earlier alpha variant, according to Public Health England. A single dose was only 35% protective against delta.

About 12.5% of the 229,218 delta variant cases across England through July 19 were among fully vaccinated people.

Israel, with high vaccination rates, has reported that full vaccination with the Pfizer vaccine might be only 39%-40.5% effective at preventing delta variant infections of any severity, down from early estimates of 90%. Israel’s findings suggest that within six months, COVID-19 vaccines’ efficacy at preventing infection and symptomatic disease declines. The good news, though, is that the vaccine is still highly effective at protecting against hospitalization (88%) and severe illness (91.4%) caused by the now-dominant delta variant.

So how well are vaccines holding up?

As of the end of July 2021, 49.1% of the U.S. population, or just over 163 million people, are fully vaccinated. Nearly 90% of Americans over the age of 65 have received at least one dose of a vaccine.

Scientists’ models suggest that vaccination may have saved approximately 279,000 lives in the U.S. and prevented up to 1.25 million hospitalizations by the end of June 2021. Similarly, in England about 30,300 deaths, 46,300 hospitalizations and 8.15 million infections may have been prevented by COVID-19 vaccines. In Israel, the high vaccination rate is thought to have caused a 77% drop in cases and a 68% drop in hospitalizations from that nation’s pandemic peak.

Across the U.S., only 150 out of more than 18,000 deaths due to COVID-19 in May were of people who had been fully vaccinated. That means nearly all COVID-19 deaths in U.S. are among those who remain unvaccinated.

The U.S. is becoming “almost like two Americas,” as Anthony Fauci put it, divided between the vaccinated and the unvaccinated. Those who have not been fully vaccinated against COVID-19 remain at risk from the coronavirus that has so far killed more than 600,000 people in the U.S.

People who already had COVID-19 should still get vaccinated, scientists urge

(Update 8/5/2021)

Vaccines boost natural immune responses and have an amazing track record of preventing serious illness and death.

As the U.S. grapples with its troubled vaccine rollout, an alarming increase in coronavirus cases across the nation has resurfaced a long-simmering question: Do people who’ve already had COVID-19 need to be vaccinated?

Natural immunity is a powerful force against certain diseases, such as chickenpox and measles. Surviving a natural measles infection can yield immunity that is comparable—or in some cases, superior—to vaccination, says Ruth Karron, a pediatrician and professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

But first, of course, the patient has to survive.

It’s also not yet crystal clear whether immunity from contracting COVID-19 is as powerful as the protection of a vaccine. What is evident is that the available vaccines mount crucial defenses against severe disease and death—even against more contagious variants such as Delta. And research shows that even a single dose of an mRNA vaccine from Moderna or Pfizer-BioNTech boosts immunity for people who’ve had the disease.

“I would recommend to anyone who hasn’t been vaccinated to go ahead and get vaccinated as soon as they can,” says Allison Greaney, a researcher at Fred Hutchinson Cancer Research Center in Seattle, adding that the vaccines “protect us so well against a very dangerous virus.”

More robust antibodies

At Fred Hutchinson, graduate student Greaney led a research team that published a recent study suggesting vaccines give people an important edge over natural immunity. The team looked at the antibodies of people who had recovered from COVID-19, as well as people who’d received two doses of the Moderna mRNA vaccine as part of the company’s phase one trial.

The researchers found that both groups generated antibodies that targeted the receptor binding domain, or RBD. As its name suggests, this part of the SARS-COV-2 virus helps it stick to and ultimately gain entry to human cells, causing an infection. If antibodies attach to the RBD instead, they can neutralize the virus.

The research revealed that the antibodies of recovered COVID-19 patients stuck mostly to an area of the RBD that includes the site E484—a portion of the virus that has mutated in some variants. By contrast, the antibodies in vaccinated people bound more broadly across the domain, allowing them to target areas that are still present in some variants, including Beta, Gamma, and Delta.

SARS-COV-2 takes “great pains” to mask its RBD, using molecular trickery to make the region hard for antibodies to find, because it’s the most vulnerable part of the virus, says Amy Hartman, an associate professor of infectious disease and microbiology at the University of Pittsburgh. But mRNA vaccines are built to target the RBD and send potent antibodies to it. And the new findings suggest that immunity from mRNA vaccines “seems to be more robust than natural immunity in many cases,” Greaney says.

Researchers already knew that COVID-19 vaccines “reliably induce antibody levels” that are as high or even higher than those of people who have recovered from severe cases of coronavirus, says Karron, who was not part of the new study. This Fred Hutchinson team’s work shows that vaccination “gives us both more antibodies and better antibodies,” she adds. “It’s a quantity and quality issue.”

So, why the debate?

Other research, however, makes the case that natural immunity to COVID-19 might be robust. A team of researchers evaluated 254 people up to eight months after they had recovered from COVID-19 and found they had “durable, broad-based immune responses.” That was true even for those who had suffered only mild disease, according to their study, which was published last month.

Scientists know that other diseases can confer lasting natural immunity. After a single chickenpox infection, a person will likely have life-long immunity against the itchy and sometimes-deadly disease. To get the same long-lasting immunity from a vaccine, that person would need two shots, given years apart.

But before chickenpox vaccines were developed, about 10,000 U.S. children and adults were hospitalized each year with the disease, with symptoms including lung and blood infections.

For SARS-CoV-2, “I can’t make the case that [vaccination or natural immunity] is necessarily better than the other based on any knowledge that I actually possess about this particular virus,” says Charlotte Cunningham-Rundles, the David S. Gottesman Professor of Immunology at the Mount Sinai School of Medicine.

But she hastens to add: “I don’t think anyone’s collected enough data to say that somebody who’s had this virus on their own does not need to get vaccinated.”

Karron also notes that one of the “great unsolved mysteries” of SARS-CoV-2 is why some people have asymptomatic or mild disease, while others are afflicted with severe infections. In the same vein, scientists are still struggling to understand when and why certain people will develop stronger immune responses than others.

For instance, says Hartman, studies have shown that some recovered patients can mount effective defenses against COVID-19, but antibody levels dropped rapidly in others who were infected. Scientists are still gathering data and racing to answer this key question and others, such as how long immunity lasts from vaccines or from natural infection.

With vaccination, most people are all but guaranteed to have a strong immune response—and that includes people who’ve already contracted COVID-19. Multiple studies have shown that even a single dose of an mRNA vaccine boosts antibody levels in recovered patients, giving them the same peak response that two shots afford people who haven’t had the disease.

Today, more than 97 percent of people hospitalized for COVID-19 in the U.S. are unvaccinated. And while a small percentage of vaccinated people have been infected with the virus, their cases are overwhelmingly mild. On Monday, U.S. Senator Lindsey Graham, who was vaccinated in December, announced that he had tested positive for COVID-19 after experiencing only mild symptoms. “I am very glad I was vaccinated,” the South Carolina Republican said in a statement, “because without vaccination, I am certain I would not feel as well as I do now. My symptoms would be far worse.”

The CDC reports 0.0018 percent of COVID-19 deaths from December 14, 2020, to July 19 were among the vaccinated. And that, experts say, is proof the vaccines work.

“For many pathogens, we’re a bit humble,” Karron says. For some diseases, such as HIV or malaria, “you don’t want to get infected at all,” she says. “But for a lot of pathogens—and especially for things like respiratory pathogens, like COVID-19—our goals are a little more modest. Our goal is really to prevent severe disease and death.”

Why kids are still waiting for their COVID-19 vaccines

(Updates 8/8/2021)

The FDA has asked companies to expand clinical trials in children ages 5 to 11 after reports of rare side effects in young adults. But as the more transmissible Delta variant drives a fourth surge, parents are getting anxious.

Millions of parents across the nation are facing a stressful dilemma in the coming weeks: whether to send their children back to school for in-person instruction as the highly transmissible Delta variant surges across the country.

There were 93,824 new cases among U.S. children recorded the week of August 5, according to the American Academy of Pediatrics, a 30 percent increase from the previous week and the highest since February. Hospitalizations are also rising among those under the age of 17.

But even though cases are rising, it’s not clear whether this means that kids are more susceptible to Delta than previous strains. Infections are surging among all those who remain unvaccinated—which includes all children under 12, who are not yet eligible for the vaccine.

Although kids 12 and older became eligible for Pfizer’s vaccine in May, it’s not clear when younger kids will be able to get their shot. Despite initial hopes that the vaccines would be available in early fall, experts now believe that the U.S. Food and Drug Administration is not likely to grant that authorization until late November. (Here’s the latest on COVID-19 vaccines.)

That has led many parents to ask what’s taking so long—and whether it’s possible to speed things up. But Joseph Domachowske, professor of pediatrics at State University of New York (SUNY) Upstate Medical University in Syracuse, points out that for every parent asking why the FDA isn’t moving faster, there are others asking, “Why are you going so fast?”

COVID-19 vaccines have been developed and authorized among adults in record-shattering time. But even as the Delta variant injects new urgency to get jabs in arms, experts say it’s equally critical to ensure the vaccines are safe and have the appropriate dose for kids. Balancing those two objectives is incredibly tricky—and necessary.

The challenges of testing vaccines in kids

Children are not just tiny grown-ups—and their immune systems work differently, too. While kids are still maturing, their immune systems are unpredictable. They might mount a different immune response to the COVID-19 vaccines, and they could have side effects that aren’t seen in adults.

“They might respond better or worse,” James Campbell, professor of pediatrics at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health, told National Geographic earlier this year. “Until you do the study with the vaccine, you don’t know what will happen.”

Typically, however, new drugs and vaccines are tested in healthy adults before launching clinical trials among riskier populations like kids and pregnant women. (Here’s why kids need their own COVID-19 vaccine trials.)

Adolescents are a different story. By September 2020, Pfizer had accumulated enough safety data in its clinical trials to expand them to include teenagers as young as 16. In October, the company expanded its trials to include kids as young as 12.

“[With teenagers] you pretty much were confident that you had the dosing,” says Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “So that was easy. It’s not so easy when you go down to five or six years of age.”

Figuring out the right dose to give kids requires additional study. First, researchers test a low dose of the vaccine in an older group—say, kids ages five to 11—to determine its safety. Then they give a higher dose to see if the vaccine remained safe and elicited an immune response comparable to a healthy adult. Then they test it among increasingly younger age groups.

A slow start—and quick acceleration

Still, some scientists were disappointed last fall when those trials were slow to materialize. Even though the FDA had granted emergency use authorization to Pfizer and Moderna’s vaccines in December, the companies didn’t launch their clinical trials among kids ages 11 and younger until March.

“It didn’t seem from early on that these trials in kids were happening with the same urgency that they were with adults,” says Sean O’Leary, a professor at the University of Colorado and vice chair of the American Academy of Pediatricians Committee on Infectious Diseases.

Once the trials got underway, however, they moved quickly. Completed within two months, the first phase of Pfizer’s clinical trials demonstrated that the vaccine was safe and effective in a small group of 144 children. In June, Pfizer launched its combined phase two and three clinical trials to assess the efficacy of the vaccines among up to 4,500 children ages six months to 11 years.

“I’ve never seen anything like it,” says Domachowske, who is supervising the Pfizer-BioNTech pediatric trials at SUNY Upstate Medical University. “If we could run clinical trials like this all the time, we would improve public health in an astonishing way.”

At the time, Pfizer said it expected to submit data to the FDA in September for emergency authorization of its vaccine for the oldest group in its trials, kids ages five to 11. Data for the younger age groups were to be expected in the subsequent weeks and months. Moderna, meanwhile, filed for emergency use authorization to use its vaccine among adolescents in June.

Side effects cause delays

But around that same time, reports arose of rare cases of heart inflammation among young adults and teens who had received the mRNA vaccines. Most of these cases were reported among males between the ages of 18 and 24. (Heart problems after vaccinations are very rare—and often resolve quickly.)

At an FDA advisory committee meeting in June, scientists debated how to balance the risk of this new side effect with the decision to authorize the vaccines among younger children. Given that kids are at a lower risk of severe disease, some argued that it would be better to conduct further study. Others argued that the vaccines were needed sooner rather than later.

Ultimately, in late June the FDA added a warning label to the vaccines and updated the consent form that’s used to enroll new clinical trial participants. Domachowske says that although it was just a small adjustment, it stalled his trial for three or four weeks.

Then, in late July, federal regulators asked Pfizer and Moderna to expand their clinical trials to include up to several thousand more children in the 5-to-11-year-old age group and provide four to six months of safety data rather than just two. Sources told the New York Times that this was a precautionary measure to allow researchers to detect rare side effects like heart inflammation. Moderna has said it will expand its trial; a spokesperson for Pfizer says it has not updated its trial at this point.

Not all scientists agree with that approach. On August 5, the American Academy of Pediatrics (AAP) sent a letter to the FDA urging it “to continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible” —and to consider authorizing the vaccines for children ages 5 to 11 based on the data from the initial cohort.

Offit says it’s unclear why the FDA requested additional months of safety data given that all safety issues so far have been seen within six weeks of a dose. A few thousand additional participants would also still be far too few to detect an extremely rare side effect. Still, he notes that he’s not privy to the FDA’s data. “Maybe they’re seeing something that worries them,” he says. “Maybe they’re not seeing enough disease in the studies so that they can actually make statements about efficacy. I don’t know.”

Ultimately, Domachowske says, researchers need more time. “We don’t know yet that we’re using the right dose at the right time at the right age,” he says. “We’re getting closer. But rushing this is not a wise decision.”

What happens next?

O’Leary says the request to enroll new participants in the vaccine trials may be frustrating and will certainly cause delays—but it might not necessarily take all that long. Parents who weren’t able to get their kids into the vaccine trials in the spring now have another chance.

Meanwhile, Pfizer says it expects to have the data to support its application for emergency use authorization among kids ages five to 11 by the end of September. Moderna told ABC News that it expects to seek emergency use authorization by the end of 2021 or early 2022. 

But it’s anyone’s guess when authorization may finally come through. Domachowske, whose Pfizer trial is just now collecting data from participants who are one month past their second dose, says he doesn’t expect authorization before Thanksgiving.

“We’re talking about sometime after Labor Day to have all of the data crunched,” he says. Then, he says, Pfizer will need at least a month to put together the request for emergency use authorization and the FDA will need a month or two to review it.

In the meantime, experts say we already have a powerful pathway to protecting kids from the Delta variant: vaccinating more adults.

“If everyone who was eligible to be vaccinated got vaccinated, we wouldn’t be seeing this surge,” O’Leary says. “That’s tragic but it’s not too late. The more people that can be vaccinated right now, the better off our children will be.”

Who qualifies for a coronavirus booster shot? Why it’s still unclear.

(Update 8/12/2021)

While people with immune-compromising conditions rejoice over the FDA decision, may questions remain unanswered.

“Finally!” exclaimed Margaret Collins, a 43-year-old geologist from Fort Worth, Texas, in response to the news that the U.S. Food and Drug Administration has authorized the use of booster vaccine doses for some people with weakened immune systems.

The Pfizer-BioNTech and Moderna COVID-19 vaccines normally require two doses to elicit full immunity. But this week the FDA updated its authorization for both shots based on mounting evidence that a third dose could significantly increase protection for certain immunocompromised people, who have been showing a decreased response to these vaccines.

Collins had received both doses of the Moderna vaccine but recently learned that she has virtually no antibodies against the SARS-CoV-2 virus. She tried to get a third dose at a local pharmacy, but the pharmacist told her they couldn’t administer it under the original FDA authorization. After hearing about the revised authorization late Thursday night, she immediately made an appointment for Friday.

“FDA authorization of a booster for immunocompromised people is wonderful news for the millions of immunocompromised people in the United States who have spent the last several months knowing that they had a suboptimal response to the vaccine and desperately waiting for some opportunity to improve their immune response,” says Dorry Segev, a transplant surgeon and researcher at Johns Hopkins Medicine. Segev published the earliest studies on vaccine-induced immune response in transplant recipients.

After initially calling for a moratorium on all COVID-19 booster shots until more people across the world had gotten vaccinated, the World Health Organization clarified its guidance a week later regarding when boosters might be justified, including inadequate protection in certain risk groups. For those who lack fully functioning immune systems, such as transplant recipients, a booster shot might mean the difference between remaining bunkered down at home and being able to venture a bit more into the world again.

“You’re dealing with a transplant community that has faced death and survived,” says Valen Keefer, a 38-year-old patient advocate in Auburn, California, who received a donated kidney 19 years ago and a liver three years ago. “For me personally, I don’t want to do anything to compromise or risk my health. But then you have the other side, that you want to live life to the fullest.”

That tension has been exacerbated by people who refuse to wear masks or haven’t had the vaccine yet, says Keefer, spurring some people to seek a booster even before the FDA changed its authorization.

“Our community has been so desperate that they’ve been lying about it and going to get a third booster shot because some people that have no antibody response may have jobs out in the public and can’t be as careful. So now, you have people that haven’t even gotten one dose, and you have us begging for a third dose just to protect ourselves.”

A third dose is safe

Several recent studies have shown that a third mRNA vaccine dose is safe to administer to solid organ transplant donors and can increase antibodies in some patients who responded poorly to the first two doses of the mRNA vaccines.

Segev published a case series in June that found a third of fully vaccinated transplant recipients with no antibodies had responded to a third dose, and all those with low levels developed strong antibody responses afterward. A subsequent pair of larger French studies confirmed the safety of a third dose and its ability to substantially boost antibody levels in those with weak or no response to two doses.

The most recent study, published in the New England Journal of Medicine one day before the FDA’s decision, is the only randomized controlled trial of a third dose in organ transplant recipients. It found a significantly greater immune response in the study group that received a third dose and concluded that the dose is “safe when risk versus benefit was considered.”

“These studies showed that the third booster is effective in inducing a good antibody response in this population—but still not to the same level expected in otherwise normal individuals—and hopefully this will be the case for other immune-compromised patients,” says Mounzer Agha, director of the Mario Lemieux Center for Blood Cancers at University of Pittsburgh Medical Center.

The next step will be conducting studies to determine the best timing for a third dose and “how to help those who fail to respond to the third vaccine dose,” he says.

All immunocompromised people are not the same

The FDA’s authorization now allows for an extra dose in “certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.” That might include people with certain blood cancers or those taking medications such as rituximab, which deplete B cells—the body’s antibody factories.

But the “devil is in the details,” says Peter Martin, a hematologist and oncologist at Weill Cornell Medicine in New York City. “The definition of immunocompromised is vague,” and people in this population vary based on their condition and how much their immune system is suppressed.

“There are probably some people who will not benefit from any number of additional doses, there are some people who might need extra doses to augment their immune response, and there are some people, such as cancer patients, who were transiently immune suppressed when they received their vaccine and are likely now nearly normal and would clearly benefit from an additional dose,” he said. “There is probably another group of people who are mildly immune compromised but responded to the vaccine and probably don’t really need a vaccine. This group with the transient immune compromise clearly has the most to gain.”

Now that the FDA has made its announcement, Emily Blumberg, director of Transplant Infectious Diseases at Penn Medicine in Philadelphia, hopes for more specific guidance from the U.S. Centers for Disease Control and Prevention. The CDC’s Advisory Committee on Immunization Practices meets on August 13 to make its recommendation for whom among the wider group of immunocompromised people should receive a third dose.

“I think that interpretation is going to be very difficult, especially because the levels of evidence vary so widely depending on the population,” Blumberg says.

Alfred Kim, a rheumatologist at the Washington University School of Medicine, also hopes the CDC will clarify the guidance regarding which vaccine brands to use for extra doses. The new authorization only applies to Pfizer-BioNTech and Moderna, leaving no guidance for immune-compromised people who may have received the Johnson & Johnson vaccine.

Paul Offit, director of the Vaccine Education Center and an infectious disease pediatrician at Children’s Hospital of Philadelphia, echoed concerns about grouping all immunocompromised people under one umbrella and pointed out another key question about administering third doses in practice.

“You would like to have some advice on how to manipulate their therapy,” Offit says. For instance, “if you’re getting methotrexate for your rheumatoid arthritis, would it be reasonable when you give a booster dose of vaccine to withhold the methotrexate? If so, for how long?” That kind of guidance could be essential to improving patients’ immune response to the vaccine. “What I fear is going to happen is we’re just going to get a blanket recommendation.”

Offit has previously served on ACIP and currently serves on the Vaccines and Related Biological Products Advisory Committee (VRBPAC), a group of independent experts outside the FDA that reviews evidence and makes recommendations to the agency regarding authorizations and approvals. But the FDA did not consult VRBPAC on this decision, Offit says.

Segev has just begun an study that will eventually address the question of whether it’s safe and effective to temporarily reduce patients’ immunosuppressive therapy before they get a third dose. He also hopes to gather more safety data regarding which patients might benefit most from a third dose.

“There are some situations where this will be a very easy decision, and there are some situations where this will be a little bit trickier of a decision,” Segev says. For his transplant patients, Segev says there could be a risk that the transplanted organ is rejected because of the immune activation after a booster dose.

“That’s why we’re studying transplant patients very carefully.” But with many other immune-compromised populations, the third dose will be as safe as the second dose, he adds. “Then, really the question is, does the person need it? And I hope that people work with their doctors to figure that out.”

Decades-old SARS virus infection triggers potent response to COVID vaccines

Dramatic antibody production in people infected during the 2002–04 outbreak furthers hopes of a vaccine against many coronaviruses.

(Update 8/19/2021)

People who were infected almost two decades ago with the virus that causes severe acute respiratory syndrome (SARS) generate a powerful antibody response after being vaccinated against COVID-19. Their immune systems can fight off multiple SARS-CoV-2 variants, as well as related coronaviruses found in bats and pangolins.

The Singapore-based authors of a small study published today in The New England Journal of Medicine¹ say the results offer hope that vaccines can be developed to protect against all new SARS-CoV-2 variants, as well as other coronaviruses that have the potential to cause future pandemics.This ‘super antibody’ for COVID fights off multiple coronaviruses

The study is a “proof of concept that a pan-coronavirus vaccine in humans is possible”, says David Martinez, a viral immunologist at the University of North Carolina at Chapel Hill. “It’s a really unique and cool study, with the caveat that it didn’t include many patients.”

SARS-CoV-2 belongs to the sarbecovirus group of coronaviruses, which includes the virus that caused SARS (called SARS-CoV), as well as closely related bat and pangolin coronaviruses.

Sarbecoviruses use what are known as spike proteins to bind to ACE2 receptors in the membranes of host cells and enter them. They can jump from animals to humans, as they did before in both the current pandemic and the 2002–04 outbreak of SARS, which spread to 29 countries. “The fact that this has happened twice in the last two decades is strong rationale that this is a group of viruses that we really need to pay attention to,” says Martinez.

Neutralizing antibodies

Last year, Linfa Wang, a virologist at Duke–NUS Medical School in Singapore who led the latest study, went looking for people who had survived SARS to see whether they offered any clues about how to develop vaccines and drugs for COVID-19. He detected ‘neutralizing’ antibodies in their blood that blocked the original SARS virus from entering cells, but did not affect SARS-CoV-2 — which he found surprising, because the viruses are closely related.

But when Singapore rolled out the Pfizer–BioNTech COVID-19 vaccine this year, Wang decided to interrogate how the SARS infection affected responses to the vaccine. What he discovered was striking. Eight vaccinated study participants, who had recovered from SARS almost two decades ago, produced very high levels of neutralizing antibodies against both viruses, even after just one dose of the vaccine.Variant-proof vaccines — invest now for the next pandemic

They also produced a broad spectrum of neutralizing antibodies against three SARS-CoV-2 variants of concern in the current pandemic — Alpha, Beta and Delta — and five bat and pangolin sarbecoviruses. No such potent and wide-ranging antibody response was observed in blood samples taken from fully vaccinated individuals, even those who had also had COVID-19.

The researchers suggest that such broad protection could arise because the vaccine jogs the immune system’s ‘memory’ of regions of the SARS virus that are also present in SARS-CoV-2, and possibly many other sarbecoviruses.

Coronaviruses found in bats have the potential to cause future pandemics, so the fact that a broad spectrum of neutralizing antibodies is generated that protects against some of them “is encouraging”, says Daniel Lingwood, an immunologist at the Ragon Institute of MGH, MIT and Harvard in Boston, Massachusetts. But researchers say it is not clear how long this protection lasts.

A vaccine that is widely effective against sarbecoviruses could be administered to the general population in high-risk areas close to animals that harbour them, limiting the potential spread of these viruses in people, adds Christopher Barnes, a structural biologist at Stanford University in California.

Which part of the virus

Barton Haynes, an immunologist at Duke University School of Medicine in Durham, North Carolina, says the study raises the question of whether a similar response could be generated if people vaccinated against COVID-19 were given a booster shot that targeted the original SARS virus. This might protect them against new variants of SARS-CoV-2 and other sarbecoviruses. Wang says preliminary studies in mice suggest that is possible.

But the latest study doesn’t identify exactly which sections of the viruses induce the broad immune response, something that would be needed to develop vaccines. That’s the “biggest question”, says Martinez. If it is a region of the virus that is present not just in sarbecoviruses, but in the entire group of coronaviruses, there is potential for creating a vaccine against all of them, he says.Rare COVID reactions might hold key to variant-proof vaccines

Several research groups have identified specific antibodies that prevent SARS-CoV-2 and other sarbecoviruses from spreading in cells. Others are already working on pan-coronavirus vaccines, and have synthesized components that induce strong protection in monkeys and mice.

Haynes and his colleagues, for example, have developed² a protein nanoparticle studded with 24 pieces of a section of the SARS-CoV-2 spike protein called the receptor binding domain, a key target of antibodies. They found that in monkeys, the nanoparticle induced much higher levels of antibodies against SARS-CoV-2 than did the Pfizer vaccine. It also induced cross-reactive antibodies against the original SARS virus and bat and pangolin sarbecoviruses.

Martinez and his colleagues have induced these widely reactive antibodies in mice, using a vaccine made from a combination of spike proteins from different coronaviruses³. But Martinez says the latest study suggests that this complex spike chimaera might not be necessary; a similar protective response could be induced simply by the original SARS virus’s spike protein.

Wang says he is already working on potential vaccines that target multiple sarbecoviruses, and he now hopes to find additional survivors of the 2002–04 SARS outbreak to conduct a much larger study, including testing their responses to other COVID-19 vaccines.

COVID vaccines protect against Delta, but their effectiveness wanes

Massive UK study of COVID-19 cases shows that people who are jabbed have good immunity at first, but quickly become more vulnerable to the fast-spreading Delta variant.

(Update 8/19/2021)

The Pfizer–BioNTech and Oxford–AstraZeneca COVID-19 vaccines are effective against the highly infectious Delta variant of SARS-CoV-2 — but their protection drops away over time, a study of infections in the United Kingdom has concluded.

Researchers at the University of Oxford, UK, and the country’s Office for National Statistics analysed a vast data set comprising the results of 2,580,021 PCR tests to check for SARS-CoV-2 from 384,543 UK adults between 1 December 2020 and 16 May 2021 — when the Alpha variant was dominant — and 811,624 test results from 358,983 people between 17 May and 1 August 2021, when the Delta variant was more prevalent.How do vaccinated people spread Delta? What the science says

The results, published in a preprint on 19 August¹, suggest that both vaccines are effective against Delta after two doses, but that the protection they offer wanes with time. The vaccine made by Pfizer in New York City and BioNTech in Mainz, Germany, was 92% effective at keeping people from developing a high viral load — a high concentration of the virus in their test samples — 14 days after the second dose. But the vaccine’s effectiveness fell to 90%, 85% and 78% after 30, 60 and 90 days, respectively.

The vaccine developed by Oxford and the pharmaceutical company AstraZeneca in Cambridge, UK, was 69% effective against a high viral load 14 days after the second dose, falling to 61% by 90 days.

The drop in effectiveness shouldn’t be cause for alarm, says Sarah Walker, a medical statistician at the University of Oxford who led the study. For “both of these vaccines, two doses are still doing really well against Delta”, she says.

Peak levels

The study shows that vaccinated people who become infected with the Delta variant carry high peak levels of virus. When the Alpha variant was dominant in the United Kingdom, vaccinated people who became infected had much lower peak viral loads.

The implications of this aren’t clear, Walker says. “Most of our tests are monthly; we can’t really say very much at all about how long people are infectious for and particularly whether that’s different with Delta,” she says. “Anyone who thinks that if they get infected having been vaccinated, they can’t transmit — that isn’t likely to be true.”Delta threatens rural regions that dodged earlier COVID waves

The data also suggest that the time between doses of vaccine doesn’t affect vaccine effectiveness, and that people who have previously tested positive for COVID-19 as well as receiving two vaccine doses have the best protection against future infection.

The analysis focused on the 18–64 age group and didn’t look at hospitalizations or fatalities, points out Dvir Aran, a biomedical data scientist at Technion — Israel Institute of Technology in Haifa. “This study is about infection, not severe disease,” he says. The results back up observations from Israel, which vaccinated its population very early in the pandemic, he says. “We are seeing high levels of breakthrough [infections] in the population that was vaccinated early, and on the other hand, we are seeing robust protection in those vaccinated recently — especially in 12–15-year-olds.”

The results raise questions about whether it could be more effective to have doses of different vaccines, rather than multiple doses of the same one, especially if a third, booster dose is to be considered. Georg Behrens, an immunologist at Hanover Medical School in Germany, says that mixing vaccines could increase their effectiveness. The immune system reacts differently to different types of vaccine — and this could be exploited to trigger a better overall response. “Using a vector-based one first and then something that has no vector, but the same antigen, absolutely makes sense,” says Behrens.

Evidence mounts that people with breakthrough infections can spread Delta easily

A new study finds that this dominant variant can grow in the noses of vaccinated people as strongly as in unvaccinated people.

(Update 8/21/2021)

A preliminary study has shown that in the case of a breakthrough infection, the Delta variant is able to grow in the noses of vaccinated people to the same degree as if they were not vaccinated at all. The virus that grows is just as infectious as that in unvaccinated people, meaning vaccinated people can transmit the virus and infect others.

Previous studies in hospitals in India; Provincetown, Massachusetts; and Finland have also shown that after vaccine breakthrough infections with Delta, there can be high levels of virus in people’s nose whether they are vaccinated or not. The next logical step was to determine whether vaccinated people could shed infectious virus. Many experts suspected they did, but until this study it hadn’t been proven in the lab.

“We’re the first to demonstrate, as far as I’m aware, that infectious virus can be cultured from the fully vaccinated infections,” says Kasen Riemersma, a virologist at University of Wisconsin who is one of the authors of the study.

“Delta is breaking through more preferentially after vaccines as compared to the non-Delta variants” because it’s extremely infectious and evades the immune response, says Ravindra Gupta, a microbiologist at University of Cambridge. Gupta’s lab was one of the first to document that fully vaccinated healthcare workers could get infected with Delta and had high levels of virus in their noses.

If the Wisconsin study finding holds up, then people with breakthrough infections—many of whom do not develop COVID symptoms—can unknowingly spread the virus. “It [is] an alarming finding,” explains Katarina Grande, a public health supervisor and the COVID-19 Data Team Lead of Madison & Dane County, who led the study.

What concerns Eric Topol, the founder and director of the Scripps Research Translational Institute, is that fully vaccinated individuals who are infected with the Delta variant can transmit the virus and this can happen at a higher rate than previous strains in the days before symptoms, or in the absence of symptoms. “Which is why masks and mitigation measures are important, even for people [who are] vaccinated,” he says.

Studies like these highlight that transmission of the Delta variant can be much higher that currently estimated, according to Ethan Berke, chief public health officer of the UnitedHealth Group. Berke’s research has shown that frequent testing with rapid results, even if preliminary, can be very effective in curtailing the COVID-19 pandemic. Berke was not involved in the Wisconsin study.

“Even though the study was based on one region, it offers important insight into how people can spread the virus to others whether they’re fully vaccinated or not. This sort of insight, especially as it’s tested and refined, is incredibly helpful as organizations develop policies around testing, social distancing, and vaccinations,” Berke says.

How do we know the virus in the sample is infectious?

To test for SARS-CoV-2, the scientists employed a measurement called threshold cycle (Ct) that uses glowing dyes to reveal the quantity of viral RNA in the nose.

“SARS-CoV-2 virus infects nose and upper airway. It is very difficult to get a very high level of antibodies for long periods of time in that area. The immune system is not really designed to put high levels of antibodies at those sites,” Gupta says.

Ct values correlate with the viral load, which is the number of viral particles present in the body. When the quantity of virus passes a certain threshold, researchers expect an infected person to shed SARS-CoV-2 and potentially infect others. The Wisconsin study analyzed the nasal swabs from 719 cases of unvaccinated and fully vaccinated people who had all tested positive and found that 68 percent of the studied breakthrough patients had very high viral loads. High viral load is a sign that the virus is replicating, Gupta says.

To discover whether the nasal swabs had infectious virus, the Wisconsin researchers grew virus from 55 patient samples (from both vaccinated and unvaccinated people who tested positive) in special cells prone to SARS-CoV-2 infection. Grande’s team detected infectious virus in nearly everyone: from 88 percent of unvaccinated individuals and 95 percent of vaccinated people.

“We put the samples onto cells, and the cells died when they got infected. And so that clearly demonstrates that there is virus there, and that it’s infectious,” Riemersma explains.

If vaccinated people can still produce a lot of infectious viruses, it means they can spread the virus as easily as those who are not vaccinated.

Masks and vaccination needed to prevent viral transmission 

“We have kind of a perfect storm of multiple things going on: super-infectious variants, really susceptible population, debates around masking,” Grande says.

More than 93.8 percent of the U.S. is at substantial or high level of risk for community transmission of SARS-CoV-2, according to the Centers for Disease Control and Prevention (CDC). CDC defines an area to be at high risk when either the number of new cases in a county exceeds 100 per 100,000 persons, or more than 10 percent of COVID-19 tests come back positive in the past seven days. In those areas, CDC recommends wearing a mask indoors in public to maximize protection from the Delta variant and prevent spreading it to others.

Although authorized vaccines prevent severe COVID-19 and death, they offer substantially lower protection among older people, those with weakened immune system, or with an underlying medical condition.

“We need more information about the Delta variant to better understand how it works, can be transmitted, and ultimately informs how we protect ourselves at home, work and within our communities,” Berke says. “In the meantime, basic hygiene, including masking, social distancing, regular testing and vaccines will continue playing a vital role in slowing transmission and preventing serious illness and death.”

What full FDA approval of Pfizer’s vaccine means for the course of the pandemic

Update 9/10/2021

Scientists say this decision is “a huge milestone” that clears the way for vaccine mandates and booster doses—and may persuade more unvaccinated people to get a shot.

By granting full regulatory approval for the Pfizer-BioNTech COVID-19 vaccine, scientists say the U.S. Food and Drug Administration has provided a critical tool to help the nation stem a worrisome rise in new infections driven by the Delta variant.

The FDA’s decision, announced on August 23, could lead to a substantial increase in vaccination rates, says Leana Wen, an emergency physician and public health professor at George Washington University. Not only is full approval expected to ease the concerns of the hesitant, but it also paves the way for more vaccine mandates, and it provides doctors more latitude in prescribing booster doses.

“It’s a huge milestone,” Wen says. Acting FDA commissioner Janet Woodcock also described the decision in a statement as one that “puts us one step closer to altering the course of this pandemic in the U.S.”

In December, the FDA made an exception to its typical approval process when it granted emergency use authorization (EUA) to Pfizer’s vaccine based on two months of safety data. At the time, the regulatory agency emphasized that the benefits of having a vaccine during a global pandemic outweighed the potential costs.

The approval process that Pfizer just cleared is the industry standard, requiring six months of data showing that a vaccine or drug is safe and effective. It is the same process that all other drugs go through before they are put on the market.

However, the approval doesn’t apply to all age groups. Pfizer’s vaccine remains under emergency use authorization for adolescents ages 12 through 15 and for immunocompromised individuals who are seeking a third dose.

Persuading the unvaccinated

Public health experts hope the FDA’s decision will convince people who have been wary of COVID-19 vaccines due to safety concerns to finally get a first dose. In May a Kaiser Family Foundation survey showed that 32 percent of unvaccinated people said they would be more likely to get a shot once it had been fully approved.

“For whatever reason there is a great deal of anxiety about the EUA because it happened so quickly,” says C. Buddy Creech, director of the Vanderbilt Vaccine Research Program in Tennessee. “I think this will take a few people off the fence.”

Experts emphasize that there’s no scientific basis for concerns about the emergency use authorization process. The vaccine clinical trials and subsequent review of the safety data were as rigorous as they are for any other drug or vaccine. Wen also points out that these vaccines have since been given to hundreds of millions of people—providing clear evidence that they are safe and effective.

“I think that full approval will also potentially change the framework for how we discuss these vaccines—that they are no different than any of the other vaccines that people routinely take,” she says.

Pfizer can also throw the full weight—and budget—of its marketing machine behind the rollout of its vaccine, which will now be sold under the brand name Comirnaty. In the weeks ahead, people can expect to see a flurry of ads and commercials aimed at persuading people to get a shot, and Wen says she thinks this will help move the needle on vaccination rates.

A rise in vaccine mandates

The FDA’s approval is also likely to trigger a new wave of vaccine mandates in the days and weeks ahead. Although some companies and universities already require their employees and students to get vaccinated, they have faced legal challenges arguing that the vaccines under emergency use authorization are experimental and risky.

“This takes the argument out of play,” Creech says.

Wen agrees. She expects that having the FDA’s full approval will help many companies and schools that have been hesitant to open themselves up to lawsuits to enact vaccine mandates.

Existing mandates, too, are on increasingly solid legal ground. Wen points out that legal challenges have not been very successful under the EUA. In June a federal judge threw out a lawsuit over the Houston Methodist Hospital’s vaccine mandate, saying it didn’t break any federal laws. Earlier this month, the U.S. Supreme Court refused to hear a challenge to Indiana University’s vaccine mandate.

Federal and state government agencies have also begun to enact vaccine mandates. The U.S. Department of Veterans Affairs already requires vaccines among its frontline healthcare workers, and California was the first state to require all teachers and school staff to either get a vaccine or undergo weekly COVID-19 testing.

On August 9, the U.S. Department of Defense announced that it planned to make COVID-19 vaccines mandatory for active-duty service members by mid-September. Now that the FDA has granted full approval to Pfizer’s vaccine, the Pentagon says it will speed up that mandate.

Paving the way for booster doses

FDA approval is also likely to drive an influx of booster doses among the fully vaccinated even sooner than anticipated.

“If you look at the numbers, we have more people who will be clamoring for that third dose than we do people who will be looking to get their first dose,” Creech says.

Under emergency use authorization, doctors are required to strictly follow U.S. regulators’ dosing guidance. Following an August 12 revision to the EUA, some people with compromised immune systems began receiving third doses—and more than a million have reportedly already received unauthorized boosters.

But with a fully approved drug or vaccine, Creech says that doctors have the latitude to use their own clinical judgment in treating their patients. For those who they deem to be at high risk, doctors may begin prescribing third vaccine doses—or a booster dose of the Pfizer vaccine to those who originally got the Johnson & Johnson shot.

On September 20, the Biden administration plans to begin offering boosters to fully vaccinated people eight months after their second dose. The rollout will begin with the elderly and frontline workers. But the FDA’s approval of Pfizer’s vaccine means that not everyone will need to wait eight months after they were fully vaccinated. Wen argues that timeline is arbitrary anyway.

“Nothing magical happens at eight months,” she says, adding that full approval allows physicians to make decisions based on the facts in front of them. For example, she says, a physician could make the call to give a third dose now to an elderly patient with chronic renal disease, emphysema, and heart failure who lives with an unvaccinated family member.

“Physicians have to be able to use their clinical judgment in discussion with their patient,” she says.

Many scientists have argued that there’s no evidence that booster shots are necessary for most Americans. The vaccines continue to be extremely effective in protecting against severe disease and hospitalization, which is what they were made to do. But Creech counters that some of the doses are nearing the end of their shelf life and it’s better to offer third doses than to let them expire, so long as we prioritize people who are more vulnerable to severe disease.

Stemming the worrying rise of COVID-19 cases

Ultimately, public health experts are hoping rising vaccination levels will put a dent in case rates, which are spiking across the country—primarily among the unvaccinated. Although 14 percent of Americans have said in recent surveys that they will never get a vaccine, Creech says any upward tick in vaccination helps.

However, the rise of the more transmissible Delta variant is rapidly changing that calculus. As the newly dominant strain in the U.S., Delta is driving that onslaught of new infections. Studies suggest, however, that Pfizer’s vaccine remains effective against the Delta variant, protecting against severe disease, hospitalization, and death. Public health experts say improving access to the vaccine could go a long way toward saving lives.

“We have been able to prevent an incredible amount of hospitalizations and deaths because of those who are vaccinated,” Creech says.

Why you may not need a COVID-19 booster yet after all

Update 9/17/2021

Given what we know about breakthrough infections, most experts remain unconvinced there’s enough data to justify an extra dose for most Americans.

Top scientists have dealt a blow to President Joe Biden’s plan to begin rolling out COVID-19 booster shots to most Americans. On September 17, a U.S. Food and Drug Administration advisory committee rejected a bid to approve a third Pfizer dose for anyone age 16 and older. Instead, the committee threw its support behind a proposal to grant emergency use authorization of boosters for people age 65 and older or who are at high risk for severe disease, such as health-care workers or people with underlying conditions.

For weeks, scientists have vigorously debated whether there is enough data to justify an extra dose for most Americans. Two top scientists reportedly resigned from the U.S. Food and Drug Administration over the plan to administer boosters, which they have since criticized in a paper published in The Lancet.

The data trickling in so far does seem to suggest that the two-dose Pfizer-BioNTech vaccines are less able to prevent infection after six to eight months, but experts point out there are wide discrepancies.

In July, Israel said data from its highly vaccinated population shows that Pfizer’s vaccine is now only 64 percent effective against preventing infection. Then there were the alarming reports that month of a large COVID-19 outbreak in Cape Cod, Massachusetts. Out of hundreds who had been infected, about three-quarters were fully vaccinated. By contrast, a United Kingdom study in August found that the Pfizer vaccine is 88 percent effective against the Delta variant. Weeks later, a study of New York State residents showed a combined vaccine effectiveness of 79.8 percent among those who had received the Pfizer, Moderna, and Johnson & Johnson jabs.

One thing that’s perfectly clear to scientists is that the COVID-19 vaccines are still performing admirably where it matters most: protecting against severe disease and death. In the aftermath of the Cape Cod outbreak, scientists pointed out that only four of the people who got breakthrough cases had to be hospitalized. And according to a September 10 report from the CDC, the vaccines are more than 90 percent effective against hospitalization and death. Unvaccinated people are 10 times more likely to be hospitalized than vaccinated people and 11 times more likely to die.

That’s why many experts have been scratching their heads since August, when President Biden announced that his administration planned to offer third doses of the Pfizer and Moderna vaccines. His team advised Americans to get the boosters eight months after their second doses, and they set a September target for clinics to start giving people third jabs. “It will make you safer, and for longer. And it will help us end the pandemic faster,” Biden said at the time.

Most scientists instead emphasize that the data will be much clearer if regulators can take more time before weighing the science behind booster shots, since breakthrough infections remain overwhelmingly mild.

“Your protection does not fall off a cliff at six months or eight months,” says Anna Durbin, a vaccine researcher at Johns Hopkins University.

Protection against severe disease

To understand why breakthrough infections happen, it helps to recall how the immune response works. Antibodies are the first line of defense against infection, and people can develop antibodies that target the SARS-CoV-2 virus both through natural infection and vaccination. When the virus enters the body through the nose or throat, the antibodies that reside there fight off the virus before it can take hold.

But your body can’t maintain high levels of antibodies against every pathogen it has ever encountered all the time. People also tend to have relatively low levels of antibodies in their noses and throats because they have to travel there from your bloodstream. So sometimes a virus—particularly one as potent as the Delta variant—can slip past them to cause a breakthrough infection.

As the virus penetrates the cells in the nose and throat, it begins to replicate. At that point, a person may exhibit symptoms characteristic of an upper respiratory infection, including stuffiness, cough, fever, and fatigue.

“It’s a nuisance but it’s not life-threatening,” says Deepta Bhattacharya, an immunobiologist at the University of Arizona College of Medicine.

That’s when the rest of the immune system kicks in to keep the infection from escalating to the lungs, where it can cause severe harm resulting in hospitalization or death. Having been trained by the COVID-19 vaccines to recognize the virus, the immune system ramps up production of new antibodies, as well as memory B and T cells that join the fight.

It takes time for an infection to travel to the lungs, giving your immune system plenty of opportunity to mount a robust defense. Bhattacharya says severe disease is low among the vaccinated because they can clear the virus from their systems more quickly. This both reduces the severity of their symptoms and reduces the window in which they can infect others. “I think we’re fairly confident in that,” he says.

Assessing the evidence

Booster shots are additional doses of the original vaccine that increase antibodies in the nose and throat, so they would decrease the chance of getting an infection in the first place. And researchers say that the data on breakthroughs is an early signal that the vaccines’ ability to prevent infection is waning, particularly among people with compromised immune systems and older populations.

These are groups that you would expect might not have a robust response to the standard dose of the vaccine, says Jack O’Horo, an infectious disease specialist at the Mayo Clinic who is based in Rochester, Minnesota. People who have had solid organ transplants, for example, take medication that suppresses the response of their memory cells. They rely on antibodies alone to fight off infection—and studies have shown that they have a poor antibody response to the vaccine.

In August, this evidence prompted the FDA to approve use of a booster dose for certain immunocompromised populations. “To the extent that a third shot gets them a little bit closer to what we see in healthy people after their second shot, I think that’s worth doing,” Bhattacharya says. “That’s the easy one.”

The next group that scientists suggested might benefit from booster shots were older Americans. According to a September CDC study, people over 65 account for about 70 percent of hospitalizations from breakthrough infections. But scientists note that there may be specific age groups or other factors in play, such as whether someone lives in a nursing home. Still, the FDA advisory committee agreed that there’s enough evidence to suggest that people over 65 should be eligible for boosters.

It’s a little trickier to parse the data for other populations. Recently, a September 7 preprint echoed the findings of previous studies when it showed that the odds of vaccinated people testing positive for COVID-19 are higher 120 days after the date they reached full vaccination. Yet O’Horo, co-author of the study, stresses that “this was from a very small risk to a small risk.” He says follow-up research is needed to break down the populations whose risk of a breakthrough infection—while still small—is most concerning.

Ultimately, O’Horo says the findings of his study provide “a very early signal” to federal regulators that it’s time to carefully assess how the vaccines are working. He also points out that the FDA and CDC have access to more and better data than what has been released publicly about the vaccines’ real-world effectiveness.

“If I had to boil it down to a single phrase, it would be, Walk, don’t run,” he says. “We have information suggesting that this is a good time to have a scientific discussion about boosters, but it is emphatically not a time to hit a panic button.”

Complicating factors

There are other factors to consider when it comes to administering booster shots to the general population. For one, the three vaccines approved or authorized for use in the U.S. aren’t all the same.

Recent studies suggest that people who received Moderna’s vaccine are better protected from severe breakthrough infections because it elicits higher and more durable antibody levels than Pfizer’s vaccine. And a recent CDC report showed that the Moderna two-dose shot remains 95 percent effective in preventing hospitalizations compared to 80 percent for Pfizer and 60 percent for Johnson & Johnson.

But it will take more in-depth investigation to tease out what that means for who needs booster shots: Scientists point out that the Moderna vaccine is administered at a higher dose than Pfizer’s vaccine and with a longer interval between doses. It also rolled out after Pfizer’s vaccine, so the data are slightly lagging.

“People shouldn’t be running out and saying, I want a Moderna vaccine now,” Durbin says, adding that Moderna’s effectiveness is likely to drop off over time as well.

It’s also possible that another dose might not be a booster at all, but rather the proper dosage. Vaccines typically take years to develop because researchers take time to study many different dosing options. For the COVID-19 vaccines, they didn’t have that luxury of time to test whether three full doses might be better than two, says Francesca Torriani, an infectious disease specialist at University of California, San Diego Health.

And that could end up being the case. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said in an earlier White House press briefing that he “would not at all be surprised that the adequate full regimen for vaccination will likely be three doses.”

The bottom line for boosters

Ultimately, the decision on boosters comes down to what regulators are trying to achieve: to reduce all symptomatic infections among Americans, or to slow transmission of the virus. Bhattacharya says there just isn’t evidence yet to show that a booster would provide much extra protection to most people.

He points to the discrepancies among global studies of vaccine effectiveness. Most show only a slight drop, but a handful of countries see a more significant change. The Biden administration has cited Israel’s reports that the Pfizer vaccine is now only 64 percent effective in its plan to roll out boosters. If that’s true, Bhattacharya says, it suggests boosters would offer a large benefit to the general population. But he cautions against putting too much weight in any one study.

“Most scientists believe that both in the short term and in the long term we have so much more to gain by getting the rest of the world vaccinated,” Bhattacharya says. He argues that the pockets of unvaccinated people around the world are far more dangerous than breakthroughs, because they create potential for even more dangerous variants that might evade the vaccines entirely.

Durbin agrees that global vaccine distribution should be the focus, and she adds that experts need to manage expectations about the purpose of vaccines.

“We are so privileged to be able to have these vaccines that are so highly effective,” she says. “Unfortunately, because of that people now think that they shouldn’t have any symptoms, there shouldn’t be breakthrough infections. And that’s just not a reasonable expectation,” she says.

Torriani points out that there might be an even easier and more effective way to prevent breakthrough infections in the U.S.: wearing a mask. Earlier this month, she was part of a team of researchers that examined breakthrough infections among health-care workers in San Diego. They noted that the drop in vaccine effectiveness from June to July was likely caused by waning immunity and the emergence of the Delta variant. Yet the study also coincided with the end of masking requirements in San Diego, which Torriani says likely increased the risk of breakthrough infections. It’s yet another factor that public health officials need to keep in mind when making policy.

“We still need to mask,” Durbin says. “It’s going to help prevent COVID, it’s going to help prevent you from getting influenza, it’s going to prevent you from getting other colds and respiratory illnesses. It just makes good sense. Wear a mask.”

Why the CDC and FDA only approved booster shots for some Americans

Given what we know about breakthrough infections, most experts remain unconvinced there’s enough data to justify an extra dose for most Americans.

Update 9/24/2021

In a blow to President Joe Biden’s plan to begin rolling out COVID-19 booster shots this month, the U.S. Food and Drug Administration granted emergency use authorization of a third dose of the Pfizer vaccine only to certain subgroups of the national population. That includes people age 65 and older and people at risk of severe disease, such as adults with underlying conditions or in high-risk jobs. The Centers for Disease Control and Prevention later gave their ruling to start administering boosters to older adults, residents of long-term care facilities, and people ages 50 to 64 with conditions that leave them vulnerable to severe disease.

But in an unusual move that highlights how complicated the decision-making on boosters has been, CDC director Rochelle Walensky overruled her agency’s advisory panel and also endorsed extra doses for younger people whose jobs put them at high risk, such as health-care workers and teachers. Walensky otherwise agreed with the advisers’ recommendation that people ages 18 to 49 with underlying conditions should only receive a booster dose if their personal benefit outweighs the risks.

This is a far different plan for boosters than what was announced in August, when President Biden said that his administration planned to offer third doses of the Pfizer and Moderna vaccines to all eligible Americans. His team advised people to get the boosters eight months after their second doses, and they set a September target for clinics to start giving people third jabs. “It will make you safer, and for longer. And it will help us end the pandemic faster,” Biden said at the time.

The FDA departed from that plan because the evidence is much stronger that boosters will benefit people age 65 and older than it is for benefits to the general population, says Anna Durbin, a vaccine researcher at Johns Hopkins University. 

“To their credit, they’re following the process that they always follow,” she says of the FDA ruling. “These decisions need to be based on data. It’s really important to maintain the integrity of the science.”

Conflicting data on breakthrough infections

The data trickling in so far does seem to suggest that the two-dose Pfizer-BioNTech vaccines are less able to prevent infection after six to eight months, but experts point out there are wide discrepancies. 

In July, Israel said data from its highly vaccinated population shows that Pfizer’s vaccine is now only 64 percent effective against preventing infection. Then there were the alarming reports that month of a large COVID-19 outbreak in Cape Cod, Massachusetts. Out of hundreds who had been infected, about three-quarters were fully vaccinated. By contrast, a United Kingdom study in August found that the Pfizer vaccine is 88 percent effective against the Delta variant. Weeks later, a study of New York State residents showed a combined vaccine effectiveness of 79.8 percent among those who had received the Pfizer, Moderna, and Johnson & Johnson jabs.

One thing that’s perfectly clear to scientists is that the COVID-19 vaccines are still performing admirably where it matters most: protecting against severe disease and death. 

In the aftermath of the Cape Cod outbreak, scientists pointed out that only four of the people who got breakthrough cases had to be hospitalized. And according to a September 10 report from the CDC, the vaccines are more than 90 percent effective against hospitalization and death. Unvaccinated people are 10 times more likely to be hospitalized than vaccinated people and 11 times more likely to die.

In interviews conducted before the FDA announced its decision, experts emphasized that the data will be much clearer if regulators can take more time before weighing the science behind booster shots, since breakthrough infections remain overwhelmingly mild in the general population. 

“Your protection does not fall off a cliff at six months or eight months,” Durbin said at the time.

Protection against severe disease

To understand why breakthrough infections happen, it helps to recall how the immune response works. Antibodies are the first line of defense against infection, and people can develop antibodies that target the SARS-CoV-2 virus both through natural infection and vaccination. When the virus enters the body through the nose or throat, the antibodies that reside there fight off the virus before it can take hold.

But your body can’t maintain high levels of antibodies against every pathogen it has ever encountered all the time. People also tend to have relatively low levels of antibodies in their noses and throats because they have to travel there from your bloodstream. So sometimes a virus—particularly one as potent as the Delta variant—can slip past them to cause a breakthrough infection.

As the virus penetrates the cells in the nose and throat, it begins to replicate. At that point, a person may exhibit symptoms characteristic of an upper respiratory infection, including stuffiness, cough, fever, and fatigue.

“It’s a nuisance but it’s not life-threatening,” says Deepta Bhattacharya, an immunobiologist at the University of Arizona College of Medicine.

That’s when the rest of the immune system kicks in to keep the infection from escalating to the lungs, where it can cause severe harm resulting in hospitalization or death. Having been trained by the COVID-19 vaccines to recognize the virus, the immune system ramps up production of new antibodies, as well as memory B and T cells that join the fight.

It takes time for an infection to travel to the lungs, giving your immune system plenty of opportunity to mount a robust defense. Bhattacharya says severe disease is low among the vaccinated because they can clear the virus from their systems more quickly. This both reduces the severity of their symptoms and reduces the window in which they can infect others. “I think we’re fairly confident in that,” he says.

Assessing the evidence

Booster shots are additional doses of the original vaccine that increase antibodies in the nose and throat, so they would decrease the chance of getting an infection in the first place. And researchers say that the data on breakthroughs is an early signal that the vaccines’ ability to prevent infection is waning, particularly among people with compromised immune systems and older populations.

These are groups that you would expect might not have a robust response to the standard dose of the vaccine, says Jack O’Horo, an infectious disease specialist at the Mayo Clinic who is based in Rochester, Minnesota. People who have had solid organ transplants, for example, take medication that suppresses the response of their memory cells. They rely on antibodies alone to fight off infection—and studies have shown that they have a poor antibody response to the vaccine.

In August, this evidence prompted the FDA to approve use of a booster dose for certain immunocompromised populations. “To the extent that a third shot gets them a little bit closer to what we see in healthy people after their second shot, I think that’s worth doing,” Bhattacharya says. “That’s the easy one.”

The next group that scientists suggested might benefit from booster shots were older Americans. According to a September CDC study, people over 65 account for about 70 percent of hospitalizations from breakthrough infections. But scientists note that there may be specific age groups or other factors in play, such as whether someone lives in a nursing home. Still, the FDA agreed that there’s enough evidence to suggest that people over 65 should be eligible for boosters.

It’s a little trickier to parse the data for other populations. Recently, a September 7 preprint echoed the findings of previous studies when it showed that the odds of vaccinated people testing positive for COVID-19 are higher 120 days after the date they reached full vaccination. Yet O’Horo, co-author of the study, stresses that “this was from a very small risk to a small risk.” He says follow-up research is needed to break down the populations whose risk of a breakthrough infection—while still small—is most concerning.

Ultimately, O’Horo says the findings of his study provide “a very early signal” to federal regulators that it’s time to carefully assess how the vaccines are working. He also points out that the FDA and CDC have access to more and better data than what has been released publicly about the vaccines’ real-world effectiveness.

“If I had to boil it down to a single phrase, it would be, Walk, don’t run,” he says. “We have information suggesting that this is a good time to have a scientific discussion about boosters, but it is emphatically not a time to hit a panic button.”

Complicating factors

There are other factors to consider when it comes to administering booster shots to the general population. For one, the three vaccines approved or authorized for use in the U.S. aren’t all the same.

Recent studies suggest that people who received Moderna’s vaccine are better protected from severe breakthrough infections because it elicits higher and more durable antibody levels than Pfizer’s vaccine. And a recent CDC report showed that the Moderna two-dose shot remains 95 percent effective in preventing hospitalizations compared to 80 percent for Pfizer and 60 percent for Johnson & Johnson.

But it will take more in-depth investigation to tease out what that means for who needs booster shots: Scientists point out that the Moderna vaccine is administered at a higher dose than Pfizer’s vaccine and with a longer interval between doses. It also rolled out after Pfizer’s vaccine, so the data are slightly lagging.

“People shouldn’t be running out and saying, I want a Moderna vaccine now,” Durbin says, adding that Moderna’s effectiveness is likely to drop off over time as well.

It’s also possible that another dose might not be a booster at all, but rather the proper dosage. Vaccines typically take years to develop because researchers take time to study many different dosing options. For the COVID-19 vaccines, they didn’t have that luxury of time to test whether three full doses might be better than two, says Francesca Torriani, an infectious disease specialist at University of California, San Diego Health.

And that could end up being the case. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said in an earlier White House press briefing that he “would not at all be surprised that the adequate full regimen for vaccination will likely be three doses.”

The bottom line for boosters

Ultimately, the decision on boosters came down to what regulators are trying to achieve: to reduce all symptomatic infections among Americans, or to slow transmission of the virus. Bhattacharya says there just isn’t evidence yet to show that a booster would provide much extra protection to most people.

He points to the discrepancies among global studies of vaccine effectiveness. Most show only a slight drop, but a handful of countries see a more significant change. The Biden administration has cited Israel’s reports that the Pfizer vaccine is now only 64 percent effective in its plan to roll out boosters. If that’s true, Bhattacharya says, it suggests boosters would offer a large benefit to the general population. But he cautions against putting too much weight in any one study.

“Most scientists believe that both in the short term and in the long term we have so much more to gain by getting the rest of the world vaccinated,” Bhattacharya says. He argues that the pockets of unvaccinated people around the world are far more dangerous than breakthroughs, because they create potential for even more dangerous variants that might evade the vaccines entirely.

Durbin agrees that global vaccine distribution should be the focus, and she adds that experts need to manage expectations about the purpose of vaccines.

“We are so privileged to be able to have these vaccines that are so highly effective,” she says. “Unfortunately, because of that people now think that they shouldn’t have any symptoms, there shouldn’t be breakthrough infections. And that’s just not a reasonable expectation,” she says.

Torriani points out that there might be an even easier and more effective way to prevent breakthrough infections in the U.S.: wearing a mask. Earlier this month, she was part of a team of researchers that examined breakthrough infections among health-care workers in San Diego. They noted that the drop in vaccine effectiveness from June to July was likely caused by waning immunity and the emergence of the Delta variant. Yet the study also coincided with the end of masking requirements in San Diego, which Torriani says likely increased the risk of breakthrough infections. It’s yet another factor that public health officials need to keep in mind when making policy.

“We still need to mask,” Durbin says. “It’s going to help prevent COVID, it’s going to help prevent you from getting influenza, it’s going to prevent you from getting other colds and respiratory illnesses. It just makes good sense. Wear a mask.”

Pregnant and Unvaccinated: Delta’s Deadly Toll

The number of pregnant people suffering from severe COVID is preventable tragedy

Update 10/1/2021

She was having trouble getting a full breath. That was the first thing. The day before, Autumn Carver, seven months pregnant with her third child, had enjoyed a CrossFit class. Now a simple cough was compounded by the breathing issues, which rapidly worsened. It wasn’t long before her husband, Zach Carver, took Autumn to Community Hospital South in the couple’s hometown of Indianapolis and then began a series of heartbreaking Facebook updates.

As COVID-19 began to ravage Autumn’s system, the 34-year-old’s condition deteriorated with dizzying speed. The physicians started her on life-supporting oxygenation therapy, then placed her on a ventilator and admitted her to the intensive care unit (ICU). She was flown by helicopter to Indiana University Health Methodist Hospital, where a crash C-section delivered Huxley Elias Carver safely, albeit two months premature.

Within a week of being admitted, Autumn was under sedation and paralyzed as physicians worked to relieve the pneumonia filling her lungs with fluid. “Please pray her lungs begin to heal,” Zach wrote on Facebook on September 9. “She is fighting so hard, and I am so proud of her,” he wrote two days later. Not long after, doctors told Zach that a double lung transplant might be his wife ’s only chance for survival. The couple is still hoping for that “miracle,” Zach wrote on September 18. More than a month into her ICU stay, Autumn has still not met her newborn son.

When Autumn became pregnant earlier this year, she and Zach considered their options. The couple had experienced three prior miscarriages. After talks with their physician, they both decided to wait on the COVID-19 vaccine. With that decision, Autumn became part of a growing and dangerous trend in the U.S.

“The Delta variant in unvaccinated pregnant patients is one of the most horrifying disease processes I’ve ever seen,” says Danielle Jones, an obstetric hospitalist who works at several centers in Austin, Tex. “My heart is broken. My patients are suffering. Families are grieving. Moms are never meeting their babies.”

Although it will take some time for corroborating data to be compiled, anecdotal and preliminary reports from the field are staggering. Some unvaccinated pregnant people are suffering far worse courses of COVID than those who have been inoculated, and the consequences can be severe. According to the Centers for Disease Control and Prevention, 22,000 pregnant people have been hospitalized, and 161 have died, because of COVID as of September 27.

Between the end of June and end of August, cases among pregnant people in the U.S. doubled from more than 500 to more than 1,000 per week, “and these numbers are likely an underestimate,” says Scott Pauley, a press officer at the CDC. Meanwhile the 22 COVID-related deaths among pregnant people recorded in August marked the highest one-month total since the pandemic hit—and shocked some obstetric doctors and nurses, who might normally see “zero to two” maternal deaths over a full career, Jones suggests. And Pauley notes that after months of decline, “we now see an increased number of pregnant people admitted to the ICU in July and August.”

Experts expect many pregnant people will be hospitalized largely because so many remain unvaccinated even as the Delta variant surges across the country. Among people who are pregnant in the U.S., only 32 percent of those aged 18 to 49 are fully vaccinated, according to CDC data from September 25. That figure stands in stark contrast to the 65 percent of people aged 12 and older who are fully inoculated and the more than 75 percent of that age group who have had at least one shot.

Simply put, pregnant people have been avoiding the vaccine, and the toll may be enormous. “The number of maternal deaths in the United States in a typical year is around 700,” Jones says. “I don’t know what the counts are going to be this year, but they are going to be astronomically higher than that.”

The road to this point is filled with misinformation but also with fears and concerns about the COVID vaccines’ impact on fertility and pregnancy, which many physicians find understandable, if mostly unsupported. These factors, combined with the inconsistent guidance patients received from their obstetricians and the delays in endorsing vaccines for expectant mothers from the CDC and key medical organizations, have left many pregnant people uncertain about receiving a shot.

“Vaccine hesitancy is not new,” says J. Martin Tucker, president of the American College of Obstetricians and Gynecologists (ACOG) and chair of the department of obstetrics and gynecology at the University of Mississippi Medical Center (UMMC). “We see vaccine hesitancy with the influenza vaccine and Tdap (tetanus, diphtheria and acellular pertussis) vaccine, which are routinely recommended in pregnancy.”

Health care professionals need to “answer questions, dispel myths and make strong recommendations for indicated vaccinations, especially the COVID vaccine,” Tucker says. But as the wild politicization of the coronavirus vaccine has demonstrated, that ’s much easier said than done.

Autumn Carver ’s case, progressing from one serious event to another, may sound extreme. And without a doubt, the overwhelming majority of pregnant people do well with COVID-19. In fact, in a study of more than 1,200 pregnant people who tested positive for COVID before vaccines became available and before the advent of the Delta variant, nearly 75 percent either had no symptoms or only mild disease.

But in my conversations with experts around the country, scenarios similar to Carver’s difficult experience are becoming more and more frequent among symptomatic, unvaccinated pregnant people.

Thomas Dobbs, Mississippi’s state health officer, says that at least eight pregnant women in Mississippi have died from COVID-19 since July. None of them were fully vaccinated. Physicians at the University of Alabama at Birmingham (UAB) Hospital have been seeing record numbers of pregnant people hospitalized: among 39 unvaccinated pregnant women with COVID admitted there in August, 10 were in the ICU, and were placed on a ventilator. Two of the 39 women died, and nine lost their babies. Tucker says that at UMMC, 12 pregnant women have died of COVID overall—five of them since August. All were unvaccinated.

“To see pregnant individuals so sick, some of whom will never see their baby, dying from a vaccine-preventable illness is absolutely tragic and traumatic,” says Linda Eckert, a professor of obstetrics and gynecology with an infectious disease fellowship at the University of Washington.

Pregnant people tend to be more susceptible to viral diseases in general, Tucker says, which may be because of “the mechanical effects of the advancing pregnancy, especially for pulmonary infections or changes in one ’s immune system.” Being pregnant may weaken one ’s immune system and render it susceptible to the highly contagious Delta variant. Delta now represents more than 99 percent of cases of COVID tracked in the country.

A CDC study of 400,000 women aged 15 to 44 who were diagnosed with symptomatic COVID-19 found that, although the absolute risk of severe outcomes was low, the pregnant women had a higher risk of severe disease and death than the nonpregnant ones. Likewise, a study of about 870,000 women found that, compared with those who did not give birth with COVID-19, those who did so had a nearly one-and-a-half-fold increase in preterm births, a sixfold increase in ICU admissions, a 14-fold increase in mechanical ventilation and a 15-fold increase in death.

Early clinical trials for COVID vaccines, though, did not include those who were pregnant. In hindsight, the exclusion “led to confusing messaging about the safety and effectiveness of the vaccines,” says Geeta Swamy, vice dean of scientific integrity and an obstetrics and gynecology professor at the Duke University School of Medicine. While that oversight has now been rectified—data from studies, such as one involving more than 2,000 pregnant and vaccinated people, show the vaccines do not raise risks for pregnancies—the misgivings linger.

“This is actually a group of vaccine-hesitant people that I very much understand,” Jones says. “People have this deep fear of performing some action that causes harm to their baby… Although we have lots of data now [supporting vaccination for pregnant people], it’s hard to not be worried when these patients were left out of the studies intentionally.”

There is another component to this story: age. As the pandemic has progressed, younger people have become sick and been hospitalized at increasing rates, according to William Grobman, vice chair of clinical operations in the department of obstetrics and gynecology at the Ohio State University College of Medicine and president of the Society for Maternal-Fetal Medicine (SMFM). “Pregnant individuals, being in a younger age category, have been part of this trend,” he says. Vaccination numbers for younger Americans are lower across the board than for the population at large, and recent data show that approximately 97 percent of pregnant people who are hospitalized with COVID are unvaccinated.

The acute progression of COVID-19 in patients like Carver can be stunning. The process “impacts families greatly,” Jones says. “Patients get sick very quickly and are often blindsided by how they walked into the hospital, were just feeling a little sick and then rapidly deteriorated.” The obstetricians themselves, far more accustomed to dealing with tragedies such as fetal and newborn deaths, have been affected, too. “Maternal deaths—it’s hard to walk a family through that,” Jones says. “It’s hard to feel helpless, like you’ve done everything that you can.”

The ACOG, SMFM and CDC have all strongly endorsed the use of vaccines by those who are pregnant, based on evidence demonstrating their safety and effectiveness in tens of thousands of pregnant people. On September 29 the CDC issued an urgent alert, recommending that pregnant people and nursing parents get vaccinated because “the benefits of vaccination outweigh known or potential risks.”

Data from eight health systems, which included more than 100,000 pregnancies, found that people who experienced miscarriages were not more likely to have received a COVID vaccine. As of September 27, more than 160,000 people have reported they were vaccinated for the disease while pregnant.

Beyond that, a recent study shows that pregnant people who received mRNA vaccines passed high levels of protective antibodies against COVID-19 to their babies. Out of 36 newborns tested at birth, 100 percent of the infants had protective antibodies—a strong endorsement for the added value of the vaccine.

“The increased circulation of the highly contagious Delta variant, the low vaccine uptake among pregnant people, and the increased risk of severe illness and pregnancy complications related to COVID-19 infection among pregnant people make vaccination for this population more urgent than ever”, the CDC’s Pauley says.

The argument for vaccines is both real and grounded in scientific evidence. The stakes, meanwhile, are neither academic nor political. They’re human, as Zach Carver’s near-daily Facebook updates make all too real. Zach and Autumn Carver met in high school, dated for a decade, married nine years ago and now have three children. The couple’s anniversary was September 15. “Autumn I love you very much, and am very proud of you,” Zach wrote on Facebook. “We will celebrate when we get you out of here.”

COVID Vaccines Show No Signs of Harming Fertility or Sexual Function

The novel coronavirus, in contrast, can disrupt both things in unvaccinated men and women

Updated 10/1/2021

Rumors and myths about COVID-19 vaccine effects on all aspects of reproduction and sexual functioning have spread like a Delta variant of viral misinformation across social media platforms, where people swap rumors of erectile dysfunction and fertility disruptions following vaccination. Yet studies so far have not linked the vaccines with problems related to pregnancy, menstrual cycles, erectile performance or sperm quality. The evidence does show that COVID-19 can involve problems in all of these areas.

Health officials have tried to ease concerns by explaining that data from clinical trials and hundreds of millions of vaccinations support the safety of the shots. Scientific American spoke with four experts in reproductive and sexual biology about pervasive myths, the evidence against them and the real damage to health caused by COVID-19. Below is a series of conclusions that can be drawn from studies of vaccinated people and those who have had the disease.

Vaccination is not associated with adverse effects in pregnancy. COVID-19 is the real threat.

The U.S. Centers for Disease Control and Prevention updated its recommendations in early August, strengthening its advice that people who are pregnant or breastfeeding should be vaccinated against COVID-19.

The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) found this month that “there is no pattern … to suggest that any of the COVID-19 vaccines used in the UK increase the risk of congenital anomalies or birth complications. Pregnant women have reported similar suspected reactions to the vaccines as people who are not pregnant.”

If infected with the virus, pregnant people are at highly increased risk for severe disease and complications from COVID-19, compared with their same-age counterparts, says Tara Shirazian, an associate professor and a gynecologist at NYU Langone Health.

The immune system effects of pregnancy itself make an infection about five times more likely, says Jane Frederick, a reproductive endocrinology and fertility specialist and medical director of HRC Fertility in California. “You get infected more quickly, and pregnant women can go downhill fast,” she adds.

People should take the opportunity to get vaccinated before conceiving, but the vaccine is safe across all three trimesters of pregnancy, says Mary Rosser, director of integrated women’s health at the Department of Obstetrics & Gynecology at Columbia University Irving Medical Center. In early August, 22 medical groups released a joint statement saying that “the best way for pregnant individuals to protect themselves against the potential harm from COVID-19 infection is to be vaccinated.”

The vaccines show no fertility effects, including among people using assisted reproductive techniques.

One origin of fertility falsehoods about the vaccines may be a letter co-written by a former Pfizer researcher and sent to the European Medicines Agency (EMA) in December 2020. The two authors asked that all vaccine studies be suspended. They claimed that vaccine-induced antibodies against a protein that SARS-CoV-2 uses to enter human cells might also attack another human protein needed for embryo implantation. SARS-CoV-2 is the virus that causes COVID.

A study published in June 2021 compared the success of transferring embryos to women who carried antibodies to SARS-CoV-2 after vaccination or infection to success rates among those without antibodies. The presence of antibodies did not appear to affect such rates during 171 transfer attempts.

In a New York Times essay, a pair of immunologists described their work showing that the sequences of amino acids that make up the implantation-related protein and those that make up the virus spike protein are not similar and that spike-targeting antibodies do not cross-react with the implantation protein.

Stress may be responsible for menstrual cycle problems following vaccination.

Some vaccinated women have reported disruptions to their monthly cycle. “We are not dismissing them,” Rosser says. “What they say about their own bodies is important, and they know their bodies best.”

But nothing in the vaccines is a likely candidate to explain these complaints. Experts agree that a probable indirect factor is stress. Getting a new vaccine is itself stressful, Shirazian says, and many kinds of stressors can throw off a menstrual cycle. The physiological effects of these tensions might disrupt pathways that drive menstrual timing.

The good news, Rosser says, is that any menstrual effects appear to be transient. “I’ve talked to enough women in the last eight months, and it seems as though whatever it is, it’s short-lived,” she says.

In early August EMA released a report noting that no cause-and-effect association had been established between complaints of menstrual disruptions and COVID-19 vaccination. Separately, MHRA found no link between menstrual disorders and COVID vaccines.

Some descriptions of menstrual problems mention clotting during heavier periods. Shirazian says that the term “blood clot” as it relates to menstrual flow is different from the term used medically to describe a clot in a blood vessel. “They have nothing to do with each other,” she says. The clotting of menstrual blood happens as the blood exits the vessels and is not a risk for blocking flow to tissues.

COVID-19 may affect the menstrual cycle.

Becoming ill with COVID is associated with clotting in the medical sense—producing pulmonary embolisms that block blood flow to the lungs, for instance. Some evidence also points to the effects of SARS-CoV-2 on menstrual cycles. A small study of 177 patients who had COVID-19, published in September 2020, showed that 28 percent experienced cycle disruptions, including less bleeding and a longer cycle.

Infectious diseases themselves also are a stressor, Rosser says. “Illness causes stress,” she adds. And next to any menstrual cycle disruptions that might follow vaccination, “it’s 100 percent worse to have COVID, if you had to choose between the two,” Shirazian says.

Vaccines do not threaten sperm or erectile function, but COVID-19 does.

Ranjith Ramasamy, director of reproductive urology at the University of Miami, has published several studies describing the novel coronavirus in penile and testicular tissue and its effects on erectile dysfunction. He and his colleagues also looked at the potential effects of vaccines in these areas and found none.

To Ramasamy, the most unsurprising observation was how COVID-19 interferes with erections, which rely on blood flow. “COVID affects the blood vessels that supply organs, and the penis is not much different from other organs that require a lot of blood,” he says.

What was more surprising was the presence of SARS-CoV-2 in penile tissue even nine months after an infection. These results were from a small study of people with penile implants because of severe erectile dysfunction. The rich blood supply to the penis seems to have ensured a route for the virus to these tissues, Ramasamy says.

Like many viruses, SARS-CoV-2 also finds its way into the testes, where it can enter cells and cause damage. A biopsy study of testis tissue from six people who died of COVID-19 showed the virus still lingering in a sample from one of the patients and decreased sperm counts in another three. A sample from a patient who had survived the disease also showed persistent SARS-CoV-2 in the testes.

Ramasamy and his colleagues have found no detrimental changes in sperm counts and other fertility measures after vaccination. “One of the biggest myths with the vaccine was that it could affect fertility,” he says, and finding no negative effect on sperm counts “was very reassuring.”

Some last words on vaccination and the ill effects of COVID-19.

All of the experts had the same take-home message: the key to protecting against the reproductive and sexual effects of COVID-19 is to get vaccinated.

COVID super-immunity: one of the pandemic’s great puzzles

People who have previously recovered from COVID-19 have a stronger immune response after being vaccinated than those who have never been infected. Scientists are trying to find out why.

(Update 10/15/2021)

Around a year ago — before Delta and other variants entered the COVID-19 lexicon — virologists Theodora Hatziioannou and Paul Bieniasz, both at the Rockefeller University in New York City, set out to make a version of a key SARS-CoV-2 protein with the ability to dodge all the infection-blocking antibodies our body makes.

The goal was to identify the parts of spike — the protein SARS-CoV-2 uses to infect cells — that are targeted by these neutralizing antibodies in order to map a key part of our body’s attack on the virus. So the researchers mixed and matched potentially concerning mutations identified in lab experiments and circulating viruses, and tested their Franken-spikes in harmless ‘pseudotype’ viruses incapable of causing COVID-19. In a study published this September in Nature¹, they reported that a spike mutant containing 20 changes was fully resistant to neutralizing antibodies made by most of the people tested who had been either infected or vaccinated — but not to everyone’s.Kids and COVID: why young immune systems are still on top

Those who had recovered from COVID-19 months before receiving their jabs harboured antibodies capable of defanging the mutant spike, which displays much more resistance to immune attack than any known naturally occurring variant. These peoples’ antibodies even blocked other types of coronaviruses. “It’s very likely they will be effective against any future variant that SARS-CoV-2 throws against them,” says Hatziioannou.

As the world watches out for new coronavirus variants, the basis of such ‘super-immunity’ has become one of the pandemic’s great mysteries. Researchers hope that, by mapping the differences between the immune protection that comes from infection compared with that from vaccination, they can chart a safer path to this higher level of protection.

“It has implications on boosters and how our immune responses are primed for the next variant that emerges,” says Mehul Suthar, a virologist at Emory University in Atlanta, Georgia. “We’re flying by the seat of our pants trying to figure this stuff out.”

Hybrid immunity

Not long after countries began rolling out vaccines, researchers started noticing unique properties of the vaccine responses of people who had previously caught and recovered from COVID-19. “We saw that the antibodies come up to these astronomical levels that outpace what you get from two doses of vaccine alone,” says Rishi Goel, an immunologist at the University of Pennsylvania in Philadelphia who is part of a team studying super-immunity — or ‘hybrid immunity’, as most scientists call it.

Initial studies of people with hybrid immunity found that their serum — the antibody-containing portion of blood — was far better able to neutralize immune-evading strains, such as the Beta variant identified in South Africa, and other coronaviruses, compared with ‘naive’ vaccinated individuals who had never encountered SARS-CoV-2². It wasn’t clear whether this was just due to the high levels of neutralizing antibodies, or to other properties.

The most recent studies suggest that hybrid immunity is, at least partly, due to immune players called memory B cells. The bulk of antibodies made after infection or vaccination come from short-lived cells called plasmablasts, and antibody levels fall when these cells inevitably die off. Once plasmablasts are gone, the main source of antibodies becomes much rarer memory B cells that are triggered by either infection or vaccination.International COVID-19 trial to restart with focus on immune responses

Some of these long-lived cells make higher-quality antibodies than plasmablasts, says Michel Nussenzweig, an immunologist at the Rockefeller. That’s because they evolve in organs called lymph nodes, gaining mutations that help them to bind more tightly to the spike protein over time. When people who recovered from COVID-19 are re-exposed to SARS-CoV-2’s spike, these cells multiply and churn out more of these highly potent antibodies.

“You get a sniff of antigen, in this case of mRNA vaccine, and those cells just explode,” says Goel. In this way, a first vaccine dose in someone who has previously been infected is doing the same job as a second dose in someone who has never had COVID-19.

Potent antibodies

Differences between the memory B cells triggered by infection and those triggered by vaccination — as well as the antibodies they make — might also underlie the heightened responses of hybrid immunity. Infection and vaccination expose the spike protein to the immune system in vastly different ways, Nussenzweig says.

In a series of studies^3,4,5, Nussenzweig’s team, which includes Hatziioannou and Bieniasz, compared the antibody responses of infected and vaccinated people. Both lead to the establishment of memory B cells that make antibodies that have evolved to become more potent, but the researchers suggest this occurs to a greater extent after infection.

The team isolated hundreds of memory B cells — each making a unique antibody — from people at various time points after infection and vaccination. Natural infection triggered antibodies that continued to grow in potency and their breadth against variants for a year after infection, whereas most of those elicited by vaccination seemed to stop changing in the weeks after a second dose. Memory B cells that evolved after infection were also more likely than those from vaccination to make antibodies that block immune-evading variants such as Beta and Delta.

A separate study found that, compared with mRNA vaccination, infection leads to a pool of antibodies that recognize variants more evenly by targeting diverse regions of spike⁶. The researchers also found that people with hybrid immunity produced consistently higher levels of antibodies, compared with never-infected vaccinated people, for up to seven months. Antibody levels were also more stable in people with hybrid immunity, reports the team led by immunologist Duane Wesemann at Harvard Medical School in Boston, Massachusetts.

‘Not surprising’

Many studies of hybrid immunity haven’t followed naive vaccine recipients for as long as those who recovered from COVID-19, and it’s possible their B cells will make antibodies that gain potency and breadth with more time, additional vaccine doses, or both, researchers say. It can take months for a stable pool of memory B cells to establish itself and mature.

“It’s not surprising that people infected and vaccinated are getting a nice response,” says Ali Ellebedy, a B-cell immunologist at Washington University in St. Louis, Missouri. “We are comparing someone who started the race three to four months ago to someone who started the race now.”COVID vaccine immunity is waning — how much does that matter?

There is some evidence that people who received both jabs without previously being infected seem to be catching up. Ellebedy’s team collected lymph-node samples from mRNA-vaccinated individuals and found signs that some of their memory B cells triggered by the vaccination were gaining mutations, up to 12 weeks after the second dose, that enabled them to recognize diverse coronaviruses, including some that cause common colds⁷.

Goel, University of Pennsylvania immunologist John Wherry and their colleagues found signs that six months after vaccination, memory B cells from naive individuals were continuing to grow in number and evolve greater capacity to neutralize variants⁸. Antibody levels fell after vaccination, but these cells should start cranking out antibodies if they encounter SARS-CoV-2 again. “The reality is you have a pool of high-quality memory B cells that are there to protect you if you ever see this antigen again,” Goel says.

Booster benefits

A third vaccine dose might allow people who haven’t been infected to achieve the benefits of hybrid immunity, says Matthieu Mahévas, an immunologist at the Necker Institute for Sick Children in Paris. His team found that some of the memory B cells from naive vaccine recipients could recognize Beta and Delta, two months after vaccination⁹. “When you boost this pool, you can clearly imagine you will generate potent neutralizing antibodies against variants,” Mahévas says.

Extending the interval between vaccine doses could also mimic aspects of hybrid immunity. In 2021, amid scarce vaccine supplies and a surge in cases, officials in the Canadian province of Quebec recommended a 16-week interval between first and second doses (since reduced to 8 weeks).

A team co-led by Andrés Finzi, a virologist at the University of Montreal, Canada, found that people who received this regimen had SARS-CoV-2 antibody levels similar to those in people with hybrid immunity¹⁰. These antibodies could neutralize a swathe of SARS-CoV-2 variants — as well as the virus behind the 2002–04 SARS epidemic. “We are able to bring naive people to almost the same level as previously infected and vaccinated, which is our gold standard,” says Finzi.How ‘killer’ T cells could boost COVID immunity in face of new variants

Understanding the mechanism behind hybrid immunity will be key to emulating it, say scientists. The latest studies focus on antibody responses made by B cells, and it’s likely that T-cell responses to vaccination and infection behave differently. Natural infection also triggers responses against viral proteins other than spike — the target of most vaccines. Nussenzweig wonders whether other factors unique to natural infection are crucial. During infection, hundreds of millions of viral particles populate the airways, encountering immune cells that regularly visit nearby lymph nodes, where memory B cells mature. Viral proteins stick around in the gut of some people months after recovery, and it’s possible that this persistence helps B cells hone their responses to SARS-CoV-2.

Researchers say that it is also important to determine the real-world effects of hybrid immunity. A study from Qatar suggests that people who get Pfizer–BioNTech’s mRNA vaccine after infection are less likely to test positive for COVID-19 than are individuals with no history of infection¹¹. Hybrid immunity might also be responsible for falling case numbers across South America, says Gonzalo Bello Bentancor, a virologist at the Oswaldo Cruz Institute in Rio de Janeiro, Brazil. Many South American countries experienced very high infection rates earlier in the pandemic, but have now vaccinated a large proportion of their populations. It’s possible that hybrid immunity is better than the immunity from vaccination alone at blocking transmission, says Bello Bentancor.

As breakthrough infections caused by the Delta variant stack up, researchers including Nussenzweig are keen to study the immunity in people who were infected after their COVID-19 vaccinations, rather than before. An individual’s first exposure to influenza virus biases their responses to subsequent exposures and vaccinations — a phenomenon called original antigenic sin — and researchers want to know if this occurs with SARS-CoV-2.

Those studying hybrid immunity stress that — whatever the potential benefits — the risks of a SARS-CoV-2 infection mean that it should be avoided. “We are not inviting anybody to get infected and then vaccinated to have a good response,” says Finzi. “Because some of them will not make it through.”

Should you mix and match COVID-19 vaccines? Experts weigh in.

While not yet authorized, small trials suggest some booster combinations are not only safe, they may yield better protection.

(Update 10/15/2021)

Can someone get their initial COVID-19 vaccine from one manufacturer and then get a booster from another? The question has intrigued medical professionals since before the first shot went into an arm—and it’s far more than an academic issue. Allowing people to mix and match COVID-19 shots could significantly improve vaccine distribution and may even offer some medical benefits.

This afternoon an advisory committee to the U.S. Food and Drug Administration will review data from a recent National Institutes of Health study that seeks to answer the question. The preliminary results of this very small study hint that the answer may be yes.

If the FDA eventually endorses mixing brands, the decision could help nationwide vaccination efforts, says Pedro Piedra, professor of molecular virology, microbiology, and pediatrics at Baylor College of Medicine in Houston. “At any time, a pharmaceutical company can have a manufacturing issue, whether that’s a contamination problem or a shortage of a reagent, so it’s helpful to have options,” he says.

Doctors and pharmacists would also benefit, says Robert M. Jacobson, medical director of the primary care immunization program at the Mayo Clinic. “Practitioners could just pick one brand to carry and know they could give that to anyone in the middle of their vaccine series, rather than have to turn some patients away,” he says. This would reduce waste, because more people could be inoculated from each open vial, he notes.

Globally, scientific support for mixing vaccines would be an especially big benefit for low-income countries, many of which don’t have national stockpiles. They’d be able to use whatever shots they receive from aid groups or donations at a given time. That’s particularly important when just 2.5 percent of people in these countries have received even one jab.

Extensive mixing data from England 

Researchers at the University of Oxford in the U.K. conducted some of the earliest research on mixing COVID-19 vaccines in studies conceived in late 2020, before any vaccines were authorized in that country. Known as the Com-COV study, for Comparing COVID-19 vaccine schedule combinations, the team initially looked at mixing and matching the vaccines made by AstraZeneca-Oxford and Pfizer-BioNTech.

“The initial thinking was really about the roll-out: What if there was a problem with the supply of one vaccine, or if there was a safety signal with it, or if a person turned up and you didn’t know which vaccine they’d had before,” says Matthew Snape, an Oxford vaccinologist and the chief investigator on the Com-COV trials.

But interest quickly shifted to whether such mixing, known in medicine as a heterologous vaccination schedule, could offer immunological advantages. When the researchers gave 830 people either a double dose of the AstraZeneca or the Pfizer-BioNTech vaccines four weeks apart, or a mix of each, all achieved an immune response above the threshold indicating good protection.

The strongest response occurred in people who first got the AstraZeneca shot followed by Pfizer. The levels of antibodies (indicating the body’s ability to fight the coronavirus) and T-cells (responsible for limiting internal spread of the disease) rose highest under this combination. Which of these two immune reactions is most important isn’t yet known, Snape says. Researchers are also still investigating whether the advantage holds months after the shots; new blood samples taken six months after the initial doses are currently being studied, he says.

Mixing vaccines did lead to slightly more adverse reactions in this research, but all the reported side effects were no worse than bothersome headaches, fevers, and chills that dissipated within days. No combinations raised safety concerns.

“These results created a lot of chatter,” says Waleed Javaid, an epidemiologist and director of infection prevention and control at Mount Sinai Downtown in New York City. But without longer-term data, they don’t confirm that the combination is worth doing, he says.

The AstraZeneca vaccine is not authorized in the U.S., but many experts compare the shot with the Johnson & Johnson vaccine because both use the same type of delivery system, known as a viral vector. In both vaccines, an adenovirus like the ones that cause the common cold delivers a small piece of the SARS-CoV-2 virus’s genetic code into the body, triggering an immune response.

However, the AstraZeneca is made from a chimpanzee adenovirus, while the J&J shot uses a human version. That means the two vaccines are distinct enough that you can’t apply study results from one to the other, says Dan Barouch, director of the Center for Virology and Vaccine Research at Boston’s Beth Israel Deaconess Medical Center.

“Heterologous vaccinations schedules might offer advantages, because each vaccine brings different features to the table. But every combination must be specifically studied for safety and immunogenicity,” Barouch says.

In recent months, Oxford has added Moderna and Novavax, another type of vaccine not authorized in the U.S., into its research mix. It expects to present results from the combinations of these four vaccines later this month, Snape says.

What the NIH found out about mixing

The NIH embarked on its own mix-and-match research in June, and the interim preliminary results were released online Wednesday. They are now under review by the FDA’s Vaccines and Related Biological Products Advisory Committee.

The scientists recruited some 450 people who had received a full series of any of the three vaccines authorized in the U.S. At least three months later these people received a booster shot, either of the same brand or a different one. When the NIH team checked the participants’ blood for antibody levels 15 days after the booster, mixing was shown to enhance the shots’ effects, especially for those whose first inoculation was with the J&J jab.

The roughly 50 people who boosted their J&J shot with Moderna saw their antibody levels rise 76-fold, compared to just 4-fold in those getting another J&J vaccine. A Pfizer booster gave this group a 35-fold increase in antibodies.

Switching from one mRNA shot to another was less dramatic. Pfizer-Moderna recipients saw a 32-fold boost, while Pfizer-Pfizer’s was 20-fold. The Moderna-Pfizer combination turned out to be largely similar to Moderna-Moderna’s. And no mRNA recipient got a larger increase with a J&J booster compared to one from their original shot type.

If the final results of this study, along with others in process worldwide, continue to find advantages, the CDC’s Advisory Committee on Immunization Practices (ACIP) might ultimately green-light a mix-and-match protocol. But it has not done so at this time.

The only combination protocol authorized in the U.S. is for immunocompromised people getting a third mRNA shot to enhance their generally weak response to the first two. The CDC recommends using the same brand throughout, but if that is unavailable, it says a different mRNA vaccine can be used.

Why only some vaccines are interchangeable

Historically, combining vaccine doses from different manufacturers has rarely been authorized for other diseases, Jacobson points out. This is due to the way vaccine research is financed in this country, he says. Before any product is authorized, its manufacturer must pay hefty sums to conduct sufficiently large studies proving their vaccine is safe and effective. They must also convince the FDA that they are able to manufacture every dose going forward to the exact same specifications as were used in its clinical trials.

“A manufacturer is not going to also put money into seeing whether its product mixes with other brands. There is no financial benefit for them to do that,” Jacobson says.

Independent scientists sometimes perform this research on their own and present the data to ACIP. Based on this independent data, for instance, the committee has agreed that children under age nine getting their first-ever flu shot, which requires two doses, can safely receive any two of the nearly one dozen products available, Jacobson says. People can similarly swap brands for subsequent doses of Hepatitis A or Hepatitis B vaccines.

“Decades of research has shown that, in general, if antigens are generated by a vaccine in similar fashion, you can mix and match. But there are some huge exceptions,” Jacobson says. For instance, mixing among meningococcal B manufacturers is not allowed. “If the provider can’t get the boost in the same brand as the original shot, you have to start the whole series over,” he says.

Some countries have already decided that certain recipients can receive a different second COVID-19 shot. When a rare blood clotting disorder appeared in a small number of younger recipients of the AstraZeneca vaccine, some governments were hesitant to insist that everyone who’d gotten the first shot continue with the second.

“This is exactly what we anticipated in wanting to generate data,” Snape says of the Com-COV studies. Canada’s policy allows people who received a first AstraZeneca dose to finish the series with an mRNA vaccine if they prefer.

Should you try to mix and match?

With the fragmented healthcare system in the U.S., it’s possible that some people here have gotten a second or third dose of a different vaccine through less than legitimate means. You probably know someone who has done this, perhaps swayed by data showing stronger protection for some vaccines or annoyed that boosters for the Moderna and J&J vaccines are not yet approved.

Even though the preliminary NIH results show some advantage, the number of people tested was small. And while no serious adverse events occurred, uncommon reactions wouldn’t be discovered until tens of thousands or more recipients get the combination, Piedra says. It also remains to be seen whether the changes in the immune system seen 15 days after the vaccine ultimately translate into disease protection.

Plus, if you choose your own unauthorized booster shot, what happens if later research proves a different combination is better? That’s why experts say it’s a bad idea to become your own vaccine advisory committee and get a shot out of turn. “Deciding whether to mix,” Javaid says, “should be done in a safe and scientific matter rather than randomly.”

Why the CDC and FDA only approved booster shots for some Americans

Given what we know about breakthrough infections, most experts remain unconvinced there’s enough data to justify an extra dose for most Americans.

(Update 10/22/2021)

In a blow to President Joe Biden’s plan to begin rolling out COVID-19 booster shots this month, the U.S. Food and Drug Administration granted emergency use authorization of a third dose of the Pfizer vaccine only to certain subgroups of the national population. That includes people age 65 and older and people at risk of severe disease, such as adults with underlying conditions or in high-risk jobs. The Centers for Disease Control and Prevention later gave their ruling to start administering boosters to older adults, residents of long-term care facilities, and people ages 50 to 64 with conditions that leave them vulnerable to severe disease.

But in an unusual move that highlights how complicated the decision-making on boosters has been, CDC director Rochelle Walensky overruled her agency’s advisory panel and also endorsed extra doses for younger people whose jobs put them at high risk, such as health-care workers and teachers. Walensky otherwise agreed with the advisers’ recommendation that people ages 18 to 49 with underlying conditions should only receive a booster dose if their personal benefit outweighs the risks.

This is a far different plan for boosters than what was announced in August, when President Biden said that his administration planned to offer third doses of the Pfizer and Moderna vaccines to all eligible Americans. His team advised people to get the boosters eight months after their second doses, and they set a September target for clinics to start giving people third jabs. “It will make you safer, and for longer. And it will help us end the pandemic faster,” Biden said at the time.

The FDA departed from that plan because the evidence is much stronger that boosters will benefit people age 65 and older than it is for benefits to the general population, says Anna Durbin, a vaccine researcher at Johns Hopkins University. 

“To their credit, they’re following the process that they always follow,” she says of the FDA ruling. “These decisions need to be based on data. It’s really important to maintain the integrity of the science.”

Conflicting data on breakthrough infections

The data trickling in so far does seem to suggest that the two-dose Pfizer-BioNTech vaccines are less able to prevent infection after six to eight months, but experts point out there are wide discrepancies. 

In July, Israel said data from its highly vaccinated population shows that Pfizer’s vaccine is now only 64 percent effective against preventing infection. Then there were the alarming reports that month of a large COVID-19 outbreak in Cape Cod, Massachusetts. Out of hundreds who had been infected, about three-quarters were fully vaccinated. By contrast, a United Kingdom study in August found that the Pfizer vaccine is 88 percent effective against the Delta variant. Weeks later, a study of New York State residents showed a combined vaccine effectiveness of 79.8 percent among those who had received the Pfizer, Moderna, and Johnson & Johnson jabs.

One thing that’s perfectly clear to scientists is that the COVID-19 vaccines are still performing admirably where it matters most: protecting against severe disease and death. 

In the aftermath of the Cape Cod outbreak, scientists pointed out that only four of the people who got breakthrough cases had to be hospitalized. And according to a September 10 report from the CDC, the vaccines are more than 90 percent effective against hospitalization and death. Unvaccinated people are 10 times more likely to be hospitalized than vaccinated people and 11 times more likely to die.

In interviews conducted before the FDA announced its decision, experts emphasized that the data will be much clearer if regulators can take more time before weighing the science behind booster shots, since breakthrough infections remain overwhelmingly mild in the general population. 

“Your protection does not fall off a cliff at six months or eight months,” Durbin said at the time.

Protection against severe disease

To understand why breakthrough infections happen, it helps to recall how the immune response works. Antibodies are the first line of defense against infection, and people can develop antibodies that target the SARS-CoV-2 virus both through natural infection and vaccination. When the virus enters the body through the nose or throat, the antibodies that reside there fight off the virus before it can take hold.

But your body can’t maintain high levels of antibodies against every pathogen it has ever encountered all the time. People also tend to have relatively low levels of antibodies in their noses and throats because they have to travel there from your bloodstream. So sometimes a virus—particularly one as potent as the Delta variant—can slip past them to cause a breakthrough infection.

As the virus penetrates the cells in the nose and throat, it begins to replicate. At that point, a person may exhibit symptoms characteristic of an upper respiratory infection, including stuffiness, cough, fever, and fatigue.

“It’s a nuisance but it’s not life-threatening,” says Deepta Bhattacharya, an immunobiologist at the University of Arizona College of Medicine.

That’s when the rest of the immune system kicks in to keep the infection from escalating to the lungs, where it can cause severe harm resulting in hospitalization or death. Having been trained by the COVID-19 vaccines to recognize the virus, the immune system ramps up production of new antibodies, as well as memory B and T cells that join the fight.

It takes time for an infection to travel to the lungs, giving your immune system plenty of opportunity to mount a robust defense. Bhattacharya says severe disease is low among the vaccinated because they can clear the virus from their systems more quickly. This both reduces the severity of their symptoms and reduces the window in which they can infect others. “I think we’re fairly confident in that,” he says.

Assessing the evidence

Booster shots are additional doses of the original vaccine that increase antibodies in the nose and throat, so they would decrease the chance of getting an infection in the first place. And researchers say that the data on breakthroughs is an early signal that the vaccines’ ability to prevent infection is waning, particularly among people with compromised immune systems and older populations.

These are groups that you would expect might not have a robust response to the standard dose of the vaccine, says Jack O’Horo, an infectious disease specialist at the Mayo Clinic who is based in Rochester, Minnesota. People who have had solid organ transplants, for example, take medication that suppresses the response of their memory cells. They rely on antibodies alone to fight off infection—and studies have shown that they have a poor antibody response to the vaccine.

In August, this evidence prompted the FDA to approve use of a booster dose for certain immunocompromised populations. “To the extent that a third shot gets them a little bit closer to what we see in healthy people after their second shot, I think that’s worth doing,” Bhattacharya says. “That’s the easy one.”

The next group that scientists suggested might benefit from booster shots were older Americans. According to a September CDC study, people over 65 account for about 70 percent of hospitalizations from breakthrough infections. But scientists note that there may be specific age groups or other factors in play, such as whether someone lives in a nursing home. Still, the FDA agreed that there’s enough evidence to suggest that people over 65 should be eligible for boosters.

It’s a little trickier to parse the data for other populations. Recently, a September 7 preprint echoed the findings of previous studies when it showed that the odds of vaccinated people testing positive for COVID-19 are higher 120 days after the date they reached full vaccination. Yet O’Horo, co-author of the study, stresses that “this was from a very small risk to a small risk.” He says follow-up research is needed to break down the populations whose risk of a breakthrough infection—while still small—is most concerning.

Ultimately, O’Horo says the findings of his study provide “a very early signal” to federal regulators that it’s time to carefully assess how the vaccines are working. He also points out that the FDA and CDC have access to more and better data than what has been released publicly about the vaccines’ real-world effectiveness.

“If I had to boil it down to a single phrase, it would be, Walk, don’t run,” he says. “We have information suggesting that this is a good time to have a scientific discussion about boosters, but it is emphatically not a time to hit a panic button.”

Complicating factors

There are other factors to consider when it comes to administering booster shots to the general population. For one, the three vaccines approved or authorized for use in the U.S. aren’t all the same.

Recent studies suggest that people who received Moderna’s vaccine are better protected from severe breakthrough infections because it elicits higher and more durable antibody levels than Pfizer’s vaccine. And a recent CDC report showed that the Moderna two-dose shot remains 95 percent effective in preventing hospitalizations compared to 80 percent for Pfizer and 60 percent for Johnson & Johnson.

But it will take more in-depth investigation to tease out what that means for who needs booster shots: Scientists point out that the Moderna vaccine is administered at a higher dose than Pfizer’s vaccine and with a longer interval between doses. It also rolled out after Pfizer’s vaccine, so the data are slightly lagging.

“People shouldn’t be running out and saying, I want a Moderna vaccine now,” Durbin says, adding that Moderna’s effectiveness is likely to drop off over time as well.

It’s also possible that another dose might not be a booster at all, but rather the proper dosage. Vaccines typically take years to develop because researchers take time to study many different dosing options. For the COVID-19 vaccines, they didn’t have that luxury of time to test whether three full doses might be better than two, says Francesca Torriani, an infectious disease specialist at University of California, San Diego Health.

And that could end up being the case. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said in an earlier White House press briefing that he “would not at all be surprised that the adequate full regimen for vaccination will likely be three doses.”

The bottom line for boosters

Ultimately, the decision on boosters came down to what regulators are trying to achieve: to reduce all symptomatic infections among Americans, or to slow transmission of the virus. Bhattacharya says there just isn’t evidence yet to show that a booster would provide much extra protection to most people.

He points to the discrepancies among global studies of vaccine effectiveness. Most show only a slight drop, but a handful of countries see a more significant change. The Biden administration has cited Israel’s reports that the Pfizer vaccine is now only 64 percent effective in its plan to roll out boosters. If that’s true, Bhattacharya says, it suggests boosters would offer a large benefit to the general population. But he cautions against putting too much weight in any one study.

“Most scientists believe that both in the short term and in the long term we have so much more to gain by getting the rest of the world vaccinated,” Bhattacharya says. He argues that the pockets of unvaccinated people around the world are far more dangerous than breakthroughs, because they create potential for even more dangerous variants that might evade the vaccines entirely.

Durbin agrees that global vaccine distribution should be the focus, and she adds that experts need to manage expectations about the purpose of vaccines.

“We are so privileged to be able to have these vaccines that are so highly effective,” she says. “Unfortunately, because of that people now think that they shouldn’t have any symptoms, there shouldn’t be breakthrough infections. And that’s just not a reasonable expectation,” she says.

Torriani points out that there might be an even easier and more effective way to prevent breakthrough infections in the U.S.: wearing a mask. Earlier this month, she was part of a team of researchers that examined breakthrough infections among health-care workers in San Diego. They noted that the drop in vaccine effectiveness from June to July was likely caused by waning immunity and the emergence of the Delta variant. Yet the study also coincided with the end of masking requirements in San Diego, which Torriani says likely increased the risk of breakthrough infections. It’s yet another factor that public health officials need to keep in mind when making policy.

“We still need to mask,” Durbin says. “It’s going to help prevent COVID, it’s going to help prevent you from getting influenza, it’s going to prevent you from getting other colds and respiratory illnesses. It just makes good sense. Wear a mask.”

What COVID vaccines for young kids could mean for the pandemic

As US Food and Drug Administration advisers recommend authorizing shots for children aged 5 to 11, researchers predict what this might mean for populations.

Pediatricians and families in the United States are eagerly waiting to see whether the Food and Drug Administration (FDA) will authorize a COVID-19 vaccine for the nation’s roughly 28 million 5- to 11-year-olds. Yesterday, an FDA advisory committee reviewed data from a clinical trial testing a low-dose version of the vaccine made by Pfizer and BioNTech on children in that age group — and voted nearly unanimously to recommend that the FDA grant the shot emergency approval.

Anticipating that the FDA and the US Centers for Disease Control and Prevention (CDC) will soon give the vaccine the thumbs up, and that distribution to children will begin in the coming weeks, infectious-disease researchers are now looking ahead to how immunizing 5- to 11-year-olds — the largest group of people in the United States not yet eligible for the vaccine — will change the course of the pandemic.

“It will save lives in that age group,” says Emma McBryde, an infectious-diseases modeller at the Australian Institute of Tropical Health and Medicine in Townsville. But it could also have a broader impact, given that many US children aged 5 to 11 have returned to school unvaccinated in the past few months, and the group now accounts for a significant portion of new COVID-19 cases, capable of transmitting the coronavirus SARS-CoV-2 to others. “For every child’s life you save, you may well save many, many more adult lives,” she says.

The benefits outweigh the risks

The FDA advisory panel voted in favour of approval on 26 October, on the basis of clinical-trial data showing that the Pfizer–BioNTech vaccine is about 91% effective at preventing symptomatic SARS-CoV-2 infection in 5- to 11-year olds. Around 4,650 children participated in the trial; nearly two-thirds received vaccine doses that were one-third that of an adult jab (the others received a placebo). In a procedure similar to that used to vaccinate adults with the messenger RNA jab in the United States, kids received two doses, three weeks apart.

For the children tested, the data show that the vaccine is safe. mRNA-based vaccines have been linked to a very small risk of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the lining around the heart, particularly in young men. But there were no reports of either condition in the 5- to 11-year olds involved in the trial, which is a very encouraging sign, says Andrew Pavia, chief of the division of paediatric infectious diseases at University of Utah Health in Salt Lake City. If the shot were distributed to a larger population, however, regulators would need to watch for any sign of the side effects, Pavia notes.

Before the advisory panel’s meeting, an independent FDA review of Pfizer’s data evaluated six fictional US scenarios, with varying levels of virus in the community, and found that, for the most part, the benefits of the vaccine “clearly outweigh the risks”. Officials determined that even if virus levels were very low across the country, the overall benefits of the vaccine would probably still outweigh the potential risks of heart problems, because these conditions typically resolve in a few days after vaccination, unlike COVID-19, which can cause death.

Although SARS-CoV-2 is not nearly as lethal in younger people as in older ones — around 440 children aged 5 to 18 have died of COVID-19 in the United States, compared with around 724,000 in all age groups, according to the CDC — the combination of kids returning to classrooms and a surge caused by the highly transmissible SARS-CoV-2 Delta variant resulted in a sharp rise in paediatric cases beginning in late July. Of the 6.3 million US children who have tested positive for COVID-19 since the pandemic began, nearly one-third were diagnosed in the 11 weeks up to 21 October, according to an American Academy of Pediatrics report.

“To me, the impact of Delta on children in this age group makes the risk side of the equation very compelling,” Pavia says. “I don’t think it’ll be a very difficult decision to approve the vaccine.”

Looking ahead

COVID-19 infections in the United States have been dropping since September, after the Delta surge. Most modellers expect that trend to continue until early 2022, regardless of whether the Pfizer vaccine is authorized for 5- to 11-year-olds. That is, unless another variant of concern emerges, says Katriona Shea, an applied theoretical ecologist tracking the pandemic at Pennsylvania State University in University Park. “If there’s a new variant, that’s like a slap to the system.”

Shea co-leads the COVID-19 Scenario Modeling Hub, which in September released its ninth forecast of the pandemic’s trajectory, factoring in how a vaccine for children aged 5–11 could affect new US infections and deaths. The forecast, which averages the predictions of nine other modelling teams, shows that although vaccines for kids would lead to lower case counts, “it might not make a huge difference at the population level if we are lucky enough just to stick with the Delta variant”, Shea says. But the data show that if a concerning variant were to emerge by mid-November, inoculating children could make a significant difference to the course of the pandemic in the United States (see ‘A kid effect’).

In preparation for US regulators’ possible authorization of the jabs, the White House last week released a plan to distribute the lower-dose shots to pediatrician’s offices, hospitals and pharmacies

But even if the Pfizer–BioNTech shot is authorized, it remains to be seen how kids in the 5–11 age group will feel about getting vaccinated — and whether their caregivers will allow them to. Mina Fazel, a child and adolescent psychiatrist at the University of Oxford, UK, and her colleagues surveyed¹ nearly 28,000 pupils aged 9 to 18 at 180 UK schools and found that the younger children were more undecided than their older counterparts.

The survey also suggested that social media plays a part: pupils who spent more than 4 hours a day on social platforms were less willing to receive the vaccine than were those who spent less time on social media. “We have a generation of young people before us who are engaging with information and learning at an unparalleled scale,” Fazel says, adding that it is more important than ever to tailor public-health campaigns for kids.

Global implications

What the authorization of a vaccine for US children aged 5–11 might mean globally also remains to be seen. Almost 70 countries have fully vaccinated less than one-fifth of their populations and will probably not vaccinate younger children for months, or even years, to come. But some countries, including Israel, are waiting to see the US regulators’ decision before approving their own jabs.

Other countries, however, are already vaccinating children under age 12. For instance, Chile, China, Cuba and the United Arab Emirates have begun inoculating kids with various COVID-19 vaccines in the past three months.

In places where the population has a very low natural immunity to the virus because community transmission has remained low throughout the pandemic, McBryde says, childhood vaccination will be essential. Australia, for example, plans to reopen its international border in November, allowing citizens and permanent residents to leave and enter the country if the vaccination rate in their state of residence has hit 80%. The move will “invite the virus” into the country, McBryde says, so it will be essential to “soften the landing” as much as possible by building up people’s immunity to the virus through vaccination — and that includes children. Shots for children under 12 have not yet been submitted to Australia’s regulators for approval.

On 25 October, vaccine maker Moderna, based in Cambridge, Massachusetts, said that a low dose of its mRNA-based jab for children aged 6 to 11 is safe and effective, but it has not yet applied for FDA authorization. Data on Pfizer’s jab for children younger than 5 is expected by the end of the year, according to a statement the company’s chief executive made at an event run by magazine The Atlantic last month. Moderna is also conducting a trial with children as young as six months old.

What to expect with COVID-19 vaccines for kids ages 5 to 11

Here’s what the science reveals about the safety of the Pfizer shot for this age group, the doses involved, and the role it will play in protecting everyone from the disease.

American families who are eagerly awaiting the ability to vaccinate their young children against COVID-19 may finally get their wish in the coming weeks.

On Friday, October 29, the U.S. Food and Drug Administration authorized Pfizer-BioNTech shots for kids ages 5 to 11. The move comes just days after an advisory committee reviewed the safety and effectiveness of the low-dose vaccine and voted unanimously in favor of it. If the Centers for Disease Control and Prevention follows suit in the coming days, the 28 million children in this age group will be able to join their older siblings and parents in getting the jab.

Documents sent to the FDA and released by Pfizer on October 22 provide results from their clinical trial with children in this age bracket. The data show that the vaccine offers strong protection for this age group, with a 90.7 percent efficacy rate in preventing symptomatic disease even against the Delta variant now in circulation.

The devastation COVID-19 has wreaked on adults has largely obscured how much children have suffered, says Ofer Levy, director of the Precision Vaccines Program at Boston’s Children Hospital, who is a member of the FDA committee that voted on the Pfizer vaccine. According to the CDC, nearly 2 million kids 5 to 11 have contracted COVID-19 since the pandemic began, and more than 150 have died.

Had COVID-19 struck as many children as it has without touching a single adult, it would still be a serious public health emergency, Levy says. The question now is how quickly parents will move to vaccinate their young children after shots become available.

When parents were asked last month in a Kaiser Family Foundation survey whether they want their 5 to 11 year old immunized against the coronavirus, 34 percent said they would do it right away. Thirty-two percent want to wait and see, and 7 percent said they will if it’s required, such as by school mandates. Twenty-four percent say they are completely opposed.

“It’s understandable that at this stage parents have a lot of questions,” says Kelly Moore, president and CEO of the nonprofit Immunization Action Coalition, of the group of parents planning to hang back. “People will always be cautious when it comes to their children, and we have not had safety and side effect information for this group before this point,” she says.

Similar dynamics occurred with adults, she notes, but “once people saw how it was working, many were eager to get vaccinated.”

Why kids need vaccines 

Given the mass mortality among older adults, it’s easy to lose sight of how children in this younger age group have been impacted by the disease.

In addition to mild or moderate illnesses, more than 5,000 children have developed the serious, full-body reaction to the coronavirus known as Multisystem Inflammatory Syndrome in Children (MIS-C), the vast majority under age 11. The syndrome can cause fever, vomiting, and diarrhea and may lead to heart dysfunction, kidney injury, and, in rare cases, death.

“When you compare COVID’s effects on children to influenza and other diseases that affect them, COVID is much more devastating,” Moore says.

Of course, children suffer even when others develop the disease. Some 140,000 children have lost a primary or secondary caregiver from COVID-19 to date. And the numerous school shut downs and curtailing of social activities have had such a profound psychological effect that the American Academy of Pediatrics and other medical groups have declared children’s mental health to be in a national state of emergency.

What’s more, protecting children with the shots adds to the defenses for all members of their family, especially those younger than 5 who would still not yet be eligible, or any adults at risk of severe disease.

Moore has a friend whose husband is on immunosuppressing drugs to protect his kidney transplant. “Their 8-year-old daughter can’t even go into an ice-cream store because her father is vulnerable if she were to catch and transmit COVID,” she says.

A recent Swedish study confirmed the value of this ring of protection: Families where one member is immunized have up to a 61 percent lower risk that others in the home will get COVID-19, while three or four immunized members gives more than a 90 percent reduction.

Inoculating children in an effort to protect others already happens in the U.S., Levy says. “Some say it’s not ethical to vaccinate kids for a disease that doesn’t affect them as much,” he says, but children are currently immunized against rubella when the main risk is to pregnant mothers, he points out.

A smaller dose

Tens of thousands of adults were tested in Pfizer-BioNTech’s original clinical trials, and with 105,000 Americans over age 12 having completed the two-dose series, the FDA already has extensive information on the effectiveness of the shots. To test the vaccine for children 5 to 11, a different type of trial was conducted, largely focused on safety and dosage.

In the first phase of the trial, Pfizer gave a small group of children either the same 30 microgram dose used for those 12 and older, or they administered 20 or 10 microgram doses. This is a process known as a dose de-escalation trial, says Onyema Ogbuagu, an infectious diseases specialist at Yale Medicine and a principal investigator of the Pfizer trials.

“You want to find the dose that gives a strong immune response while trying to limit adverse events,” he says. The two-dose regimen of 10 micrograms each eventually won out. Pfizer is presenting the test results from some 2,268 participants to the FDA.

The FDA’s Vaccines and Related Biological Products Advisory Committee will comb through every bit of Pfizer’s data before deciding whether to recommend its authorization for 5 to 11s. Pfizer is also currently studying even smaller doses for children between 2 and 5 years old and for those between 6 months and less than 2 years. And more good news for parents of young children: Moderna announced on October 25 that its clinical trial in 6 to 11 year olds also produced a robust immune response.

Side effects seen in the Pfizer trial were similar to those for older children, including short-term injection site pain, fatigue, headache, and chills. There were no serious adverse events linked to the vaccine. “You can never say never in medicine, but we feel pretty confident that nothing untoward is expected when even more children get the vaccines,” Ogbuagu says.

Rare events that happen in 1-in-10,000 or 1-in-100,000 people will not emerge until that many children have been vaccinated. The rare cases of the heart inflammation known as myocarditis, which has primarily impacted male adolescents and young men after their mRNA vaccine series, is estimated to occur in roughly 1 in 26,000 males, and nearly all have since recovered.

Addressing parents’ concerns

When weighing any potential risks, parents must compare a vaccine with the disease it aims to protect their child against, Moore says. Even mild cases of COVID-19 can make children feel awful and keep them from attending school. Plus, an unknown number of children continue to suffer for months after their acute illness, a condition that’s come to be known as long COVID.

Among parents who worry, some are concerned about stimulating their child’s immune system with a vaccine, Ogbuagu says, but he counters that “the stimulation it gets when a person gets COVID is much more intense.”

Other resisters focus on the vaccine’s delivery system—the mRNA that instructs the body to create spike proteins for the immune system’s response. But vaccines routinely given to children for other diseases use many different technologies and most parents haven’t much cared, says Robert Jacobson, medical director of the Primary Care Immunization Program at the Mayo Clinic in Rochester, Minnesota.

For example, he says, the measles, mumps, and rubella (MMR) jabs and the chicken pox shots use a weakened form of a live virus. The vaccine for diphtheria employs an altered form of the bacteria. And hepatitis B’s vaccine involves tricking yeast through recombinant technology to produce a protein they don’t naturally make.

What’s more, Ogbuagu says, RNA-based viruses like influenza or respiratory syncytial virus (RSV) routinely infect kids, so it’s not as if their bodies haven’t seen the structure before. “If people knew the host of RNA viruses that enter their child’s cells all the time, they would worry less about the vaccine,” he says.

Pfizer-BioNTech’s shots are already proving valuable for children ages 12 to 17. Some 11 million Americans in this age group, or 57 percent of the total, have gotten at least one shot, while 47 percent are fully vaccinated, according to the AAP. The vaccines have been 93 percent effective in protecting kids this age from going to the hospital, the CDC announced last week.

If the CDC ultimately authorizes the vaccine for kids 5 to 11, Levy wants the shots to be mandated for school, as others currently are. In a recent medical journal editorial, he writes that decreasing virus circulation in children may be our best hope for controlling the spread of COVID-19.

“We’re not out of the woods: We have the winter months coming, and maybe some other variant will emerge. Protecting children and their families could help a lot,” Levi says.

Other doctors simply want to convince families that the shots are a smart approach even if they are not mandated. “As a primary care pediatrician. I will recommend that children get this vaccine as strongly as I do for flu, pertussis, MMR, and others routinely recommended for this age group,” Jacobson says.

“The research shows it to be safe and effective, and with the coronavirus still in widespread circulation, there is clearly a need.”

Why scientists worldwide are watching UK COVID infections

The country’s relaxation of measures such as masking — especially in England — is showing the limits of relying on vaccines alone.

(Update 11/3/2021)

The COVID-19 pandemic in the United Kingdom has often foreshadowed what came later elsewhere. The highly contagious Alpha variant was first detected there, and the country then reported high caseloads of the more-contagious Delta strain before this variant dispersed around the rest of the world. The United Kingdom also saw a wave of infections that seems to have preceded a similar glut now sweeping Western Europe.

Furthermore, England was among the first regions in Western Europe to lift almost all of its COVID-19 restrictions, following one of the world’s fastest vaccine roll-outs. It ended the legal requirements for social distancing and mask use on 19 July, with Wales and Scotland — which set their own public-health policies — lifting most of their restrictions on 7 and 9 August, respectively. Northern Ireland followed on 31 October.

As one of the first countries to trust high vaccine coverage and public responsibility alone to control the spread of SARS-CoV-2, the United Kingdom has become a control experiment that scientists across the world are studying. “We are watching the increase in cases closely, trying to dissect what is going on and how that might influence our situation right now,” says Rafael Radi, a biochemist and coordinator of Uruguay’s COVID-19 Scientific Advisory Group.

Nature spoke to scientists around the world about what they hope to learn from the UK experience.

Can vaccines alone prevent infections from surging?

The United Kingdom was hit by three million infections between July and October this year — comparable to when the country was under a strict lockdown in late 2020. This is despite 79.5% of those aged 12 years and older having received two vaccine doses as of 31 October.

UK infection rates are higher than those in countries in continental Europe, where COVID-19 restrictions were relaxed later or remain in place. In the 7 days between 17 October and 23 October, Spain recorded 286 infections per one million people, and Germany 1,203. The United Kingdom registered 4,868 over the same week.

The surge in infections shows that vaccines alone cannot contain the virus, say scientists calling for the introduction of ‘soft’ public-health measures to avoid another lockdown.

“The vaccines are amazing and doing exactly what they’re supposed to do,” says Susan Butler-Wu, director of medical microbiology at the LAC+USC Medical Center in Los Angeles, California. “But why don’t we want to give them the best chance by combining them with other measures?”

Was the behaviour of individuals responsible for the recent surge?

The surge in infections is not the result of the public suddenly abandoning caution, researchers say. “We have not seen a continuous rise [in social interaction], but rather a small increase and then fluctuations driven by whether schools are open and how many people are attending work,” says Christopher Jarvis, a statistician who heads the London School of Hygiene & Tropical Medicine’s CoMix Social Contact Survey.

The average adult now has contact with three to four other people per day, compared with more than ten before the pandemic. For children, the numbers are much higher now that schools have reopened. Mask use dropped once the mandate was lifted, but this is harder to measure.

The gradual pace of behaviour readjustment could explain why the country has experienced a sustained high level of infections rather than the spike that models predicted in August or September. Ongoing high transmission suggests that measures such as free rapid COVID-19 testing will not contain infections while high-risk events in crowded indoor environments are permitted, says William Hanage, an epidemiologist at the Harvard T. H. Chan School of Public Health in Boston, Massachusetts.

“This shows how cautious we need to be with the return to normality,” says Radi. “Increasing human interactions, even with a high proportion of the population fully vaccinated, may lead to new surges, hospitalizations and death.” Uruguay is using the United Kingdom’s rise in infections as a cautionary tale to warn people of the risk of easing restrictions prematurely, Radi says.

Is vaccine protection waning?

The United Kingdom had one of the fastest COVID-19 vaccination campaigns in Europe. But that strength now seems to be its Achilles heel. The country’s first COVID-19 vaccines were administered ten months ago, and antibodies have had time to decline.

Vaccine effectiveness against infection, hospitalization and death fell considerably after six months, particularly in older people, a UK-based study has found¹. A separate study in Israel — another country that deployed vaccines early — found similar results².

One of the driving forces behind this might have been dropping antibody levels, says Paul Hunter, who studies health protection and medicine at the University of East Anglia in Norwich, UK. Despite high infection rates and the ongoing vaccination campaign, antibody levels plateaued in May and then began to drop, according to the UK Office for National Statistics.

A decline in infection-blocking, or ‘neutralizing’, antibodies does not mean that someone is susceptible to infection, because memory immune cells also play a part, “but we do know that the level of neutralizing antibodies early on is a good indicator of protection”, Hunter says.

But are vaccines are still holding up against death and serious illness?

The Delta variant’s mutations — combined with waning vaccine antibodies — are causing more breakthrough infections. But vaccines are still offering remarkable protection against hospitalization and death. A study at the University of Edinburgh, UK, found that the Pfizer–BioNTech and Oxford–AstraZeneca vaccines were 90% and 91% effective, respectively, at preventing death³. Furthermore, around 75,000 people required hospital treatment for COVID-19 in the United Kingdom between the start of July and early October this year, compared with 185,000 between October 2020 and January 2021, when the number of infections was comparable but vaccines were less available.

Relative to the size of its population, the United Kingdom has around three times as many infections as the United States, but only two-thirds the daily deaths. “The amount of infection that is currently going on in the UK would be expected to have much worse consequences if replicated elsewhere,” says Hanage.

Can boosters help to control future surges?

UK authorities began offering a third dose of the COVID-19 vaccines to residents aged 50 years and older, and to those in high-risk groups, on 16 September. Although the precise impact of booster doses has not been established, “the emerging evidence is that they are a lot more effective at reducing infections than we were expecting”, says Hunter.

A study at the Weizmann Institute of Science in Rehovot, Israel, found that people who received a third dose of the Pfizer–BioNTech vaccine were almost 20 times less likely to get seriously ill from COVID-19, and 10 times less likely to be infected, than were people who had received their second and last dose at least 5 months before⁴.

The World Health Organization has criticized the roll-out of third doses in wealthy nations when many people in poorer ones are yet to receive their first. But boosters could get the United Kingdom through the coming winter without new restrictions being imposed, says Marc Baguelin, who models COVID-19 infections for the UK government at Imperial College London. His team’s most optimistic models — based on assumptions regarding behaviour and the effectiveness of immunity — predict a sustained high number of infections between October 2021 and March 2022, leading to around 43,000 hospital admissions and more than 5,000 deaths.

High circulation of the virus, as the cold pushes people indoors where the virus spreads more easily, and as immunity wanes, means that marginal increases in vaccine protection should have “a significant impact on hospitalizations and deaths”, Baguelin says. “Now everything relies on the boosters.”

Biden Vaccine Mandate For Private Employers: Everything You Need To Know

(Update 11/6/2021)

The Biden administration unveiled a sweeping federal labor rule on Thursday, requiring private employers with at least 100 employees to assure that all of their employees are fully vaccinated against COVID-19 or submit to regular testing and wear a face mask. The new rule represents a virtually unprecedented government intervention between employers and the people they entrust to carry out their business every day. Here are the facts you need to know:

What does OSHA’s COVID-19 vaccination mandate require?

The Occupational Safety and Health Administration (OSHA) announced it is issuing an emergency temporary standard (ETS), which requires all employers with 100 employees or more to require that all workers be fully vaccinated against COVID-19 no later than January 4, 2022, or face stiff financial penalties.

Can a worker refuse to get vaccinated without losing his or her job?

The OSHA rule, which applies to most of the U.S. workforce, requires any employee who chooses not to get vaccinated to submit to weekly testing for COVID-19 and to “wear a face covering” while on the job. The rule also allows employees seeking an exemption for medical reasons, or who have a sincerely held religious objection, to apply for an exemption. OSHA instructs employers to deal with these requests on a case-by-case basis.

What is the government’s definition of “fully vaccinated”?

The government considers anyone fully vaccinated who has received two doses of either the Moderna or Pfizer-BioNTech mRNA vaccinations, or one dose of the Johnson & Johnson vaccination.

Does this OSHA ETS affect health care workers?

The Centers for Medicare and Medicaid Services (CMS) issued a separate rule on Thursday that requires any health care employee who works in a facility receiving Medicare or Medicaid funding to receive the COVID-19 vaccination. Unlike the OSHA rule, this mandate has no exception allowing for testing.

Who pays for the vaccinations or the testing?

The OSHA regulation requires employers to give unvaccinated workers paid time off to receive the shot(s) — which are available at no charge — as well as to recover from any side effects the vaccine may produce. Who pays for weekly COVID-19 tests is less clear. The Biden administration allows employers to force employees to get their own tests. Testing kits currently run between $11 and $15 each, so a worker could spend a minimum of $572 a year to remain in compliance with the Biden administration’s edict. National Public Radio said the move “appears designed to push workers to choose vaccinations over testing.”

What is the cost if employers refuse to comply with the mandates?

If employers of 100 employees refuse to comply with the OSHA mandate, the Biden administration may impose fines of $13,653 per violation—and $136,532 for “willful or repeated” violations.

Does this rule apply to all employees if their workplace has at least 100 workers?

No: remote workers and people who work outdoors or in isolation are exempted. OSHA states that its rule “does not apply to employees who do not report to a workplace where other individuals such as coworkers or customers are present, employees while they are working from home, or employees who work exclusively outdoors.”

How many people would these mandates affect?

Private businesses of the scale discussed in the ETS employ an estimated 84 million workers, according to the Biden administration. The CMS rule would apply to an estimated 17 million Americans who work in 76,000 health care facilities. With the administration’s other COVID-19 rules and regulations, roughly two-thirds of the U.S. workforce falls under a federal government COVID-19 vaccination mandate.

How many companies currently have vaccination mandates in effect?

It’s impossible to know, but a recent survey of more than 1,000 companies found that only 13% currently required all employees to take the shot, while 66% said their “employees are not required to be vaccinated.”

What is the deadline for compliance?

Employers have until January 4, 2022, to comply or face financial penalties.

Where can I read the exact wording of the OSHA ETS?

Although the exact text of the rule will not be published until Friday, an unpublished draft regulation is available online. When the text is finalized, you can read it at the Federal Register.

How does this rule apply to states that have banned vaccine or mask mandates, like Texas?

“The ETS preempts any state or local requirements that ban or limit an employer’s authority to require vaccination, face covering or testing,” according to Labor Secretary Marty Walsh.

How have state leaders responded to the mandate?

Legal action is a certainty. Texas Attorney General Ken Paxton (R) tweeted, “Biden just announced his plan to wield OSHA to mandate vaccines on private businesses. And I’m announcing my plan to sue him once this illegal, unconstitutional regulation hits the Federal Register.”

Before its current iteration, Florida Governor Ron DeSantis (R) said, “We don’t live with a one-person rule in this country. We live in a constitutional system, [where] peoples’ rights are protected.” Arizona Governor Doug Ducey (R) released a statement calling the president’s mandate an “egregious, big government overreach” that robs Americans of their fundamental right to make health care decisions for themselves and their children. He went on to call it “dictatorial,” wrong,” and “un-American.” Oklahoma Governor John Stitt (R) put out a statement saying, “As long as I am governor, there will be no government vaccine mandates in Oklahoma.”

What legal challenges lie ahead for this rule?

The Biden administration insists it has authority to impose a federal vaccine mandate on private employers. “This rule is well within OSHA’s authority under the [1970 Occupational Safety and Health] Act, and consistent with OSHA’s requirements to protect workers” from safety hazards like infectious diseases, Secretary Walsh told Fox News on Thursday. But a Congressional Research Service report released in April found that the federal government had exceedingly slim statutory or constitutional authority to impose a vaccine mandate, a power usually exercised by state and local officials. The executive branch can require immigrants to prove they are vaccinated and it can impose vaccine mandates on members of the armed forces.

In September, the attorneys general of 24 states wrote a letter to President Biden, calling his then-proposed vaccine mandate “disastrous,” “counterproductive,” “a threat to individual liberty,” “a public health disaster,” and “illegal.” The letter, which previews legal objections likely to be made in court, closes by promising to “seek every available legal option to hold you accountable and uphold the rule of law.”

The Daily Wire Files Lawsuit Against Administration

On Thursday, The Daily Wire filed a lawsuit against the federal government over the OSHA mandate. The Daily Wire reported:

The Dhillon Law Group, Inc. and Alliance Defending Freedom filed the legal challenge on behalf of The Daily Wire in the U.S. Court of Appeals for the 6th Circuit. The mandate requires all private employers of 100 or more employees to force unvaccinated employees to receive a COVID-19 vaccine, be subject to weekly testing, or lose their job. Attorneys for The Daily Wire will also file an emergency motion to stay the mandate.

“The Daily Wire will not comply with President Biden’s tyrannical vaccine mandate, and we are suing the Biden Administration to put a stop to their gross overreach,” said Daily Wire Co-Founder and Co-CEO Jeremy Boreing. “President Biden, the federal government, social media, and the establishment media have conspired to rob Americans of their freedoms in the name of public health. They have broken faith with the American people through conflicting messaging, false information, and by suppressing data and perspectives with which they disagree.”

The lawsuit alleges that the Biden Administration lacks constitutional and statutory authority to issue the employer mandate, and that the mandate failed to meet the requirements for issuing a rule taking effect immediately without the normal process of considering public comments.

The Daily Wire Challenges Biden Administration Vaccine Mandate

(Update 11/6/2021)

The Daily Wire filed a lawsuit against the federal government on Thursday over President Joe Biden’s order mandating that large employers must require their employees be vaccinated against COVID-19 or submit to regular testing.

The Dhillon Law Group, Inc. and Alliance Defending Freedom filed the legal challenge on behalf of The Daily Wire in the U.S. Court of Appeals for the 6th Circuit. The mandate requires all private employers of 100 or more employees to force unvaccinated employees to receive a COVID-19 vaccine, be subject to weekly testing, or lose their job. Attorneys for The Daily Wire will also file an emergency motion to stay the mandate.

“The Daily Wire will not comply with President Biden’s tyrannical vaccine mandate, and we are suing the Biden Administration to put a stop to their gross overreach,” said Daily Wire Co-Founder and Co-CEO Jeremy Boreing. “President Biden, the federal government, social media, and the establishment media have conspired to rob Americans of their freedoms in the name of public health. They have broken faith with the American people through conflicting messaging, false information, and by suppressing data and perspectives with which they disagree.”

The lawsuit alleges that the Biden administration lacks constitutional and statutory authority to issue the employer mandate, and that the mandate failed to meet the requirements for issuing a rule taking effect immediately without the normal process of considering public comments.

“The federal government lacks the legal authority to compel private employers to play the role of vaccine or COVID police, lack the police power to force private employees to undergo medical treatment, and may not ignore constitutional limits on its ability to regulate every aspect of our lives,” said Dhillon Law Group’s partner Harmeet K. Dhillon. “The Biden administration’s attempt to impose this unprecedented and unlawful federal medical mandate on the U.S. workforce without considering the public’s views is arbitrary, capricious, unsupported by the evidence, and would produce a willfully ignorant rule.”

The lawsuit takes no position on any COVID-19 vaccine or whether any person should make the personal decision to receive it or not. The Daily Wire has employees who have received a COVID-19 vaccine and those who have not.

“The Biden administration’s decision to mandate vaccines through an OSHA rule is unlawful and compels businesses like The Daily Wire to intrude on their employees’ personal health decisions,” said ADF Senior Counsel Ryan Bangert. “The government has no authority to unilaterally declare that employees are workplace hazards or to compel employers to become vaccine commissars, and we are asking the 6th Circuit to put a stop to it immediately.”

The Daily Wire said in a press release:

As the motion for stay filed with the 6th Circuit will argue, the federal government has no power under the Constitution to force half the U.S. private sector workforce — 80 million workers or more — to be vaccinated against their will or endure repeated medical testing as a condition of simply earning a living. Nor is OSHA empowered to compel employers to enforce this government diktat or face punishing fines. Yet the OSHA mandate would do just that. Even if it had such power, Congress did not delegate it to OSHA, which is overtly trying to ram this unconstitutional, extra-statutory, and unprecedented mandate into immediate effect through emergency rulemaking to avoid public comment in violation of the Administrative Procedure Act.

Forced to invade employees’ medical choices or histories and their religious beliefs in connection with a condition of employment, The Daily Wire risks being trapped between its obligations under the mandate and the prohibitions against discrimination under the Americans with Disabilities Act and the Civil Rights Act of 1964, as well as the burdens of laws regulating the possession of private information. The mandate is unconstitutional because the Constitution does not grant Congress — much less OSHA — the general police powers needed to mandate vaccination and virus testing as a condition of private employment, or to deputize employers to enforce that mandate on its behalf.

Why kids under 5 still can’t get a COVID-19 vaccine

After disappointing results from clinical trials last year, vaccine companies are working to make the shots more effective. Here’s where the science stands now.

(Update 1/21/2022)

Though vaccines have restored some semblance of pre-pandemic life for most people in the United States, one group is still waiting: kids under five, who are not yet eligible for the COVID-19 vaccines. That’s been particularly frustrating for their parents, who must decide what activities are safe for their unvaccinated children—and who are often left scrambling when outbreaks shut down schools and daycare.

Compared to adults, children in this age group are less at risk for severe COVID-19. But currently the coronavirus’s Omicron variant is driving a surge in pediatric hospitalizations—more than double that of the previous peak in the fall—because it’s more transmissible than earlier strains.

Elizabeth Lloyd, a pediatric infectious diseases expert at University of Michigan Health C.S. Mott Children’s Hospital, says it’s hard to tease out how many children were hospitalized for COVID-19 versus for other reasons. “But from my experience, we’re definitely seeing more kids who are sick and who are sometimes needing ICU-level care,” she says. “This is something we’re hoping with this [children’s] vaccine could be preventable.”

Emerging evidence shows vaccines can help prevent complications that kids may develop such as long COVID, or a rare multisystem inflammatory syndrome. And offering shots to the under-fives almost certainly would reduce the numbers of unvaccinated children who can spread the virus in their communities, posing a threat to vulnerable adults and creating logistical nightmares for daycare centers and parents.

Older children have been eligible for the Pfizer-BioNTech vaccine since early November. At that time, the expectation was that vaccines suitable for younger kids would follow shortly.

Those hopes were dashed in mid-December when Pfizer and BioNTech revealed that their clinical trials had yielded disappointing results. The companies decided to add a third dose to the vaccination series for this age group, which pushed back the timeline for authorization.

So where do things stand now? White House advisor Anthony Fauci said on January 19 that he hopes authorization could come “within the next month or so and not much later than that.” But Fauci acknowledged that vaccine availability would depend on how quickly the regulatory process moves. Moderna, meanwhile, says it won’t have study data on vaccines for kids ages two to five until March. And neither Moderna nor Pfizer-BioNTech has released any data yet.

Even in the face of all these uncertainties, Lloyd says that parents can be reassured about one thing—which is that the delays don’t mean the vaccines aren’t safe, only that the companies are still working to make them effective.

Here’s what Lloyd and other experts say about the process for approving vaccines for kids under five—and how to keep them safe in the meantime.

1. Why was the Pfizer vaccine delayed?

Pfizer and BioNTech began testing their vaccine in kids ages six months to five years in the spring of 2021—offering reason to believe that all children might be eligible for a vaccine by the end of the year. After a small dose-finding study showed that the 10-microgram dose that older children had received elicited more side effects in the younger group, the companies ultimately decided to administer two smaller doses 21 days apart.

“We weren’t hearing about any serious adverse events,” says Kristin Moffitt, a pediatric infectious disease specialist at Boston Children’s Hospital. “But you could imagine that parents will be very carefully considering side effects from these vaccines when they’re making decisions about vaccinating their children under five.”

As recently as last fall, Pfizer CEO Albert Bourla said initial data for kids under five could be available by the end of October. But October came and went. Finally, in December, Pfizer and BioNTech announced that the vaccine didn’t generate the same robust antibody protection in kids ages two to five as it had in older populations.

While the lower dose had reduced the vaccine’s adverse effects in young children, Moffitt says it seems to have weakened the immunity generated by the two-dose vaccine.

Rather than file for emergency use authorization, Pfizer and BioNTech said they would extend their clinical trials to see if a third dose would improve results. While it’s hard to know how far off that immune response was without seeing the data, Lloyd suggests that “they must have felt that it was bad enough that if they took that data to the FDA it wouldn’t have moved forward.”

2. Why did they extend clinical trials for babies and infants, too?

What has left many parents scratching their heads, however, is why Pfizer and BioNTech also extended the clinical trials for babies and infants ages six months to two years old. According to the companies’ December statement, the low-dose vaccine was safe and did produce an adequate immune response for children under two.

It’s unclear why the companies didn’t pursue emergency use authorization for this age group. Pfizer declined an interview request for this article and referred National Geographic to its December statement for the latest updates on its pediatric trials.

Moffitt says it’s possible the companies made the decisions on trials with vaccine hesitancy in mind. For every parent who is eager to get their child vaccinated, there’s a parent who is worried about the potential side effects. Moffitt speculates that Pfizer and BioNTech might want to wait until they have more safety and efficacy data in the two-to-five-year-old population before seeking authorization for the littlest kids.

“As a provider who has had a lot of conversations with families about vaccine safety,” she says, “I can tell you that these are much easier conversations to have when you have hundreds of thousands to even millions of children who have safely received that vaccine compared to a couple of thousand, which is what we typically get from clinical trial data.”

3. What dosing regimens are Pfizer and Moderna testing now?

Pfizer and BioNTech are now evaluating a third three-microgram dose administered at least two months after the second dose. That regimen “reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile,” they said in a statement.

The companies did not say why they’re testing a third dose rather than conducting another dose-finding study to determine whether there might be an even sweeter spot between three and 10 micrograms. Lloyd says it might have been in the interest of getting data back faster or it could have been related to recent discussion about whether three doses is in fact the right regimen for the mRNA vaccines.

Moderna, meanwhile, is testing higher doses of its vaccine for kids in this age group. Last March, the company said it would first test two doses of either 50 or 100 micrograms given 28 days apart to kids ages two to 12. For babies and infants ages six months to two, the company would also test a 25-microgram dose. After an interim analysis, the company would select the best dosage and expand the study. But it’s unclear where those trials stand right now.

“We’re all eager to hear more,” Moffitt says. She points out that Moderna has slowed its efforts to seek authorization for older children after safety signals pointed to a higher risk of heart inflammation in young men ages 18 to 29. “I think that has subsequently held up all the age groups,” she says.

In late December, William Hartman, principal investigator of the University of Wisconsin’s Moderna pediatric COVID-19 vaccine trial, told local news station WSAW that the vaccine appears to be safe for kids under five and that results from that trial could come toward the end of January. However, the University of Wisconsin referred National Geographic to Moderna, which didn’t respond to a request for information.

4. What is the earliest a vaccine might be authorized?

Fauci has said that he hopes the Pfizer-BioNTech vaccine will be authorized before March. But Moffitt thinks that assessment is optimistic. If you look at the precedent set for older children, she says, the FDA and CDC have typically taken three to four weeks to consider emergency use authorization of the Pfizer-BioNTech vaccine. So even if the companies submitted their data to the FDA tomorrow, it might still take a month.

And there’s no indication when that data is going to be available to submit. Moffitt says that clinical trial investigators would typically wait another month after a third dose has been administered to measure antibody responses and compile the data. She says that Fauci would certainly have the best information on when Pfizer and BioNTech expect to have that data but depending how long it takes, “we could be looking at late winter or even to early spring.”

Moderna, meanwhile, has said that it expects to report data for kids ages two to five in March and “may proceed” with seeking emergency use authorization afterward. Following the precedent set by Pfizer, Moffitt says that could mean the shot would be available as early as April.

But Moderna may have a steeper road to climb than Pfizer, Moffitt says. Pfizer has been able to secure authorization fairly quickly for younger age groups in part because the company had already amassed a large body of safety data from older groups, she explains. For example, by the time Pfizer sought authorization for children ages five to 11, it was already clear to regulators that the vaccine was safe and effective for adolescents ages 12 to 15.

“So I do worry that the lack of authorization for Moderna in 12- to 17-year-olds would potentially further delay a decision,” Moffitt says.

5. Will the kids’ vaccine take Omicron into account?

In short, no. Although there has been discussion about adjusting the mRNA vaccines specifically to target the Omicron variant, Moffitt says the clinical trial data that the FDA and CDC will be assessing are the same formulations as the vaccines that older populations have received—just lower doses. And because the clinical trials began before the Omicron variant emerged, there likely won’t be any clear data on how well the vaccine works against the variant.

6. What should parents do in the meantime?

While parents of young kids continue to wait for a vaccine, Lloyd says that one thing they can do to protect their kids is to ensure that everyone else in the household is vaccinated and boosted, if eligible. Meanwhile, everyone in the household should also follow standard COVID-19 guidance on handwashing, social distancing, and wearing masks.

Moffitt says the best mask is one with multiple layers that fits well and can be worn for a long time. She recommends upgrading to surgical masks or KN95 and N95 masks. She agrees with Lloyd that these steps are not just up to the unvaccinated.

“If everyone can be wearing a mask when they’re leaving the house, especially when they’re heading indoors in public spaces, that could go a long way toward protecting those that are not yet eligible for vaccination in a household.”

Long-COVID symptoms less likely in vaccinated people, Israeli data say

People who’ve both been vaccinated and had COVID-19 are less likely to report fatigue and other health problems than unvaccinated people.

(Update 1/27/2022)

Data from people infected with SARS-CoV-2 early in the pandemic add to growing evidence suggesting that vaccination can help to reduce the risk of long COVID¹.

Researchers in Israel report that people who have had both SARS-CoV-2 infection and doses of Pfizer–BioNTech vaccine were much less likely to report any of a range of common long-COVID symptoms than were people who were unvaccinated when infected. In fact, vaccinated people were no more likely to report symptoms than people who’d never caught SARS-CoV-2. The study has not yet been peer reviewed.

“Here is another reason to get vaccinated, if you needed one,” says co-author Michael Edelstein, an epidemiologist at Bar-Ilan University in Safed, Israel.

People with the debilitating condition called long COVID continue to experience symptoms — such as fatigue, shortness of breath and even trouble concentrating — weeks, months or years after SARS-CoV-2 infection. Some estimate that up to 30% of infected people, including many who were never hospitalized, have persistent symptoms.

Vaccination reduces long COVID’s incidence by preventing people from getting infected in the first place. In theory, the shots could also protect against the condition by minimizing the length of time the virus has free rein in the body during breakthrough infections. But so far, the few studies that have looked into whether vaccines protect people from long COVID have had mixed results, says Akiko Iwasaki, a viral immunologist at the Yale School of Medicine in New Haven, Connecticut.

To examine the pandemic’s long-term effects, between July and November 2021, Edelstein and his colleagues asked more than 3,000 people whether they were experiencing the most common symptoms of long COVID. All had been tested for SARS-CoV-2 between March 2020 and the study period.

The researchers compared the prevalence of each symptom to self-reported vaccination status and found that fully vaccinated participants who had also had COVID-19 were 54% less likely to report headaches, 64% less likely to report fatigue and 68% less likely to report muscle pain than were their unvaccinated counterparts.

A shot for long-haul COVID?

Edelstein says his team’s study is the most “comprehensive and precise” to date on vaccination and long COVID, and that the results echo those of other research, including a UK-based study² from last September that found that vaccination halved the risk of long COVID.

Claire Steves, a geriatrician at King’s College London who led the UK study, agrees that the Israeli data support earlier findings. “It’s really good to see different study designs correlating, with the same results,” she says.

Although the results of both the UK and Israel studies show that vaccination reduces the risk of long COVID, she says, even fully vaccinated people are still at risk of developing the condition. And whether vaccination protects people from Omicron-induced long COVID is still unclear.

Regardless, Iwasaki says these findings are encouraging. “Long COVID is a terrible and debilitating disease. Any measures we can take to prevent long COVID are key to limiting more suffering in the future,” she says. “One more reason to get vaccinated.”

Why is it so hard to compensate people for serious vaccine side effects?

Though very rare, complications from shots can shatter lives and trust. Now the federal programs designed to help them are struggling with COVID-19.

(Update 3/12/2022)

From the start, 14-year-old Aiden Ekanayake and his mom Emily didn’t question whether Aiden would get a COVID-19 vaccine. “We take COVID extremely seriously, so our plan has always been to vaccinate,” Emily says. Aiden was “pretty excited for it” because it meant doing more activities and worrying less about getting sick. And though Emily had heard about possible side effects, she knew they were usually mild.

Aiden got his first dose of the Pfizer mRNA vaccine on May 12, 2021, the day it came available for people his age. Four weeks later he got his second dose. The very next day Aiden began feeling mild chest pain. He dismissed it, assuming it was related to his asthma, but the pain kept waking him up that night.

“I began to get frightened because I was able to fall back asleep and then woke up an hour later with the same pain,” Aiden says. He woke his mother at dawn, and Emily recognized the signs of myocarditis, an inflammation of the heart known to occur in rare cases after the Pfizer vaccine.

Aiden spent four days in the acute cardiac unit at their local hospital, where he was given anti-inflammatory drugs for the pain. After discharge, Aiden discovered that any activity that raised his heart rate could still trigger mild chest pain. Though he’s expected to fully recover, his parents are watching the medical bills roll in, despite their insurance coverage. “We did everything we were told to do, and we shouldn’t be paying the price in more than one way,” Emily says. “It’s adding insult to injury.”

Emily discovered that two U.S. programs exist for compensating people with severe side effects likely caused by immunizations. But only one of these programs covers COVID-19 vaccines, and so far it hasn’t actually paid any claims. Some experts question whether it ever will. This ambiguity isn’t just a problem for those with injuries. When people don’t know if they’ll be compensated for legitimate vaccine injuries, or when those who do get them feel dismissed and abandoned, it erodes vaccine confidence.

“Vaccine hesitancy stems from lack of public trust,” says Maya Goldenberg, who studies vaccine hesitancy at the University of Guelph in Ontario. As of March about 216 million people are fully vaccinated in the U.S., but 16 percent of Americans still refuse to get the vaccine, according to the Kaiser Family Foundation. A previous survey found that one in five people cite side effects as the top reason for not getting vaccinated. “People need to be confident that vaccines are safe and effective when they make a decision to get vaccinated. They also need to know that, insofar as there are real dangers involved, people will be cared for and not stranded in that rare situation.”

Without a robust compensation program, the resulting loss of trust further fuels anti-vaccine advocacy and increases vaccine hesitancy, hindering efforts to reach herd immunity.

“Vaccination is not a per-individual benefit, it’s for societal benefit, and when someone is injured by that vaccine, I think society owes that individual compensation,” says Walter Orenstein, associate director of the Emory Vaccine Center in Atlanta. “People who are willing to get the vaccine are helping our society. Obviously, the vast majority are not injured, but we need some mechanism in place to compensate people legitimately harmed.”

All vaccines have risks

Like any drug, vaccines have side effects. But they’re required to have a far better safety record than other pharmaceutical products because they’re given to prevent disease. Most vaccine side effects are therefore mild and temporary. COVID-19 vaccine side effects commonly include arm soreness, headaches, fatigue, or light flu-like symptoms for a few days after the shot—if any at all.

But in rare cases, patients have developed far more serious complications.

Jessica McFadden, a 44-year-old fundraising officer in Indiana, chose to get the Johnson & Johnson vaccine in early April because a single shot was more appealing than a two-dose vaccine. But one week after her jab, breathing became increasingly difficult. By late April a coughing fit required her to lay down to breathe. A CT scan showed a pulmonary embolism, a blood clot wedged in a lung artery. More imaging revealed another clot headed straight to McFadden’s heart.

The cardiologist told her she needed emergency surgery, adding “you have 12 hours to live,” McFadden recalls. “At that point I had to call my husband and give him a goodbye message.”

Doctors ultimately removed the clot near her heart, several from her lungs, another in her leg, and two from her brain. McFadden spent five days recovering in the ICU from a diagnosis of thrombosis with thrombocytopenia syndrome, or TTS, an extremely rare adverse event that can occur after the J&J vaccine. TTS occurs in approximately four people per million doses, but its severity led the CDC to recommend mRNA vaccines over the J&J shot in December.

Since it’s not possible to create vaccines without any potential severe reactions, medical ethicists say that governments encouraging vaccination have a moral obligation to compensate those experiencing such events.

“You do want to try to be generous toward the individual who may have been harmed, and you buffer that slightly with the moral principle of encouraging what you honestly believe to be safe, effective, and important vaccines,” says Art Caplan, a bioethicist at the New York University.

McFadden accepts that tradeoff, but she’s vexed that the government has pushed so hard for everyone to get vaccinated and not pushed to compensate those like her who were harmed. “It’s like [we’re] the cost of doing business in a pandemic,” she says. McFadden is fortunate to have good health insurance—though her bills after insurance still exceeded $7,000—and her sick leave covered all but two weeks of missed work.

But others may lack paid sick leave or insurance coverage, leaving them even more vulnerable in the rare event a vaccine causes serious side effects.

Anna Kirkland, a professor of women’s and gender studies at the University of Michigan and author of Vaccine Court: The Law and Politics of Injury, says the country’s already fragmented and inequitable healthcare system makes it even more important that an injury compensation program functions efficiently.

“Vaccine injury compensation may be a last line of support for families confronting devastating or lifelong medical conditions because we don’t have a medical or social safety net that reliably keeps sick and disabled people out of poverty in this country,” Kirkland says. “Medical bills are a major cause of bankruptcies.”

That’s what Chelsea Giovanni, a mother of a high school athlete in Utah, fears. Her son Kam worked at a fast-food restaurant and figured he’d be required to get vaccinated, so he got the Pfizer jab in late September. Like Aiden, he developed myocarditis with severe chest pain and spent six days in the hospital, including treatment with intravenous immune globulin—a common therapy for myocarditis—in the cardiac ICU. He was released for light duty work a month later, but he was not cleared for sports. He missed basketball and baseball seasons and remains sidelined now as football spring training begins.

“This vaccine has screwed up any chance he had of getting a sports scholarship,” Giovanni says. Though insurance has covered about $125,000 of Kam’s $350,000 in medical bills, the company won’t pay more because his condition was caused by a vaccine. Even with financial assistance from the hospital, Giovanni can’t afford the $15,000 she owes, leaving her seeking donations.

Origin of the vaccine court

The U.S. vaccine injury compensation program has roots in the early 1980s, when a slew of lawsuits from parents alleging that their children suffered severe vaccine injuries began costing pharmaceutical companies so much money in litigation that several halted vaccine production or left the market, causing national vaccine shortages. By 1985 families were seeking a combined $3.16 billion in damages for just the diphtheria-pertussis-tetanus (DPT) vaccine—30 times that vaccine’s entire annual market share.

“It really brought home the risks to our system by not having a compensation program,” Emory’s Orenstein says.

Congress created the Vaccine Injury Compensation Program (VICP) in 1986 under the National Childhood Vaccine Injury Act, which established VICP as a “no-fault” system, funded by an excise tax on covered vaccines, to compensate families for injuries likely caused by vaccines.

“No-fault” means it’s not necessary to show wrongdoing or fault on the manufacturer’s part to receive damages, explains Dorit Reiss, a professor specializing in vaccine law at the University of California, Hastings. Families can still file suits against pharmaceutical companies for anything besides claiming the vaccine design is defective, but only after going through the vaccine court, which requires a lower level of proof to show a vaccine caused injury than standard courts do.

”The idea was to provide easier compensation for people who might have been injured,” says Dan Salmon, director of the Institute for Vaccine Safety at Johns Hopkins and a former director of vaccine safety at the National Vaccine Program Office. For the most part, experts say, that’s exactly what it’s done.

Then in 2005 President George W. Bush enacted the Public Readiness and Emergency Preparedness Act to protect pharmaceutical companies from financial liability for products developed to address public emergencies. The law bars people today from suing Pfizer, Moderna, or Johnson & Johnson for COVID-19 vaccine injury. The act also introduced the Countermeasure Injury Compensation Program (CICP) to cover any injuries arising from emergency measures, including non-routine immunizations, medical devices, and drugs.

Since COVID-19 vaccines were developed during a pandemic, they’re currently covered by the less robust CICP program, which has a lower budget than VICP and covers fewer expenses. Of more than 4,000 claims filed so far to CICP for COVID-19 vaccine injuries, the program has resolved five—all denied.

“We call the CICP program a black hole,” says Greg Rogers, a lawyer with Rogers Hofrichter & Karrah LLC in Atlanta who offered to help Emily Ekanayake file a claim pro bono. Nine months after Aiden’s vaccination, Emily still has no idea when—or if—she’ll receive any compensation for her son’s injury.

CICP versus VICP: What’s the difference?

The CICP’s track record pre-pandemic doesn’t inspire optimism. Of approximately 400 eligible cases, CICP compensated just 7 percent, totaling about $6 million. Nearly all the denied claims were related to a vaccine. VICP, meanwhile, has compensated 41 percent of resolved cases and paid out more than $4.6 billion since 1988.

But CICP was supposed to be only for interventions that are not widely distributed in the U.S., such as anthrax or Ebola vaccines, says Renee Gentry, a vaccine injury lawyer who has spent 25 years representing clients in VICP and who directs the Vaccine Injury Litigation Clinic at the George Washington University Law School. “It was never designed for something that was going to be administered to 70 percent of the American population.”

CICP’s shortcomings become especially evident in cases like that of Edmara Depaula, a mother of two in Concord, New Hampshire. After losing both her grandparents to COVID-19, Depaula overcame her uncertainty about the vaccine and decided to get it before anyone else in her household.

“I’m the healthiest one in the house, so if nothing happens to me, it will be safe for everybody else to take it,” Depaula says. “I thought I was doing the right thing.”

But the cramps, nausea, and fatigue she began feeling after the J&J vaccine never subsided. Two weeks after her vaccination, chest pain brought her to the hospital, where she spent the next nine days. Her doctors diagnosed her with postural orthostatic tachycardia syndrome (POTS), a condition affecting blood flow that isn’t well understood. One doctor suggested her symptoms could be a rare vaccine reaction and connected her with Gentry, who is helping Depaula file a CICP claim. Depaula says her health issues have completely changed her household dynamic as she struggles to do housework or play with her daughters.

“I keep asking myself, am I ever going to get better?” she says. “Am I going to one day go back to work and have a normal life? What if this is my new normal?”

Virtually no evidence links POTS with COVID-19 vaccination except a single case study, but VICP was devised to handle cases like that, Gentry says. Many vaccine injury claims filed to VICP are settled using a Vaccine Injury Table that streamlines the process for qualifying injuries. More complex cases take longer, sometimes dragging out for a decade as the court pores over the evidence to determine whether the vaccine might have caused a given condition.

Still, VICP requires the lowest standard of proof: “50 percent and a feather,” UC Hastings’ Reiss says. That is, the court rules for the plaintiff if the chance the vaccine caused the injury is just a smidge over 50 percent.

By contrast, CICP only compensates injuries if people provide “compelling, reliable, valid medical, and scientific evidence” that the countermeasure—a COVID-19 vaccine—led to the injury. That’s an ambiguous standard that David Bowman, a spokesperson for the Department of Health and Human Services, says via email is higher than the VICP one.

Unlike VICP, whose coverage includes pain and suffering up to $250,000, CICP compensates only for out-of-pocket medical expenses and lost wages up to $50,000. VICP has open proceedings and judicial appeal, but “none of those rights are available under CICP,” adds Michael Milmoe, a vaccine injury attorney at the law firm of Leah V. Durant, who spent nearly 30 years working in VICP in the Department of Justice. There’s no way to know who decides your case and no paid legal representation, whereas VICP covers all attorney costs for families seeking compensation. Claimants can appeal CICP decisions to a panel of non-CICP federal reviewers, but HHS makes the final decision. CICP doesn’t even have an injury table for COVID-19 vaccines, despite clear evidence linking them to conditions such as myocarditis and TTS that multiple experts say is sufficient for an injury table.

Lawyers who spoke with National Geographic said many people calling their offices aren’t sure whether to even file a claim to CICP without knowing whether COVID-19 vaccines will eventually be added to VICP. Adding a vaccine to VICP requires that the CDC recommend the vaccine for children or pregnant individuals—it has been since May—and that Congress pass an excise tax on the vaccine. Though the tax can be tacked onto any bill, it hasn’t been. Once added, a vaccine has a “lookback” period allowing anyone who had an injury from it in the previous eight years to file a claim.

But, “because this was a countermeasure, everything’s treated differently,” Gentry says. There’s never been a completely new vaccine added to CICP that then becomes routinely recommended. No one knows if that lookback period will apply if COVID-19 vaccines are added to VICP—or whether applying to CICP now could block additional VICP compensation later.

“We’re worried because we don’t know what to tell clients,” Milmoe says, and people are running out of time. While VICP gives people three years to file a claim after a vaccine injury occurs, CICP’s statute of limitations is just one year after receiving the vaccine—which has already passed for many people.

When asked about these questions, Bowman at HHS wrote, “We cannot speculate about future actions.”

Reform on the horizon?

Adding COVID-19 vaccines to VICP would mean more people getting the compensation they deserve, but it would also compound a problem that’s been festering for years: VICP has been sagging under its own weight with the sheer volume of claims currently in the system.

“It’s an exceptionally well-run program, but it’s not efficient right now simply because it’s overwhelmed,” Gentry says.

When the program began, VICP covered just six childhood vaccines. Since then, another 10 vaccines have been added to the schedule, including the flu vaccine administered to approximately 175 million people—mostly adults—annually. The program wasn’t designed with adults in mind, but the influenza vaccine’s addition in 2005 led to an explosion of adult claims that now outnumber child cases.

“You’re talking about loss of work, inability to support a family,” says bioethicist Caplan. “These are things that didn’t come up with kids.”

Per the 1986 law, VICP is supposed to resolve cases within a year, or 14 months at most. But it’s currently taking 12 to 16 months just to review a case to confirm all necessary documentation before the decision process even begins.

“They already have 4,000 cases and eight special masters [administrative judges who decide cases]. If COVID people start coming in, it’s going to destroy them,” Gentry says. “If you want a strong universal immunization program that people can count on, you have to have a vibrant safety net, and the safety net is about to collapse.”

Every expert who spoke with National Geographic agreed that reform for the vaccine court is long overdue. “It’s important in the middle of a pandemic that we maintain confidence in vaccines, and one way of doing that is compensating for injuries that meet the criteria,” says Saad Omer, director of the Yale Institute for Global Health. “These [processes] should be streamlined.”

U.S. Rep. Lloyd Doggett (Texas) has introduced two bills that would substantially improve vaccine injury compensation, says Gentry, who was consulted on drafting the bills.

The Vaccine Injury Compensation Modernization Act of 2021 (HR 3655) would allow vaccines recommended for adults—not just children or pregnant women—to be added to VICP. It would also increase the statute of limitations from three to five years, shorten the time required to decide cases, increase the number of special masters, and raise the maximum compensation for death or “pain and suffering and emotional distress” to $600,000 with annual inflation adjustments.

Meanwhile, the Vaccine Access Improvement Act of 2021 (HR 3656) would expedite the addition of new vaccines to VICP—including COVID-19 vaccines—by automatically adding an excise tax to vaccines when the CDC recommends them and shortening the time the HHS Secretary has to add them to VICP. Senator. Bob Casey (Penn.) is sponsoring the Senate companion bill (S. 3087).

“Significant delays up to two years have previously stalled the addition of new vaccines to the Vaccine Injury Compensation Program,” Doggett says, and automating the excise tax process resolves that problem for COVID-19 vaccines and future ones.

However, Salmon and other experts are skeptical that Congress has the stomach for reform. There’s long been historical tension between giving the vaccine court the attention, resources, and support it needs without giving legitimacy to vaccine injury conspiracy theories, says Jason Schwartz, an associate professor of public health at Yale.

“The existence of the program is often used as sort of ammunition by critics of vaccine safety,” he says. That’s especially concerning now that vaccines are a partisan issue: Polls show greater vaccine hesitancy and refusal among Republicans, and more Republican legislators support bills against vaccine mandates.

“The anti-vaccine movement, which now has political power that it never had before, would very much want to make it easier to sue pharmaceutical companies” and to eliminate the vaccine court entirely, says David Gorski, a surgical oncologist who has blogged about the anti-vaccine movement for nearly two decades.

The moral dilemma of vaccine mandates

Aside from vaccination as a public good, there’s another reason bioethicists urge compensating generously for COVID-19 vaccine injuries: Not since the smallpox vaccine have widespread mandates required adult vaccination outside a healthcare or military setting.

Cody Robinson, a 36-year-old stuntman from Atlanta, has won awards for some of his two dozen film credits. After having COVID-19 last July, Robinson didn’t see a reason to get vaccinated right away, but the Screen Actors Guild began allowing productions to require vaccines on set.

After losing several jobs worth more than $40,000 in wages, he felt “strong-armed” by his industry. “It became clear to me that the message in the industry was, if you don’t get vaccinated, you ain’t working,” he says.

Like McFadden, Robinson developed multiple blood clots after his J&J jab, including one in his jugular vein. Now, despite having encouraged his mom to get vaccinated, he feels disillusioned. Since he can’t do stunts while taking blood thinners, he’s losing more money now than before—and more than CICP’s wage cap of $50,000. “If the government’s going to force you to do something, they should provide compensation if they’re screwing you over,” he says.

Vaccine mandates raise the government’s moral obligation to generously compensate people harmed by vaccines, Caplan says. At the very least, Schwartz adds, “we should treat COVID-19 vaccines the same way we treat all vaccines that we recommend or mandate.” Without Doggett’s and Casey’s bill passing, that only happens if Congress passes the excise tax on COVID-19 vaccines. No imminent action is expected, according to a Senate Democratic aide, but the aide said it’s an important issue that Congress members will be working toward in the weeks and months ahead.

Meanwhile, the experiences of Ekanayake, McFadden, Giovanni, Depaula and Robinson have colored their attitudes toward COVID-19 vaccines.

Despite wanting to vaccinate Aiden’s younger siblings, Emily Ekanayake hasn’t done so in case there’s risk of a genetic component. McFadden isn’t filing a CICP claim for now, lest it exclude her from collecting VICP compensation later. Giovanni worries about her son’s future while she considers filing for bankruptcy. The rest of Depaula’s family aren’t comfortable getting vaccinated. And Robinson has become more outspoken in opposing vaccine mandates. Though they all recognize the importance of COVID-19 vaccination, they also feel betrayed and sidelined by the government when they did what their president asked them to.

“They hung me out to dry,” Ekanayake says. “I trusted them. I did what they said, and then you get a vaccine injury, and they’re like, I’m sorry.” Fixing the program and ensuring her family receives compensation, she asserts, would at least make her feel as though there’s accountability and a genuine belief that “we’re all in this together.”

Boost now? Boost later? Tricky calculation for a 4th coronavirus shot.

(Update 4/20/2022)

Bill and Rudi Weissinger remain covid-cautious. They’ve had three shots of the Moderna coronavirus vaccine. They wear masks at the grocery store and avoid large gatherings. When Bill recently offered a friend a fist-bump rather than a handshake, the friend said, “Oh, still?” Yes is the answer, and most of their friends in Friday Harbor, Wash. — an island community — are similarly vigilant.

The Weissingers want to get another booster shot. They’re in their mid-70s and eligible. But they also plan to travel to France later this year. Boost now? Boost later?

“Our fear is if we get the booster now, it will have faded by then,” Bill says.

“We definitely believe in the boosters. We are not anti-vaxxers. Give me any shot you can,” Rudi says.

Most Americans aren’t trying to time their next booster for an overseas vacation, and many people in low-wage jobs and crowded multigenerational households are far more exposed than the Weissingers are. But their uncertainty about a fourth shot reflects the widespread confusion about boosters — who exactly should get them, and when, and why — that has dogged the government’s vaccination campaign.

Even highly informed consumers of pandemic news may struggle to sift through the latest government guidance and newest scientific studies. And even at this stage in the crisis, they may be unclear on what additional boosters can and can’t do.

Public health officials who authorized a second booster shot last month for people 50 and older and for immunocompromised people 12 and older have insisted it’s a stopgap, aimed primarily at keeping the most vulnerable people out of the hospital or the cemetery. A second booster appears to add to protection against severe illness in people 60 and older but offers only a modest, temporary shield against infection.

The booster issue reveals some tension between public health priorities and individual interests. The disease experts worry about epidemic waves that can overwhelm the health-care system. To a doctor, a vaccine has worked fine if it keeps a person out of the hospital, with just a mild to moderate case — which can mean anything from a few sniffles to a miserable week in bed utterly flattened by the virus. Many people, though, don’t want that bad week — with the attendant risk of long covid — and will do anything to keep it off their calendar.

“I think the expectations [from] the first performance of the vaccines is that it is possible to be completely protected against infection, or any small cough even,” Hanneke Schuitemaker, head of viral vaccine development and translational medicine at Janssen, a division of Johnson & Johnson, said at a recent forum held by the New York Academy of Sciences.

The reality is that a person who is up to date on vaccination is very unlikely to wind up in the hospital, although the virus may still be able to break through the initial line of immune defense and generate sickness.

“You may have sort of a common cold, but your immune system will deal with it and prevent severe disease,” Schuitemaker said.

Even as many people rush to get a fourth shot, many others still haven’t received their third, second or first. Despite clear evidence that a third shot can save lives and better protect people, more than 90 million eligible people in the United States haven’t rolled up their sleeves for their first booster. Booster uptake has been higher among White people than in communities of color.

Medical advisers to the federal government have debated the necessity and ethics of a fourth shot given that there are higher public health priorities, including reaching unvaccinated communities and ensuring wider global access to vaccines. But in their late March authorization, federal agencies said people 50 and older could get an additional booster it they are at least four months past their previous shot.

Strikingly, the agencies did not clearly recommend that booster for everyone who is eligible, and federal officials’ advice varies.

Rochelle Walensky, director of the Centers for Disease Control and Prevention, said people 65 and older and those 50 and older with underlying medical conditions are most likely to benefit. Ashish Jha, White House covid-19 response coordinator, told “Fox News Sunday” the data were “pretty compelling” for people older than 60 to get a second booster. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said on MSNBC that people older than 50 should get a fourth shot.

Data from Israel, which offered fourth shots to people 60 and older during the omicron surge, show that the additional shot increases protection against severe illness and death compared with a third shot. But against infections — most of which are officially deemed “mild” — a fourth shot provided only a modest and brief increase in protection, peaking at four weeks after the booster dose and dropping back to the baseline after eight weeks.

“These findings suggest that protection against confirmed infection wanes quickly,” the researchers concluded.

“I was shocked,” said Robert M. Wachter, chair of the department of medicine at the University of California at San Francisco. He said he thought the additional protection against infection from the fourth shot would mirror that of the third rather than be so brief.

If the forth shot offers a relatively brief window of higher protection, he said, timing that booster according to plans — a wedding, a family reunion, visiting an elderly relative, a vacation — seems reasonable. But it’s not an easy calculation, he said, because there are so many factors in the equation.

“There’s no perfect plan. You’re weighing risks, benefits, uncertainties, your own personal circumstance,” Wachter said. “I do this for a living, and I get a headache when I try to think this through.”

Risk analysis is not the strong suit of most people. Guidance from the CDC about the risk of infection has not always been clarifying. The risk on any given day depends a great deal on the current level of community transmission, but that data may not be easily found or interpreted and could be out of date.

And the virus itself is not a fixed entity. The omicron variant is more transmissible than earlier forms of the virus, and there is now a growing roster of omicron subvariants, including BA.2, which are more transmissible yet. As it mutates, the virus has become more evasive of the human immune system.

The result is that an individual’s risk analysis — is it safe, on this day, with this level of community transmission of this latest omicron subvariant on the prowl, to dine indoors at a restaurant? — is thoroughly contaminated with guesswork, wishful thinking and/or fear.

There is no simple test of an individual’s protection. There isn’t a line in the sand — what experts call a “correlate of immunity” — that means someone is immune or not immune, or is or isn’t likely to end up in a hospital bed.

Antibodies may have become the public face of the immune system, to the detriment of public understanding. Antibodies naturally drop after most vaccinations, but protection against the worst outcomes clearly persists longer, because ofthe multifaceted way immunity works.

T cells provide a layer of immune defense and stick around in the body for at least six months, with only modest erosion. Memory B cells persist and kick into action to churn out virus-fighting antibodies through what is called a “recall response.”

Neutralizing antibodies wane naturally — the body doesn’t want to arm itself endlessly with battalions of defenders against a hypothetical invader — and in the case of covid, they wane more quickly than some disease experts had hoped two years ago.

The boosters authorized to date are identical to the first vaccines. Those shots were designed to deal with the original Wuhan strain of the coronavirus, which has since evolved into an array of slippery variants.

This confusion about the goal of vaccination — and thus when shots should be considered to be failing — even extends to the experts as they debate the long-term booster strategy for the public.

“At what point will we say the vaccine isn’t working well enough?” asked H. Cody Meissner, a pediatric infectious-diseases specialist at Tufts Medical Center in Boston at a recent federal advisory committee meeting.

“What is enough? What is our expectation?” CDC official Amanda Cohn asked. “Given that our effectiveness against hospitalization in immunocompetent individuals is over 80 percent — and that’s in older adults and persons with chronic medical conditions — I think we may have to accept that level of protection and then use other alternative ways to protect individuals with therapeutics and other measures.”

Vaccine expert Paul A. Offit at Children’s Hospital of Philadelphia argues that it was a mistake to call mild and asymptomatic infections “breakthroughs.” The immunity mustered by current vaccines is not expected to protect against all infections.

“The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus,” Offit wrote in a recent perspective piece in the New England Journal of Medicine.

The decision about when, whether and who to boost has also been complicated by imperfect data. A widely quoted CDC study showed that protection against severe illness from three shots waned over four months, from 91 percent to 78 percent.

What was lost in the messaging was that those who had been vaccinated for more than four months in that study were primarily people with poorly functioning immune systems, who typically respond less well to vaccination. When the data was instead limited to people with functioning immune systems, there was little evidence that protection against hospitalization was waning among people 65 and older, according to data presented by Ruth Link-Gelles, part of the CDC’s Epidemiology Task Force at a federal advisory committee meeting this month.

The Food and Drug Administration’s decision on boosters came amid skepticism from some vocal members of the scientific community, who would like to see more data showing it is necessary.

“We’re very much on board with the idea that we simply can’t be boosting people as frequently as we are, and I’m the first to acknowledge that this additional fourth booster dose that was authorized was a stopgap measure,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a meeting where experts debated future boosters.

The debate continued Wednesday when a CDC advisory committee held a virtual meeting at which members discussed who should get an additional booster. Breaking with typical CDC practice, Walensky did not wait for that advisory committee to weigh in before issuing guidance supporting the extra booster for people 50 and older. The committee on Wednesday did not make any new recommendations beyond current CDC guidance.

The FDA is also developing strategies for the rest of the year and trying to decide under what circumstances the vaccines should be modified to deal with variants. Vaccine companies are testing alternative formulas and delivery systems.

The booster debate comes as many scientists say that what the world needs are vaccines that would provide a broader blanket of immunity to respond to whatever the virus evolves into.

“Instead of more boosts of the same original thing, I think we need to use a better vaccine,” said Erica Saphire, president and CEO of the La Jolla Institute for Immunology.

Kristian Andersen, an immunologist at Scripps Research, has contended that people need to be boosted every six months or so.

“We just need to realize that immunity, unfortunately, wanes pretty quickly,” Andersen said. “We don’t want that to be true. We want lifelong immunity. We want measles-type immunity.”

He said that is wishful thinking at the moment.

“Our default assumption should be that we need to broaden immunity. If we don’t, the virus will bypass immunity even more than it has already with omicron. … But we’re not planning for that,” Andersen said. “Our entire response to this has been based on equal measure hope and wishful thinking, and that continues to this day.”

FDA authorizes COVID-19 vaccines for kids under five

Good news has finally arrived for the parents of approximately 18 million children under five years old who have remained ineligible for COVID-19 vaccines. The long wait is now over: This morning, the U.S. Food and Drug Administration authorized the use of low-dose Pfizer and Moderna vaccines for kids between six months through four years of age.

These shots are likely to be rolled out as early as next week. All U.S. states except Florida pre-ordered the pediatric doses. “There’s not going to be any state programs that are going to be trying to get COVID jabs to infants, and toddlers, and newborns,” Florida governor Ron DeSantis said at a press conference on Thursday. “That’s not where we’re going to be utilizing our resources.”

Although the federal government has been able to purchase these vaccines for the youngest kids, it won’t be able to buy the updated jabs that could provide better protection against Omicron when they become available for adults this fall. Ongoing negotiations for a $10 billion COVID-19 response funding, which have been stalled in Congress for months, continue to lose momentum. This is happening as two relatively new and more transmissible versions of Omicron, BA.4 and BA.5, spread across the country, now accounting for about 21 percent of the genetically sequenced samples collected between June 4 and June 11.

Some Vaccines Last a Lifetime. Here’s Why Covid-19 Shots Don’t.

Researchers have calculated a key number—the threshold of protection—for other vaccines. Covid-19’s is still a mystery.

(Update 7/2/2022)

Recent studies have shown that the effectiveness of Covid-19 vaccines is decreasing, though experts say the shots still work well. WSJ explains what the numbers mean and why they don’t tell the full story.

Why don’t Covid-19 vaccinations last longer?

Measles shots are good for life, chickenpox immunizations protect for 10 to 20 years, and tetanus jabs last a decade or more. But U.S. officials are weighing whether to authorize Covid-19 boosters for vaccinated adults as soon as six months after the initial inoculation.

The goal of a vaccine is to provide the protection afforded by natural infection, but without the risk of serious illness or death.

“A really good vaccine makes it so someone does not get infected even if they are exposed to the virus,” said Rustom Antia, a biology professor at Emory University who studies immune responses. “But not all vaccines are ideal.”

The three tiers of defense, he said, include full protection against infection and transmission; protection against serious illness and transmission; or protection against serious illness only.

The effectiveness depends on the magnitude of the immune response a vaccine induces, how fast the resulting antibodies decay, whether the virus or bacteria tend to mutate, and the location of the infection.

The threshold of protection is the level of immunity that’s sufficient to keep from getting sick. For every bug, it’s different, and even how it’s determined varies.

Windows of immunity for selected vaccines

Sources: San Francisco Department of Public Health (hepatitis A); National Institutes of Health (human papillomavirus); Centers for Disease Control and Prevention (tetanus, typhoid, influenza, Covid-19)

“Basically, it’s levels of antibodies or neutralizing antibodies per milliliter of blood,” said Mark Slifka, a professor at Oregon Health & Science University.

(T-cells also contribute to protection, but antibodies are easier to measure.)

A threshold 0.01 international units per milliliter was confirmed for tetanus in 1942 when a pair of German researchers intentionally exposed themselves to the toxin to test the findings of previous animal studies.

“One of them gave himself two lethal doses of tetanus in his thigh, and monitored how well it went,” Dr. Slifka said. “His co-author did three lethal doses.”

Neither got sick.

A threshold for measles was pinned down in 1985 after a college dorm was exposed to the disease shortly after a blood drive. Researchers checked antibody concentrations in the students’ blood donations and identified 0.02 international units per milliliter as the level needed to prevent infection.

A healthcare worker prepared a dose of the Pfizer-BioNTech Covid-19 vaccine at a mobile vaccination clinic in Los Angeles last month.PHOTO: JILL CONNELLY/BLOOMBERG NEWS

With these diseases, the magnitudes of response to the vaccines combined with the antibodies’ rates of decay produce durable immune responses: Measles antibodies decay slowly. Tetanus antibodies decay more quickly, but the vaccine causes the body to produce far more than it needs, offsetting the decline.

“We’re fortunate with tetanus, diphtheria, measles and vaccinia,” Dr. Slifka said. “We have identified what the threshold of protection is. You track antibody decline over time, and if you know the threshold of protection, you can calculate durability of protection. With Covid, we don’t know.”

Historically, the most effective vaccines have used replicating viruses, which essentially elicit lifelong immunity.

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Measles and chickenpox vaccines use replicating viruses.

Non-replicating vaccines and protein-based vaccines (such as the one for tetanus) don’t last as long, but their effectiveness can be enhanced with the addition of an adjuvant—a substance that enhances the magnitude of the response.

Tetanus and hepatitis A vaccines use an adjuvant.

The Johnson & Johnson and AstraZeneca Covid-19 vaccines use non-replicating adenovirus and don’t contain an adjuvant. The Pfizer and Moderna messenger RNA Covid-19 vaccines, which work differently, don’t contain any virus at all. 

Complicating things further, viruses and bacteria that mutate to escape the body’s immune response are harder to control.

Measles, mumps, rubella and chickenpox hardly mutate at all, but at least eight variants of SARS-CoV-2, the virus that causes Covid-19, have been found, according to the British Medical Journal.  

“It does make it more complicated for the vaccine to work,” Dr. Slifka said. “You’re chasing multiple targets over time. Flu also mutates. With flu, we’ve adjusted by making a new flu vaccine each year that as closely as possible matches the new strain of flu.”

Flu vaccines can offer protection for at least six months.

Setting aside the complexities of crafting an effective vaccine to combat a shape-shifting virus, some hope has revolved around the possibility of defeating Covid-19 by achieving herd immunity, but, according to Dr. Antia, the way coronaviruses infect the body makes that challenging.

“Vaccines are very unlikely to lead to long-lasting herd immunity for many respiratory infections,” Dr. Antia said. “The herd immunity only lasts for a modest period of time. It depends on how fast the virus changes. It depends on how fast the immunity wanes.”

Part of the problem is that coronaviruses replicate in both the upper and lower respiratory tracts.

“We have good circulation in our lungs and body, but not on the surfaces of our nostrils,” Dr. Slifka said. “We can block severe disease because there are antibodies in the lower respiratory tract.”

But the risk of low-level infections in the upper respiratory tract can persist.

Moving forward, Covid-19 vaccines will be updated to combat variants of the virus, and according to researchers at Imperial College London, the next generation of vaccines might also focus on enhancing immunity in the moist surfaces of the nose and lungs.

In the meantime, avoiding the slippery virus might require another shot.

Multiple COVID infections can lead to chronic health issues. Here’s what to know.

A previous SARS-CoV-2 infection can protect you for a little while, but the immunity wanes—and each new infection, no matter how mild, takes a toll on your body.

(Update 9/14/2023)

Mehnaz Qureshi has caught COVID-19 seven times, despite being fully vaccinated and boosted. A veterinarian and a virologist at The Pirbright Institute in England, she first caught the disease in March 2020 when the COVID-19 pandemic was just beginning; then everyone in her family got sick.

While Qureshi’s own symptoms were mild, her family members fared worse—some requiring hospitalization and supplemental oxygen to breathe. As the mother of two children and the family’s primary care giver she didn’t have much time to think, or treat, her own symptoms. “I almost forgot about myself,” says Qureshi. But COVID-19 hadn’t forgotten her.

“For me, it has been just four to six months of window between each reinfection,” says Qureshi. Aside from disrupting her life seven times, her symptoms during subsequent reinfections have been more severe.

While a previous SARS-CoV-2 infection can protect against a reinfection for an average of seven months, the immunity wanes afterwards. Repeated bouts of COVID-19 are harmful—even if the episodes are mild—because the long-term consequences add up for each additional infection, as demonstrated in a study of U.S. veterans. While veterans don’t necessarily reflect the broader public—because they tend to be older, white, and male—the research shows that patients who were reinfected with any SARS-CoV-2 variant are much more likely to develop chronic health issues like diabetes, kidney disease, organ failure, and even mental health problems.

Qureshi’s first infection was mild, with a fever that lasted a couple of days, aches, and cold symptoms, she recalls. “My major symptom was that I lost smell and taste.” But the most recent infection was disabling. She was bedridden for a week, could barely stand, and had severe cognitive impairment. “I couldn’t think straight,” says Qureshi. “The most recent one was really bad.”

With reinfections rising it is good news that the U.S. Food and Drug Administration approved Pfizer’s and Moderna’s new COVID-19 boosters on September 11. The preliminary data from Moderna, which has not yet been peer reviewed and published, shows that the XBB.1.5 based booster, which could be available to the public as soon as this week generates ample levels of antibodies not only against the latest highly mutated Omicron BA.2.86 variant, but also against other currently circulating strains, EG.5.1 and FL.1.5.1. 

After the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices met yesterday and voted in favor of the new shots, CDC director Mandy Cohen signed off on the panel’s recommendations. “CDC is now recommending updated COVID-19 vaccination for everyone six months and older to better protect you and your loved ones.” 

“I certainly recommend at all of my preventative visits that patients complete their primary COVID series and stay up to date on the boosters,” says Natalie Paul, a family nurse practitioner at Lavender Spectrum Health in Longview, Washington. While vaccines and boosters may not block new or reinfections, they provide a strong protection against serious complications or hospitalization. “I personally would get it myself.”

Soaring reinfection rates

The CDC defines a reinfection as when someone tests positive for SARS-CoV-2—the virus that causes COVID-19—on a PCR test 45 days after recovering from a previous confirmed infection. In the United States, about 2.7 percent of all reported COVID cases during the Delta variant surge in late 2021 were reinfections. But the problem became significantly worse when Omicron emerged, and its more infectious subvariants became dominant.

A CDC analysis of lab-confirmed, adult COVID cases between September 2021 and December 2022, found that reinfection rates jumped to 10.3 percent during the Omicron BA.1 wave; 12.5 percent when BA.2 was dominant; 20.6 percent during BA.4/BA.5; and 28.8 percent during the BQ.1/BQ.1.1. The good news is that a meta-analysis of 91 published studies showed that vaccination lowered the risk of getting reinfected, although vaccines became less efficient in preventing reinfections against Omicron variants.

But the numbers of reinfections are likely to be underestimated because not everyone who gets infected with SARS-CoV-2 gets sick enough to get tested. Since reinfection often generates somewhat milder symptoms, it is even more difficult to fully assess the true tally. Being a virologist, Qureshi frequently takes COVID tests when she suspects something is off, and that’s why she knows she has had frequent re-infections.

A Canadian study estimated that 40 percent of people who had antibodies in their blood—proof that they had been infected with SARS-CoV-2—had not experienced any symptoms in the previous six months and were unaware they had gotten the disease.

Studies from various other countries also suggest that reinfection rates can range from 5 percent to 15 percent. An analysis of COVID-19 cases in Serbia, for example, found that risk of getting reinfected has steadily increased during the pandemic, but it spiked after the arrival of Omicron variants in December 2022.

Who is most likely to get reinfected?

People who work in jobs with a lot of face-to-face contact, such as teachers and other school employees, healthcare professionals, and those who live in multigenerational households often have frequent recurrent COVID infections, says Paul. For example, healthcare employees working in COVID-19 clinical units can have a four-fold higher risk of getting reinfected relative to those working in non-clinical units.

Studies show that the risk of someone getting COVID-19 are much higher among families with young children. In fact, over 70 percent of nearly 850,000 U.S. households might have caught COVID-19 through a child during the school year.

“I now treat a lot of people with multiple COVID infections,” says nurse Paul. “A lot of them have risk factors like having young children in the school system.”

Christine Micheel, like Qureshi, is also a mother of two young children. She first got COVID-19 in December 2020 just before vaccines became available. However, even after getting fully vaccinated and boosted, she ended up getting COVID-19 again in July 2022 during the BA.5 Omicron wave. Her son also got infected three times, while her daughter has caught it twice, although both children were fully vaccinated at the time.

“Their symptoms were so minor, I think only I, as their mother, could have noticed them as unusual and given them a test,” says Micheel, a cancer researcher at the Vanderbilt-Ingram Cancer Center in Nashville.

With schools reopening amidst rising numbers of COVID-19 cases, children might unknowingly be spreading the disease to their households. “How many kids have probably been walking around spreading COVID-19 with no one the wiser?” says Micheel.

The antibodies against SARS-CoV-2 wane substantially within three months, especially in patients with less severe symptoms. However, immune response to a previous infection, or vaccine, can vary a lot between individuals.

“Nobody is immune to this,” says Qureshi. “Sooner or later, you will get an infection.”

It’s good to feel bad after your COVID shot

(Update 10/19/2023)

Jeremy Warner has had six shots of the COVID vaccines. He’s an oncologist at Brown University in Providence, Rhode Island, where he treats immunocompromised patients with cancer who are especially vulnerable to COVID-19. To keep his patients safe, Warner rolls up his sleeves as soon as the U.S. Food and Drug Administration recommends a new vaccine, but he dreads the aftermath. “Each time I’m like, oh my God, I can’t do this again!”

After each COVID shot Warner gets a fever, headaches, shaking chills, and painful, swollen joints along with the expected tenderness at the site of injection. “The worst was the second shot that lasted two or three days,” recalls Warner. “This recent round, maybe one or two days.”

The good news: new research shows that more side effects might be beneficial because they reflect greater production of virus-fighting antibodies after vaccination.

“The more symptoms people reported, the higher their antibody levels were,” says Aric Prather, a clinical psychologist at the University of California San Francisco, who led the study.

Fear of reactions make some people hesitant to get a COVID shot and a third of adults in one study blamed vaccine side effects for not taking the bivalent boosters last winter that targeted two strains—the original SARS-CoV-2 virus and an Omicron subvariant.

“[But] the side effects show the vaccine is working,” says Drew Weissman, an immunologist at the University of Pennsylvania, whose research led the development of the mRNA vaccines, including Moderna’s and Pfizer’s. Weissman and Katalin Karikó were recently awarded the 2023 Nobel Prize in Physiology or Medicine for their work on modifying mRNA. 

COVID-19 vaccines are overwhelmingly safe and effective. Fewer than 1 percent of the 10.1 million U.S. respondents who have completed health surveys through the Centers for Disease Control’s V-safe program—launched in December 2020—have reported needing a medical care after vaccination.

But mRNA vaccines are among the most painful of vaccines, comparable to the shingles vaccine. Scientists don’t yet know why. “There’s still a lot that’s being learned about the side effects of mRNA vaccines,” says Deborah Fuller, a vaccinologist at University of Washington School of Medicine, Seattle. Fuller is attempting to develop next generation of nucleic acid vaccines and hopes they will be better tolerated.

Side effects after jab indicate high antibody levels 

During COVID-19 vaccine trials, between 50 and 90 percent of participants reported chills, fatigue, headache, and malaise, and more than 30 percent of vaccinated people experience some discomfort.

About 70 percent of V-safe respondents reported pain at the injection site; fatigue was the most common side effect in the first week after receiving the vaccine.

Prather wanted to know whether psychological, behavioral, or biological symptoms could predict the vaccine response. To address the question, he recruited 364 adults to donate blood samples before their first dose of a COVID vaccine, and then again donate samples one and six months after getting two doses of an mRNA vaccines. Prather and his colleagues measured the level of antibodies in volunteers’ blood; not just the ones that react with the spike protein used in the vaccine, but also the “neutralizing antibodies” that suppress the original SARS-CoV-2 virus.

The scientists compared the levels of antibodies against the volunteers’ self-reported symptoms—such as chills, feeling tired, feeling unwell, headache, pain at the injection site—over seven days. They found that when the worst symptoms occured after the second shot it was associated with higher antibody levels.

Though the symptoms may be unpleasant, our data and other studies provide evidence that your immune system is doing what it needs to do, says Prather. “That’s a good thing.”

Although the new study is not yet peer reviewed, it is consistent with previous research.

“Generally speaking, if you develop more symptoms, you have a better antibody response,” says Kevin Dieckhaus, an infectious diseases specialist at UConn Health, in Farmington, Connecticut. Dieckhaus’s own research has shown that people who experience COVID-19 vaccine-associated symptoms develop longer lasting immunity.

Mild to moderate symptoms after the flu vaccine also lead to reduced hospitalizations or death. “Our study suggests that some adverse reactions can be viewed as a good sign of the body’s appropriate response to COVID vaccines as well,” says Orly Vardeny, a clinical pharmacist researcher at the University of Minnesota Medical School who led the influenza vaccine study but was not involved with the latest COVID-19 research.

Studies also show that compared to those who only have localized pain or itchiness around the injection site, people reporting symptoms all over the body (fever, chills, muscle pain, nausea, vomiting, headache, and/or moderate to severe fatigue) generate greater antibody response.

Measuring post vaccine discomfort 

In the new study, unlike previous ones that only relied on self-reporting of symptoms—which can vary because of individual perceptions of symptom intensity—some participants wore a digital ring for about two months during which they got their COVID jabs. This wearable device measures heart and breathing rate, and body temperature, indicators of sleep patterns and stress. Skin temperature and heart rate increases predicted antibody levels following the second but not the first vaccine dose.

“The symptoms add up, and more symptoms in response to the vaccines seem to be associated with the greater durability of neutralization antibody levels,” says Prather.

However, researchers warn that the study doesn’t imply that people without symptoms are not protected.

“In fact, there were lots of people that reported low symptoms or no symptoms and had high neutralizing antibody titers,” says Prather. An earlier research has shown that 98 percent of people who had mild to no symptoms at all after vaccination still produced sufficient antibodies, compared with 99 percent of those who had more severe symptoms.

While milder symptoms may be associated with lesser mobilization of immune system upon vaccination, and potentially lower levels of anti-SARS-CoV-2 antibodies, this does not mean that the vaccine response is going to be less effective or less protective against viral disease, says Florian Douam, an immunologist at Boston University Chobanian & Avedisian School of Medicine.

It is also unclear if the relationship between symptom intensity and antibody response would be same for subsequent doses, and for more current variants. “Because people are experiencing the same sort of symptoms, perhaps these patterns would also be true as people get boosters,” Prather speculates.

It’s not yet clear why some people get different levels of antibodies after a specific vaccination, or why some develop more adverse effects such as more pain or more fever. It is also not clear why some can develop sufficient protection, even without developing the bad symptoms, says Alexander Ploss, an infectious disease biologist and virologist at Princeton University.

Factors such as age, gender, and if someone has ongoing infection or disease, may play a role in affecting the symptom intensity, Douam says.

Ploss and Douam have shown that some “protection-defining genes” affect why some people get sicker than others from COVID-19. In the event of a real infection, these genes ensure a rapid mobilization of multiple arms of the immune system to help control and clear infection, says Douam. But whether these genes could be involved in how people respond differently to vaccines is not yet known.

Despite a possibility of uncomfortable symptoms, scientists emphasize people should not be afraid of vaccines. But if someone gets very serious symptoms after getting vaccine, they must seek medical advice, cautions Prather.

“The risks of contracting COVID, or potentially a much more severe illness is probably far worse than the unpleasant symptoms that people experience when they get a vaccination,” says Prather.

While Warner, the oncologist at Brown University, loathes getting each COVID shot he emphasizes, “It’s not just for me, but also for my patients and loved ones who I come in contact with.”

Resources:

mayoclinic.org, “COVID-19 (coronavirus) vaccine: Get the facts,”cnn.com, “These 3 Covid-19 vaccines have been in the news. Here’s what you need to know about them,” By Theresa Waldrop; nih.gov, “Fourth large-scale COVID-19 vaccine trial begins in the United States: Trial evaluating investigational Janssen COVID-19 vaccine;” nationalgeographic.com, “Why vaccine side effects really happen, and when you should worry,: By Linda Marsha; nationalgeographic.com, “Heart problems after vaccinations are very rare—and often resolve quickly,” By Emily Sohn;

nationalgeographic.com, “Why Is Hesitancy Rising As Vaccines Get Better?”, By Victoria Jaggard; nationalgeographic.com, “Vaccines are highly unlikely to cause side effects long after getting the shot: Science shows that even the most serious side effects for any vaccine, including COVID-19, occur within just a few weeks,” BY MERYL DAVIDS LANDAU;

nationalgeographic.com, “Scientists say COVID-19 booster shots aren’t needed yet—here’s why: For the fully vaccinated, the Pfizer shot generates an immune response that could last years and is protective against severe disease and death.” BY AMY MCKEEVER; morningwire.com, “COVID Vaccine Mandates Are Coming;” dailywire.com, “SHAPIRO: When Does The COVID-19 Panic End?, By Ben Shapiro; theconversation.com, ” What is a breakthrough infection? 6 questions answered about catching COVID-19 after vaccination, ” By Sanjay Mishra, PhD; nationalgeographic.com, “People who already had COVID-19 should still get vaccinated, scientists urge: Vaccines boost natural immune responses and have an amazing track record of preventing serious illness and death.” BY JILLIAN KRAMER; nationalgeographic.com, “Why kids are still waiting for their COVID-19 vaccines: The FDA has asked companies to expand clinical trials in children ages 5 to 11 after reports of rare side effects in young adults. But as the more transmissible Delta variant drives a fourth surge, parents are getting anxious.” BY AMY MCKEEVER; nationalgeographic.com, “Who qualifies for a coronavirus booster shot? Why it’s still unclear. While people with immune-compromising conditions rejoice over the FDA decision, may questions remain unanswered.” BY TARA HAELLE;

nature.com, “Decades-old SARS virus infection triggers potent response to COVID vaccines: Dramatic antibody production in people infected during the 2002–04 outbreak furthers hopes of a vaccine against many coronaviruses.” By Smriti Mallapaty; nature.com, “COVID vaccines protect against Delta, but their effectiveness wanes: Massive UK study of COVID-19 cases shows that people who are jabbed have good immunity at first, but quickly become more vulnerable to the fast-spreading Delta variant.” By Katharine Sanderson; nationalgeographic.com, “Evidence mounts that people with breakthrough infections can spread Delta easily: A new study finds that this dominant variant can grow in the noses of vaccinated people as strongly as in unvaccinated people.” BY SANJAY MISHRA; Nationalgeographic.com, “What full FDA approval of Pfizer’s vaccine means for the course of the pandemic: Scientists say this decision is “a huge milestone” that clears the way for vaccine mandates and booster doses—and may persuade more unvaccinated people to get a shot.” BY AMY MCKEEVER;

nationalgeographic.com, “Why you may not need a COVID-19 booster yet after all: Given what we know about breakthrough infections, most experts remain unconvinced there’s enough data to justify an extra dose for most Americans.” BY AMY MCKEEVER; nationalgeographic.com, “Why the CDC and FDA only approved booster shots for some Americans: Given what we know about breakthrough infections, most experts remain unconvinced there’s enough data to justify an extra dose for most Americans.” BY AMY MCKEEVER; scientificamerican.com, “Pregnant and Unvaccinated: Delta’s Deadly Toll: The number of pregnant people suffering from severe COVID is preventable tragedy,” By Carolyn Barber; scientificamerican.com, “COVID Vaccines Show No Signs of Harming Fertility or Sexual Function: The novel coronavirus, in contrast, can disrupt both things in unvaccinated men and women”, By Emily Willingham; nature.com, “COVID super-immunity: one of the pandemic’s great puzzles: People who have previously recovered from COVID-19 have a stronger immune response after being vaccinated than those who have never been infected. Scientists are trying to find out why.” By Ewen Callaway;

nationalgeographic.com, “Should you mix and match COVID-19 vaccines? Experts weigh in. While not yet authorized, small trials suggest some booster combinations are not only safe, they may yield better protection.” BY MERYL DAVIDS LANDAU; nationalgeographic.com, “Why the CDC and FDA only approved booster shots for some Americans: Given what we know about breakthrough infections, most experts remain unconvinced there’s enough data to justify an extra dose for most Americans.” BY AMY MCKEEVER; nature.com, “What COVID vaccines for young kids could mean for the pandemic: As US Food and Drug Administration advisers recommend authorizing shots for children aged 5 to 11, researchers predict what this might mean for populations.” By Max Kozlov; nationalgeographic.com, “What to expect with COVID-19 vaccines for kids ages 5 to 11: Here’s what the science reveals about the safety of the Pfizer shot for this age group, the doses involved, and the role it will play in protecting everyone from the disease.” BY MERYL DAVIDS LANDAU; nature.com, “Why scientists worldwide are watching UK COVID infections: The country’s relaxation of measures such as masking — especially in England — is showing the limits of relying on vaccines alone.” BY Luke Taylor; dailywire.com, “Biden Vaccine Mandate For Private Employers: Everything You Need To Know,: By Ben Johnson; dailywire.com, “The Daily Wire Challenges Biden Administration Vaccine Mandate,” By Tim Pierce;

nationalgeographic.com, “Why kids under 5 still can’t get a COVID-19 vaccine: After disappointing results from clinical trials last year, vaccine companies are working to make the shots more effective. Here’s where the science stands now.” BY AMY MCKEEVER; ature.com, “Long-COVID symptoms less likely in vaccinated people, Israeli data say: People who’ve both been vaccinated and had COVID-19 are less likely to report fatigue and other health problems than unvaccinated people.” By Freda Kreiser; nationalgeographic.com, “Why is it so hard to compensate people for serious vaccine side effects? Though very rare, complications from shots can shatter lives and trust. Now the federal programs designed to help them are struggling with COVID-19.” By Tara Haelle; washingtonpost.com, “Boost now? Boost later? Tricky calculation for a 4th coronavirus shot.” By Joel Achenbach and Carolyn Y. Johnson; nationalgeographic.com, “FDA authorizes COVID-19 vaccines for kids under five.”; wsj.com, “Some Vaccines Last a Lifetime. Here’s Why Covid-19 Shots Don’t. Researchers have calculated a key number—the threshold of protection—for other vaccines. Covid-19’s is still a mystery.” By Jo Craven McGinty;

nationalgeographic.com, “Multiple COVID infections can lead to chronic health issues. Here’s what to know.” By Sanjay Mishra; nationalgeographic.com, “It’s good to feel bad after your COVID shot.” By Sanjay Misha;

Addendum

(Update 8/25/2021)

covid links
https://common-sense-in-america.com/2020/06/08/mask-or-no-mask-for-covid-19/
https://common-sense-in-america.com/2020/10/14/why-is-the-coronavirus-so-confusing/
https://common-sense-in-america.com/2020/10/14/the-corona-virus-exposed/
https://common-sense-in-america.com/2020/10/09/masks-how-they-work/
https://common-sense-in-america.com/2020/10/01/is-dr-fauci-a-devil-or-an-angel/
https://common-sense-in-america.com/2020/09/30/fauci-and-hiv-and-now-coronavirus-sounds-like-dejavu/
https://common-sense-in-america.com/2020/09/16/covid-19-manufactured-or-altered-that-is-the-question/
https://common-sense-in-america.com/2020/09/10/president-trump-acted-appropriately-and-in-a-timely-manner-with-regards-to-covid-19-part-1-of-2/
https://common-sense-in-america.com/2020/09/10/president-trump-acted-appropriately-and-in-a-timely-manner-with-regards-to-covid-19-part-2-of-2/
https://common-sense-in-america.com/2020/08/11/no-hazard-pay-for-covid-19-front-line-medical-professionals-while-hospitals-get-rescue-money/
https://common-sense-in-america.com/2020/07/18/covid-19-just-the-facts-please/
https://common-sense-in-america.com/2020/07/13/releasing-prisoners-early-for-covid-considerations-sets-a-bad-precedent/
https://common-sense-in-america.com/2020/06/16/hydroxychloroquine-is-it-the-medication-of-the-devil/
https://common-sense-in-america.com/2020/06/10/how-covid-19-is-spread-who-needs-who/