The Covid-19 Vaccine, Safe or Unsafe?

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.

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?

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.

(Updated 7/15/2021)

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

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 PfizerModerna, 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.”

(Updated 7/19/2021)

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, “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;

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