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.
Table of Contents
-Why Are People Afraid Of Vaccines?
–Where does a fear of vaccines come from?
–COVID-19 Vaccine Distrust: Why It’s High, and How to Respond to It
–Fear of Adverse Effects and COVID-19 Vaccine Hesitancy
–Why do parents worry about vaccines?\
-Who isn’t getting vaccinated, and why
–Needle Fear Is an Underrecognized Vaccination Challenge
–VACCINE MYTHS DEBUNKED
–Anti-Vaccine Activists Use A Federal Database To Spread Fear About COVID Vaccines
-China and India approve nasal COVID vaccines — are they a game changer?
–Moral Courage and Our Common Future
–Spate of polio outbreaks worldwide puts scientists on alert
-Afraid of needles? China using inhalable COVID-19 vaccine
-HUGE NUMBER OF WOMEN MISCARRIED FOLLOWING COVID VACCINE, DATA CONFIRMS
-COVID can trigger tinnitus. Could the vaccines do the same?
–How do vaccines work?
–5 Tips for Handling COVID-19 Vaccine Anxiety
-Weighing the risks and benefits of vaccines
-History Shows Americans Have Always Been Wary of Vaccines
-How the CIA’s fake Hepatitis B vaccine program in Pakistan helped fuel vaccine distrust
–CIA’s hunt for Osama bin Laden fueled vaccine hesitancy in Pakistan
–Why polio is making a comeback
-COVID vaccine hoarding might have cost more than a million lives
-The next generation of coronavirus vaccines: a graphical guide
Why Are People Afraid Of Vaccines?
Within medicine, few technologies have had more impact than vaccines. Each year they prevent more than 3 million childhood deaths worldwide from diphtheria, tetanus, pertussis and measles, to name a few. Vaccines, such as those for HPV and Hepatitis B, have extended those preventative benefits for young and mature adults. And now a new generation of vaccines, ones that harness a body’s immune system to treat disease rather than prevent it, are moving through clinical trials and into the marketplace.
Yet for all their existing benefits and future potential, vaccines are still bedeviled by problems of perception and adoption. Patients can be suspicious of vaccines or confused by them, or they can fall into complacency, believing that certain diseases are no longer a threat. Regardless, the overall efficacy of vaccines is largely dependent on coverage, so when coverage dwindles, outbreaks occur. Take for example the recent measles outbreak in Minnesota, which began in a community that was suspicious of vaccines. Vaccine hesitancy also has a subtler and more insidious implication. It dampens the appetite for new vaccines, stifling innovation and robbing patients of better solutions.
“We must help people better understand the enormous impact that vaccines have on the health of the population and we must continue to improve our ability to keep terrible diseases in check through the use of this tool,” says William Hearl, the CEO of Immunomic Therapeutics, a clinical stage biotechnology company that is developing its nucleic acid immunotherapy platform to treat cancer, allergies and animal health issues. Immunomic has developed what it calls LAMP-Vax™ technology (lysosomal-associated membrane protein), which has the potential to improve the efficacy of nucleic acid vaccines. And while a LAMP-based vaccine based on Immunomic’s technology, which could treat peanut allergies, could hit the market within the next couple of years, Hearl says that vaccine hesitancy is an ever present concern for all those working in his field.
In June, Scientific American Custom Media and Immunomic convened some 40 scientists, policymakers and executives in Washington, D.C. to discuss the promise of new vaccines, along with threats to their development. Below are some of the major takeaways from the evening’s forum.
LOOKING BEYOND THE ROOTS OF FEAR
The first step to improve vaccine uptake is to address the fear that prevents it. But that is more complex than it sounds. “It’s not like people fear all vaccines for the same reasons. Throughout history, it was common to believe that vaccines were violating God’s way or perhaps violating the sanctuary of the body,” says Arthur Allen, author of Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver. For example, fears can arise from practical concerns, say the modern vaccine schedule, which requires children to receive up to 24 shots before the age of two. Or they can arise from scientific or moral misgivings, as is the case with MMR and HPV.
Not only has the number and complexity of vaccines grown, and with that the possibility of confusion and misperception, but patients are left to sort through that information in an increasingly fractured media environment. In an age of self-publishing and alternative facts, “anyone can go into that rabbit hole and grasp onto the bits of information that fits into other aspects of their belief system,” Allen explains. The challenge, then, is to reach across those many groups to address their fears directly. At the same time, healthcare professionals need to ensure that those hesitant or simply complacent about vaccines have access to them, and the incentive to get them.
ACKNOWLEDGING THE ROLE OF INFORMATION
For decades, the communication of reliable, accessible information about vaccines—backed with sound, scientific data—has been central to the strategy of addressing fear and inspiring action. Yet that strategy does not seem to be working as well as it once did. Even with an increase in the amount of information shared—by some counts up to four times more—a national survey of healthcare providers in 2009 found that 43% thought parents’ level of concern had greatly increased while 28% thought it had moderately increased compared with levels five years prior.
One solution could be a communications campaign targeted to doctors. According to Phyllis Arthur, Managing Director of Infectious Disease and Diagnostics Policy for the Biotechnology Innovation Organization (BIO), “Patients’ parents often cite the recommendation of their health care provider as one of the most important factors in their decision whether to vaccinate.” Doctors need to be incentivized to stand up for vaccines—even with patients that might disagree. They also need to be told how to communicate about them in a way that works.
More and more, communicators are relying on behavioral science to ensure their messages are heard. For example, the Academy of Pediatrics recently published a guide for pediatricians to discuss vaccines with patients and parents, which emphasizes that vaccines are rigorously tested, safety is continually monitored and the risks associated with skipping or delaying vaccines—yet challenges persist.
Arthur offers an example. “What we’ve seen, historically, is that if a physician walks in and says, ‘you’re going to receive the Hepatitis B shot and the DTP vaccine, and you can also receive the HPV vaccine,’ then there’s an implication that one shot is more important than another. A better approach would be stating, ‘these are the recommendations I make for your child or teen today and this is why.’” Arthur adds that following up with a phrase like ‘I had my own children vaccinated’ or ‘I’ve had the vaccine’ can go a long way when comforting parents or patients.
While such changes can seem nuanced, pursuing communication without a strong methodological approach can actually do more harm than good. A 2014 study, for example, found that when parents who are hesitant about vaccines are given more information, their concerns and misperceptions about vaccines increased and they were less likely to immunize their children.
Brian Harvey, executive vice president of scientific and regulatory affairs at the Global Liver Institute, agrees that sound scientific data is key for relaying information and encourages the industry to find creative ways to educate the general public with data. “We need to fundamentally change the way we share scientific information,” he explains. “Most people aren’t looking to scientific journals for information, but to Netflix and Hollywood. It’s our job to educate the folks in Hollywood, the television script writers, the Kardashians and others who influence our culture with sound scientific evidence so that they can share it accurately,” he says.
WEIGHING PUBLIC GOOD OVER INDIVIDUAL INTEREST
While communication is one lever to address vaccination coverage, public policy is another. Lately, more and more states and countries are pursuing public health policies that aim to increase vaccination rates. Amid measles outbreaks, Italy earlier this year declared that vaccines are mandatory for children as a condition of school registration, and Germany announced it would penalize parents with fines for not vaccinating children. Australia’s “No Jab, No Pay” bill mandates that only parents of immunized children can receive credits such as the Child Care Benefit, the Child Care Rebate and the Family Tax Benefit. In the U.S., states like California, Vermont and Washington have recently tightened requirements for using the personal belief exemption, calling for medical exemptions from a doctor for students to skip vaccinations.
This approach has worked. By and large, vaccine coverage increases as mandates are put in place. That has some calling for greater reliance on mandates as a way to short circuit the shortcomings of communication. But Bruce Gellin, President, Global Immunization for the Sabin Vaccine Institute in Washington, D.C. and the former Deputy Assistant Secretary for Health and Director for the National Vaccine Program, cautions against relying too heavily on policy alone. “It is a double-edged sword. Insisting on a mandate can be polarizing, and we’re pretty polarized already,” he says. Mandates could, for example, work for a while but then inspire a more robust anti-vaccination movement as individuals fight for their right to choose.
CLEARING THE PATH FOR A NEW ERA OF VACCINES
Despite immunization hesitancy, “there will never be a lesser need for vaccines,” says Michael Vajdy, president of EpitoGenesis and Director of Vaccines R&D Innovation at the Trudeau Institute. “New pathogens are constantly popping up and older pathogens are changing surface proteins,” he explains.
That is why vaccines are undergoing such a swift evolution. Among the many approaches that scientists are exploring, DNA and RNA vaccines are showing particular promise. When foreign DNA or RNA is taken up by a cell and translated into a given antigen protein, it elicits an immune response. If that antigen is associated with cancer or HIV or some other chronic condition, you could train the immune system, in essence, to treat it with a learned immune response.
Immunomic Therapeutics’ investigational LAMP-Vax technology, which was developed by Tom August at the John Hopkins University School of Medicine, may improve the body’s immune response to nucleic acid vaccines. It is believed that LAMP-Vax diverts target antigens directly to a major histocompatibility complex (MHC II) on antigen-presenting cells, such as dendritic cells, which helps the immune system recognize foreign molecules. “It’s a very direct way to teach the immune system about, say, an allergen, virus or bacteria and to then tell the body to attack that molecule,” Hearl explains. In the past, during nucleic-based immunotherapy, DNA could get lost in the shuffle. LAMP-Vax is designed to point it in the right direction.
“We started with a focus on allergies as a simple way to show that we could activate the immune system with the LAMP platform, but we’ve always had our eye on the oncology immunology space,” Hearl says. LAMP-Vax is currently being employed in Phase II clinical trials as a cancer immunotherapy.
“These new vaccines show an immense amount of promise, although additional study is needed to confirm the benefits,” Hearl says. But to realize that promise, patients, regulators, and clinicians need to recognize it first.
Where does a fear of vaccines come from?
In places where successful vaccination programs have been carried out, we no longer see as many people dying from diseases like polio or measles. With a vaccine now available for COVID-19, it’s important that as many people as possible receive this safe and effective vaccine. So where does vaccine fear come from, and how can we help people get through it?
Back in July, when a COVID-19 vaccine seemed far off, a YouGov poll revealed that nearly one third of people said they would probably or definitely refuse to have it, should one be developed.
Fast forward four months and the public is apparently now more receptive. The proportion of people who wouldn’t have the jab has fallen to one in five and, positively, more than two thirds now say they would have it.
Although encouraging, that’s still a long way off the up-to 90% of the population who, according to scientists, would need to be immunised for it to be effective at stopping COVID-19 in its tracks by generating so-called ‘herd immunity’.
So, what’s behind this apprehension and how can it be tackled to keep people safe from dangerous diseases like coronavirus?
Nobody enjoys having a blood test or an injection, but for some people, the thought of a needle puncturing their skin can send shivers down the spine. In fact, it’s thought that between 3.5 and 10% of the population suffer from trypanophobia – an extreme fear and avoidance of injections or having blood taken.
Learning from experience
Marie Brown from Kent knows first-hand the impact a fear of needles can have on your life. Former globetrotter Marie used to plan her far-flung travels around her fear.
“I used to be terrified of vaccines,” she says. “I’ve been all over the place, travelling around Asia, South Africa and Europe, but whether I would need vaccinations was a strong influencing factor when I was deciding where to go.”
Now aged 49, Marie can’t pinpoint a specific incident that could have triggered her fear, but recalls being apprehensive about having immunisations at school. “The first vaccination I can remember having was my BCG at 11 or 12 years old. I was definitely fearful,” she recalls. “My memory is of my classmates screaming as they had it done, and a fair amount of hysteria. So my fear possibly could have been caused by other people’s anxiety.”
According to psychotherapist Gin Lalli, this is fairly common; phobias often develop from learned behaviour. “A needle phobia does not have to have had a traumatic needle association, although they often do,” she explains. “When we are highly stressed, we go into survival mode and that means we revert to trying to keep ourselves safe by staying away from the perceived danger – in this case, needles.
“I explain it that we have a little filing cabinet in our brain – the hippocampus – and we refer to that for all our behaviour patterns. The first time we actively filed away the experience of getting a vaccination is really important.”
If that first experience was traumatic or frightening, that becomes the blueprint for your response if and when you encounter the same experience again. So, a pattern of fear develops. Our picks for Where does a fear of vaccines come from?
Suspicion of and myths surrounding vaccines in general are also driving mistrust about a COVID-19 jab, with the growth of the anti-vaccine movement facilitated largely by social media.
A report by the Centre for Countering Digital Hate (CCDH) found that anti-vax social media accounts have gained almost 8 million new followers since 2019. The global coronavirus pandemic and focus on a potential vaccine to stop its spread have undoubtedly brought anti-vax sentiment to the fore.
Huge swathes of the population have seen anti-vax messaging and in addition to many people believing them, these posts have put doubt into the mind of an even higher proportion.
A new report by King’s College London and Ipsos MORI shows:
- 1 in 3 have been exposed to anti-vax messages about COVID-19 vaccination.
- Almost half of 16- to 34-year-olds have seen anti-vax messages about the COVID-19 vaccine.
- 1 in 7 believe the COVID-19 vaccine’s real purpose is to track and control the population.
- 1 in 11 think Bill Gates is pushing the programme in order to implant us all with microchips, although this rises to 1 in 5 among people who get a lot or a fair amount of their information from social media.
- 2 in 5 don’t know whether the COVID-19 vaccine might cause autism in children.
- 3 in 10 are unsure if it will alter their DNA.
While it should go without saying that all the myths above are without the smallest basis in truth, health leaders and doctors could face a struggle to convince people to take up a vaccine when it becomes widely available.
Speed of development
Arguably, it’s understandable that people are worried about the COVID-19 vaccines we’re hearing so much about because they’ve had to be researched, developed and trialled very quickly – all under the glare of the public eye.
Dr Simon Royal is a GP at a practice in Nottingham that was involved in the trial of the Oxford vaccine. “Things have moved quickly and typically a big vaccine study like the one we’ve been involved with would take months of planning,” he explains.
“But it has been meticulously planned and the vaccines have all been through the normal and very stringent NHS ethics and safety approvals, so people can be assured that any vaccine that becomes available is safe and effective.”
COVID-19 Vaccine Distrust: Why It’s High, and How to Respond to It
Refusing a vaccine when one is available is known as “vaccine hesitancy.” In recent years, vaccine hesitancy has increased worldwide — so much so that the World Health Organization considered it a top 10 global health threat in 2019. Misinformation is a major cause of vaccine hesitancy, and there is much misinformation about both COVID-19 and its vaccine because they are new.
We’ll go over common causes of vaccine hesitancy and explore some ways to handle it, as well as provide some reliable sources of information.
Why is vaccine hesitancy a problem?
Vaccine hesitancy or distrust is a problem because it can make it harder to contain a disease. To improve disease control in a community, the community must reach “herd immunity.” Herd immunity means that the majority of people cannot get sick or spread the disease to others. In this way, the whole community is protected.
The percent of people that need to be immunized to achieve herd immunity is different for different diseases. For COVID-19, experts estimate that between 70% and 90% of a community would need to be immunized against the virus to achieve herd immunity, although the exact number is not known. People can become immunized either by having a COVID-19 infection or through taking a vaccine.
Since COVID-19 can be a very serious illness, if 70% to 90% of Americans became sick, a large number of people would need to be hospitalized and many could die. This is why having a vaccine that works is so important. With a vaccine, many more people could become immunized without getting sick. If not enough people take the vaccine, though, achieving herd immunity becomes much more difficult.
Why are some people hesitant to get the COVID-19 vaccine?
There are many reasons why people may hesitate to take the COVID-19 vaccine.
- Distrust of vaccines: Some people will not accept any vaccines at all. For example, some people choose not to get the yearly flu vaccine because they think it does not work or they worry that it will make them sick. Others worry about links between vaccines and autism disorder, and although these links have been disproven, they choose to skip recommended childhood vaccines.
- Vaccine timeline: Others may accept common vaccines, but may hesitate to take the COVID-19 vaccine because it is new and was created quickly. In the past, development and approval of most vaccines took years. For the COVID-19 vaccine, creation and approval took less than a year. This seems rushed to some, and may contribute to concerns about vaccine safety. However, development of the vaccine was not as rushed as it seems. Scientists have used the technology behind the COVID-19 vaccine for 20 years. This is why they were able to create the vaccine as fast as they did.
- Effectiveness: While some people worry about safety, others worry about effectiveness. After development of the vaccine, scientists studied it in human volunteers. These early studies have shown that the vaccine is safe and effective, but there is still much that is unknown, including how long the vaccine is effective, if it works against new strains of the virus, and whether or not someone who is vaccinated can still spread the disease to others.
- Side effects: Fear of unknown side effects and frustration about unknown long-term effects are other reasons that some people may not accept the vaccine.
- Lack of concern about the virus: Finally, there are also some communities where people do not consider COVID-19 to be a serious risk. In these communities, people may not accept a COVID vaccine because to them the risks of the vaccine seem greater than the risks of the disease.
Why are communities of color and rural communities reluctant to receive the vaccine?
Communities of color may be more likely to distrust the vaccine because they have less trust in the medical system — which unfortunately has a history of mistreating them.
In the past, African Americans were subject to medical experiments. For example, in 1932, the U. S. Public Health Service started the Tuskegee Syphilis Study in Alabama. The study involved nearly 400 Black men and went on for 40 years. During this time, the men were never told the true purpose of the study and were not offered treatment for the disease, even when one became readily available.
Another example of medical mistreatment of African Americans is the story of Henrietta Lacks. Lacks was an African American woman who had cervical cancer in the 1950s. Her doctor sent a sample of her cells, without her consent, to Dr. George Gey, a cancer researcher. Dr. Gey soon discovered that Lacks’ cells continuously doubled and did not die, unlike any other cells he studied. He named them HeLa cells. The study of these cells over decades has aided many medical discoveries, including cancer treatment and the creation of the polio vaccine.
Today, these cells are still being used to study cancers, toxins, drugs, and viruses. However, Lacks never knew that her cells were being studied, and neither she nor her family were ever compensated, despite the discoveries that emerged from her cells.
Other communities of color, such as Native Americans, have faced similar medical mistreatment.
- In the 1960s and 1970s, the Indian Health Services forcibly sterilized approximately 1 in 4 Native American women under the guise of different medical procedures and without consent.
- In 1989, the Havasupai Tribe agreed to allow the Arizona State University to study their communities’ blood samples to determine if there was a genetic reason for their increased rates of diabetes. The tribal members who signed a consent form believed they were giving consent for the study of diabetes only. Instead, researchers went on to study and publish findings on several unrelated medical conditions, as well as the tribe’s likely historical origins.
Experiences such as these led to understandable distrust of the medical community and any new medical treatment, including vaccines.
Not all members of these communities completely distrust vaccines, however. Compared to Non-Hispanic White Americans, only 10% of Native American children are less likely to be fully vaccinated against common diseases, and 20% of Native American adults are less likely to accept a flu vaccine.
Even the COVID-19 vaccine has support within tribal communities. Despite the centuries-old distrust of the medical system, there are tribal members who have volunteered for COVID-19 vaccine trials and have encouraged others to get vaccinated because they feel it is ultimately best for their community.
Although they may not have the same history of medical experimentation, Hispanic communities are also wary of new medical treatments. This is because, like African Americans, they have a history of racism and discrimination with the government and medical system. Unfortunately, these are also the communities most affected by COVID-19.
In rural communities, vaccine reluctance is due to misinformation rather than a historical distrust of the medical system. In many rural areas, particularly where local leaders have not required precautions, members may not consider COVID-19 to be a serious danger. Similarly, many rural community members view vaccination as a personal choice, rather than a community responsibility.
In other communities, members have spread conspiracy theories about vaccine safety and effectiveness. Such misinformation appears common in rural areas and contributes to increased vaccine distrust.
Why is vaccine distrust higher in some countries (like Russia) than others (like China)?
Vaccine hesitancy is a worldwide problem and occurs in more than 90% of countries.
Research on acceptance of the COVID-19 vaccine shows that vaccine acceptance depends on how much the people of a particular country trust the government. For example, vaccine acceptance rates in Asian countries where citizens overwhelmingly trust the government are close to 80%. In the United States, COVID-19 vaccine acceptance is around 69%.
In countries with low government trust, like Russia, people do not believe that the vaccine is effective and so the acceptance rate is less than 50%.
Why are some healthcare workers hesitant to get the COVID-19 vaccine?
Healthcare workers share some of the same concerns about the COVID-19 vaccine as lay people, including worries about vaccine safety, unknown long-term effects, and the possibility of studies being rushed.
In a recent survey, 29% of healthcare workers were hesitant to accept the COVID-19 vaccine. It is important to remember, however, that the term “healthcare worker” includes not only doctors and nurses, but also those who work in roles requiring only a high school education. The same survey showed that those with a college education are more likely to accept the vaccine.
Additionally, 40% of healthcare workers are members of minority communities, which as previously mentioned are more likely to distrust vaccines due to a history of mistreatment by the medical community. Healthcare workers, like the members of the communities they serve, can also be affected by misinformation.
What is the best way to handle misinformation around vaccination?
The best way to approach misinformation is with education and accurate, fact-based information. Here are some tips for different groups.
- Community leaders: Provide correct information about vaccine development, safety, and effectiveness, and make this information easily accessible.
- Healthcare providers: Educate patients and colleagues, dispel myths for friends and family, and stay up to date on the rapidly evolving science. The most important way, however, that doctors, nurses, and pharmacists can help their communities is by showing them that they accept the vaccine for themselves and recommend it for their loved ones. Providing people with resources for accurate information is important, but showing people that the leaders and healthcare workers of their communities accept the vaccine is likely to be much more effective.
- General public: Be curious about everything you see and hear. See something on the news? Read something on the internet? Hear something from a friend? Check verified sources to see if they agree. Then, ask your doctor or a healthcare provider in your community what he or she thinks about it. If verified sources or your doctor tell you something different, ask them to explain why and then where you might be able to get more information.
What are the best resources for objective, verified information about vaccines?
The World Health Organization, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics websites are all excellent resources for objective, fact-based, and verified vaccine information.
Local universities, hospitals, and doctors’ offices are also good resources for accurate and reliable information.
The bottom line
There is a lot of misinformation around COVID-19 and its vaccine. This misinformation contributes to vaccine distrust in many communities. Vaccine distrust can lower vaccination rates and make achieving control of the disease difficult.
The best way to improve vaccine acceptance is through education and example. With increased vaccine acceptance among healthcare workers and community leaders, people may be more likely to get vaccinated.
How can you overcome your fears?
Whether you have a phobia of needles, or you’re concerned about possible risks associated with vaccines, the chances are there will come a time when you need to confront the problem.
Focus on the outcome
For Marie, that time came when she had difficulty conceiving and needed to undergo in vitro fertilisation (IVF) to have a baby. She describes being like a ‘human pin cushion’ throughout the treatment, which involves lots of blood tests and series of hormone injections.
“It wasn’t easy coping with the needles, but the prize at the end was worth overcoming it,” Marie comments. “I certainly don’t enjoy needles now, but having gone through all that, I’ve learned to tolerate them and, although it’s unpleasant and it can be painful, you just have to get on with it.”
The trade-off, although certainly not guaranteed, was worthwhile for Marie – and she applies a similar logic to being immunised against COVID-19, which she plans to do. “It’s not so much that it will benefit me, but if we need people to be vaccinated for herd immunity, then I will willingly do my bit because it will benefit society as a whole.”
Gin adds that for anyone who’s unsure about having the jab, for whatever reason, it’s important to keep the outcome in mind. In the case of COVID-19, that is to protect yourself and others from the virus and its effects, which are particularly potent for those who are clinically extremely vulnerable.
“You need to remember why you’re getting the vaccine, seek out the right information, and remain objective and rational,” she comments.
Finding out more
Dr Royal suggests it’s entirely normal that people will want more information about immunisation against coronavirus. “We expect people to have questions about the safety and effectiveness of vaccines. There has been a lot of publicity and sometimes it’s difficult to distinguish between trustworthy reports and fake news,” he says.
“Before a national programme is rolled out I expect much more information to be made available from the various agencies involved in its planning and delivery so that we can all make informed choices.”
In addition, if you’re in doubt, your pharmacist or practice nurse should be able to provide information about the vaccine and its pros and cons.
Calm your fears
If your issue is fear-related, there are steps you can take, too. “Try to go to your vaccination appointment after a good night’s sleep, when you’re feeling calm and relaxed, rather than after a stressful day at work for example, because that stress could trigger the fight or flight response,” Gin says. “Take deep breaths when you’re there, and explain to the person administering the vaccine that you’re nervous – they should be able to help to keep you calm.”
More severe fears and phobias will probably need to be addressed in consultation with a specialist therapist, who can use different techniques to support you to overcome your fear.
Fear of Adverse Effects and COVID-19 Vaccine Hesitancy
The current pandemic has posed an unpresented challenge on many levels. Therefore, the development of vaccines was eagerly awaited, and the first breakthroughs were celebrated. However, it soon became clear that to end the pandemic, we would have to address another ubiquitous problem: the widespread hesitancy toward or downright rejection of vaccination. To achieve population immunity, a large majority of people has to participate. However, in a recent survey of US health care workers, 48% had not yet been vaccinated, and of those, 18% did not plan on receiving a COVID-19 vaccine because of concerns over adverse effects and the vaccines’ newness.
Health care decisions, including whether to take part in vaccination against COVID-19, are based on the comparison of the potential costs of participation with the expected benefits. Costs can span a variety of factors, but fear of adverse effects has featured prominently in recent surveys. As extensive research of our groups and others on nocebo effects has shown, it is—ironically—this very same fear that can amplify and even induce adverse effects. Therefore, addressing concerns by providing evidence-based information as part of larger information campaigns and individual conversations is key to increasing vaccine uptake. We present a number of strategies that can be adopted to target a fear of adverse effects.
Providing Accurate Information About Vaccination Adverse Effects
Acknowledging that vaccines can cause unwanted effects and that concerns about adverse effects are understandable is an important first step in any conversation about concerns. This is particularly relevant for those who have experienced adverse effects in the past or are more likely to be affected. However, it is also worth pointing out that most people experience no or only mild adverse effects. It is also important to explain that not all symptoms that occur following vaccination are caused by the vaccine. In fact, the major trial investigating the Pfizer-BioNTech vaccine, which included more than 40 000 people, reported fatigue rates after the first shot in the placebo group of 23% to 33%, headache rates of 18% to 34%, and muscle pain rates of 8% to 11%. Easy access to medical advice when adverse effects occur is pivotal to build trust and address concerns before they trigger a level of fear that amplifies the negative experience.
Positive Framing of Mild Adverse Effects
Legal regulations demand full transparency about potential side effects. However, the way this information is presented strongly influences decision-making and perceptions of symptoms. Instead of stating the probability of experiencing a particular adverse effect, we can provide the probability of not experiencing this effect. Moreover, instead of offering a noncurated list of all possible adverse effects without an estimate of their likelihood to occur, we can provide more graduated information about the likelihood of experiencing an adverse effect (eg, from very common to very rare). Lastly, while severe adverse effects are of course a matter of concern and need to be monitored closely, mild forms of fever, muscle pain, or fatigue also indicate that the immune system is responding appropriately to the vaccine. Pointing out the healthy nature of reactogenicity can help the individual experience adverse effects in a less threatening manner and thereby avoid the amplifying effect of fear.
Balancing Risk and Benefit Information
Beyond the future protection of the individual, the benefits of receiving the vaccination may be less obvious. These benefits need to be communicated to balance out the more readily available information about risks and adverse effects. Conveying the relevance of the societal impact of the individual’s decision and appealing to their altruistic motivations are particularly important for groups that are less likely to become severely ill if infected (eg, adolescents).
Providing Easy-to-Access and Easy-to-Understand Information
While negative information about vaccinations is usually easy to find in the form of lead stories on mass and social media, constructive information is often noticeably absent. Strategic placement of key information in physical and virtual places where people spend time can help to spread the word beyond scientific journals. Modern science has found new and exciting ways to leave its ivory tower and use social media platforms to convey complex or less intuitive information and engage in a dialogue with those it is aiming to reach (eg, Dear Pandemic).
Addressing Misinformation About Adverse Effects
Misinformation about consequences of vaccination can range from half-truths and unfounded speculations to targeted disinformation rooted in conspiracy theories. As far from our current scientific understanding as they might be, misinformation can shape people’s perceptions and decision-making if left unchallenged and lead to a self-perpetuating cycle of negative news. People who are exposed to negative information about medication in the media report more adverse events, thereby increasing and validating other people’s concerns. Therefore, conversations about vaccine adverse effects need to address common misconceptions without elevating them through public discourse. However, clinicians need to be aware that further actions may be needed when working with people with higher levels of anxiety because providing correcting information does not necessarily decrease vaccination hesitancy.
Information campaigns on vaccinations are commonly tailored to those who are vaccine hesitant, ie, individuals who have not yet decided whether the benefits outweigh the costs of getting vaccinated but who are open to information to inform their decision. Hesitancy usually involves mistrust of vaccine benefit, worries about future unknown effects, concerns about commercial profiteering, or a preference for natural immunity. It is important to identify the predominant belief and focus discussion or information in this area.
Research on placebo and nocebo effects has shown that expectations become the filters through which we perceive the world. What determines these expectations is far broader than our knowledge about vaccines and their effect on the virus. Decision-making about whether to participate in vaccination programs is influenced by those around us, by the way we incorporate or dismiss evidence, and by our willingness to accept individual costs for the greater good. Trustworthiness and a societal commitment to equity encourages people to receive the vaccine. The extent to which we are able to integrate these aspects in our vaccination campaigns will determine their success.
Why do parents worry about vaccines?
How many children receive vaccines?
Most children in the US are immunized. Only a little more than 1% of children have no immunizations. This is important not only for the children who are immunized, but also for those around them who either cannot be immunized — because they are too young, or because they have a problem with their immune system that prevents it — or have not been immunized. Having enough immunized people around stops a virus like measles from spreading. For measles, this “community” or “herd” immunity exists when around 95% of the people are immune. When clusters of people aren’t immunized, this allows cases, usually brought in from other countries where a virus like measles is more common, to spread.
Fear spreads as easily as measles does. People hear something about a vaccine that worries them, and they tell their friends and family. With social media, fear can spread even more quickly and broadly. Once you are afraid, it’s hard to get unafraid. And on the internet, all information — whether based on scientific studies or not — is equally available. Agreeing to vaccines requires a choice to do something; it requires action, and when parents get afraid, it can seem easier to just not take action.
The consequences, though, can be deadly — not just for the unimmunized child, but for those around them. The vaccine decision isn’t just an individual one; it affects whole communities.
Why are parents hesitant to vaccinate?
I have been a pediatrician for 28 years. I talk to a lot of parents who are hesitant to vaccinate. Here’s what they tell me they worry about:
Side effects. It’s certainly true that vaccines can have side effects. Any medical treatment can have a side effect. With vaccines, the most common side effects are mild, like soreness where the needle went in, or a slight fever. Serious side effects are rare. There is a database, called the Vaccine Adverse Events Reporting System, which keeps track of all reported side effects. The information is publicly available, and I always encourage parents to look at it.
Autism is not a side effect of vaccines. I can understand why people might look at vaccines as a possible cause of autism. The symptoms of autism become apparent early in life, which is a time when we are giving a lot of vaccines (since infants are very vulnerable to infections). But this has been researched extensively, and there has been no link found. There are lots of other things going on during pregnancy and those first couple of years, and hopefully we will find the cause of autism soon. But it’s not vaccines.
Additives. The worry used to be about thimerosal, a preservative that contains mercury. While its use was never linked to autism or any other problem, it was removed from everything except multi-dose vials of the flu vaccine out of an abundance of caution. Thimerosal-free versions of the flu vaccine are available if you’re concerned. Now the worry is about other additives, such as aluminum, that are added to keep vaccines safe and make them work better. Before getting alarmed about additives, it’s important to learn about them — because once people do, they are usually reassured. I encourage people to read about additives, and to make sure all their questions are answered.
Overwhelming the immune system. It’s true that we give more shots to babies than we used to, but the antigens in vaccines are nothing compared to the antigens that babies, and all of us, encounter as we breathe, eat, touch things, get dirty, and otherwise live our lives. Vaccines give babies a “sneak peek” of an infection — one that can’t cause the infection, but which gives the body a chance to make antibodies so that it’s ready to fight the infection should it be exposed. It’s not overwhelming the immune system. It’s helping to make the immune system work more efficiently.
Because that’s the point: we don’t want our children — and the children around them — to get sick. Too often, that point gets lost. People get so worried about the risks of vaccines that they forget to worry about the risks of the diseases vaccines prevent. It’s important to know — and worry — about those, as they can be serious. Because vaccines work so well, we’ve nearly forgotten about how dangerous polio, Haemophilus influenzae infections, or even chickenpox can be.
It’s normal, and understandable, to be afraid as a parent. But we need to be afraid of the right things — and we need to make decisions that keep everyone safer.
Who isn’t getting vaccinated, and why
A new report highlights why different groups are hesitant to get the coronavirus vaccine and what can be done about it.
Since April 2020, the Delphi Group at Carnegie Mellon University, in partnership with Facebook, has collected 18 million responses — the biggest survey of its kind — regarding people’s attitudes and behaviors surrounding the coronavirus, ranging from questions about vaccinations and symptoms to mask-wearing and mental health. Focusing on the data from January 10 through the end of February, the report highlights the specific challenges health officials will face in getting the country vaccinated, and how those vary by demographics, including where people live, their age, and their race.
The share of adults surveyed who are vaccinated or are willing to be vaccinated has grown from 72 percent to 77 percent from January through the end of February, a rise that reflects the increased availability of vaccines. However, the share of unvaccinated adults who are hesitant to get a vaccine has remained constant, at around 23 percent. It is this group that poses the greatest challenge to health care officials hoping to vaccinate the population to the point of herd immunity to stop the spread of coronavirus.
Some respondents hesitant about vaccination indicated general health concerns. Forty-five percent of those who said they definitely would not get the vaccine feared side effects, and 40 percent said they wanted to wait to see if vaccines were safe. (The vaccines have been shown to be safe and have generally mild side effects under clinical trials.) Others cited more conspiratorial reasons, with 29 percent of people not wanting the vaccine saying they didn’t trust vaccines and 27 percent saying they didn’t trust the government. Meanwhile, 20 percent said they didn’t think the vaccines work. People could select multiple reasons for not wanting a vaccine.
The vaccine rollout has been marred by misinformation, especially on social media. Some of the top narratives around the vaccine on social media include mentions of coronavirus conspiracy theories involving microchips and Bill Gates, according to new data from media insights company Zignal Labs. There’s also a conspiracy theory known as “the Great Reset,” the debunked idea that the coronavirus was created by the government to take control of the global economy.
Facebook, which has long been a bastion for the anti-vaccine movement, helped Carnegie Mellon survey its users for the report and is hoping to lead a large inoculation information campaign. After trying for years to crack down on vaccine misinformation, Facebook finally banned users from sharing anti-vaccine content in February. But vaccine misinformation can still be found on the site. A recent Washington Post report by Elizabeth Dwoskin examined internal documents at Facebook that suggest QAnon-supporting groups and a relatively small number of influential people are responsible for a significant share of vaccine skepticism on the site.
The Carnegie Mellon survey showed that acceptance of the vaccine varied by demographic, including race. Respondents who considered themselves to be of more than one race were most likely not to have been vaccinated and to not want to be vaccinated, followed by American Indians and Black Americans. Part of the disparity has to do with where vaccines are being made available. American Indians reported the highest rate of vaccination of any racial group, in part because of distribution efforts by Indian Health Services.
Misinformation on social media geared to Black and Latinx communities also plays a role in vaccine hesitancy, although the roots of distrust are complicated. Zignal Labs has been tracking spikes in mentions on social media of Tuskegee, a reference to the decades-long medical experiment on Black Alabamians who were not given treatment for syphilis, and to Henrietta Lacks, a Black woman whose cancer cells were collected without her consent. The firm also documented a rise in Spanish-language posts about the debunked relationship between Covid-19 vaccines and infertility. The data uses keyword matching, so it includes posts with factual news stories on these topics in addition to misinformation.
The Carnegie Mellon data also showed that young people, who are less likely to be vaccinated since priority has gone to people 65 and older, are also less likely than older people to say they want the vaccine.
Vaccine acceptance also varies by state. The states where unvaccinated people were least likely to say they’d accept a Covid-19 vaccine were Wyoming, Mississippi, Oklahoma, Alaska, and North Dakota — all sparsely populated or Southern states. Washington, DC, and states in the Northeast have some of the highest levels of vaccine acceptance. Generally, willingness to get vaccines is higher in cities.
Vaccine hesitancy has also been perpetuated by Fox News, which is considered a key news source by many Republicans, according to data from Pew Research Center. The Carnegie Mellon study did not include data broken down by political party, but a NPR/PBS NewsHour/Marist poll conducted earlier this month showed Republican men and Trump supporters were more likely than any other group to say they wouldn’t get a vaccine if it were offered.
What to do with this data
The report’s authors suggest vaccination campaigns should address fear of side effects, a main reason some unvaccinated people said they weren’t willing to get a vaccine. Mild side effects like fatigue and soreness are actually a good thing and can show that the vaccine is working.
Transmitting vaccine-related messaging through local health care workers also is likely to convince people who are hesitant. People across demographics said vaccination recommendations from a local health care professional meant more than from any other group (they were least likely to cite politicians). Health organizations have been courting influencers to help spread the message about getting vaccines, but perhaps encouraging doctors and nurses to spread the word could be more effective.
Finally, the report encouraged state-specific approaches to vaccine messaging for vaccine-hesitant people. While vaccine hesitancy is higher in Florida than the national average, for example, Floridians were also more likely to say that side effects from the vaccine were a concern, so vaccine campaigns in that state should address the issue specifically.
As time goes on, and as more people get Covid-19 vaccines, their experiences could affect how those who’ve been hesitant view vaccination. This new data suggests there are numerous ways to go about marketing the vaccines, and some people whom the vaccine-hesitant are more likely to listen to than others.
Needle Fear Is an Underrecognized Vaccination Challenge
No one likes needles. Of all the barriers to Covid-19 vaccination, fear of needles may seem trivial to overcome. But millions of American adults, not to mention children, still need to be injected to keep themselves and their communities safe. And it’s likely some of them aren’t doing so in part because they fear or just don’t like needles.
About one in four adults and two out of three children have some fear of needles, and adults may find their fears too shameful to share. This is a substantial public health problem, because a body of research shows that around one in 10 adults are so afraid of needles that they will delay or avoid vaccinations.
Vaccine hesitancy is a complex phenomenon with many contributing factors, including needle fear. Fear can be adaptive in a dangerous situation — like reacting to seeing a bear in the woods — or it can be out of proportion to the danger that’s present. Needle fear also exists on a spectrum, with people who are nervous about needles on one end and people with extreme levels of needle fear that meet the diagnostic criteria for what’s called “blood injection injury phobia” on the other. The latter is a mental health diagnosis that’s estimated to occur in 3.2 percent to 4.5 percent of people, which is most likely an underestimate given that many people do not acknowledge these fears to health care professionals and never receive a diagnosis.
High levels of needle fear, with or without a diagnosis, can affect vaccination programs. Some people might avoid getting vaccinated altogether, and others might endure it under immense distress, putting them at risk for what experts call immunization stress-related responses such as feeling dizzy or fainting during an injection. Experiencing an immunization stress-related response can worsen needle fears, both among people getting vaccinated and those who see or hear about them. The vaccine can also be falsely blamed for an immunization stress-related response, which can derail vaccination programs.
Adults shouldn’t feel ashamed if they are fearful of needles and should know that it’s common. Health care professionals and vaccination site organizers should be conscious of these fears and embrace methods to ease them. There are plenty of science-backed strategies to help.
Organizers of vaccination programs have important roles to play in setting up their vaccination sites to minimize needle fears and immunization stress-related responses. Strategies like organizing one-way clinic flow with privacy options help avoid long lines and having people being injected “on display” for others waiting. And it doesn’t start and end at the vaccination site — people working to promote vaccines should keep needle fears in mind and consider positive and neutral images that don’t show the needles themselves.
There are also strategies for individuals to help ease their own needle fears that clinicians can teach and support. People with low to moderate needle fear can use the research-backed C-comfort A-ask R-relax D-distract, or CARD, system. This method helps people develop a coping plan for before, during and after vaccination. To prepare, those with needle fears can think about what they will wear for easy access to their upper arms. They should consider what might relax or distract them while waiting at the clinic, such as reading a book, listening to music on their phone or playing a video game. Even purchasing a topical anesthetic can be helpful.
Organizers should anticipate and support small changes or requests that can improve the vaccination experience. For example, providers can ask people being vaccinated how they want to be told the injection is starting (e.g., “1, 2, 3, here we go”) and whether they want to look at the needle or away. During the procedure, do people want to talk about something else, play on their phone or listen to guided imagery? After the vaccination, how will they be rewarded?
Reminders of coping strategies can be posted at vaccination sites, and clinicians can put people being vaccinated at ease by answering their questions and supporting their coping plans.
People who have a history of feeling faint or dizzy around needles can also practice a simple technique called muscle tension. Feeling dizzy happens when blood pressure has dropped, and muscle tension works by keeping blood pressure up. To do this, clinicians should recommend that people do repeated cycles of tensing leg and stomach muscles for 10 to 15 seconds and then releasing them back to normal (not fully relaxed) before, during and after vaccination.
People at the high end of the needle fear spectrum will most likely need another approach to manage that fear first rather than get a vaccination while extremely frightened. Exposure-based therapy is recommended. This involves the safe, voluntary and slow facing of fear. Individuals create their own list of needle-related situations, order them by how scary they are and practice facing them starting with the easiest (for example, looking at needles in a book, holding a plastic needle, watching vaccine injection videos). Each step is practiced until fear is substantially reduced, and the individual then moves to the next. With practice, people learn that their anxiety can lessen, that it is manageable and that what they are most afraid of won’t happen. Exposure is usually guided by a mental health professional but can be self-guided.
Vaccination campaigns need to address adult needle fears head on. Doing so now can lay the groundwork for better vaccination experiences as eligibility expands and children — who are even more likely to have needle fears — can get their injections. As the pandemic in the United States moves into a new phase, every vaccine counts.
VACCINE MYTHS DEBUNKED
U.S. public health officials and physicians have been combating misconceptions about vaccine safety for over twenty years. They’ve had mixed success. Despite the fact that numerous studies have found no evidence to support the notion that vaccines cause autism and other chronic illnesses, a growing number of parents are refusing to vaccinate their children.
Researchers now link falling immunization rates to recent resurgences of vaccine-preventable diseases. In 2010, California saw 9,120 cases of whooping cough, more than any year since the whooping cough vaccine was introduced in the 1940s. Ten infants too young to be vaccinated died of whooping cough during the outbreak. The CDC warns that events like these will become more frequent and harder to control if vaccination rates continue to fall.
Fears over the safety of vaccines are understandable. The CDC vaccination schedule calls for children to receive up to 14 inoculations by the age of six – many of them vaccines developed within the last twenty years. Many parents distrust these vaccines; worried about the potential for risks and long-term side effects. Research, however, shows that most of our biggest fears about vaccinations are unfounded. These eight major vaccine myths that research has shown to be baseless:
Myth #1: Vaccines cause autism.
The widespread fear that vaccines increase risk of autism originated with a 1997 study published by Andrew Wakefield, a British surgeon. The article was published in The Lancet, a prestigious medical journal, suggesting that the measles, mumps, rubella (MMR) vaccine was increasing autism in British children.
The paper has since been completely discredited due to serious procedural errors, undisclosed financial conflicts of interest, and ethical violations. Andrew Wakefield lost his medical license and the paper was retracted from The Lancet.
Nonetheless, the hypothesis was taken seriously, and several other major studies were conducted. None of them found a link between any vaccine and the likelihood of developing autism.
Today, the true causes of autism remain a mystery, but to the discredit of the autism-vaccination link theory, several studies have now identified symptoms of autism in children well before they receive the MMR vaccine. And even more recent research provides evidence that autism develops in utero, well before a baby is born or receives vaccinations.
Myth #2: Infant immune systems can’t handle so many vaccines.
Infant immune systems are stronger than you might think. Based on the number of antibodies present in the blood, a baby would theoretically have the ability to respond to around 10,000 vaccines at one time. Even if all 14 scheduled vaccines were given at once, it would only use up slightly more than 0.1% of a baby’s immune capacity. And scientists believe this capacity is purely theoretical. The immune system could never truly be overwhelmed because the cells in the system are constantly being replenished. In reality, babies are exposed to countless bacteria and viruses every day, and immunizations are negligible in comparison.
Though there are more vaccinations than ever before, today’s vaccines are far more efficient. Small children are actually exposed to fewer immunologic components overall than children in past decades.
Myth #3: Natural immunity is better than vaccine-acquired immunity.
In some cases, natural immunity — meaning actually catching a disease and getting sick– results in a stronger immunity to the disease than a vaccination. However, the dangers of this approach far outweigh the relative benefits. If you wanted to gain immunity to measles, for example, by contracting the disease, you would face a 1 in 500 chance of death from your symptoms. In contrast, the number of people who have had severe allergic reactions from an MMR vaccine, is less than one-in-one million.
Myth #4: Vaccines contain unsafe toxins.
People have concerns over the use of formaldehyde, mercury or aluminum in vaccines. It’s true that these chemicals are toxic to the human body in certain levels, but only trace amounts of these chemicals are used in FDA approved vaccines. In fact, according to the FDA and the CDC, formaldehyde is produced at higher rates by our own metabolic systems and there is no scientific evidence that the low levels of this chemical, mercury or aluminum in vaccines can be harmful. See section III of this guide to review safety information about these chemicals and how they are used in vaccines.
Myth #5: Better hygiene and sanitation are actually responsible for decreased infections, not vaccines.
Vaccines don’t deserve all the credit for reducing or eliminating rates of infectious disease. Better sanitation, nutrition, and the development of antibiotics helped a lot too. But when these factors are isolated and rates of infectious disease are scrutinized, the role of vaccines cannot be denied.
One example is measles in the United States. When the first measles vaccine was introduced in 1963, rates of infection had been holding steady at around 400,000 cases a year. And while hygienic habits and sanitation didn’t change much over the following decade, the rate of measles infections dropped precipitously following the introduction of the vaccine, with only around 25,000 cases by 1970. Another example is Hib disease. According to CDC data, the incidence rate for this malady plummeted from 20,000 in 1990 to around 1,500 in 1993, following the introduction of the vaccine.
Myth #6: Vaccines aren’t worth the risk.
Despite parent concerns, children have been successfully vaccinated for decades. In fact, there has never been a single credible study linking vaccines to long term health conditions.
As for immediate danger from vaccines, in the form of allergic reactions or severe side effects, the incidence of death are so rare they can’t even truly be calculated. For example, only one death was reported to the CDC between 1990 and 1992 that was attributable to a vaccine. The overall incidence rate of severe allergic reaction to vaccines is usually placed around one case for every one or two million injections.
Myth #7: Vaccines can infect my child with the disease it’s trying to prevent.
Vaccines can cause mild symptoms resembling those of the disease they are protecting against. A common misconception is that these symptoms signal infection. In fact, in the small percentage (less than 1 in one million cases) where symptoms do occur, the vaccine recipients are experiencing a body’s immune response to the vaccine, not the disease itself. There is only one recorded instance in which a vaccine was shown to cause disease. This was the Oral Polio Vaccine (OPV) which is no longer used in the U.S. Since then, vaccines have been in safe use for decades and follow strict Food and Drug Administration (FDA) regulations.
Myth #8: We don’t need to vaccinate because infection rates are already so low in the United States.
Thanks to “herd immunity,” so long as a large majority of people are immunized in any population, even the unimmunized minority will be protected. With so many people resistant, an infectious disease will never get a chance to establish itself and spread. This is important because there will always be a portion of the population – infants, pregnant women, elderly, and those with weakened immune systems – that can’t receive vaccines.
But if too many people don’t vaccinate themselves or their children, they contribute to a collective danger, opening up opportunities for viruses and bacteria to establish themselves and spread.
Not to mention, as the Centers for Disease Control (CDC) warn, international travel is growing quickly, so even if a disease is not a threat in your country, it may be common elsewhere. If someone were to carry in a disease from abroad, an unvaccinated individual will be at far greater risk of getting sick if he or she is exposed.
Vaccines are one of the great pillars of modern medicine. Life used to be especially brutal for children before vaccines, with huge portions being felled by diseases like measles, smallpox, whooping cough, or rubella, to name just a few. Today these ailments can be completely prevented with a simple injection.
So as science continues to advance and tackle new challenges, people should not forget how many deaths and illnesses vaccines have prevented, and how they continue to protect us from potentially devastating forms of infectious disease.
Anti-Vaccine Activists Use A Federal Database To Spread Fear About COVID Vaccines
The largest U.S. database for detecting events that might be vaccine side effects is being used by activists to spread disinformation about COVID-19 vaccines.
Known as the Vaccine Adverse Event Reporting System, or VAERS, the database includes hundreds of thousands of reports of health events that occurred minutes, hours or days after vaccination. Many of the reported events are coincidental — things that happen by chance, not caused by the shot. But when millions of people are vaccinated within a short period, the total number of these reported events can look big.
Epidemiologists consider this database as only a starting point in the search for rare but potentially serious vaccine side effects. Far more work must be done before a cause-and-effect link can be determined between a reported health event and a vaccine.
In fact, VAERS has played a major role in the spread of misinformation about COVID-19 vaccines. The data is regularly appropriated by anti-vaccine advocates, who use the reports to claim falsely that COVID-19 vaccines are dangerous. They are aided by the fact that the entire VAERS database is public — it can be downloaded by anyone for any purpose.
“There’s very little control over what can be accessed and what can be manipulated,” says Melanie Smith, director of analysis at Graphika, a company that tracks vaccine misinformation online. She says that she sees VAERS data being shared across a wide variety of anti-vaccine social media channels. “I would say almost every mis- and disinformation story that we cover is accompanied by some set of VAERS data.”
VAERS was established decades ago, partly in direct response to the anti-vaccine movement. In 1982, a TV documentary called DPT Vaccine Roulette aired nationwide. It was filled with unsubstantiated claims that the vaccine given at the time against diphtheria, pertussis and tetanus could lead to intellectual and physical disability.
“It led to a massive number of lawsuits,” says Dr. Walter Orenstein, associate director of the Emory Vaccine Center and a former director of the U.S. immunization program at the Centers for Disease Control and Prevention.
The legal battles got so bad that many pharmaceutical companies decided it wasn’t worth making the vaccines. The U.S. began experiencing shortages. Congress stepped in with a law protecting manufacturers, and part of that act created VAERS in 1990. Right away, the database looked different from other collections of government medical data: Anybody could report a side effect from a vaccine (not just doctors), and anyone could request the entire VAERS database for any reason. Orenstein says the goal was to make it as open as possible.
“There were conspiracy theories, there were concerns that people were hiding things, and we didn’t want to hide anything,” he recalls. “It was very important that this system be publicly available so that others could look at it, and make their own conclusions if they didn’t trust what the data were that the CDC and [Food and Drug Administration] were putting out.”
Ever since, anti-vaccine groups have been using VAERS to push their unfounded theories about the dangers of vaccination. “VAERS data is often shared in the anti-vax community with the understanding that it’s something that they fought for,” Smith says. Since the rollout of the COVID-19 vaccines, Smith says that anti-vaccine advocates have been sharing YouTube videos showing how to download the data. Lately, she says infographics based on the data “seem to be really popular at the moment.” They proliferate on alternative social media platforms such as Telegram.
The most commonly cited statistic among anti-vaccine groups is death following vaccination. Graphics from anti-vaccine proponents frequently tick off the number of deaths directly reported in VAERS — without noting the reports there have not been investigated or verified as causally linked to an immunization. Those numbers even made it onto the show of Fox News commentator Tucker Carlson last month. In a segment on the supposed dangers of COVID-19 vaccines, Carlson incorrectly claimed the system had recorded thousands of unexplained deaths. “It’s clear that what is happening now is not even close to normal,” he told his audience.
The problem, says Saad Omer, director of the Yale Institute for Global Health, is that many of those deaths in the VAERS database were caused by other illnesses that happened around the same time as the immunization and had nothing to do with a vaccine: “Vaccines decrease your risk of COVID-19,” Omer notes. “They don’t make you immortal.”
In fact, COVID-19 vaccines were given first to some of the oldest and sickest people in America. Their risk of dying from COVID was high, but “their risk of mortality due to other causes was also high. In fact, very high,” Omer says.
He says it’s not surprising that, after administering many millions of doses, a few thousand might coincidentally die soon after getting the vaccine. VAERS is where that data is recorded, and anti-vaccine campaigners then cite the number as people killed by the vaccine.
Meanwhile, Omer and his colleagues have done their own analysis and found the vaccines are saving quite a few people’s lives. “We showed that there is a 99% reduction in mortality after two doses, and a 64% reduction in mortality even after one dose,” he says.
Individual case reports in VAERS are also often cited as though they were studies of what can go wrong with vaccination, says Moss of Johns Hopkins. “This is really hard, because individual stories are really powerful,” he says. But because of the system’s openness, these anecdotes are unverified. In the early 2000s, an anesthesiologist falsely reported he had been turned into the Incredible Hulk by the flu shot, and the report appeared in VAERS. (It was later removed.)
“There’s absolutely no screening,” Moss says. Even if most reports are honest, they still don’t come close to proving a causal link between a vaccine and a health event.
In an emailed statement, the CDC tells NPR the agency is aware of the misuse of the VAERS data but has no immediate plans to change the system. That’s in part because VAERS is one of the agency’s best sources for early warnings about real side effects. VAERS data helped to identify allergic reactions and blood clotting disorders caused by the COVID-19 vaccines. Both side effects are extremely rare, and doctors say the benefits of vaccination far outweigh the risks.
“While VAERS has limitations, keeping the system open to all reporters and users is essential for VAERS to serve its early detection function,” the agency says.
Orenstein says he agrees with keeping VAERS as open as possible. “My feeling is that this is what we have to live with,” he says, “because I think it’s very important that we have an open and transparent system.”
Even though some anti-vaccine advocates will distort the data, he says he thinks it’s better to have it out there — available for any member of the public to see.
China and India approve nasal COVID vaccines — are they a game changer?
Scientists hope the immunizations, delivered through the nose or mouth, will prevent even mild cases of illness.
Two needle-free COVID-19 vaccines that are delivered through the nose or mouth have been approved for use in China and India. China’s new vaccine, announced on Sunday, is inhaled through the nose and mouth as an aerosolized mist, and India’s, announced on Tuesday, is administered as drops in the nose.
These mucosal vaccines target thin mucous membranes that line the nose, mouth and lungs. By prompting immune responses where SARS-CoV-2 first enters the body, mucosal vaccines could, in theory, prevent even mild cases of illness and block transmission to other people — something COVID-19 shots have been unable to do. Vaccines that produce sterilizing immunity would be game changing for the pandemic.
“These approvals validate the need for mucosal vaccines,” says Marty Moore, co-founder of Meissa Vaccines in Redwood City, California, which is developing a COVID-19 immunization that is delivered through the nose. “That’s the direction we need to go globally, and the United States needs to catch up.”
The regulatory nods from China and India bring the number of approved COVID-19 mucosal vaccines in the world to four, including one already approved in Iran and another in Russia. More than 100 mucosal vaccines against the disease are in development globally, and about 20 have reached clinical trials in humans, according to Airfinity, a health-analytics company in London. Delivery methods include sprays, drops, aerosols and pills.
China’s inhaled vaccine, developed by CanSino Biologics in Tianjin, contains the same ingredients as the company’s COVID-19 shot that is already available in the country. A device called a nebulizer turns the liquid vaccine into an aerosol spray that is inhaled. China’s health department and National Medical Products Administration approved the vaccine to be used as a booster dose.
India’s vaccine, developed by Bharat Biotech in Hyderabad, is approved as a two-dose primary inoculation, rather than a booster.
Both companies have produced ‘viral vector’ vaccines that use a harmless adenovirus to deliver SARS-CoV-2 genetic material into host cells. Neither company has published phase III clinical trial data, but both say they have completed those studies.
Data from a phase II trial of CanSino’s inhaled vaccine found that, when given as a booster, the vaccine raised blood serum antibody levels significantly more than did a boost from an injection. This suggests that the inhaled vaccine will offer protection that is as good as, or better than, that provided by the shot.
Similarly, Bharat compared its intranasal vaccine to Covaxin, a COVID-19 jab available in India, by measuring antibody levels in the blood. The company did not release results of this study, but deemed the trial “successful”.
Exactly how successful these vaccines will be is unclear. Expecting a vaccine to stop transmission of a virus or prevent even mild illness — achieving what is called sterilizing immunity — is a high bar. Bharat and CanSino won’t know whether their vaccines can achieve this until they have conducted further efficacy studies.
Scant data is available on the efficacy of the two other mucosal COVID-19 vaccines. Iran approved a COVID-19 vaccine administered as a nasal spray and made by Razi Vaccine and Serum Research Institute in Karaj, in October 2021. More than 5000 doses have been delivered to the public. And Russia’s health ministry is reported to have approved an intranasal spray version of Sputnik V, the country’s injected COVID-19 vaccine.
Mucosal vaccines have been developed for other diseases, including poliovirus, influenza and cholera. Most of these vaccines are taken orally, and one, against flu, is administered through the nose.
I have covered several fallacies about vaccinations and reasons that people fear to get them. While it is true that there are side effects to any medication, treatment or vaccination, the benefits outweigh them. In the case of the Covid-19 virus, children and young healthy adults are simply not severally affected by the virus and in their cases, the side effects outweigh the benefits. There is also no denying that vaccines have been instrumental in reducing the effects of deadly viruses. So it behooves us to get vaccines when they are available.
80% of cardiac issues are related to our lifestyle. Statins only prevent 1% of heart attacks. Prescription drugs after heart disease and cancer is the third leading cause of death in the US. Coronary inflamation has increased substantially since the advent of the mRNA COVID vaccine has been administered. In 1976 the Swine Vaccine was pulled off the market because it wasw found to cause Guillain Barre Syndrome in 1 out of 100,000 individuals. In 1999the Rotto-Virus Vaccine was also pulled off the market because it was found to cause a bowel obstruction in children in 1 out of 800 cases. In 2022 the COVID MRNA Vaccine casued a 25% increase in cardiac arrests in men from ages 16-40 and the vaccine is still on the market.
65% of the FDA’s funding comes from Big Pharma in the US and 87% of the funding for the sister agency in England is funded by them.
There are some solutions for this problem: (1) drug companies should not set up their own drug trials, (2) regulators shoulsd not be funded by the pharmaceutical industry, (3) politicians should not be taking campaign contributions from big pharma.
Why the general population mistrusts vaccines and the medical industry now. (1) there is too much bias in peer review publications, (2) there are too many cases ofdefensive medicine beig practiced–medicine practiced in such a way as to reduce the risk of malpractice litigation, typically by the use of excessive diagnostic testing.”the analysis estimated that defensive medicine accounted for 0.3 % of national healthcare expenditures”, (3) there is an increased inability of medical professionals to explain the reasons for various treatments.
Instead of taking so many medications we should avoid ultra processed foods which are foods with more than 5 ingredients, such as preservatives and chemical sounding names.
Moral Courage and Our Common Future
I have for the most part been pro vaccine for most of my life, however, the more I read and the more I find out about them, the less pro I am. Let me get one thing straight that there is nothing wrong with the concept of vaccinations. Where the problem lies is with the execution and the lack of transparency and refusal to admit when mistakes have been made. Let us face it, vaccinations have become big business, literally billons of dollars are made every year by these companies. Even pharmaceutical companies have joined the party. These vaccines are fast becoming their cash cows. When so much money is at stake, any delay or set back occurs, billons of dollars are lost. As a result peoples lives and health are being put at jeopardy by these companies due to haphazard techniques, short-cuts and inadequate and faulty testing. These companies are not capitalizing on previous mistakes and are just repeating them over and over. When a contamination or issue is discovered with the vaccines, the existing vaccines are not destroyed, they are used right along with the revised products.
This is analogous to car manufactures correcting a deadly defect in their new cars on the manufacturing line, but allowing all the cars in the car dealers and those on the road to be either sold or continue to be driven without the revision being made.
Nobody can deny how the polio vaccine has helped mankind, but what most people including myself did not know at what price these advances came. Thousand and even millions of people over the generations have become infected with contaminated vaccines. Vaccines that have been manufactured using mouse brain tissue contaminated with Xenotropic Murine Leukemia Related Virus (XMRV) which can be spread to new borne infants via breast milk and to adults via contaminated blood. It can cause Chronic Fatigue Syndrome, autism, leukemia, autoimmune diseases and Alzheimer’s disease. In 1954 200,000 vaccines were administered with live polio strains and caused the worst polio outbreak in history. 70,000 people became sick, leaving 200 children paralyzed and ten dead. By 1961 98 million polio vaccines had been contaminated by using monkey tissue that contained a cancer causing monkey virus, SV40. Merck and Park-Davis stopped production of the vaccine when they discovered the problem, but the NIH continued administering the vaccines because they did not want to tarnish the reputation of the vaccine program. Thanks to SV40 skin cancers are up (being blamed on the sun, which is causing reduction in Vitamin D and is resulting in higher infection rates by viruses), prostate cancer numbers are up, lymphomas, brain tumors and mesotheliomas are also up in our country.
I thought vaccines were supposed to help? What the hell? Guess what I have just read the first chapter of this book. What am I going to find by the time I finish reading it?
Spate of polio outbreaks worldwide puts scientists on alert
Cases of paralysis in the United States and Israel suggest vaccine-derived poliovirus has infected many people.
The recent outbreak of polio, is showing the folly of our vaccine policy. even though Small Pox and Polio have virtually been irradicated from out planet, they still are a threat, as evidenced by the increase in polio casses and the emergence of Monkey Pox, which is related to small pox. If everyone was still vaccinatd for small pox, monkey pox would not even be a footnote in our history.
The discovery of poliovirus in New York state, London and Jerusalem this year has taken many by surprise — but public-health researchers fighting to eradicate the disease say it was only a matter of time.
“No country in the world is immune to the effects of polio,” says Zulfiqar Bhutta, a global-health researcher at the Aga Khan University in Karachi, Pakistan. “It’s all interconnected.”
The virus found in these regions is derived from an oral polio vaccine used in some countries. So far, only two cases of polio-related paralysis have been reported, in Jerusalem in February and New York in June; the New York infection was the first such US case in nearly a decade. But wastewater samples in all three areas suggest that the virus is circulating more widely.
Polio causes irreversible paralysis in less than one in 200 of the susceptible people it infects, so the cases of paralysis suggest that many other people there have been infected, says Walter Orenstein, who studies infectious diseases at Emory University in Atlanta, Georgia. “Cases like that are just the tip of the iceberg,” he says. “It’s very concerning.”
Nature talked to researchers about the scale of the outbreak, and what can be done to stop it.
Why are these outbreaks happening?
Wild poliovirus circulates in only two countries — Afghanistan and Pakistan — where this year nine cases had been reported by June.
But vaccine-derived poliovirus appears periodically elsewhere, particularly in Africa and Asia. These cases come from a widely used oral vaccine that contains live, weakened virus that sometimes mutates to a dangerous form capable of infecting the nervous system.
Neither the United States nor the United Kingdom use that vaccine, opting instead for an injectable vaccine containing inactivated virus. This vaccine can keep the virus from infecting the nervous system, but it is not as effective as the oral virus at reducing viral shedding and halting transmission, says Raul Andino-Pavlovsky, a microbiologist at the University of California, San Francisco.
High polio vaccination rates in the United Kingdom, Israel and the United States mean that most children will be spared the virus’s worst effects (about 94% of US 5- and 6-year-olds are vaccinated). But unvaccinated people are vulnerable to the illness.
“This virus is very, very good at finding unvaccinated individuals,” says Orenstein. In the 1990s, a poliovirus outbreak in the Netherlands established a foothold in a community with a relatively low vaccination rate, despite the country’s overall vaccination coverage of more than 90%, says Oliver Rosenbauer, a spokesperson for the Global Polio Eradication Initiative of the World Health Organization (WHO) in Geneva, Switzerland. The outbreak resulted in 2 deaths and 59 cases of paralysis, and occurred 14 years after the country’s last endemic case of polio.
Has poliovirus spread beyond the regions where it was first identified?
Wastewater surveillance for polio is rare in rich countries; the United Kingdom routinely monitors sewage for the disease only in London and Glasgow. And New York began testing waste water in July, after officials learnt about the case of polio-related paralysis.
So it’s unclear how far the virus might have spread. But there is reason to hope that it hasn’t gone far: in London, which has been detecting poliovirus in sewage since February, the virus seems to have remained concentrated in the city’s north and east, and there have been no reports of polio-related paralysis. “It appears to be fairly localized, even within London,” says infectious-disease epidemiologist Nicholas Grassly at Imperial College London.
In New York, the virus has been detected in two counties as well as New York City, a geographical spread that is “very concerning”, says Orenstein. “It suggests we have had substantial transmission.”
The US Centers for Disease Control and Prevention (CDC) will prioritize wastewater surveillance for polio in under-vaccinated communities linked to the paralysis case. “Poliovirus testing from wastewater samples is very labour- and resource-intensive,” a CDC spokesperson told Nature. But surveillance systems set up to monitor the coronavirus SARS-CoV-2 are working to provide support, she added.
Can the outbreaks be contained?
The United States, Israel and the United Kingdom are all boosting vaccination efforts, which should fill gaps created during the COVID-19 pandemic. This includes an ambitious effort to vaccinate all one-to-nine-year-olds in London.
This strategy should nip the outbreaks in the bud, says Grassly. But the campaigns in London and New York will use injectable vaccine, so they will not stop virus transmission.
If, in six months or so, wastewater testing suggests that poliovirus has continued to spread, it might be necessary to look at other options, he says. For example, in 2020, the WHO listed a new oral polio vaccine for emergency use.
This vaccine contains weakened poliovirus. But researchers used knowledge of the virus’s genome — including how an error-prone enzyme involved in replicating the genome can generate genetic changes — to create a suite of mutations that keep the virus from regaining its ability to infect the nervous system. “It’s like putting the virus in an evolutionary cage,” says Andino-Pavlovsky, who helped to design the vaccine.
That vaccine has not yet undergone large-scale human testing, and has not been approved by UK or US regulators. But more than 100 million people have received it, says Andino-Pavlovsky, with no signs of vaccine-derived poliovirus emerging.
What is the status of polio outbreaks elsewhere?
Outbreaks in wealthy countries get lots of attention, says Rosenbauer. “But over the past 20 years, we’ve had many, many serious outbreaks around the world in developing countries.”
Rosenbauer says there are encouraging signs that the battle to eradicate polio is making progress, despite the disruption caused by COVID-19. Outbreaks in Yemen and a few countries in Africa are still active, he says, but their range is shrinking.
In places where there is armed conflict, such as areas of Afghanistan and Yemen, vaccination is difficult. “We need the political will to implement a plan to reach all the children in challenging areas,” he says. Otherwise, “the disease will come back globally”.
-Afraid of needles? China using inhalable COVID-19 vaccine
The Chinese city of Shanghai started administering an inhalable COVID-19 vaccine on Wednesday in what appears to be a world first.
The vaccine, a mist that is sucked in through the mouth, is being offered for free as a booster dose for previously vaccinated people, according to an announcement on an official city social media account.
Scientists hope that such “needle-free” vaccines will make vaccination more accessible in countries with fragile health systems because they are easier to administer. They also may persuade people who don’t like getting a shot in the arm to get inoculated.
China wants more people to get booster shots before it relaxes strict pandemic restrictions that are holding back the economy and are increasingly out of sync with the rest of the world. As of mid-October, 90% of Chinese were fully vaccinated and 57% had received a booster shot.
A video posted by an online Chinese state media outlet showed people at a community health center sticking the short nozzle of a translucent white cup into their mouths. The accompanying text said that after slowly inhaling, people hold their breath for five seconds, with the entire procedure completed in 20 seconds.
“It was like drinking a cup of milk tea,” one Shanghai resident said in the video. “When I breathed it in, it tasted a bit sweet.”
The effectiveness of non-needle vaccines has not been fully explored. Chinese regulators approved the inhalable one in September, but only as a booster shot after studies showed it triggered an immune system response in people who had previously received two shots of a different Chinese vaccine.
A vaccine taken as mist could fend off the virus before it reaches the rest of the respiratory system, though that would depend in part on the size of the droplets, one expert said.
Larger droplets would train defenses in parts of the mouth and throat, while smaller ones would travel further into the body, said Dr. Vineeta Bal, an immunologist in India.
The inhalable vaccine was developed by Chinese biopharmaceutical company CanSino Biologics Inc. as an aerosol version of the company’s one-shot adenovirus vaccine, which uses a relatively harmless cold virus.
The traditional one-shot vaccine has been approved for use in more than 10 markets including China, Hungary, Pakistan, Malaysia, Argentina and Mexico. The inhaled version has received a go-ahead for clinical trials in Malaysia, a Malaysian media report said last month.
Regulators in India have approved a nasal vaccine, another needle-free approach, but it has yet to be rolled out. The vaccine, developed in the U.S. and licensed to Indian vaccine maker Bharat Biotech, is squirted in the nose.
About a dozen nasal vaccines are being tested globally, according to the World Health Organization.
China has relied on domestically developed vaccines, primarily two inactivated vaccines that have proven effective in preventing death and serious disease but less so than the Pfizer and Moderna vaccines at stopping the spread of the disease.
Chinese authorities also have not mandated vaccination — entering an office building or other public places requires a negative COVID-19 test, not proof of vaccination. And the country’s strict “zero-COVID” approach means that only a small proportion of the population has been infected and built immunity that way, compared to other places.
As a result, it’s unclear how widely COVID-19 would spread if restrictions were lifted. The ruling Communist Party has so far shown no sign of easing the “zero-COVID” policy, moving quickly to restrict travel and impose lockdowns when even just a few cases are discovered.
Authorities on Wednesday ordered the lockdown of 900,000 people in Wuhan, the city where the virus was first detected in late 2019, for at least five days. In remote Qinghai province, the urban districts of Xining city have been locked down since last Friday.
In Beijing, Universal Studios said it would close its hotels and attractions “to comply with pandemic prevention and control.” The city of more than 21 million people reported 19 new cases in the latest 24-hour period.
HUGE NUMBER OF WOMEN MISCARRIED FOLLOWING COVID VACCINE, DATA CONFIRMS
In May, Operation Rescue reported on information gained from Pfizer documents released by court order. The data revealed that by February 8, 2021, at least 82% of pregnant women followed after receiving the Pfizer vaccine lost their babies. The outcomes represented 270 women who received the mRNA injection during pregnancy. Of those pregnant women, 238 were not followed – even though 75 of them experienced a serious, early adverse reaction.
Of the 34 pregnant women followed, at least 82% of the cases resulted in the death of a developing child.
Just two months after that crucial data was gathered, on April 23, 2021, the Centers for Disease Control and Prevention (CDC) began recommending pregnant women get the COVID-19 vaccine. By the end of that month, the number of miscarriages reported to Vaccine Adverse Event Reporting System (VAERS) jumped to 264 – from 159 the previous month. Four months later, the number of reports had nearly tripled. And by the end of the year, over 3,379 reports of post-COVID vaccine miscarriage were submitted.
The total number of suspected vaccine-related miscarriage/stillbirth reports shot up in 2021. The number of miscarriages suspected to be related to other non-COVID vaccines (Flu, MPV, TDAP, MMR, Varicella) before or after the roll-out of the COVID vaccine did not begin to compare.
Now, let’s consider that because reporting adverse vaccine reactions to VAERS is completely voluntary, it is estimated to capture only about 1% of the actual injuries . Based on reports from healthcare providers, vaccine manufacturers, and the public, it contains nowhere close to all-inclusive figures. If that 1% estimate is correct, then over 334,000 women experienced a miscarriage after being vaccinated for COVID in 2021. That’s about 9% of the total number of live births in 2021.
Granted, considering the fear Americans were experiencing during the pandemic and the CDC’s recommendation, the number of pregnant women who received the COVID vaccine likely far outweighed the number of pregnant women who received other vaccines during the same time frame or in previous years. Also, it is possible that miscarriages experienced by some women following vaccination were coincidental.
However, according to the VAERS data, of 2,601 women who reported miscarriages that occurred within 1-24 days following the COVID shot, nearly half happened within two days of the injection (37% occurred the same day, and 10% the following day).
“These numbers are not just numbers,” said Operation Rescue President Troy Newman, “but they represent real people, families that have been deeply affected and wounded by the loss of a child – a child that would otherwise be part of this year’s joyous Christmas festivities. Even pro-abortion people recognize the deep grief felt when a child that is wanted is lost through miscarriage.
“It is incredibly disheartening that Americans have been betrayed after trusting our government to ensure that the vaccines would be researched, the results of that research would be transparently communicated, and safeguards would be applied to protect the men, women, and children of this nation.”
-COVID can trigger tinnitus. Could the vaccines do the same?
After Gregory Poland, an internal medicine doctor at Mayo Clinic who directs its Vaccine Research Group, got his second dose of COVID vaccine in February 2021 he developed such severe and sudden ringing in his ears that he nearly veered into the next lane of traffic while driving home.
“It sounded like somebody took a whistle and out of nowhere started blowing it in my ear,” Poland said, “and it has never gone away.”
Poland, one of the foremost vaccine researchers in the world and editor in chief of the medical journal Vaccine, is one of thousands of people who believe the ringing, or tinnitus, they developed after a COVID immunization could be linked to the vaccine. The condition is a known consequence of a COVID infection.
Mounting evidence—from scientific studies and case reports—suggests that there might be a connection between COVID vaccines and rare cases of severe tinnitus. Johnson & Johnson listed it as a possible adverse effect on its U.S. COVID-19 vaccine fact sheet in February 2021. The World Health Organization advised investigating whether there’s a link between multiple COVID vaccines and tinnitus in their first newsletter of 2022. In July 2022, the European Medicines Agency added tinnitus as a possible adverse event from taking the Astra Zeneca vaccine. And Australia updated the Novavax label on January 27 to recognize tinnitus as a potential adverse event.
In the United States, more than 16,000 people have reported developing tinnitus after a COVID vaccine, some within hours and others in the following days or weeks. But, on Wednesday, Martha Sharan, a spokesperson for the Centers for Disease Control and Prevention, said the agency has determined it does “not have sufficient evidence from our surveillance to justify launching an epidemiologic study.”
“We are aware that this is occurring, but tinnitus is a very common condition that has many causes and many risk factors,” Sharan said. “We’re not dismissing it, and we’ll continue to monitor it, but there’s nothing that shows us that there’s a safety problem between COVID-19 [vaccine] and tinnitus.”
The CDC has come under criticism from Poland and others who have asked it to study the issue. Poland said Thursday that he was disappointed with the CDC’s response. “Show me the data, what the threshold is, because what do you do with all of these reports?” Regarding the CDC’s decision not to pursue a larger study at this time, he said, “I’d like to see transparency and how the decision was made.”
But other experts express skepticism that there could be a link between a vaccine and an adverse event that occurs so quickly, including Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and co-developer of the rotavirus vaccine.
“As a general rule, side effects associated with vaccines are associated with the immune response to the vaccine,” he said, explaining that it usually takes at least several days to occur at a level that could cause adverse effects. “What is happening one hour after you get a vaccine to cause you to have tinnitus?”
A phantom sound
Tinnitus affects more than 25 million American adults at some point, according to the American Tinnitus Association, and it’s a symptom of about 200 different disorders, from common colds to more serious conditions. It can also stem from hearing loss or taking different medications. Tinnitus can be temporary or chronic, but there’s no cure and few effective treatments exist.
Studying tinnitus is difficult and there are unique challenges to investigating a possible link.
“Unlike most any other side effect, you can’t measure it, you can’t image it, you can’t do a blood test for it, at least not currently. It’s all subjective,” Poland said. “That makes it more difficult because for clinicians—and I’m raising my hand as guilty until it happened to me—side effects that I can’t see, measure, or even treat, you tend to discount and dismiss. And I think that’s what’s happening at the CDC level.”
The difficulties Poland raises are problematic, said Stanford otolaryngologist Konstantina M. Stankovic. “Tinnitus is a phantom sound that is generated by the brain, and the brain typically makes it when there is an injury to the inner ear,” she explained, adding that the lack of objective markers is a “huge impediment” in the field. “We have to rely on patient reports and subjective questionnaires.”
But for many people, their own experience is powerful evidence.
Robert Edmonds, a 37-year-old mechanical engineer who works for the federal government in Las Cruces, New Mexico, said the ringing in his ears developed after his second vaccine dose and was louder than driving his Ford F250 truck. He’s now taking acetazolamide—a glaucoma medicationsometimes used off-label to treat other conditions including tinnitus—and, he says that has dampened it enough for a loud radio to drown it out.
“There’s no escaping it,” Edmonds said. “I’ve called it a jail inside my head. There’s nowhere to go, and you can’t put on headphones to tune it out. It’s just there all the time.”
Edmonds has spent two years raising awareness about the need for more research, including serving as administrator to a social media group with nearly 1,000 people suffering from tinnitus. He has regularly communicated with the Food and Drug Administration and the CDC’s vaccine safety division, scoured medical research, and put his own statistical chops to work (from his master’s in mechanical engineering and doctorate in astronomy).
“I’m just trying to get someone to look into this,” he said.
A Nature Medicine study of more than 150,000 people receiving care for long COVID from the Department of Veteran Affairs found tinnitus had a much greater impact on daily functioning than other sensory symptoms, including vision abnormalities and loss of smell or taste. Even with studies like this one, Edmonds says it’s difficult to convey how disruptive the condition can be. He says he knows of two people who committed suicide because their tinnitus was so crippling, one after the vaccine and one after a COVID infection.
Kathleen DesOrmeaux, a 46-year-old from Hampton Roads, Virginia, was happy to get the jab because her father had died from COVID, and she wanted to do her part in slowing the pandemic. Within 15 minutes of her first dose in March 2021, she had several bouts of vertigo, and over the next two weeks, her ears began ringing off and on until it became louder and constant.
At 67 years old, Poland judged a COVID infection was still a substantial risk, so he chose to get a booster despite developing tinnitus after the second dose. At first, his tinnitus was diminished, but it returned at a higher pitch. He recalls sitting outside that evening looking at the stars, “and tears came to my eyes when I realized I will never hear quiet again. That has a profound effect on you.”
What the CDC did
As of February 3, the Vaccine Adverse Event Reporting System (VAERS) maintained by the CDC has more than 16,354 reports of tinnitus from patients developing it after one of the COVID-19 vaccines. About 43 percent of those cases occurred within a day of vaccination. It’s one of the most common reports after already known side effects of the vaccine.
But VAERS cannot show that an adverse event is caused by a vaccine because it’s a passive monitoring system, which means anyone can report an adverse event. The reports may also be inaccurate, unverified, duplicates, or coincidental. Further, the number of reports cannot be used to establish a rate—how frequently the adverse event occurs—since it cannot account for the usual population rate of the condition.
To determine whether an adverse effect is a potential side effect of a vaccine, the CDC analyzes VAERS data. The CDC requests medical records for all individuals who file VAERS reports of “serious” adverse events. It only conducts a more detailed analysis if it detects a higher-than-expected rate.
In this instance, the CDC says it looked for tinnitus diagnoses that occurred up to 70 days after COVID vaccination in 6.6 million people’s medical records in the Vaccine Safety Datalink, a database of 13 healthcare system medical records used to examine whether a particular health condition is statistically linked to a certain vaccine.
The agency said in September that it found no evidence that tinnitus diagnoses were clustered together following vaccination but hasn’t published that analysis and declined to share the preliminary report with National Geographic.
In early October, Sharan said Tom Shimabukuro, who heads the COVID-19 vaccination safety team, wished to delay an interview with National Geographic because the CDC was conducting an additional analysis of tinnitus and hearing loss with COVID vaccines. On Thursday, nearly four months later, Sharan wrote that CDC does not currently plan to launch an epidemiologic study in VSD and again declined a National Geographic interview request with Shimabukuro.
If the CDC had found a statistically significant link to tinnitus, it could have taken steps to add an official warning to the vaccine labels. Those steps depend on what the side effect is and usually involve actions by the FDA and the vaccine manufacturer.
What does the data show?
Many studies have documented that a COVID infection can cause tinnitus. Stankovic’s research has shown the SARS-CoV-2 virus can infect specific cell types in the inner ear. But that discovery does not prove a link between COVID-19 vaccination and tinnitus.
Research on tinnitus or, more broadly, on hearing loss and COVID vaccines is sparse and contradictory, based mainly on case reports.
The only large-scale study, from September 2022, compared new cases of tinnitus after COVID-19 vaccination to new cases after flu, pneumonia, and tetanus-diphtheria-pertussis vaccinations in 2019. That study found, among nearly 2.6 million people, that approximately one in 2,600 developed a first-ever case of tinnitus within three weeks after their first COVID-19 vaccine dose. That’s lower than new tinnitus cases after the other vaccines, but higher than after a COVID-19 vaccine second dose.
The reason might be that “patients with a predisposition to vaccine-related tinnitus may be more vulnerable after the first dose than after the second dose, or that the first dose provokes an inflammatory response more likely to cause tinnitus,” the authors speculated.
The study could not, however, show a causal link between COVID-19 vaccination and tinnitus and didn’t adjust for the general population rate of tinnitus. The authors also noted that risk of tinnitus after vaccination is “likely lower than after the infection.”
Researchers from Oracle Health Sciences, a life sciences data company, analyzed VAERS data through September 2021 using a method designed to overcome one of the statistical challenges of looking for a rare possible side effect that’s common in the general population. The study, published in June 2022 and whose authors also include a current FDA employee and a retired one, “imply there is strong statistical evidence that links the mRNA vaccines with tinnitus,” lead author Rave Harpaz said. But VAERS data cannot show a causal relationship. National Geographic asked the CDC to comment on the results on September 29, 2022, but Shimabukuro said through an email from Sharan that he could not comment on a study conducted outside the agency.
The WHO report disclosed that 31,644 tinnitus cases, from 86 countries, had been reported by November 2021, more than three times as many as would be expected (8,549) based on ordinary background rates of tinnitus. A post-vaccination rate that’s higher than the background rate in a population is one of several criteria used to determine whether an adverse event might be directly caused by a vaccine, according to Poland.
A safety analysis of the Johnson & Johnson vaccine in 43,776 clinical trial participants found nine cases of tinnitus in the vaccine group and none in the placebo group in the four weeks after vaccination, but the authors didn’t calculate the statistical significance of that imbalance.
Even if the authors had calculated it, however, that imbalance could be a statistical anomaly, Offit says. Merck’s trials of his rotavirus vaccine included five cases of Kawasaki disease, a condition causing inflammation of blood vessels, in the vaccine group and none in the placebo group, he says. But that statistically significant finding disappeared when larger numbers of children received the vaccine. In fact, the same trial found five cases of arm and leg fractures in the placebo group and none in the vaccine group, but the vaccine certainly didn’t prevent fractures. “These initial observations just have to be taken with a grain of salt until you see it in large numbers,” he said.
A Pfizer spokesperson said the company has reviewed tinnitus cases and found no causal link to their vaccine. Moderna, Novavax, and AstraZeneca, did not respond to queries by the time of publication.
Where do we go from here?
Poland has been struck by the severity of his and other cases. “In 40 years of clinical practice, I never had somebody talk about [tinnitus] in those kinds of terms,” he said. For him and many others around the world, it’s been a “life-changing and never-ending consequence.” That’s why it vexes him that the CDC doesn’t currently plan to investigate it more thoroughly. His assessment: “The CDC needs to do as deep a dive into this concern as it did myocarditis. People are suffering.”
Other scientists, however, are taking note by adding tinnitus to their surveillance of adverse events. Former CDC scientist Robert Chen, who helped develop the Vaccine Safety Datalink, founded and runs the Brighton Collaboration, a group of scientists whose mission includes developing standardized definitions of adverse events from vaccines. The Brighton Collaboration added tinnitus to its adverse events of interest list in early November. The Collaboration was previously responsible for characterizing vaccine-associated myocarditis when it was identified as a rare side effect of the mRNA vaccines.
Researcher Shaowen Bao, an associate professor of neuroscience at the University of Arizona who studies neuroinflammation and tinnitus in animal models, is analyzing data from 400 people who have reported that they developed tinnitus after COVID vaccines. His research, currently unpublished, reveals patterns that he believes suggest a possible causal relationship between vaccination and tinnitus. Bao’s research has no control group and relies on a non-random sample of people, but he thinks the associations are strong enough that the CDC should look more closely at tinnitus.
Poland believes that the data offers clues to a possible link that deserves further study. One is when an adverse event’s timing occurs close to vaccination, as it did in nearly half the tinnitus cases reported in VAERS. Just because an adverse event occurs close to the time of the shot doesn’t prove it’s the cause,” Poland said, “but it is a hypothesis that deserves to be tested.”
It’s also important to look at whether the adverse event is happening under unexpected circumstances. For example, said Poland, “we don’t expect 20- and 30-year-olds to develop chronic tinnitus in the absence of known disease.”
Another consideration is whether there is a dose response—whether a symptom increases or changes with additional doses. Poland and others have noted changes in the pitch or severity of their tinnitus with a second or booster dose.
Poland emphasizes that all vaccines have some risk of side effects, and, in terms of public health, he says the good of these vaccines far outweighs the risks. But he thinks it’s critical for the public to be fully informed of possible adverse events. “You don’t get the choice of whether you’re going to get infected, whether you’re going to have a complication, or whether you’re going to have a side effect from a vaccine,” he says. All you can do is look at the balance of risks and benefits and not make fear-based decisions.
“We need to advocate that this is a serious enough hypothesis that the CDC should look into this,” Poland said. He has received messages from people from around the world whose tinnitus after COVID vaccination is so severe that they have considered taking their own lives, he says. “This is how profoundly this changes one’s quality of life.”
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How do vaccines work?
Germs are all around us, both in our environment and in our bodies. When a person is susceptible and they encounter a harmful organism, it can lead to disease and death.
The body has many ways of defending itself against pathogens (disease-causing organisms). Skin, mucus, and cilia (microscopic hairs that move debris away from the lungs) all work as physical barriers to prevent pathogens from entering the body in the first place.
When a pathogen does infect the body, our body’s defences, called the immune system, are triggered and the pathogen is attacked and destroyed or overcome.
The body’s natural response
A pathogen is a bacterium, virus, parasite or fungus that can cause disease within the body. Each pathogen is made up of several subparts, usually unique to that specific pathogen and the disease it causes. The subpart of a pathogen that causes the formation of antibodies is called an antigen. The antibodies produced in response to the pathogen’s antigen are an important part of the immune system. You can consider antibodies as the soldiers in your body’s defense system. Each antibody, or soldier, in our system is trained to recognize one specific antigen. We have thousands of different antibodies in our bodies. When the human body is exposed to an antigen for the first time, it takes time for the immune system to respond and produce antibodies specific to that antigen.
In the meantime, the person is susceptible to becoming ill.
Once the antigen-specific antibodies are produced, they work with the rest of the immune system to destroy the pathogen and stop the disease. Antibodies to one pathogen generally don’t protect against another pathogen except when two pathogens are very similar to each other, like cousins. Once the body produces antibodies in its primary response to an antigen, it also creates antibody-producing memory cells, which remain alive even after the pathogen is defeated by the antibodies. If the body is exposed to the same pathogen more than once, the antibody response is much faster and more effective than the first time around because the memory cells are at the ready to pump out antibodies against that antigen.
This means that if the person is exposed to the dangerous pathogen in the future, their immune system will be able to respond immediately, protecting against disease.
How vaccines help
Vaccines contain weakened or inactive parts of a particular organism (antigen) that triggers an immune response within the body. Newer vaccines contain the blueprint for producing antigens rather than the antigen itself. Regardless of whether the vaccine is made up of the antigen itself or the blueprint so that the body will produce the antigen, this weakened version will not cause the disease in the person receiving the vaccine, but it will prompt their immune system to respond much as it would have on its first reaction to the actual pathogen.
Some vaccines require multiple doses, given weeks or months apart. This is sometimes needed to allow for the production of long-lived antibodies and development of memory cells. In this way, the body is trained to fight the specific disease-causing organism, building up memory of the pathogen so as to rapidly fight it if and when exposed in the future.
When someone is vaccinated, they are very likely to be protected against the targeted disease. But not everyone can be vaccinated. People with underlying health conditions that weaken their immune systems (such as cancer or HIV) or who have severe allergies to some vaccine components may not be able to get vaccinated with certain vaccines. These people can still be protected if they live in and amongst others who are vaccinated. When a lot of people in a community are vaccinated the pathogen has a hard time circulating because most of the people it encounters are immune. So the more that others are vaccinated, the less likely people who are unable to be protected by vaccines are at risk of even being exposed to the harmful pathogens. This is called herd immunity.
This is especially important for those people who not only can’t be vaccinated but may be more susceptible to the diseases we vaccinate against. No single vaccine provides 100% protection, and herd immunity does not provide full protection to those who cannot safely be vaccinated. But with herd immunity, these people will have substantial protection, thanks to those around them being vaccinated.
Vaccinating not only protects yourself, but also protects those in the community who are unable to be vaccinated. If you are able to, get vaccinated.
Throughout history, humans have successfully developed vaccines for a number of life-threatening diseases, including meningitis, tetanus, measles and wild poliovirus.https://www.youtube.com/embed/SkSdFnzjNPs
In the early 1900s, polio was a worldwide disease, paralysing hundreds of thousands of people every year. By 1950, two effective vaccines against the disease had been developed. But vaccination in some parts of the world was still not common enough to stop the spread of polio, particularly in Africa. In the 1980s, a united worldwide effort to eradicate polio from the planet began. Over many years and several decades, polio vaccination, using routine immunization visits and mass vaccination campaigns, has taken place in all continents. Millions of people, mostly children, have been vaccinated and in August 2020, the African continent was certified wild poliovirus free, joining all other parts of the world except Pakistan and Afghanistan, where polio has not yet been eradicated.
5 Tips for Handling COVID-19 Vaccine Anxiety
Dealing with the fear of easily catching and spreading a deadly virus is new. Being forced to make extreme lifestyle sacrifices is new. Weighing the risks vs. the rewards of everything we do outside of our home is new. Coping with social isolation is new.
Now, we’re faced with something else that’s new: COVID-19 vaccines.Stay up-to-dateBy signing up, you will receive our newsletter with articles, videos, health tips and more.Subscribe
And you’re not alone if you’re feeling nervous about these brand new vaccines, despite the safety data that’s available.
“We like to know what we’re getting into, and we generally don’t do well with a lot of uncertainty, especially when it comes to our health and our bodies,” explains Dr. William Orme, a psychologist at Houston Methodist. “There are plenty of ‘what-ifs’ a person could ask themself before getting vaccinated. What if I have uniquely bad side effects? What if they rushed things too much? What if there are long-term side effects we don’t yet know about? All of these what-ifs can, understandably, contribute to anxiety.”
If you’re feeling anxious about the COVID-19 vaccine and struggling to make a decision about getting vaccinated in the midst of your anxiety, Dr. Orme shares the following tips:
Face your anxiety rather than avoid it
First thing’s first, there’s nothing wrong with being anxious about something new.
What can be problematic, however, is letting your anxiety automatically drive your decision-making process instead of you.
“If you’re coping with your anxiety related to the COVID-19 vaccines by putting off a decision or avoiding even thinking about it altogether, you don’t have control over your decision — your anxiety does,” explains Dr. Orme. “Similarly, if your anxiety is causing you to spiral through all the what-ifs without much progress, your overthinking may paralyze you from ever being able to make a decision.”
The best way to begin dealing your vaccine anxiety is to recognize and accept that it’s real, and then make a conscious effort to handle it in a productive way.
“Think of anxiety as a signal to slow down and be thoughtful about how you want to respond. A productive way might be to start with researching what’s known about the vaccines so you can accurately appraise the risk level. From there, you can make the decision that you feel is best and hold on to that feeling when you need reassurance when anxiety surfaces again,” recommends Dr. Orme.
Keep in mind, however, if you hope to arrive at a place where you don’t feel any anxiety or nervousness whatsoever about these new vaccines, you’re not likely to ever actually make a decision at all.
Do your due diligence
Right now, information and opinions about the new COVID-19 vaccines are likely coming at you from all directions: your TV, the internet, your social media feeds, your friends and family.
Feeling that you’ve assessed the perceived risk level as thoroughly as possible can help ease your anxiety. But not all information about these new vaccines is created equal.
“While appraising the situation and how it might impact your health, make sure you’re gathering your facts from a trusted source of information. Some good options are your primary care doctor, the CDC’s vaccine web page or credible health websites,” recommends Dr. Orme. “Be aware that headlines and personal opinions expressed on social media may be based on less credible news sources.”
Even after doing plenty of research, there are still some what-ifs that just won’t come with answers right now. This is when it’s helpful to weigh the known and unknown risks.
For instance, if you’re concerned about the potential for long-term side effects of COVID-19 vaccines, it may help to consider what we know about the side effects of COVID-19 , as well as the frequency and severity of long-term side effects of other common vaccines that have been studied for a long time.
Discuss your concerns with someone you trust
As mentioned, there’s a lot of information to take in about the new COVID-19 vaccines. After trying to digest it all on, it may help to discuss your concerns with someone you trust.
“With any feeling of anxiety, it can be beneficial to turn to someone you trust for support. While this can be hard to do during the pandemic, even something simple as talking through your decision with someone on the phone can help reassure you,” says Dr. Orme. “Let the person know you’re nervous and give them space to constructively weigh in on your decision-making process if they have concerns.”
Avoid generalizing fear of COVID-19 with fear of the vaccine
Fear can be both very strong and easily generalizable.
For example, after being bitten by a stray dog at a park, you’ve become afraid of dogs — all dogs, even the ones that are on a leash or wagging their tails affectionately. You might even be afraid to visit that same park, regardless of whether there are dogs present or not. Your fear has generalized from one dog and one event towards the things that are associated: all dogs and the park.
“In the case of vaccine anxiety, your mind has already identified that COVID-19 is a threat that’s very real and dangerous. Now, your fear may generalize to the COVID-19 vaccine, and it may be an automatic, conditioned response you might not even realize is happening,” says Dr. Orme. “While COVID-19 and the COVID-19 vaccine are related, they are distinctly separate. The threat from COVID-19 is real, while the threat you may feel from the COVID-19 vaccine could very well be perceived.”
Ask yourself if you have a deeper motivation for being vaccinated
Look — we all, of course, want this pandemic to end. And we also know that vaccine-induced immunity is a huge step in the right direction. But this truth may not be enough as you make a decision that you feel is right for your health but is still anxiety-inducing.
“Make space beyond the obvious reasons for getting vaccinated and see if you can find other powerful sources of motivation to lean into. For instance, maybe getting vaccinated is important to you because it might reduce your risk of passing the virus to someone who’s more likely to get very ill from COVID-19. There’s always value in finding a deeper sense of purpose,” adds Dr. Orme.
Weighing the risks and benefits of vaccines
All medical interventions carry risks and benefits. Scientists from PATH’s Center for Vaccine Innovation and Access apply insights from rotavirus to COVID-19.
When the US Food & Drug Administration recommended a pause on the Johnson & Johnson vaccine due to six recipients developing blood clots, it felt like déjà vu to scientists at PATH. For decades, PATH has worked alongside partners to advance, evaluate, and inform decisions related to rotavirus vaccines, another vaccine with a very rare side effect.
“Evidence has shown time and again that the benefits of rotavirus vaccines significantly outweigh the known low-level risk of adverse reaction, and the vaccines’ use continues to save lives today,” says David C. Kaslow, MD, head of PATH’s Center for Vaccine Innovation and Access.
“The experience we’ve gained with rotavirus offers important insights for assessing the benefits and risks of COVID-19 vaccines going forward—whether Johnson & Johnson, Oxford-AstraZeneca, or new formulations yet to be developed.”
Rotavirus vaccines and intussusception
About 15 years ago, another virus was circulating around the world out of control, striking fear into families. This wasn’t a novel virus—it was rotavirus, which causes severe, rapidly dehydrating diarrhea in young children.
At that time, rotavirus was responsible for around half a million child deaths each year, mostly in countries with limited access to health care. In countries with robust health systems, rotavirus still caused hundreds of thousands of hospitalizations and sleepless nights for parents and children.
The development and licensure of two rotavirus vaccines, ROTARIX® and RotaTeq®, began to change things in 2006, but these weren’t the world’s first attempts at vaccines against rotavirus. An earlier vaccine, RotaShield®, had been taken off the US market in 1999 due to a rare and unanticipated side effect called intussusception: a life-threatening intestinal condition where the bowel folds in on itself cutting off blood supply and interrupting the passage of food and fluid. The risk of intussusception with RotaShield was estimated at 1 in 10,000 vaccinated children.
Before new rotavirus vaccines could be licensed, regulatory authorities required manufacturers to perform large clinical trials—with more than 60,000 infants—specifically to evaluate the potential risk of intussusception associated with rotavirus vaccine administration. These studies detected no risk, so countries began to license and introduce the vaccines.
As countries began introducing the new rotavirus vaccines, post-licensure surveillance continued to watch for intussusception. With the vaccines being given to millions of children, some post-vaccination intussusception did start to show up—but at a far lower rate.
The new rotavirus vaccines had an estimated risk of intussusception between 1 in 20,000 and 1 in 100,000. This is in addition to the rate of naturally occurring intussusception in the general population, which occurs in about 1 in 2,000 children every year. The new rotavirus vaccines had a significantly lower risk—approximately one-half to one-tenth—of intussusception compared to that observed for RotaShield.
The risk of intussusception with ROTARIX® and RotaTeq® is significantly smaller than with an earlier vaccine or the risk of naturally occurring intussusception. Each box shows the scale needed to produce one case of intussusception. Image: PATH.
With all the surveillance coming in, another observation became clear: rotavirus vaccines work very well.
Countries that have introduced rotavirus vaccines have seen swift and significant reductions in rotavirus hospitalizations—a median reduction of 59 percent—in children under 5 years of age. Given the overwhelming evidence in favor of the vaccines, the World Health Organization recommended in 2009 that rotavirus vaccines be included in all national immunization programs for infants.
In the decade since, more than 100 countries have added rotavirus vaccines into routine immunization. Real-world vaccine effectiveness has ranged from 45 to 90 percent. Scientists have continued to monitor intussusception over the years and maintain the recommendation that the vaccines’ benefits heavily outweigh the risks.
Miren Iturriza-Gomara, head of PATH’s rotavirus vaccine initiative, observes, “Rotavirus vaccines are a runaway public health success story. They are saving children’s lives and saving parents from heartache all over the world.”
“If regulators had removed rotavirus vaccines because of the 1 in 100,000 risk of intussusception, about 900,000 children would not be alive today.”
“If regulators had removed rotavirus vaccines because of the 1 in 100,000 risk of intussusception, about 900,000 children would not be alive today.”
— Miren Iturriza-Gomara, PATH’s rotavirus vaccine initiative
COVID-19 vaccines and blood clots
With the Johnson & Johnson COVID-19 vaccine, the stakes are even greater. The pandemic continues to claim hundreds of thousands of lives every day, and the threat of new variants makes vaccination an urgent priority.
However, the Johnson & Johnson vaccine’s use in the United States was paused after six women developed blood clots with low levels of blood platelets after receiving the vaccine. While research is ongoing, this risk so far appears to be less than 1 in a million.
A risk of blood clots with low platelet counts, which may or may not be caused by the same mechanism of action as in the Johnson & Johnson vaccine, also appears to exist for the Oxford-AstraZeneca COVID-19 vaccine. This vaccine has been in use throughout Europe and much of the world through the COVAX initiative. After countries started seeing a small increase in blood clots—estimated at 4 in a million—several countries paused or limited the vaccine’s use.
“Monitoring vaccine safety is paramount to any vaccination program,” notes Dr. Kaslow.
“The rapid identification of these blood clot cases with low levels of blood platelets underscores the importance of reporting any adverse events and quickly determining if there is a plausible link to the vaccine. At the same time, every medical intervention comes with some level of risk, and an essential role of public health officials is to assess the balance and to effectively communicate both the benefits and the risks to the public.”
Applying lessons from rotavirus for COVID-19
In the case of rotavirus vaccines, public health officials carefully analyzed the evidence before affirming that the lifesaving benefits of the vaccines outweighed the low-level risk of intussusception. Officials continue to communicate the risk to health care workers so they can warn parents to look out for intussusception in the rare chance that it does occur.
Additionally, because they knew the risk was small due to data from the clinical trials, officials did not pause rotavirus vaccine usage during post-licensure surveillance. This decision allowed children to continue being protected from life-threatening diarrheal disease while they continued to gather more data on rare side effects.
As scientists and officials weigh the risks and benefits of COVID-19 vaccines, the success of rotavirus vaccination is an important lesson to keep in mind.
“The risks of life-threatening blood clots with low blood platelet levels now reported for the Johnson & Johnson and Oxford-AstraZeneca vaccines appear to be rare, and we know that currently in many countries the individual and public health risks of not being vaccinated are extraordinarily high,” says Dr. Kaslow.
“Rotavirus vaccines are an instructive example of the importance of balancing rare-frequency risks with lifesaving benefits, and of the importance of carefully communicating the benefit-risk balance to health care providers and, most importantly, to the public.”
The problem: Low immunization rates
Childhood vaccines prevent an estimated 2 to 3 million deaths every year. They are recognized as one of the most cost-effective child health interventions in low-income countries. Yet, in 2019, an estimated 14 million infants around the world were still not reached by vaccination services. The problem of low immunization rates is especially clear and pressing in Nigeria. Nigeria is home to just 2.6% of the world’s population , yet it accounts for 16% of the world’s mortality of children under five. As of 2019, Nigeria had the highest mortality rate in the world among children under five years (117 deaths per 1,000 live births). Strikingly, an estimated 40% of under-five deaths in Nigeria are from vaccine-preventable diseases. North West Nigeria specifically has the highest under-five mortality rate in the country. It also has the lowest vaccination coverage in the country, with only around one quarter of the infants getting fully immunized, leaving a large population of infants vulnerable to disease outbreaks.
The problem of low vaccination coverage in Nigeria is further exacerbated by extreme poverty. This is especially true in North West Nigeria, where many mothers live on less than US$2 a day and cannot visit the clinic for various reasons. They face challenges such as affording the transportation cost to the clinic, associated loss in earnings from small-scale trading or farming, receiving permission from their partners, fear of vaccination side effects, cultural barriers to vaccination, or often a combination of these factors. Many of them are stuck in a cycle of poverty. Living at the bottom of the economic ladder forces them to make choices between their survival today and a better future for them and their children tomorrow.
The solution: Conditional cash transfers (CCTs)
Conditional cash transfer programmes (CCTs) give money to low-income households in return for fulfilling specific behavioral conditions. These conditions include, for example, children’s school attendance, up-to-date vaccinations or regular visits to a health care facility by pregnant women. CCTs have a direct effect on poverty by providing an immediate additional income for the poor, who can make their own choices as to how to spend or save this money.
New Incentives is a pioneer in a growing movement committed to providing small incentives to caregivers whose infants get immunized while also increasing awareness of the overall health benefits of childhood vaccinations. They offer cash transfers to caregivers who vaccinate their infants after verifying that their infant has gotten the latest vaccinations. New Incentives distributes a total of around US$11 for each infant — enough to cover transport, medicine, and food for their families — across five separate cash transfers (disbursed over five separate visits to the clinic in the first year of the infant’s life).
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How New Incentives works
New Incentives runs a conditional cash transfer (CCT) program in North West Nigeria (Jigawa, Katsina, Zamfara) that disburses cash incentives to caregivers conditional on infants receiving four vaccines: BCG (against tuberculosis), PENTA (against diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae type b), PCV (against pneumococcal disease), and MCV (against measles). These vaccinations are part of the routine schedule for infant immunizations in Nigeria and are provided at no cost to the caregiver through government-supported clinics.
The New Incentives program trains field staff to attend immunization days at health clinics, disburse cash transfers after verifying that a vaccination was given, monitor clinics to ensure that vaccines are in stock and not expired, and provide photographic monitoring that cash transfers are given in the correct amount to parents whose infants have received a vaccine. The cash transfers are in the amount of 500 naira (~US$1.40) for each of the first four vaccine visits (from birth to 14 weeks) and 2,000 naira (~US$5.50) for a fifth visit for the measles vaccine (at 9 months). In other words, caregivers can receive up to 4,000 Naira (~US$11) if the infant receives all doses in the routine immunization (RI) schedule over the course of five clinic visits.
Multiple studies show that expanding vaccination reduces illness and death among young children. IDinsight, in coordination with Hanovia Limited and three Nigerian state governments, conducted a three-year randomized controlled trial studying the efficacy of New Incentives’ work. The study found that the program led to increased immunization, increased likelihood that immunization was received at the recommended age and better knowledge and attitudes among caregivers towards immunization. In addition, children in areas served by the program had higher coverage for all major injectable vaccines – including those not directly incentivized by the program – and were more likely to have visited a health clinic. In other words, by incentivizing four vaccines, New Incentives was able to indirectly promote all vaccines that are part of the routine immunization schedule in Nigeria. Finally, New Incentives supported program clinics were more likely to report no or rare stock outs (instances where a vaccination is out-of-stock and unavailable) than those clinics not supported by the program, a finding that suggests the program’s impact may go beyond stimulating vaccine demand to also reducing vaccine supply-side constraints.
History Shows Americans Have Always Been Wary of Vaccines
Even so, many diseases have been tamed. Will Covid-19 be next?
By Alicia AultSMITHSONIANMAG.COM
JANUARY 26, 202113231
As long as vaccines have existed, humans have been suspicious of both the shots and those who administer them. The first inoculation deployed in America, against smallpox in the 1720s, was decried as antithetical to God’s will. An outraged citizen tossed a bomb through the window of a house where pro-vaccination Boston minister Cotton Mather lived to dissuade him from his mission.
It did not stop Mather’s campaign.
After British physician Edward Jenner developed a more effective smallpox vaccine in the late 1700s—using a related cowpox virus as the inoculant—fear of the unknown continued despite its success in preventing transmission. An 1802 cartoon, entitled The Cow Pock—or—the Wonderful Effects of the New Innoculation, depicts a startled crowd of vaccinees who have seemingly morphed into a cow-human chimera, with the front ends of cattle leaping out of their mouths, eyes, ears and behinds.
Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, says the outlandish fiction of the cartoon continues to reverberate with false claims that vaccines cause autism, multiple sclerosis, diabetes, or that the messenger RNA-based Covid-19 vaccines from Pfizer/BioNTech and Moderna lead to infertility.
“People are just frightened whenever you inject them with a biological, so their imaginations run wild,” Offit recently told attendees of “Racing for Vaccines,” a webinar organized by the Smithsonian’s National Museum of American History.
“The birth of the first anti-vaccine movement was with the first vaccine,” says Offit. People don’t want to be compelled to take a vaccine, so “they create these images, many of which obviously are based on false notions.”
“There’s a history of the question of how you balance individual liberty—the right to refuse—versus the policing of the public health,” agrees Keith Wailoo, a medical historian at Princeton University and another panelist at the event.
Because vaccines are given to otherwise healthy people that always brings an element of fear into the picture, says Diane Wendt, a curator in the museum’s division of medicine and science.
Wendt and her colleagues have been holding webinars under the moniker “Pandemic Perspectives.” The online panel discussions provide a vehicle to show off some of the museum’s images and artifacts while the building remains closed in Washington, D.C., during the Covid-19 pandemic. Experts provide context to the various topics, says Arthur Daemmrich, director of the museum’s Lemelson Center for the Study of Invention and Innovation. “Racing for Vaccines” highlighted centuries of scientific progress and technological innovation, which has persisted even in the face of vaccine hesitancy. Of all the diseases for which humans have developed vaccines, only smallpox has been almost fully vanquished on Earth. The Centers for Disease Control and Prevention (CDC) says 14 other diseases that used to be prevalent in the U.S. have been quashed by vaccination.
After smallpox, vaccine efforts around the globe focused on diseases that were decimating livestock—the lifeblood of many economies. The French scientist and physician Louis Pasteur had by the late 1870s come up with a method to vaccinate chickens against cholera. He then moved on to help develop an anthrax vaccine for sheep, goats and cows in 1881. A few years later, Pasteur had come up with the first vaccine to protect humans against rabies, which by 1920 required one shot a day for 21 days.https://3d7bca66a9931ea6f3a390ae3aec59be.safeframe.googlesyndication.com/safeframe/1-0-38/html/container.html
Early vaccines relied on developing science. When the influenza pandemic of 1918 crashed down on the world, no one had the ability to visualize viruses. Bacteria cultured from victims’ lungs was erroneously thought by leading scientists to be the cause of the illness, says John Grabenstein, the founder of Vaccine Dynamics and a previous director of U.S. Department of Defense Military Vaccine Agency.
Researchers created flu vaccines that failed because they targeted bacteria, not the true viral cause. The viruses weren’t isolated until the 1930s and the first inactivated flu virus for widespread use was not approved until 1945. By contrast, the Covid-19 vaccine went from genetic sequence to near-complete clinical trials, full scale production and delivery to Americans within eight or nine months.
The technology has come a long way. Early smallpox inoculation required scraping out material from a pustule or a scab of someone who had been vaccinated and then scratching it into someone else’s arm, using a hollowed-out needle or something like the spring-loaded vaccinator device from the 1850s that can be found in the museum’s collections. A bifurcated needle that delivers a tiny amount of vaccine subcutaneously is still used today.
In the 1890s, the development of an antitoxin to treat diphtheria gave rise to the pharmaceutical industry and to a regulatory infrastructure to help ensure the safety of drugs. Diphtheria led to sickness and death when toxins emitted by the Corynebacterium diphtheriae bacteria coated the lungs and throat, giving rise to its common name, the “strangling angel.” Between 100,000 to 200,000 American children contracted the illness each year, and 15,000 died.
The New York City Health Department was a leader in diphtheria antitoxin production in the late 19th and early 20th centuries. Scientists gave horses ever-increasing doses of toxins; the animals in turn produced antitoxins, which were harvested by bleeding the horses. The horse serum was purified and then administered to children. It helped prevent disease progression and conferred some short-term immunity, says Wendt.
“The impact of this particular product, the antitoxin, in the 1890s was huge,” she says.
Several drug companies—including H.K. Mulford Co., which also manufactured a smallpox vaccine, and Lederle, founded in 1906 by a former New York health commissioner who had been active in the agency’s diphtheria efforts—commercialized the antitoxin. But tragedy struck. The St. Louis health department allowed contaminated antitoxin serum from one of its horses—who had died of tetanus—to be distributed. Twenty-two children died.
That led to the Biologics Control Act of 1902, which set the stage for federal regulation of vaccines with the establishment of the Food and Drug Administration.
However, as seen through history, “getting vaccines to their destination is a continuing challenge,” says Wailoo. In 1925, Nome, Alaska, experienced a diphtheria outbreak. The town was snowbound. Twenty mushers and 150 sled dogs, including the famous lead dog Balto, relayed antitoxin across the state to Nome, helping to end the epidemic.
“We don’t have dog sleds to deal with today,” says Grabenstein, but the ultra-cold temperatures of -70 degrees Celsius/-94 degrees Fahrenheit required for transport and storage of the Pfizer/BioNTech vaccine is a high hurdle.
Before Covid-19, the largest nationwide emergency effort to eradicate a disease came in the 1950s, when the polio virus reached a peak of almost 60,000 cases, fomenting anxiety across America. Children experienced paralysis, disability and death. Jonas Salk—who helped develop the influenza vaccine—created a new, equally important vaccine for polio. It was tested in one of the largest-ever trials, involving 1.8 million children, who were known as the Polio Pioneers, says Offit.
When Salk announced on April 12, 1955, that it was “safe, potent and effective,” the vaccine was approved within hours and rolled out immediately, Offit says. “This was Warp Speed One,” he says, playing off the Operation Warp Speed program that aided development of the Covid-19 vaccines.
Ultimately, for vaccines to work, they have to be administered. Public health officials in 1970 encouraged rubella vaccination for children with posters that stated that “Today’s little people protect tomorrow’s little people.” That’s because pregnant women who contract rubella are at risk for miscarriage or stillbirth. “This speaks to communal responsibility,” says Wendt, noting that many campaigns have aimed to motivate Americans to accept vaccines to protect not just themselves, but society at large.
In the past, some pharmaceutical companies—such as Mulford—have produced stickers and buttons that allow the wearer to declare they’ve been vaccinated. The CDC has created stickers that lets Covid-19 recipients tell the world they got their shot.
But many Americans—especially people of color—are still skeptical. “The African American community, for good reason, unfortunately, has seen a legacy of disparate care, of lack of care, including several high-profile incidents like Tuskegee and others where they feel the medical system abandoned them,” says Daemmrich. In the Tuskegee experiment, government researchers studied black men with syphilis and told them they were being treated, but they were not receiving any therapies. The men were never offered proper treatment, either.
“There’s a lot of distrust,” Daemmrich says, adding, “it’s not entirely clear how you overcome that distrust,” but that, “just showing up now in the midst of the pandemic and saying ok trust us now isn’t the way to do it.”
The Kaiser Family Foundation has been tracking hesitancy around the Covid-19 vaccine. In December, before the two vaccines had been distributed, 35 percent of black adults said they would definitely or probably not get vaccinated, compared to 27 percent of the public overall. About half of those black adults said they didn’t trust vaccines in general or that worried they would get Covid-19 from the vaccine. By January this year, Kaiser found that while about 60 percent of black respondents said they thought vaccines were being distributed fairly, half said they were not confident that the efforts were taking the needs of black people into account.
Early data on the vaccine rollout confirms some of those fears. Kaiser found that in more than a dozen states, vaccinations in black Americans were far lower than for white Americans and not proportionate to black people’s share of case counts and deaths.
And, few people alive now have seen anything comparable in terms of the scale of the Covid-19 pandemic, says Wailoo. “Maybe the scale of this is enough of an incentive,” he says.
Offit isn’t as certain. “We saw polio as a shared national tragedy—it pulled us all together,” he says. “It’s harder to watch what goes on today, where it feels like we’re not getting together, rather just more finger-pointing.”
How the CIA’s fake Hepatitis B vaccine program in Pakistan helped fuel vaccine distrust
Skepticism about vaccines is often rooted in history for many communities of color.
In the early 2010s, the CIA ran a fake vaccination program in Abbottabad, offering free Hepatitis B vaccines to children in an attempt to collect DNA evidence linking Osama bin Laden to the compound where he was suspected of residing. It is unclear how samples were to be collected or how they would lead to bin Laden, but when news of this scheme broke, it added proof to existing conspiracy theories about vaccinations. As a consequence, many local leaders began urging people not to vaccinate their kids, various districts banned vaccination teams, and the Taliban issued a fatwa against vaccination programs. To this day, local leaders rail against vaccines as Western spying programs.
In 2013, in response to pressure from leaders in public health and science, the CIA promised to stop using vaccination programs to gather intelligence. However, the legacy of the fake vaccine campaign in Pakistan has understandably not been easy to overcome. Trust in public health officials has been dangerously eroded.
Pakistan is one of the three countries in the world where polio has not been eradicated. Along with neighboring Afghanistan, the country is seeing its highest increase in polio cases since 2014: 54 cases were reported in the first quarter of 2020, up four times from the year before. Polio vaccinators are targeted with violence; since 2012, at least 95 polio workers, including many women, are estimated to have been killed in attacks. As recently as this December, members of a vaccination team were wounded or killed in an incident that garnered very little coverage in the media.
Pakistan is not the only country with a history of medicalized violence. In the US, there is a long history of Black and brown people being used for medical experimentation, and it feels unsurprising that many other people of color I have come across have expressed hesitation about the Covid-19 vaccine.
The Black nurse who swabbed my nose for a PCR test last week says she didn’t take the vaccine when it was offered to her because she wanted to wait for the next round in case there were any side effects. The Latino delivery person at work tells me he turned down the vaccine because it hasn’t been tested properly. My friend, a Black organizer and educator, says on a Zoom meeting that she’s not going to take the vaccine because she doesn’t trust the medical establishment.
Vaccine distrust in the US cannot be divorced from recent history. In a class I teach on the legacy of racism in science research, we read about the US government’s study of untreated syphilis on Black men in Tuskegee; about J. Marion Sims, who carried out practice surgeries without anesthesia on enslaved Black women, who had a statue memorializing him as the “father of gynecology” in Central Park as recently as 2018; about Henrietta Lacks, a Black woman whose tumor cells were used without her consent to develop a cell line for cancer research; about glaring health disparities between white and BIPOC communities.
“Why didn’t we know about this?” ask my white, East Asian, and South Asian students. “Why didn’t we learn this in our science classes?” It’s hard not to feel like the forgetting is willful, and willful forgetting only creates more distrust.
For Covid-19 vaccination programs to undo distrust in time for the mass drives that will be needed to build herd immunity, what is needed is willful remembering and willful repair. It is morally imperative that vaccination drives engage with the history of medical harm in the US and abroad, acknowledge the role that both the government and individual scientists have played, and repair the fissures with community outreach, material resources, and firm commitments to undoing health disparities between white and non-white people.
Until that happens, the success of the Covid-19 vaccination program is going to come down to something Black doctors and scientists have already been doing: making individual pitches to their communities and families to take the vaccine. Here’s mine: I’m a Pakistani scientist who has looked at the data from the clinical trials of the vaccine and has decided to take the vaccine.
I feel happy that I got this chance, and that happiness lives with other feelings. I feel relief knowing I’m unlikely to get Covid-19, a horrible disease that has known long-lasting side effects, and I’d rather risk the unknown side effects of the vaccine for the relief of knowing I won’t pass the virus to more vulnerable members of society.
I feel anger, too, that BIPOCs will continue to die because of the legacies of medical racism, that children in Pakistan will die of polio despite an effective vaccine. And I feel guilt for receiving the Covid-19 vaccine ahead of so many others: my father, who lives in Pakistan and is immunocompromised; essential workers such as bus drivers and those in the food distribution chain who kept this country running during the pandemic; everyone who lives in a non-Western country who isn’t anticipated to receive the vaccine until 2024.
None of which I tell the nurse who wishes me a happy vaccination day. I sit patiently as she asks me questions about allergies, fills out my vaccine card, and loads up a syringe. “Wait,” I ask right as she’s about to jab me, a little embarrassed at what I’m about to ask. “Can I take a selfie?”
“Of course!” she says. “Will you do me a favor and post it with a positive message? So that more people get the vaccine?”
I promise her I will.
CIA’s hunt for Osama bin Laden fueled vaccine hesitancy in Pakistan
The CIA’s efforts to capture Osama bin Laden via a fake vaccination drive in Pakistan led to a rise in vaccine hesitancy in the years after the scheme was revealed.
In 2011, it was reported that the CIA had organised a fake vaccination drive in Abbottabad, Pakistan, reportedly administering hepatitis B vaccines to babies, while obtaining DNA samples to compare with that of bin Laden’s sister, who died in the US the year before. The CIA was attempting to find a child who was related to bin Laden, in an effort to pin down his whereabouts.
These reports led to uproar in Pakistan and a number of anti-vaccine campaigns were started by Islamic extremist parties. Monica Martinez-Bravo at the Centre for Monetary and Financial Studies in Madrid, Spain, and her colleague Andreas Stegmann at the University of Warwick, UK, have investigated the effect this had on vaccine uptake.
They collected data from the Pakistan Social and Living Standards Measurement survey on 18,795 children born between January 2010 and July 2012 across 115 districts of the country. The records showed whether a newborn had received their diphtheria, tetanus and pertussis (DTP), polio, and measles vaccines.
The pair then compared these records to the political stance of each district as measured by the 2008 Pakistani general election, the most recent one before the reports on the fake vaccination drive. They found a 23 per cent decline in DTP vaccination rates in districts with more support for Islamic extremism, along with a 28 per cent and 39 per cent decline for polio and measles, compared with districts with lower levels of such electoral support.
“Parents in those districts are probably more exposed to the anti-vaccine propaganda campaigns advertised by the extremist parties,” says Martinez-Bravo. The pair also found a greater decrease in vaccination rates among girls compared with boys, on average 3 percentage points larger. This is most likely to be due to a rumour spread by the Pakistani Taliban that vaccines were made to sterilise young girls, she says.
The researchers also investigated whether the decrease in vaccination led to a rise in disease prevalence. Districts where there was greater support for Islamic extremism had 1.66 more cases of polio on average compared with districts with lower levels of support – almost twice the average number of cases per district.
The vaccine hesitancy appears to be short-lived, according to preliminary data. “More optimistically, these effects seem to diminish for children born around two years after the event,” says Martinez-Bravo.
“This has important lessons for today’s fight against covid-19 in rich and poor countries alike, where concerns over misinformation and anti-vaccine sentiments remain relevant,” says Imran Rasul at University College London.
Why polio is making a comeback
Experts warn that new cases of the deadly disease, long gone from most of the world, are just the tip of the iceberg. Here’s what went wrong—and how we can eradicate polio once and for all.
*Note I have included this article in this posting because it helps to show what the failure of adhering to a vaccine protocol and policy can lead to. When you become complacent with Mother Nature, it can come back to bite you in the ass. Not only are polio cases coming back there have been a few isolated cases of small pox and of course monkey pox a less virulent strain has appeared. This would not have happened if we wee still vaccinating for small pox.
The world seemed to stop on April 12, 1955, when officials at the University of Michigan School of Public Health announced that Jonas Salk had developed a vaccine that protected against polio.
As the news was broadcast across the country, Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, remembers that businesses and schools closed so that Americans could celebrate, and churches and synagogues held special prayer services. His own mother cried at the news, relieved that her children would finally be safe from the disease that was known to paralyze its victims, leaving them unable to walk or even breathe.
“This was a major event, which tells you how scared people were of polio—and for good reason. If it paralyzed your ability to breathe, you were well aware of what was happening,” Offit says. Many patients stricken by polio were forced to rely on an iron lung for years.
In the decades since Salk’s breakthrough, wild polio has been eliminated in all but two countries, Afghanistan and Pakistan. Yet the disease has crept back in countries that believed polio was long behind them. In recent weeks, the United States has been shaken by the news that a New York man was left paralyzed by polio, the nation’s first such case in nearly a decade. Israel also reported a case of paralytic polio in February.
“You can assume that when you see that case in New York City of a man who wasn’t vaccinated, who now is infected…that he represents the tip of an iceberg,” Offit says, explaining that paralytic polio is so rare that it suggests there are many other cases that have so far gone undiagnosed. And, indeed, the virus has since been found in the wastewater of New York, Jerusalem, and London.
Offit and other experts warn that all this suggests that growing numbers of unvaccinated people have left some communities particularly vulnerable to polio’s most horrific outcomes. (Why sewage is one of the best tools for predicting COVID-19 outbreaks.)
Here’s what you need to know about the risks of polio, vaccines used to combat it, and where we stand in the global push to eradicate the virus.
What is polio—and how did we almost wipe it out?
Polio is an ancient disease caused by three strains of poliovirus. Perhaps its earliest depiction was a circa-1400 B.C. Egyptian funerary tablet that shows a priest with a withered leg walking with a cane. First clinically described in 1789, the virus primarily spreads through contact with the feces of an infected person and is infamous for causing severe paralysis.
Paralytic polio is rare, however. Most people who are infected don’t have any symptoms at all and a quarter only experience flu-like symptoms. According to the U.S. Centers for Disease Control and Prevention, only about one in 200 people—or one in 2,000, depending on the virus strain—develop paralysis.
Still, polio was so rampant in the 20th century that the U.S. recorded about 16,000 cases of paralytic polio a year by the time Salk developed his vaccine. Developed using an inactive form of the poliovirus that can induce immunity without causing disease, Salk’s viral vaccine was administered in a series of injections. It quickly proved safe and effective: Case numbers dropped from 29,000 new cases in 1955, when the shot was licensed, to fewer than 6,000 within two years. (Here’s how teens made polio vaccination hip in the 1950s.)
Just as Salk’s vaccine was circulating, another American researcher, Albert Sabin, was working on a polio vaccine that used a weakened form of live virus, which at the time was thought to provide more enduring immunity. Taken orally rather than by injection, the Sabin vaccine was shown to induce an immune response in the gut, critical to stopping the transmission of wild poliovirus. What’s more, the weakened virus could spread and induce immunity when vaccinated people came in contact with those who hadn’t yet had the jab.
“The invention of the poliovirus vaccine with Salk and Sabin competing was just a major medical achievement and a real revolution in global health,” says Daniel Caplivski, an infectious disease specialist at the Icahn School of Medicine at Mount Sinai in New York.
Thanks to a mass immunization campaign—which gained momentum in the 1980s after the eradication of smallpox—polio has nearly been eliminated worldwide. In fact, two of the three strains of wild polio have been “certified eradicated,” says Ananda Bandyopadhyay, deputy director of polio technology, research, and analytics at the Bill & Melinda Gates Foundation.
Today, polio remains a routine immunization, one that’s required to enroll a child in public school in every U.S. state. Vaccine coverage is overwhelmingly high in most countries and protection from both the vaccines is now believed to last a lifetime.
So why are there still polio outbreaks?
Although mass immunization campaigns have eliminated wild polio from much of the world—most recently in Nigeria and India—there have at times been outbreaks in countries that have eliminated it. In those cases, the disease is triggered not by wild virus but by something called vaccine-derived polioviruses—mutated forms of the weakened live virus in Sabin’s oral vaccine.
These rare viruses develop in communities where immunization against polio is persistently low, giving the weakened virus in the vaccine plenty of time to find enough unvaccinated people in the community to infect. As it replicates, the viral genome can mutate and revert to a virulent form of the virus in what Bandyopadhyay describes as a “desperate attempt to survive.” Although people who are vaccinated remain protected from the new strain, anyone who is unvaccinated risks paralysis.
Researchers have known about this phenomenon for decades, Bandyopadhyay says. In the early 2000s, some countries like the U.S., which had already eliminated polio, stopped administering the oral vaccine in favor of Salk’s original inactivated vaccine, which cannot cause new infections. But for the rest of the world, that wasn’t practical.
Sabin’s oral vaccine is more affordable than the inactivated vaccine, and because it’s administered in drops rather than by injection, it is easy for volunteers to carry into remote villages and administer with minimal training. The oral vaccine is also more effective for stopping transmission of the virus, which is essential for eradication.
“I think that is probably the best way to eliminate the virus from the world—but it comes with a price,” Offit says, adding that these vaccine-derived strains of polio are likely circulating around the world, even in places where it hasn’t been detected because we’re simply not checking for it. “If we let our guard down as happened with this community in New York, then polio can come back.”
How can you protect yourself?
Scientists stress that vaccination is the key to ending all polio outbreaks. Unlike COVID-19 variants that can evade vaccine immunity, the polio vaccines are broadly protective against wild polio and the vaccine-derived polioviruses. Meanwhile, high vaccine coverage keeps communities safe by making it harder for the virus to find a new host.
Offit points to a 1972 polio outbreak at a Christian Science boarding school in Greenwich, Connecticut, that paralyzed eight children who had not been vaccinated. Although there were concerns at the time that the virus could spread into the surrounding communities, Offit says this never came to pass, thanks to the high levels of protection in those areas.
What does all this mean now? If you’ve been vaccinated already, there’s nothing more to do to protect yourself. But if you haven’t gotten a jab, now is the time. Even if you aren’t sure whether you’ve been vaccinated, Caplivski says both the polio vaccines are so safe that there’s really no downside either to getting a booster dose or taking the whole series of shots.
In New York, he adds, the Department of Health has asked medical providers to ensure kids are up to date on their vaccines—especially given evidence that the COVID-19 pandemic has disrupted routine childhood immunizations globally. In the United Kingdom, public health officials have launched a polio vaccination campaign to reach kids ages 1 through 9.
But scientists are particularly concerned about reaching the communities that have so far refused to vaccinate their children. “I think there’s a tendency when we live for many years without the memory of some of these childhood illnesses to take for granted the basic effectiveness of the vaccines,” Caplivski says, adding that often parents decide not to vaccinate their kids because they don’t understand the risks of polio and other childhood diseases like measles that have mostly been eliminated.
Offit agrees. “That’s the frustrating thing here,” he says. “There are so many things in medicine we don’t know, there’s so many things we can’t do. This we know and this we can do. To watch people reject it, it’s painful.”
What else is needed to end polio?
Containing the threat of vaccine-derived polioviruses will require a shift away from the oral vaccines that have been so essential to global eradication. But while the goal is to abandon them entirely, Bandyopadhyay says the oral vaccines are still needed to reach communities in Afghanistan and Pakistan where polio remains endemic.
That’s why researchers with the Global Polio Eradication Initiative (GPEI)—a public-private organization that includes the Gates Foundation, World Health Organization, Rotary International, and other partners—have come up with an interim solution: a version of the oral vaccine that cannot revert to an infectious state.
“What we have done is to tighten the loose ends of the existing vaccine virus,” Bandyopadhyay says. He explains that researchers have pinpointed the specific part of the weakened live virus in the oral vaccine that is prone to reverting to an infectious state. By tweaking the genetic instructions that encode the structure of the virus they have attempted to stabilize it.
“So far the data looks exceptionally promising,” Bandyopadhyay says. About 450 million doses of the novel oral polio vaccine (nOPV2) have been administered globally since the World Health Organization listed it for emergency use in November 2020. In the time since, Bandyopadhyay says there haven’t been any new outbreaks of vaccine-derived poliovirus in the areas where it was administered. Sewage surveillance shows that the virus is not mutating back to a virulent state.
Once all forms of wild virus transmission stop, Bandyopadhyay says the GPEI plans to switch to using the inactivated vaccine to eliminate the potential for vaccine-derived polioviruses to emerge. But in the meantime, he says, it doesn’t matter: “If you can reach that last child in that last community with the vaccine, irrespective of the vaccine choice, the job is done.”
Ultimately, this will rest on reaching the growing community of people who have resisted vaccines. Will a new outbreak change their minds? If not, Offit says it doesn’t bode well for the future. “If polio doesn’t scare you, what does?”
COVID vaccine hoarding might have cost more than a million lives
Low- and middle-income nations would have had lower death rates if vaccines had been shared more equitably.
More than one million lives might have been saved if COVID-19 vaccines had been shared more equitably with lower-income countries in 2021, according to mathematical models incorporating data from 152 countries.
The impact of vaccine sharing would have been even greater if the distribution of more vaccines to poorer countries happened alongside wealthier countries keeping other mitigation measures — such as smaller gatherings and mask wearing — in place for longer. In that case, the models suggest, as many as 3.8 million lives could have been saved.
It has been widely assumed that inequitable vaccine distribution led to unnecessary loss of life. But having an estimate of the size of that loss could aid in planning for future epidemics, says Oliver Watson, an infectious-disease epidemiologist at Imperial College London. “This is another piece of evidence to show how big of an impact pushing for vaccine coverage may have had,” he says. “That’s really important for engaging political will and framing big political decisions.”
By the end of last year, nearly half of the world’s population had received two doses of a COVID-19 vaccine. But those vaccines were not distributed equitably: vaccination rates were 75% in high-income countries, but less than 2% in some low-income countries. Wealthy countries ended the year with vaccine surpluses and plans to vaccinate young children, who are at relatively low risk of serious disease. Meanwhile, many poorer countries still did not have enough supply to vaccinate the people at highest risk of death from COVID-19.
Mathematical epidemiologist Sam Moore and his colleagues at the University of Warwick in Coventry, UK, used data on excess mortality and vaccine availability to model what would have happened if vaccines had been distributed according to need rather than wealth. They considered the impact of vaccination on both SARS-CoV-2 spread and the severity of COVID-19.
The team found that, assuming no other policies that reduced physical contact, more equitable vaccine coverage could have prevented 1.3 million deaths worldwide (see ‘Vaccine inequity’s grim toll’). More than twice that many deaths would have been avoided if higher-income countries had also stuck with other measures to reduce transmission. The results were published on 27 October in Nature Medicine.
The study looked only at vaccine provisions, and did not consider other factors, such as the capacity to store and administer the shots.
The results mesh well with a previous study conducted by Watson and his colleagues, which used a similar modelling technique but with different data. That study found that about 45% of COVID-19 deaths in low-income countries could have been averted if the countries had achieved 20% vaccination coverage by the end of 2021, a target set by the global vaccine-sharing campaign COVAX.
More equitable sharing of vaccines, and a resulting drop in infections, might also have slowed the emergence of fresh SARS-CoV-2 variants, says Moore.
Policymakers could look to studies like these to lay the groundwork for better responses to the next pandemic. Although it might not be realistic to expect countries to give away vaccine supplies before vaccinating their own citizens, governments might be able to find a middle ground, Moore says. “First-world countries might vaccinate everyone over the age of 60 to protect the most vulnerable population, before helping other nations to catch up,” he says. “Even if not equitable, maybe there would be some sort of room for helping other countries once you’ve managed to get your own vaccine in place to some degree.”
The next generation of coronavirus vaccines: a graphical guide
New technologies might provide more potent or broader immunity — but will have to fight for market share.
Vaccines against the coronavirus SARS-CoV-2 have been given to billions of people to protect them from COVID-19, and have saved more than 20 million lives. But viral variants can evade some of the immunity provided by the original vaccines. As a result, vaccine developers around the world are working on dozens of ‘next-generation’ COVID-19 vaccines: not just updates of the first versions, but ones that use new technologies and platforms.
These vaccines are a diverse group, but the overarching aim is to deliver long-lasting protection that is resilient to viral change. Some could protect against broader classes of coronavirus, including ones that have yet to emerge. Others might provide more potent immunity, might do so at lower doses, or might be better at preventing infection or transmission of the virus.
Here’s what to expect of this next generation of vaccines.
Why do we need more vaccines?
In a word: evolution. The first approved COVID-19 vaccines were tested for protection against versions of SARS-CoV-2 that had not changed much since the virus was first identified. These vaccines come in different types — some are composed of messenger RNA, others are inactivated versions of the coronavirus itself or some of its proteins — but all work by exposing the body to antigens (portions of the virus) to provoke an immune response without causing disease.
Broadly speaking, this immune response comes from B cells, which produce antibodies that can block SARS-CoV-2 from infecting cells, and from T cells, which can destroy infected cells (and support other immune responses).
The vaccinations also generate a pool of ‘memory cells’ for prolonged immunity, even after initial antibody levels dwindle. On subsequent infection, memory B cells begin proliferating and differentiating into cells that churn out more antibodies (see ‘How coronavirus vaccines protect against SARS-CoV-2’).
Although these vaccines provide long-lasting protection against severe disease, the protection they offer against viral infection dwindles in months. And variants of SARS-CoV-2, such as Omicron, have since evolved with mutations that allow them to escape some of this immunity. For instance, memory responses generated by the initial vaccines produce antibodies that don’t latch on to Omicron as easily. That contributes to the reduced protection against infection (see ‘Coronavirus variants avoid immunity’).
A second generation of vaccines has already been introduced to boost immunity against the Omicron variant. It’s likely that further, variant-specific updates to vaccines will follow, to try to keep up with viral evolution — although it’s not clear whether the protection they offer will be particularly long-lasting as immunity wanes and SARS-CoV-2 evolves further.
As a result, research teams are taking several approaches to develop new vaccines.
To tackle SARS-CoV-2 variants, the vaccine developers Pfizer–BioNTech and Moderna introduced updated mRNA vaccines last year. These are called bivalent, because they encode molecules of the spike protein from the original virus and from Omicron. (The spike protein is what SARS-CoV-2 uses to bind to cells.)
The bivalent vaccines work in several ways. Like other COVID-19 booster shots, they stimulate the memory B cells already established by previous vaccines; some of this cellular response leads to antibodies that can recognize Omicron. Their potency can strengthen over time, too: when presented with Omicron’s spike, memory B cells go through an evolutionary ‘training’ process of mutation and selection, producing a pool of B cells that encode antibodies that bind more tightly to Omicron’s spike. Finally, the Omicron components of bivalent vaccines also recruit new B cells that produce their own antibodies (see ‘Updated vaccines’).
These effects might mean that a bivalent booster provides better protection against Omicron than does a booster dose of the original vaccine. But it’s still unclear how substantial that advantage is in practice.
Some developers, including Pfizer–BioNTech, are also working on combination vaccines to protect people against COVID-19 and other diseases — most commonly influenza. Nearly all are in the early stages of development.
Broadly protective vaccines
Updates to COVID-19 vaccines will always be a step or two behind the evolving virus. Scientists hope to develop ‘broadly protective’ vaccines that can target future SARS-CoV-2 variants — and even related coronaviruses.
The goal of some of these vaccines is to generate an immune response against particular regions of the spike protein that are conserved across SARS-CoV-2 variants and some related coronavirus species, meaning that they tend not to mutate in new variants. One region of interest is the receptor-binding domain (RBD), which binds to the ACE2 receptor protein on human cells and is targeted by some of the body’s most potent infection-blocking antibodies.
At least two teams, at the University of Washington in Seattle and at the California Institute of Technology (Caltech) in Pasadena, are making ‘mosaic’ vaccines: nanoparticles dotted with RBDs from SARS-CoV-2 and coronaviruses from the same family (called sarbecoviruses), such as SARS-CoV and others isolated from bats.
When a B cell recognizes more than one RBD on these mosaic nanoparticles — latching on to conserved regions from multiple virus species — it binds strongly. This, in turn, triggers that B cell to multiply and produce more antibodies (as well as memory B cells to fight future infections). B cells that recognize an RBD from just one viral species bind weakly, and do not generate this response. Researchers hope that using mosaic nanoparticles will result in an enriched pool of antibodies that can recognize multiple RBDs across coronavirus species (see ‘Broader protection?’).
Animal studies suggest that these vaccines do trigger protective responses against diverse sarbecoviruses (see, for example, A. A. Cohen et al. Science 377, eabq0839; 2022). The first clinical trials are set to begin in the next two years.
Going beyond spike
Many first-generation COVID-19 vaccines prompt an immune response only against SARS-CoV-2’s spike protein.
But some next-generation vaccines deliver other viral proteins as well, in the hope of generating a more diverse immune response that safely mimics the protection conferred by infection. This approach could also mitigate the impact of new spike variants (see ‘Targeting other viral proteins’).
The spike protein is the main target of antibody-making B cells. But T cells that destroy infected cells can recognize many other SARS-CoV-2 proteins. For this reason, vaccines that deliver other proteins could help protect people whose immune systems do not generate strong antibody responses. Such vaccines might also be more resilient to viral evolution, because non-spike proteins tend to vary less between variants.
The US biotechnology company Gritstone is developing one such vaccine: it delivers instructions for several SARS-CoV-2 proteins using mRNA vaccine technology. Meanwhile, Texas biotech company Vaxxinity is developing a protein-based vaccine that would expose the body to multiple antigens. The company says it plans to apply for UK and Australian authorization this year, after a phase III trial showed the vaccine was safe and prompted a strong antibody response when used as a booster.
New platform designs
Another way of categorizing next-generation vaccines is by the method of delivery into the body. Existing vaccines use one of at least four approaches: nucleic-acid vaccines (mostly mRNA) instruct cells to make the SARS-CoV-2 spike protein; inactivated vaccines use versions of the coronavirus itself; protein vaccines are composed of the spike protein or its RBD; and viral-vector vaccines use modified viruses to shuttle instructions for the spike protein into cells. Next-generation vaccines could involve tweaks to these designs or changes to delivery mechanisms that might improve performance.
mRNA vaccines helped to turn the tide of the pandemic, particularly in wealthy countries, where the vast majority of doses have been sold. A twist on this technology might make vaccines cheaper and even more potent, while minimizing side effects.
The vaccines developed by Pfizer–BioNTech and by Moderna (with the US National Institute of Allergy and Infectious Diseases) consist of mRNA instructions for a modified version of spike packaged in a fatty nanoparticle. In an updated version of this technology, self-amplifying RNA (saRNA) vaccines also include instructions for an enzyme that instructs cells to churn out more copies of spike (see ‘Self-amplifying RNA’).
This means that a smaller — and potentially cheaper — dose of saRNA vaccines could achieve the same or even a stronger immune response, compared with conventional mRNA vaccines. A smaller initial dose might also reduce side effects.
One saRNA vaccine, developed by US firm Arcturus Therapeutics, completed a phase III trial in April 2022; the company has now started another phase III trial in Japan that, it says, could lead to an application for authorization there. Gritstone is using saRNA technology to deliver additional SARS-CoV-2 proteins in a candidate T-cell vaccine that has completed a phase I trial.
Proteins on nanoparticles
Several protein-based COVID-19 vaccines have been authorized globally, including one made by US biotech firm Novavax. Their low cost and ease of production makes them appealing; they are usually made of stabilized forms of the entire SARS-CoV-2 spike protein or its RBD.
A new class of these vaccines is made of proteins that self-assemble into a soccer-ball-shaped structure, studded with spike or RBD. The repetitive arrangement of the viral molecules, mimicking an actual virus, generates an especially potent immune response.
The ‘mosaic’ vaccines developed by Caltech and the University of Washington (which are studded with RBDs from multiple kinds of coronavirus) are one example of this effort.
Another nanoparticle vaccine has already been approved: in April 2022, South Korean regulators authorized a vaccine, also developed at the University of Washington, containing RBDs from the original version of SARS-CoV-2. A phase III trial showed that the vaccine boosted antibody responses to levels that were several times higher than those generated by the viral-vector vaccine developed by AstraZeneca and the University of Oxford, UK, which uses a chimpanzee adenovirus encoding spike antigens.
However, the South Korean company developing the vaccine, SK biosciences, said in late 2022 that it had paused production amid low demand for the vaccine in South Korea.
A team led by researchers at the US Walter Reed Army Institute of Research in Silver Spring, Maryland, is developing another protein nanoparticle vaccine, using an iron-carrying protein called ferritin. This self-assembles into a spherical particle, and is then studded with the full SARS-CoV-2 spike protein. It is currently being tested in an early-stage trial (see ‘Nanoparticle platforms’).
Some COVID-19 vaccines are inhaled as a mist through the nose or mouth, or as nasal drops. By prompting immune responses at the point where SARS-CoV-2 enters the body — in the thin mucous membranes that line the nose and mouth — these vaccines could, in theory, stop the virus before it spreads.
Data from animal studies suggest this might be possible, and at least five nasal vaccines have already been approved for use — two in China and one each in India, Iran and Russia. But there are no data yet on whether these vaccines are better than injections at cutting down infection or transmission of the virus (see ‘Nasal vaccines’).
A key challenge to the development of these and other next-generation COVID-19 vaccines is proving that they offer genuine improvements over existing jabs, says Melanie Saville, executive director of vaccine research and development at the Coalition for Epidemic Preparedness Innovations (CEPI), an Oslo-based foundation that is a leading funder of next-generation COVID-19 vaccines.
All the next-generation vaccines will have to fight for market share. More than 50 vaccines have already been approved, and there are hundreds in early- and late-stage clinical trials; hundreds more have been abandoned (see ‘A lively market’).
Among the approved vaccines, just a few dominate the doses that have been administered (see ‘Leading players’).
Despite the flurry of research, current mRNA jabs such as the Moderna and Pfizer–BioNTech ones are likely to hold sway, says Matt Linley, analytics director at Airfinity, a life-sciences information firm in London. The fast development of bivalent vaccines that included an Omicron component showed that these vaccines could be adapted quickly. If another update is needed, “mRNA vaccinations would be market leaders in being able to react quickly”, says Linley.
COVID-19 is no longer seen as the all-encompassing emergency it once was, and so developers and regulators will move more slowly compared with the breakneck pace of the first-generation vaccines, adds Saville. “We shouldn’t rush these through, because these need to be the types of vaccine that will be durable in the long term for COVID-19.”
But even if work on new vaccine technologies doesn’t directly pay off against COVID-19, it could still support efforts to combat other diseases, Saville says, such as CEPI’s work on a ‘vaccine library’ for different virus families to improve preparation for future threats.
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