Better safety studies could restore America’s confidence in vaccines

In February 2021, I received my second Covid-19 shot — the newly developed vaccine that would eventually save millions of lives worldwide — with great anticipation. It proved to be a life-changing event: Two hours later as I was driving home, the shock of a sudden loud and high-pitched whistling nearly caused me to veer off the road. It was as if an audible dog whistle began blaring right next to me. But it wasn’t a dog whistle. It was the acute onset of tinnitus, a ringing in the ear with no external source.

For several years I had lived with minimal, intermittent tinnitus, but never anything like this, so loud and unrelenting.

Could the Covid-19 vaccine have amplified my tinnitus, or was this just a coincidence? I was suspicious, but at that time no data had demonstrated any relationship between the mRNA Covid-19 vaccines and tinnitus.

When I got my third dose in November 2021, the sound became even louder and more bothersome. This new noise level has continued to this day, nonstop, often keeping me from sleep and sometimes bringing me to tears.

As someone who has studied vaccines for 40 years, I know that the mRNA Covid-19 vaccines, and other vaccines, have saved millions upon millions of lives. For the vast majority of people, the benefits of getting vaccinated far exceed the risks.

But some people, like me, have unexpected effects from vaccines that affect our health and well-being. I say “some” because no one really knows how often vaccine-related injuries occur. Understanding that would be a first step toward reducing these rare risks even further. Are such adverse events predictable, and can they be prevented by identifying risk factors for the onset of a vaccine injury? I believe the answer is yes, but it won’t be achievable without increased funding for vaccine safety research.

Americans’ trust in vaccines has been slowly eroding. It accelerated with the advent of the World Wide Web in the 1990s and has been declining ever since. The Covid-19 outbreak temporarily obscured the problem, as many expressed the desire for a vaccine against this plague and millions got it once it became available.

Covid-19 also obscured the problem another way: lockdowns and sheltering in place reduced people’s normal activities and movements, and with it the spread of all viruses, not just SARS-CoV-2. But as people once again gathered and shopped and worshipped together, as well as traveled from country to country, measles — one of the most infectious viruses — has returned. In the first three months of 2024, the United States has had 17 times more measles cases than during the same time period for the past three years. The United States is now on the verge of losing its status as a nation in which measles has been eliminated.

Increasing vaccine hesitancy and rejection has contributed to ongoing outbreaks of measles in the U.S. Last year, the number of parents in the U.S. seeking exemptions to vaccinate their children increased in 41 states, and similar trends are being seen with the flu, pneumonia, and HPV vaccines.

Although the Covid-19 vaccines were a huge public health success, politicization and opposition to them became weaponized through disinformation for political gain. Whether or not to receive a Covid-19 vaccine became an expression of opinion, rather than an informed health decision, and this has had a trickle-down effect to other vaccines.

A renewed and well-funded focus on the study of vaccine safety is among the critical measures needed to stop the return of vaccine-preventable infectious diseases like measles and to reverse the loss of public confidence in vaccines. While the system to evaluate vaccine safety is extensive, it must be strengthened. Researchers and public health experts need to know which events are caused by vaccines, who is at increased risk for them, and why. With that information in hand they can move forward to reduce such risk.

To be sure, systems are in place for vaccine safety monitoring. The national Vaccine Adverse Event Reporting System (VAERS) collects reports of possible side effects after vaccinations. It’s an important tool for spotting potential safety issues, but it has limitations. VAERS mainly captures problems that are obvious, lead to doctor visits, or show up on medical tests. This means it might not catch all types of side effects, especially those that are less visible or don’t prompt immediate medical attention.

Large and ongoing studies using real-world data are also needed to fully understand vaccine safety. Once vaccine-related injuries have been identified, federal entities overseeing vaccine safety must take them seriously and investigate thoroughly, publishing the method and data used.

Myocarditis following mRNA Covid-19 vaccination is an example of a rare vaccine adverse reaction that can be detected only after the vaccine has been administered to millions of people — it would almost never show up in clinical trials testing the vaccine. Once a rare adverse reaction is discovered, understanding its biological mechanism is necessary to prevent it. This hasn’t yet been done for vaccine-induced myocarditis, which will require a significant scientific investment.

Compensating people who have been injured by vaccines is another dimension of the issue. The National Vaccine Injury Compensation Program has been in place since the 1980s. Through it, individuals who file a petition and are found to have been injured by a covered vaccine can receive financial compensation.

Vaccine injury reporting and compensation have worked adequately for routine vaccines. For vaccines provided under emergency use authorization, however, such as vaccines against H1N1 in 2009 and now Covid-19, safety science and compensation programs have been chronically underfunded. While the Centers for Disease Control and Prevention has an annual vaccine budget of up to $5 billion to purchase and promote vaccines, the study of vaccine safety at the CDC has been limited to $20 million per year since the time when Dr. Louis Cooper, former president of the American Academy of Pediatrics, warned of the vaccine confidence crisis more than 20 years ago. Since then, many new vaccines have been developed, including some intended for children, pregnant people, and older Americans, who can require different preparations and protocols.

While federal budgets are under intense scrutiny, there is a budget-neutral solution for vaccine safety science. The law that created the National Vaccine Injury Compensation Program provided liability protection to pharmaceutical companies and no-fault compensation to people who are injured by a vaccine. The law also focused on vaccine safety monitoring and the prevention of adverse reactions. Funding was created from a separate tax law by adding a 75-cent excise tax to childhood vaccines for any disease the vaccine was intended to prevent. This law, however, allowed the excise tax money to be used only for compensation. Vaccine safety science and prevention of vaccine injuries, as intended by the initial law, were not allowed.

As recently published in The New England Journal of Medicine, the compensation program currently has an excess of more than $4 billion. Congress should amend this tax law to allow these revenues — a budget-neutral approach — to fund vaccine safety science and prevent rare vaccine injuries.

Americans’ confidence in vaccines will improve only if the vaccine safety system is trusted, transparent, and credible. The independent National Academies of Sciences, Engineering, and Medicine should be asked to review the current vaccine safety system and develop an optimal structure and governance for an adequately funded vaccine safety and compensation system.

Because of the difficulty of eradicating infectious diseases, vaccines will always be needed. The United States needs a robust, sustainable, and well-funded vaccine safety system to help overcome the crisis in vaccine confidence. For too many Americans, confidence in vaccines is truly a matter of life and death.

Gregory A. Poland, M.D., is a virologist who studies the immunogenetics of vaccine responses in adults and children, the editor of the academic journal Vaccine, and president of the Atria Academy of Science and Medicine. He reports being chair of a Safety Evaluation Committee for novel investigational vaccine trials being conducted by Merck Research Laboratories, has been a consultant for various vaccine and pharmaceutical companies, and is an adviser to the White House on Covid-19 vaccines and the World Health Organization on mpox.