In February 2021, I eagerly received my second Covid-19 vaccination – the newly developed vaccine that would ultimately save millions of lives around the world. It turned out to be a life-changing event: Two hours later, as I was driving home, I was shocked by a sudden loud and high-pitched whistle that almost made me veer off the road. It was as if a dog whistle had started to sound 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.
I had lived with mild, intermittent tinnitus for several years, but never anything as loud and relentless as this.
Could the Covid-19 vaccine have made my tinnitus worse or was it just a coincidence? I was suspicious, but at that time there was no data supporting a link between the mRNA Covid-19 vaccines and tinnitus.
When I got my third dose in November 2021, the noise became even louder and more disturbing. This new level of noise continues unabated to this day, often keeping me from sleeping and sometimes bringing me to tears.
As someone who has been studying vaccines for 40 years, I know that the mRNA vaccines for Covid-19 and other vaccines have saved millions and millions of lives. For the vast majority of people, the benefits of vaccination far outweigh the risks.
However, some people, like me, experience unexpected side effects from vaccinations that affect our health and well-being. I say “some” because no one really knows how common vaccine-related injuries are. Understanding this 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 occurrence of vaccine injuries? I believe the answer is yes, but this will not be possible without increased funding for vaccine safety research.
Americans’ confidence in vaccines is slowly eroding. This process 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 a desire for a vaccine against this scourge and millions got it when it became available.
Covid-19 also obscured the problem in other ways: lockdowns and curfews restricted people’s normal activities and freedom of movement and thus also the spread of all Viruses, not just SARS-CoV-2. But as people began to come together again, shop and pray together, and travel from country to country, measles—one of the most contagious viruses—made a comeback. In the first three months of 2024, the United States saw 17 times more measles cases than in the same period of the past three years. The United States is now on the verge of losing its status as a nation where measles has been eradicated.
Increasing vaccine hesitancy and refusal have contributed to the ongoing measles outbreaks in the United States. Last year, the number of parents requesting exemptions to vaccinate their children increased in 41 states. Similar trends are observed for flu, pneumonia and HPV vaccinations.
Although the Covid-19 vaccines have been a major public health success, politicization and resistance to them have been exploited for political ends through disinformation. The decision to get vaccinated against Covid-19 has become an expression of opinion rather than an informed health decision, which has also affected other vaccines.
A renewed and well-funded focus on vaccine safety research is one of the critical actions needed to prevent the return of vaccine-preventable infectious diseases such as measles and reverse the loss of public confidence in vaccines. The system for assessing vaccine safety, while extensive, needs to be strengthened. Researchers and public health experts need to know what events are caused by vaccines, who is at increased risk, and why. Armed with this information, they can take action to reduce that risk.
Certainly, there are systems in place to monitor vaccine safety. The national Vaccine Adverse Event Reporting System (VAERS) collects reports of possible side effects following vaccinations. It is an important tool for detecting potential safety problems, but it has limitations. VAERS mainly records problems that are obvious, lead to doctor visits, or show up during medical tests. This means that it may not capture all types of side effects, especially those that are less obvious or do not require immediate medical attention.
Fully understanding vaccine safety also requires large and ongoing studies using real-world data. Once vaccine-related harms are identified, federal agencies responsible for vaccine safety must take them seriously and investigate them thoroughly, publishing the methods and data used.
Myocarditis following mRNA vaccination against Covid-19 is an example of a rare vaccine side effect that can only be detected after the vaccine has been administered to millions of people – it would almost never occur in clinical trials testing the vaccine. Once a rare side effect is discovered, it is necessary to understand its biological mechanism in order to be able to prevent it. This has not yet been done for vaccine-induced myocarditis and requires significant scientific investment.
Compensating people injured by vaccines is another dimension of the problem. The National Vaccine Injury Compensation Program has been in place since the 1980s. Under this program, people who apply and are found to have been injured by a covered vaccine can receive financial compensation.
Vaccine injury reporting and compensation payments have worked adequately for routine vaccinations. But for vaccines provided under emergency authorization, such as vaccines against H1N1 in 2009 and now Covid-19, safety research and compensation programs are chronically underfunded. While the Centers for Disease Control and Prevention has an annual vaccination budget of up to $5 billion to buy and promote vaccines, vaccine safety research at the CDC has been capped at $20 million a year since Dr. Louis Cooper, former president of the American Academy of Pediatrics, warned of the crisis of confidence in vaccines more than 20 years ago. Since then, many new vaccines have been developed, including some for children, pregnant women and older Americans, who may require different preparations and protocols.
While federal budgets are under intense scrutiny, there is a budget-neutral solution for vaccine safety research. The law that created the National Vaccine Injury Compensation Program provided pharmaceutical companies with liability protection and no-fault compensation for people harmed by a vaccine. The law also focused on monitoring vaccine safety and preventing adverse reactions. Funding came from a separate tax law by imposing a 75-cent excise tax on childhood vaccines for any disease the vaccine was designed to prevent. However, that law allowed the excise tax money to be used only for compensation. Vaccine safety research and preventing vaccine injuries, as envisioned in the original law, were not allowed.
As recently published in the New England Journal of Medicine, the compensation program currently totals over $4 billion. Congress should amend this tax law to allow these revenues—a budget-neutral approach—to be used to fund vaccine safety research and prevent rare vaccine injuries.
Americans’ confidence in vaccines will only increase if the vaccine safety system is trustworthy, transparent, and credible. The independent National Academies of Sciences, Engineering, and Medicine should be called upon to review the current vaccine safety system and develop an optimal structure and administration for an adequately funded vaccine safety and compensation system.
Because infectious diseases are so difficult to eradicate, vaccines will always be needed. The United States needs a robust, sustainable, and well-funded vaccine safety system to overcome the crisis of vaccine confidence. For too many Americans, trust in vaccines is truly a matter of life and death.
Gregory A. Poland, MD, is a virologist who studies the immunogenetics of vaccination reactions in adults and children, the editor of the Vaccine journaland President of the Atria Academy of Science and MedicineHe reports that he chairs a safety assessment committee for novel vaccine trials conducted by Merck Research Laboratories, has been a consultant to various vaccine and pharmaceutical companies, and advises the White House on Covid-19 vaccines and the World Health Organization on monkeypox.
