Restoring Faith in Vaccines

A recent op-ed in the New England Journal of Medicine offered a solution that is readily available but unlikely to succeed

On July 11, 2024, the New England Journal of Medicine (NEJM) published an opinion piece titled “Funding Postauthorization Vaccine-Safety Science.” The authors argued that the “widespread vaccine hesitancy observed during the Covid-19 pandemic” could have been mitigated if public health authorities had identified serious Covid-19 vaccine side effects quicker and determined their biological mechanisms. According to the authors, this could have been achieved by spending more money on post-authorization safety studies using the $4.3 billion currently available in the Vaccine Injury Compensation Program.

Covid-19 mRNA vaccines were authorized in December 2020. Only four months later, myocarditis (i.e., inflammation of the heart muscle) following these vaccines was detected in the Vaccine Adverse Events Reporting System, then quickly confirmed by the Vaccine Safety DataLink (VSD) to occur in about 1 in 50,000 recipients. Because this side effect was rare, it could only have been detected post-authorization, after hundreds of thousands of people had been immunized. Nonetheless, the public remained distrustful. Shouldn’t we have known about this problem before authorizing these vaccines? And why did public health agencies mandate a vaccine with a serious side effect?

Determining biological mechanisms also didn’t restore trust. For example, Johnson & Johnson’s adenovirus vectored vaccine was first made available in February 2021. Two months later, VAERS detected a clotting problem that was confirmed by the VSD to occur in about 1 in 250,000 recipients. We soon learned that J&J’s vaccine had stimulated platelet-activating antibodies against platelet factor 4 (PF4). By May 2023, J&J’s vaccine was removed from the U.S. market. Again, the rapid detection of the problem and determination of the biological mechanism were far from reassuring. The public remained distrustful. Why was this vaccine recommended when it caused a fatal side effect? Shouldn’t we have known about this earlier?

The authors of the NEJM op-ed further argued that past concerns about vaccine safety, such as measles-mumps-rubella (MMR) vaccine as a possible cause of autism, wouldn’t have gained traction if the public health community had responded more quickly. In 1998, Andrew Wakefield, a British physician, published a case series of eight children who developed autism within one month of receiving the MMR vaccine. The authors of the NEJM op-ed state that studies exonerating the MMR vaccine “were not available until years after [this] possibility [was] raised publicly.” However, within weeks of Wakefield’s publication, a large, retrospective study by Brent Taylor and colleagues was completed, submitted for publication, and published within the year. It’s hard to respond more quickly than that. Taylor found no association between MMR and autism. Ten more studies followed, all confirming the first one. Nonetheless, anti-vaccine activists and their lawyers continue to promote the notion that the MMR vaccine causes autism when it doesn’t. Arguing cover-up and conspiracy, many parents of children with autism don’t trust a system that has failed to confirm their unfounded beliefs.

The authors of the op-ed conclude that more funding to study vaccine safety “would be an important step toward rehabilitating public confidence in the immunization system.” But would it? People distrust the immunization system for several reasons. 1) Some don’t trust a system that fails to acknowledge vaccine harms when such harms don’t exist, arguing that vaccines cause a variety of chronic diseases that the medical establishment is simply unwilling to admit. 2) Others believe that serious vaccine safety issues should be detected before a vaccine is authorized even when the problem is so rare that it couldn’t possibly be detected until millions of people had been vaccinated. 3) Some aren’t willing to accept any serious vaccine side effects no matter how quickly defined, well understood, or uncommon. 4) Many reject the notion of vaccine mandates. They don’t like the government telling them what to do.

While it would certainly be of value to have a more robust, better funded system to study vaccine safety, it remains unclear whether this would in any way address the real reasons for the public’s distrust of vaccines.