Rumors are flying everywhere that RFK, Jr. and his recent appointees at the CDC and FDA plan to announce new risks associated with vaccines such as Covid and Hepatitis B. For example, in a memo recently sent to FDA staff, Vinay Prasad, the controversial director of the FDA’s Center for Biologics Evaluation and Research (CBER), said COVID-19 vaccines caused at least 10 deaths in children and added that regulatory requirements for new vaccines would be heightened as a result.
Prasad said that this past summer, Tracy Beth Høeg, a sports medicine doctor with a Ph.D. in epidemiology, who was then a senior adviser to CBER and is now CDER’s acting director, started investigating reports to the Vaccine Adverse Event Reporting System (VAERS) of children who died after receiving a COVID-19 vaccine. By late summer, Prasad said Høeg had concluded “that there were in fact deaths — a fact this agency had never publicly admitted.” An investigation was then conducted by FDA staff; in his memo, Dr. Prasad claimed ten deaths were linked to the vaccine, but the leaked report does not support this: the investigators did not find that.
These claims, which will likely lead to more regulatory action, including tougher warnings on vaccine labels, more emphasis on risks in informed consent discussions, and restrictions on recommendations about who ought to consider vaccination, draw on a safety monitoring system created by the FDA and the CDC in 1990 called VAERS-the Vaccine Adverse Event Reporting System. But although VAERS has an important role in vaccine oversight, using reports made to it to claim causation is wrong.
The VAERS database has collected more than 2 million reports of vaccine-related problems. But, VAERS reports by themselves are not a reliable source for understanding vaccine safety. Before those intent on ruining decades of evidence-based, sound vaccine policy begin to trot out VAERS claims, it is important to understand the purpose and limits of VAERS. The misuse of VAERS needs to be cut off at the sound evidence pass.
When VAERS was created, there was concern that clinical trials might not reveal all the possible side effects of new vaccines. The FDA requires large, carefully designed randomized trials to approve new vaccines. But those trials have limitations, and there might be problems missed. First, even the largest trials do not have enough people to capture very, very rare problems – problems at a rate of 1:100,000 or 1:million. Second, what if a problem developed later? It’s unlikely from vaccines – problems usually appear quickly – but it is theoretically possible. And people with many co-morbidities may not qualify for a trial but may be at greater risk if vaccinated.
VAERS was created to collect reports from anyone who thinks vaccines caused harms. Because the goal is to alert us to things we would not catch otherwise, VAERS casts a wide net. Reports into it were not screened or verified. Anybody could send in a complaint, and indeed anybody did. For example, in one report, a girl fell into a well 49 days after an HPV vaccine – and that was recorded as an HPV VAERS death report.
So, VAERS is a mishmash of unverified allegations, campaigns by organized vaccine opponents who want vaccines off the market, and genuine reports from people who had a shot and then had a symptom or complication afterwards – an issue which may or may not be caused by vaccines.
VAERS is a mess. A claim of harm absolutely does not establish causality between getting a shot and then getting sick, much less dying. In fact, the FDA website says:
“We encourage you to report any clinically important medical event or health problem that occurs after vaccination. Report the adverse event even if you are not sure if it was a result of vaccination…”
This, in short, is not the place to look to establish conclusions about vaccine safety or risk. At best, it is information to use to launch an inquiry or a study, not to prove anything.
VAERS information is neither data nor evidence of harm. Government officials who try to use it by itself to impugn vaccine safety understand little about data end less about evidence.
Arthur Caplan PhD, NYU Grossman School of Medicine
Dorit Reiss JD is a Professor of Law at UC Law San Francisco