Vinay Prasad, the FDA’s top vaccines regulator, sent a memo to staff this fall that has set off an unusually public scramble inside the agency. In it he wrote that “at least 10 children have died after and because of receiving COVID‑19 vaccination” and outlined plans to require larger, longer randomized trials and clinical‑endpoint evidence for many future vaccine changes. The memo — and the lack of publicly released data to back the child‑death claim — has prompted sharp pushback from scientists, former FDA leaders and public‑health experts.
What Prasad proposed (and what he said about the child deaths)
Prasad’s internal note argues the agency must demand randomized controlled trials showing clinical outcomes (for example, actual reductions in pneumonia) rather than relying on surrogate measures such as antibody levels for most vaccine approvals and updates. He singled out annual flu shots, updated pneumococcal vaccines and immunization in pregnant people as areas that would face new, tougher standards.
He also wrote that an internal review identified at least 10 deaths among children aged roughly 7–16 between 2021 and 2024 that he attributes to COVID‑19 vaccination. He referenced myocarditis as a possible mechanism but did not publish case details, autopsies or the clinical evidence that would allow outside scientists to evaluate the claim.
Prasad’s role — as director of the FDA’s Center for Biologics Evaluation and Research and the agency’s chief medical and scientific officer — gives unusual weight to the memo. Still, the absence of released data is what many critics have seized on.
For official background on the FDA office responsible, see the Center for Biologics Evaluation and Research page at the FDA: CBER at FDA. For established CDC information on myocarditis and vaccine safety monitoring, the CDC maintains a vaccine safety pages including information on myocarditis: CDC myocarditis information.
Why experts are alarmed
Scientists and former regulators say extraordinary claims require extraordinary evidence — autopsy reports, medical records that rule out other causes, or robust analyses from active surveillance systems. Many pointed out that spontaneous‑reporting systems such as VAERS (the Vaccine Adverse Event Reporting System) collect unverified reports and cannot on their own establish causation; follow‑up using medical records (for example, the CDC’s Vaccine Safety Datalink) is needed to confirm signals.
“I think it’s incumbent upon you to provide evidence that supports that claim,” said one senior vaccine expert, reflecting a line common in public comments from infectious‑disease physicians who’ve reviewed the memo. Others warned that demanding randomized trials for routinely updated vaccines — flu shots that change strain composition annually, for example — would be impractical and could delay or effectively eliminate seasonal vaccines.
Those practical worries have concrete roots: updating an influenza vaccine involves selecting strains months before the season and manufacturing at scale; running fresh randomized clinical endpoint trials each year would take too long and cost far more than manufacturers or public programs could bear.
The potential real‑world consequences
If the FDA were to adopt the changes Prasad outlines, the impact could be broad:
- Annual influenza vaccines and other updated shots might face multi‑year delays or disappear from the U.S. market.
- Pregnant people could be excluded from receiving newly authorized vaccines in the absence of pre‑market RCT data — a group traditionally protected through post‑licensure safety monitoring and observational evidence rather than randomized trials.
- Manufacturers could opt not to pursue costly clinical endpoint studies for incremental updates, shrinking the pipeline of improved vaccines.
Public‑health officials warn that reduced access to routine vaccines would raise the risk of preventable illness — exactly as the U.S. is already seeing declines in coverage for some respiratory immunizations. Recent coverage trends suggest fewer people are getting respiratory vaccines, a context that makes any regulatory shockwaves especially risky for population health fewer people are being vaccinated against respiratory diseases.
Legal and procedural questions
Observers note that sweeping regulatory changes normally follow formal rule‑making: proposed rules, opportunity for outside comment, advisory‑committee review and, often, publication of supporting evidence. Absent that process, any abrupt policy shifts could invite lawsuits arguing that new requirements are “arbitrary and capricious.” Some former FDA officials have said the agency typically brings such consequential topics before the Vaccines and Related Biological Products Advisory Committee (VRBPAC) and publishes data for outside review — a step that did not precede this memo.
The way the memo and related public comments reached staff and the press — rather than a VRBPAC presentation or peer‑reviewed paper — has also drawn criticism. Several former commissioners publicly condemned the approach, saying it undermines the agency’s tradition of transparency and deliberation.
Politics, communication and trust
The controversy isn’t just technical. FDA Commissioner Marty Makary has publicly accused the prior administration of withholding myocarditis data; his comments and Prasad’s memo have fed into a highly charged political environment around vaccines. That turbulence has spilled into other advisory forums and public meetings (for instance, recent chaotic deliberations around hepatitis B recommendations), complicating consensus building and potentially influencing whether vaccines remain recommended or covered by insurers during chaotic meeting, CDC advisers handpicked by RFK Jr. postpone vote on changing hepatitis B vaccine recommendations.
Public trust is fragile. Experts warn that dramatic, data‑free assertions from within the FDA can damage confidence in vaccines at a time when maintaining high coverage matters — influenza seasons remain dangerous, and pockets of low uptake contribute to outbreaks.
What happens next
Agency officials say scientists are still assembling and analyzing the findings Prasad cited; the data have not been released for public scrutiny. Pragmatically, any durable change in standard‑setting will require transparent publication of evidence, advisory‑committee deliberations and, likely, legal clearance if the new rules are to survive challenge.
Until the FDA posts the underlying analyses or convenes external experts, the debate will continue to hinge on competing priorities: the need to investigate (and transparently report) rare vaccine harms, and the need to preserve practical pathways for timely vaccine updates that protect populations from seasonal and evolving threats.
If you want to read more about the broader decline in some vaccine coverage that frames this debate, see reporting on the trend in respiratory vaccines fewer people are being vaccinated against respiratory diseases. And for how advisory committees and agency friction have affected other vaccine discussions this year, the upheaval around hepatitis B advisory votes is instructive during chaotic meeting, CDC advisers handpicked by RFK Jr. postpone vote on changing hepatitis B vaccine recommendations.
This story is evolving. Watch for any FDA or CDC releases that publish the case‑level evidence, autopsy reports or active‑surveillance analyses that can be independently evaluated.