Six days after an internal email from Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research, alleged that covid vaccines had caused "at least 10 children" to die, 12 former FDA commissioners issued a warning in the New England Journal of Medicine. They stated that Prasad’s claims and proposed policy changes threaten evidence-based vaccine policy and public health security, diverging from established scientific practices.
Prasad’s memo signaled his intention to change how the FDA assesses vaccine safety and efficacy. He wrote, "Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it," and told employees that the agency's mission and "worldview" would shift.
The core of Prasad’s argument relied on reports from the Vaccine Adverse Event Reporting System (VAERS), which he used to claim at least 10 pediatric deaths occurred “after and because of” covid vaccination. However, VAERS is an open reporting system where anyone can submit claims; scientists emphasize that these reports are not proof of causation but serve as early warnings for further investigation.
On December 11, Inside Medicine reported on Substack that Prasad used incomplete information. An internal FDA memo dated December 5 put the number of potential pediatric deaths between zero and seven. Emily Hilliard, spokesperson for the Department of Health and Human Services, commented: "The FDA's investigation into deaths caused by Covid vaccines is still ongoing and there's no final count yet of those deaths."
Prasad also criticized how federal agencies communicated about heart inflammation risks in young men, questioned approvals for teenage vaccinations, and suggested school or workplace mandates may have done more harm than good. He argued that current methods relying on immune markers such as antibody levels are insufficient, advocating instead for large placebo-controlled trials tracking hospitalizations or deaths before approving new vaccines.
Many experts say this approach is unethical if a vaccine is already proven effective. Lawrence Gostin, professor at Georgetown University, said: "There is a rock-solid principle in bioethics that it is unethical to test any drug or vaccine against a placebo if it is known to be safe and effective. The reason is that such placebo-controlled trials would effectively deny patients access to a vaccine that could prevent a dangerous infectious disease."
Former FDA leaders expressed concern that Prasad’s stance could undermine decades of childhood immunization success. Robert Califf, former FDA commissioner, said: "This is really different. And it's really dangerous. And people will be hurt, particularly by the vaccine decisions." He warned that policies echoing those advocated by Health and Human Services Secretary Robert F. Kennedy Jr., who has long opposed vaccines, could destabilize the market: "If the proposals advance...it won't be a viable business."
Hilliard defended Prasad’s approach: "The American people deserve evidence-based science. Prasad's email lays out a philosophical framework that points us toward that higher standard. We will soon release documents laying out that framework and data confirming how the COVID vaccine resulted in children's deaths that previous leadership failed to properly investigate."
Experts highlighted risks beyond covid vaccines if trust erodes in regulatory processes or safety monitoring systems like VAERS are misused as definitive proof rather than signals needing confirmation through rigorous studies.
Katherine Yih of the CDC’s Vaccine Safety Datalink program stated: "VAERS signals should never be taken as proof of true vaccine risks without careful, confirmatory studies." Robert Hopkins from the National Foundation for Infectious Diseases added: "Causation requires converging evidence, not just one report or coincidence."
If parents lose confidence in longstanding childhood vaccines due to perceived mishandling at the FDA level—experts warn—protection against diseases like measles or polio could falter.
Gostin noted: "Science must be transparent...Once they believe that the agency is marginalizing scientists and cherry-picking evidence, their trust will plummet."
The former commissioners cautioned in their NEJM article that requiring full clinical trials for every new or updated shot would slow improvements and leave people unprotected against fast-changing viruses like flu or covid.
Additionally, there are concerns about industry effects if development slows or companies exit due to increased regulatory burdens—potentially resulting in shortages or fewer innovations.
Internally at the FDA, Prasad discouraged public debate among staff over these issues; he instructed dissenters to resign and called leaks “unethical” and “illegal.” Susan Ellenberg—a former director within the agency—warned this attitude could weaken scientific integrity: "If disagreement is treated as disloyalty, you lose the only mechanism that keeps science honest." Kathryn Edwards from Vanderbilt University Medical Center echoed this sentiment regarding weakened checks on safety reviews.
