Six days after a senior FDA official sent thorough internal email 12 former FDA members released a statement claiming Covid vaccines caused the deaths of “at least 10 children.” emergency warning in the December 3 issue of the New England Journal of Medicine.
They wrote that the statements and policy changes contained in the memo from Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research, pose a “threat to science-based vaccine policy and public health safety” and dramatically violate long-standing scientific norms.
What's unfolding inside the FDA is not a narrow dispute over coronavirus vaccines. Critics and vaccine scientists say it's an attempt to rewrite the rules that govern the entire U.S. vaccination system: how risks are weighed, how benefits are proven and how quickly life-saving shots reach the population. Former agency leaders warn that if these changes take hold, the consequences could be long-lasting: fewer vaccines, slower updates, weakening public trust and more preventable outbreaks.
Prasad made it clear that he considered this a corrective moment. “Never again will the US FDA Commissioner have to find pediatric deaths himself for staff to identify,” he wrote, telling staff that the agency's mission and “world view” would change.
Prasad's email reopened an old debate about coronavirus vaccines, using what is generally considered weak and misleading science in the peer-reviewed research community. He said FDA officials found “at least 10” child deaths that occurred “after and due to” Covid vaccinations, using reports Vaccine Adverse Event Reporting System.
The VAERS system is known to be crowdsourced, meaning anyone can contribute, and scientists say it only serves as a clearinghouse for reporting. For example, a person may file a claim that their hair turned purple after receiving a flu shot. Although this report will remain in the database until it is reviewed, it cannot prove the cause of medical events. But Prasad says the true number of deaths is likely higher because many cases go unreported.
In the substack Inside medicine reported December 11 that Prasad used incomplete information and that an internal FDA memo dated December 5 put the number of childhood deaths from Covid vaccinations at somewhere between zero and seven. Department of Health and Human Services spokeswoman Emily Hilliard wrote: “The FDA's investigation into deaths caused by Covid vaccines is still ongoing and there is no final count of these deaths yet.”
Prasad also accused the FDA and Centers for Disease Control and Prevention of downplaying the risk of a heart inflammation called myocarditis in young men; criticized the agency for approving vaccinations for teenagers; and suggested that vaccine requirements in schools and workplaces may have “hurt more children than we saved,” adding that “we don't know if we saved lives overall.”
For comparison: more than 2,100 American children died from covid itself from the very beginning of the pandemic, the CDC said.
Based on his erroneous and misleading claims about Covid vaccines, Prasad has proposed a major overhaul of the vaccine approval process. He said the FDA should stop relying on immune markers to establish the effectiveness of shots, such as antibody levels, and instead require large placebo-controlled randomized trials that track hospitalizations and deaths before approving most new vaccines.
Many immunologists and vaccine experts say it is unethical to test vaccines known to be effective against diseases on a control group that will receive a placebo, exposing them to the risk of infection.
“It is a strong principle in bioethics that it is unethical to test any drug or vaccine against a placebo that 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,” said Lawrence Gostin, professor of global health law at Georgetown University.
Prasad called the current flu vaccination system an “evidence-based disaster,” questioned the approval of vaccines for pregnant women based only on immune response, and expressed concern about administering multiple vaccines at once. He advised employees to rewrite FDA guidelines to fit his new “worldview” and said anyone who disagreed with his “core principles” should resign.
Former FDA leaders expressed alarm in an NEJM article. They said Prasad is using public disappointment over the federal government's response to Covid to raise doubts about the entire childhood vaccination system, which could undo decades of progress in protecting children from deadly diseases.
“It's really different. And it's really dangerous. And people are going to get hurt, especially from decisions about vaccines,” former FDA Commissioner Robert Califf said in an interview. He also warned that Prasad's proposed policies — which he noted echoed the vaccine stance of Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist — could shake up the entire vaccine market.
“It appears that RFK's goal is to make it impossible for vaccines to become available in the United States,” he said. If the proposals are accepted, he added, “it will not be a viable business.”
Hilliard sharply rebutted these concerns, writing: “The American people deserve evidence-based science. Prasad's email lays out a philosophical framework that points us to this higher standard. We will soon release documents laying out this framework and data documenting how the COVID vaccine led to infant deaths that previous management failed to properly investigate.”
For generations, the childhood vaccination program has depended on clear rules, strong safety nets, and public trust. Experts say Prasad's ideas, based on claims they say are not backed by actual evidence, could make it much more difficult to test, approve and deliver vaccines to families.
Stoking Parental Doubts
Prasad's memo indicated that he believes the VAERS reports are evidence that vaccines cause infant deaths. However, the system is designed to be only “early warning system” for potential vaccine safety issues that can be investigated further.
“The VAERS signals should never be taken as evidence of the true risks associated with vaccines without rigorous, confirmatory studies,” said Katherine Yih, an epidemiologist and longtime researcher with the Vaccine Safety Datalink, a CDC program.
Scientists say this directly fuels public fear at a time when many parents are no longer sure who to trust.
“Causation requires converging evidence, not just one report or coincidence,” said Robert Hopkins, medical director of the National Foundation for Infectious Diseases.
However, Prasad's concept considers uncertainty as the reason for the complete stoppage of development.
Experts fear this hesitancy will not be limited to Covid vaccines. Once parents begin to question the FDA's integrity, they may begin to question long-standing measles, polio or whooping cough vaccines—shots that have protected children for decades.
“Science needs to be transparent,” Gostin said. If families believe the FDA is misusing data or silencing experts, trust in the entire vaccination system could crumble, he said. “There is a perception that people have lost trust in science, but that is not true. The vast majority want the FDA to make decisions based on the best science. Once they believe the agency is marginalizing scientists and cherry-picking evidence, their trust will plummet.”
Delicate vaccine conveyor
Prasad's new structure will likely make it much more difficult for companies to produce or update vaccines. 12 former FDA members warned that requiring clinical trials for all new or updated shots would slow vaccine improvement and leave people unprotected. His plan, they wrote, “impedes the ability to keep vaccines updated in a timely manner, especially against respiratory viruses.”
For fast-moving viruses like flu and covid, this can have catastrophic consequences. There simply isn't enough time to conduct full clinical trials every time the virus mutates.
There are also significant business effects. Developing a vaccine is expensive, and companies may decide the U.S. is no longer worth the risk. If companies slow down or exit the market, families could face shortages, less innovation and less protection for their children.
“Checks and Balances”
Science depends on open and public debate. Prasad's note warned his staff against this. In addition to demanding that FDA employees who disagree with him resign, he said their disputes should remain confidential and called the leaks “unethical” and “illegal.”
Susan Ellenberg, former director of the FDA's Office of Biostatistics and Epidemiology, warned that Prasad risks undermining the process that makes science trustworthy. “If disagreement is seen as disloyalty, you lose the only mechanism that keeps science honest,” she said.
Without strong internal debate, safety reviews become weaker. “You're losing the checks and balances that make vaccine safety science credible,” said Katherine Edwards, a pediatric infectious disease specialist at Vanderbilt University Medical Center who has worked on the Immunization Safety Clinical Evaluation Network during the Covid pandemic.
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