Six days after a senior FDA official sent A Internal email sweeper Claiming that Covid vaccines have caused the deaths of “at least 10 children”, 12 former commissioners of the Food and Drug Administration Chest Exceptional warning In the December 3 New England Journal of Medicine.
They wrote that claims and policy changes Note from Dr. Vinay Prasadhead of the FDA’s Center for Biological Evaluation and Research, poses a “threat to evidence-based vaccine policy and public health security” and sharply violates long-standing scientific standards.
What’s unfolding inside the FDA is not a narrow dispute over Covid vaccines. It is an attempt, according to critics and vaccine scientists, to rewrite the rules that govern the entire American vaccine system — how risks are weighed, how benefits are proven, and how quickly life-saving vaccines reach the public. Former agency leaders warn that if these changes take hold, the consequences could be lasting: fewer vaccines, slower updates, weakened public confidence, and more preventable outbreaks.
Prasad explained that he sees this as a corrective moment. “The FDA commissioner will never again have to find deaths among children for staff to identify,” he wrote, telling staff that the agency’s mission and “worldview” would change.
Prasad’s email reopened old arguments about Covid vaccines, using what is generally considered weak and misleading science in the peer-reviewed research community. He claimed it FDA employees It found “at least 10” deaths among children that occurred “after and because of” coronavirus vaccination, using reports from the World Health Organization. Vaccine Adverse Event Reporting System.
VAERS is known to be crowdsourced, meaning anyone can contribute, and scientists say it acts only as a reporting clearinghouse. For example, a person could report that after getting a flu shot, their hair turned purple. Although this report will remain in the database until it is reviewed, it cannot prove the cause of the medical events. But Prasad said the real number of deaths is likely higher because many cases go unreported.
On the substack, Within medicine Reported on December 11 That Prasad used incomplete information and that an internal FDA memo dated December 5 put the number of child deaths from Covid shots at somewhere between zero and seven. “The FDA’s investigation into deaths resulting from COVID vaccines remains ongoing and there is not yet a final count of those deaths,” HHS spokeswoman Emily Hilliard wrote.
Prasad also accused the Food and Drug Administration and Centers for Disease Control and Prevention of underestimating the risk of heart inflammation, called myocarditis, in young people. The agency was criticized for approving footage of teenagers; He suggested that vaccine mandates in schools and workplaces may have “harmed more children than we saved,” adding, “We don’t know if we saved lives on balance.”
In comparison, More than 2,100 American children He has died from the coronavirus itself since the pandemic began, the Centers for Disease Control and Prevention reported.
Based on his false and misleading claims about Covid vaccines, Prasad proposed a comprehensive overhaul of how vaccines are approved. He said the FDA should stop relying on immune markers to determine the effectiveness of shots, such as antibody levels, and instead require large, randomized, placebo-controlled 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 the disease with a control group that receives a placebo, exposing them to infection.
“There is a well-established 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,” said Dr. Lawrence Gostin, professor of global health law at Georgetown University. “The reason is that such placebo-controlled trials would effectively deprive patients of access to a vaccine that could prevent a serious infectious disease.”
Prasad called the current flu vaccine regimen an “evidence-based disaster,” questioned the approval of vaccines for pregnant women based on immune response alone, and raised concerns about giving multiple vaccines at once. He asked staff to rewrite FDA guidelines to fit his new “worldview” and said anyone who disagreed with his “fundamental principles” should resign.
Former FDA leaders expressed concern in the NEJM article. They said Prasad is exploiting public frustration over the federal response to COVID-19 to sow doubt about the entire childhood vaccine system, which could undo decades of success in protecting children from deadly diseases.
“This is really different. And it’s really dangerous. People are going to be hurt, especially by vaccine decisions,” Dr. Robert Califf, former commissioner of the U.S. Food and Drug Administration, said in an interview. He also warned that Prasad’s proposed policies — which he noted reflect positions held by Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist — could shake up the entire vaccine market.
“RFK’s goal appears to be to make it impossible for vaccines to be available in the United States,” he said. He added that if the proposals went forward, “it would not be a viable business.”
Hilliard responded sharply to these concerns, writing: “The American people deserve evidence-based science. Dr. Prasad’s email lays out a philosophical framework that guides us toward this higher standard. We will soon release documents clarifying this framework and data confirming how the COVID vaccine led to childhood deaths that previous leadership failed to properly investigate.”
For generations, the childhood vaccine program has relied on clear rules, strong safety systems, and public trust. Experts say Prasad’s ideas, based on claims they say are not supported by real evidence, could make it difficult to test, approve and deliver vaccines to families.
Fueling parental doubt
Prasad’s memo notes that he considers the VAERS reports to be evidence that vaccines caused children’s deaths. However, the system is designed to be merely “Early warning system“For potential safety issues related to the vaccines that could be further investigated.
“VAERS signals should never be taken as evidence of the true risks of vaccines without careful confirmatory studies,” said Dr. Katherine Yeh, an epidemiologist and longtime investigator for the Vaccine Safety Datalink, a program of the Centers for Disease Control and Prevention.
Doing so directly feeds public fear at a time when many parents are already unsure of who to trust, scientists say.
“Causation requires converging evidence, not just a single report or coincidence,” said Dr. Robert Hopkins, medical director of the National Foundation for Infectious Diseases.
However, Prasad’s framework treats uncertainty as a reason for stopping development entirely.
Experts fear that this skepticism will not be limited to Covid vaccines. Once parents begin to question the FDA’s honesty, they may begin to question long-standing vaccines against measles, polio, or whooping cough, which have protected children for decades.
“Science should be transparent,” Justin said. If families believe the FDA is misusing data or silencing experts, trust in the entire vaccine system could collapse, he said. “There is a general narrative that people have lost confidence in science, but that is not true. The vast majority want the FDA to make its decisions based on the best scientific evidence. Once they believe that the agency is marginalizing scientists and cherry-picking evidence, their trust will decline.”
Precision vaccine pipeline
Prasad’s new framework will likely make it very difficult for companies to produce or update vaccines. The 12 previous FDA commissioners have warned that requiring clinical trials for all new or updated doses would slow vaccine improvements and leave people unprotected. His plan “would hamper the ability to update vaccines in a timely manner, especially for respiratory viruses,” they wrote.
For rapidly changing viruses like influenza and Covid, this could be disastrous. There simply is not enough time to conduct full clinical trials every time the virus mutates.
There are also significant commercial implications. Vaccine development is expensive, and companies may decide that the United States is no longer worth the risk. If companies slow down or leave the market, families may face shortages, less innovation, and less protection for their children.
High fear, low standards, under pressure
Science depends on open and public debate. Prasad’s memo warned his employees about this. In addition to demanding the resignation of FDA employees who disagree with him, he said their disagreements should remain private and called the leaks “unethical” and “illegal.”
Susan Ellenberg, former director of the US Food and Drug Administration’s Office of Biostatistics and Epidemiology, warned that Prasad risks destroying the process that makes science credible. “If disagreement is treated as betrayal, you lose the only mechanism that keeps science honest,” she said.
Without strong internal debate, safety reviews are weaker. “You lose the checks and balances that make vaccine safety science credible,” said Dr. Katherine Edwards, a pediatric infectious disease specialist at Vanderbilt University Medical Center who worked on the Clinical Immunization Safety Evaluation Network during the Covid pandemic.
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