Six days after a senior FDA official sent Internal email organization A dozen former FDA commissioners have claimed that “at least 10 children” have died from coronavirus vaccines. special warning Published in the December 3 issue of the New England Journal of Medicine.
They wrote that the claims and policy changes in the memo by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, pose a “threat to evidence-based vaccine policy and public health security” and are a sharp departure from long-standing scientific norms.
What’s unfolding inside the FDA is not a narrow debate about COVID-19 vaccines. According to critics and vaccine scientists, it is an attempt to rewrite the rules that govern the entire U.S. vaccine system, including how risks are assessed, how benefits are proven and how quickly life-saving shots reach the public. Former agency leaders have warned that if these changes persist, the consequences could persist, including lower vaccine numbers, slower updates, eroded public trust and an increase in preventable outbreaks.
Prasad has made it clear that he believes this is the moment to make things right. He told employees that the FDA’s mission and “world view” would change, writing, “No longer will the Director of the U.S. Food and Drug Administration have to rely on his employees to personally detect the deaths of children.”
Prasad’s email reopened old claims about COVID vaccines using what is generally considered weak and misleading science in the peer-reviewed research community. He claimed that FDA staff found “at least 10” deaths of children “after and as a result” of COVID-19 vaccinations. Vaccine adverse event reporting system.
The VAERS system is notoriously crowdsourced, so anyone can contribute, and scientists say it only acts as a clearinghouse for reports. For example, you may submit a report that your hair turned purple after getting a flu shot. The report will remain in the database until reviewed, but cannot establish the cause of the medical event. However, Prasad claimed the actual death toll is likely higher as many cases go unreported.
In the substack internal medicine Reported on December 11th Prasad used incomplete information, and a Dec. 5 internal FDA memo put the number of pediatric deaths from COVID-19 vaccinations at between 0 and 7. “The FDA’s investigation into deaths from Covid vaccines is still ongoing and there is no final tally yet on the number of deaths,” Emily Hilliard, a spokeswoman for the Department of Health and Human Services, wrote.
Prasad also accused the FDA and the Centers for Disease Control and Prevention of downplaying the risk of heart inflammation, called myocarditis, in young men. He criticized the agency that approved the shot for teenagers. And he suggested that vaccine mandates in schools and workplaces may have “harmed more children than we saved,” adding, “We don’t know whether we have saved lives on balance.”
By comparison, More than 2,100 American children The CDC said there have been no deaths from COVID-19 itself since the pandemic began.
Based on false and misleading claims about COVID vaccines, Prasad proposed a major overhaul in how vaccines are approved. He said the FDA should stop relying on indicators of immunity to establish the efficacy 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 a vaccine known to be effective against a disease with a control group that receives a placebo and exposes the vaccine to infection.
“There is a well-established principle in bioethics that it is unethical to test drugs or vaccines known to be safe and effective against a placebo, because such placebo-controlled trials effectively deny patients access to vaccines that could prevent dangerous infectious diseases,” said Lawrence Gostin, professor of global health law at Georgetown University.
Prasad called the current flu vaccine system an “evidence-based disaster,” questioned the approval of vaccines for pregnant women based solely on immune response, and raised concerns about receiving multiple vaccines at the same time. He ordered his staff to rewrite FDA guidelines to fit his new “world view” and said anyone who disagreed with his “core principles” should resign.
Former FDA leaders expressed warnings in the NEJM article. They said Prasad was exploiting public dissatisfaction with the federal government’s response to COVID-19 to sow doubts about the entire childhood vaccination system that could ruin decades of success in protecting children from the deadly disease.
“This is really different. And it’s really dangerous. And people are going to be hurt, especially by the vaccine decision,” former FDA Commissioner Robert Califf said in an interview. He also warned that Prasad’s proposed policy could shake up the entire vaccine market, citing positions on vaccines echoed by Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist.
“RFK’s goal appears to be to make the vaccine unavailable in the United States,” he said. He added that if the proposal were to advance, “it would not be a viable project.”
Hilliard addressed these concerns, writing: “The American people deserve evidence-based science. Prasad’s email lays out a philosophical framework that points us toward higher standards. We will soon be releasing a document laying out the framework and data identifying how COVID-19 vaccines that previous leadership failed to properly investigate led to the deaths of children.”
For generations, childhood vaccination programs have 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 much more difficult to test, approve and get vaccines to families.
fueling parents’ suspicions
Prasad’s memo indicates that he considers the VAERS report as evidence that the vaccine caused the child’s death. But this system “early warning system“There are potential safety issues associated with the vaccine that could be investigated further.”
“The VAERS signal should not be taken as evidence of actual vaccine risk without careful, confirmatory studies,” said Katherine Yih, an epidemiologist and longtime investigator for the Vaccine Safety Datalink, a CDC program.
Scientists say doing so directly feeds public fear at a time when many parents are already unsure who to trust.
“Establishing causal relationships requires converging evidence, not just a single report or coincidence,” said Robert Hopkins, medical director of the National Foundation for Infectious Diseases.
However, Prasad’s framework views uncertainty as a reason to stop development altogether.
Experts fear these doubts will not be limited to COVID-19 vaccines. When parents begin to question the honesty of the FDA, they may begin to question vaccines for measles, polio, or pertussis (vaccination that has protected children for decades).
“Science should be transparent,” Gostin said. If families think the FDA is misusing data or silencing experts, trust in the entire vaccine system could erode, he said. “There is public talk that people have lost trust in science, but this is not true. The majority want the FDA to make decisions based on the best scientific evidence. If they believe the FDA is marginalizing scientists and cherry-picking the evidence, their trust will plummet.”
Delicate vaccine pipeline
Prasad’s new framework would make it much more difficult for companies to produce or update vaccines. A dozen former FDA commissioners warned that requiring clinical trials for every new or updated shot would delay vaccine improvements and leave people unprotected. They wrote that his plan would “impede the ability to update vaccines in a timely manner, especially for respiratory viruses.”
For rapidly changing viruses like the flu or COVID-19, this could be disastrous. There isn’t enough time to run a full clinical trial every time the virus mutates.
The business effect is also significant. Developing a vaccine is expensive, and companies may decide it’s no longer worth the risk for the United States. As companies slow down or leave the market, families may face shortages, less innovation, and less care for their children.
‘Checks and balances’
Science relies on open and public debate. Prasad’s memo warned employees about this. In addition to calling on FDA employees who disagree with him to resign, he said the dispute should be kept private and that the leaks were “unethical” and “illegal.”
Susan Ellenberg, former director of the FDA’s Office of Biostatistics and Epidemiology, warned that Prasad risks destroying the process that makes science trustworthy. “If disagreement is seen as disingenuous, we lose the only mechanism that keeps science honest,” she said.
Without strong internal discussions, safety reviews are weak. “You lose the checks and balances that make vaccine safety science credible,” said Kathryn Edwards, a pediatric infectious disease specialist at Vanderbilt University Medical Center who served on the Clinical Immunization Safety Assessment Network during the COVID-19 pandemic.
