The Food and Drug Administration’s top vaccine regulator asserted in an email to staff sent Friday that the Covid-19 vaccine caused at least 10 deaths in children and called for changes to the way the agency regulates vaccines. But experts told STAT they are skeptical of the memo’s “extraordinary” claim because it was not presented with detailed data.
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in the email that regulatory requirements for new vaccines would be heightened as a result of the deaths.
“This is a profound revelation,” Prasad wrote in the memo, which was obtained by STAT and has since been made available online by other news organizations. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
“In many cases, such mandates were harmful,” Prasad wrote. “It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.”
Prasad and representatives of the the Department of Health and Human Services, which oversees the FDA, did not respond to a detailed request for comment.
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It is unclear what the FDA’s next steps will be. The memo does not contain any information on plans to release more detailed information on the deaths or to publish the result in a medical journal. Prasad said the agency would require more definitive data for vaccines administered during pregnancy and that he plans to reform the way that annual influenza vaccines are regulated. He also stated that the FDA may look at whether multiple shots should be given at once, a concern that could disrupt the childhood vaccine schedule.
“The talk about purported danger of combined vaccines or multiple vaccines given at same visit is concerning if applied to ban or un-recommend combo vaccines, or require spacing-out in a way that greatly reduces uptake and done without evidence of harm,” said Jeffrey Morris, a professor of public health and preventive medicine at the University of Pennsylvania.
It was not clear which vaccines Prasad was talking about in many of his comments, such as those related to vaccines given during pregnancy.
Outside experts said they would need much more evidence to understand whether it had been established that the Covid vaccine caused deaths in children. They said it was surprising that more data were not included in the memo, which they viewed as certain to be made public. Some claims in the memo, such as the implication that the federal government sets school vaccine mandates, are incorrect.
“It’s irresponsible science at best and it’s dangerous to the public at the very least,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy. Osterholm said the FDA should refer the question of whether there was a causal link between Covid vaccination and the deaths Prasad identified to the National Academies of Sciences, Engineering, and Medicine for independent review.
Several CBER staff members who work with vaccines, and who were granted anonymity for fear of repercussions, told STAT they were upset over what they called a “misleading” and “politically charged” email. One worried a team member would ask to be moved to another center.
“Jumping from these case reports to their preexisting vaccine policy preferences is awfully convenient,” said another employee.
Paul Offit, a professor at Children’s Hospital of Philadelphia, the co-developer of a vaccine for rotavirus, and a longtime critic of HHS Secretary Robert F. Kennedy Jr., said it was “frustrating” to respond to a document when it was unclear exactly what vaccine policy is being proposed. “It is a lot of vague handwaving.”
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Prasad states there are data, but “he doesn’t show the data,” Offit said. He added: “It’s an extraordinary claim and should be backed by extraordinary evidence.”
Jesse Goodman, who led CBER during the George W. Bush administration, said the memo was “destined to go externally,” given that it was emailed to the entire center. “When you send a letter to a thousand people or more, this is a really extraordinary claim that would normally merit a very detailed scientific analysis and presentation at an appropriate forum.”
Without the data that such an analysis would contain, Goodman said, it was difficult to know what to make of Prasad’s assertion.
In the memo, Prasad noted that he and FDA Commissioner Marty Makary had written two widely discussed journal articles, one with Tracy Beth Høeg — who is now a senior adviser for clinical sciences at CBER — prior to joining the agency. Those articles criticized the way that the FDA and the Centers for Disease Control and Prevention handled early evidence that the mRNA Covid vaccines — the shots made by Moderna and Pfizer/BioNTech — increased the risk of an inflammation in the heart called myocarditis in adolescents and young men.
Prasad said that this summer Høeg began investigating reports to the Vaccine Adverse Event Reporting System (VAERS) of children who had died after the administration of the Covid-19 vaccine. By late summer, he wrote, Høeg had concluded “that there were in fact deaths– a fact this agency had never publicly admitted.”
STAT had previously reported on Høeg’s work and of the objections of some FDA staff to her methods.
VAERS is an early warning system that tracks reports from physicians and members of the public of what might be vaccine side effects, but it is used cautiously by experts because such reports can be unreliable.
Prasad said he asked the FDA’s Office of Biostatistics and Pharmacovigilance to look at 96 deaths between 2021 and 2024 that were reported to VAERS. Of these, he wrote, “no fewer than 10 are related” to receipt of Covid shots. He wrote that the team was conservative in assigning blame, and that “the real number is higher.”
But vaccine experts, including those who had served on important advisory committees or in regulatory roles in the past, worried that it would be difficult to make such a firm conclusion.
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“It is not clear what process was used for attributing deaths to the vaccine,” said Daniel Jernigan, the former director of CDC’s National Center for Emerging and Zoonotic Infectious Diseases, in a text message. “Some greater transparency is needed.”
Jernigan resigned from the CDC in August to protest Kennedy’s firing of CDC Director Susan Monarez.
Kathyrn Edwards, a professor emerita at Vanderbilt University and a veteran vaccine researcher, ticked off some of the information she’d like to have: “We don’t know where it’s coming from. We don’t know which vaccines. We don’t know what the time frame was. We don’t know how many of these cases have an autopsy that shows actual cardiac involvement.”
Offit said that if the cases did actually involve myocarditis, which Prasad did not state clearly, one key question would be how well it had been shown that the cases were not caused by viruses other than Covid that can cause the condition, such as adenovirus and parvovirus.
Prasad’s memo also understated the risk Covid posed to children, experts said. Prasad said that children faced “a tremendously low risk of death.” Although they were at lower risk than other age groups, Covid did kill children. A 2023 JAMA paper said that during the 12 months ending in July 2022, 821 people aged 19 and under died of Covid, making it the eighth leading cause of death in that age group.
An analysis presented at a CDC meeting in June 2021 focused on people aged 12 to 29 — those at highest risk for myocarditis. In that population, Covid had killed 2,767 since the beginning of the pandemic.
Prasad noted that while Covid is most likely to result in death and hospitalization in older people than in children, myocarditis occurs most often in young, healthy boys and men. In other words, those who bore the side effects, no matter how rare, were also at lowest risk. The FDA-approved package inserts for the mRNA Covid vaccines state that they are associated with 27 myocarditis cases per million doses in males 12 years through 24 years of age, based on analyses of commercial insurance claims — or about 1 in every 37,000 doses given to adolescent or young adult males.
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But it is not clear how Prasad is doing the math now, or even what changes may be proposed. Deaths, incidence of Covid-caused autoimmune conditions, and myocarditis due to vaccines all appear to have dropped dramatically since the pandemic. Previous FDA analyses have tried to weigh the benefits of the vaccine against the risk of myocarditis.
There has been debate among vaccine experts about exactly how frequently children need boosters, and their risk-benefit profile. Offit has been skeptical of the need to offer annual Covid boosters to healthy children and adults.
When called about the memo, Offit invited his 2-year-old granddaughter to say hello to a STAT reporter on the phone, and then noted that he’d recommend she get her primary Covid vaccinations but not an annual booster.
But he said that some vaccination was a good idea for those who had not had a confirmed case of Covid, because it clearly prevents hospitalization and death. Offit noted that the CDC’s Advisory Committee on Immunization Practices had seemed likely to advise changing booster recommendations, but was disbanded in June by Kennedy and replaced with a new, handpicked panel.
Experts saw other issues with Prasad’s reasoning: He criticized the CDC for not seeing the myocarditis signal before Israel, but Israel had an earlier vaccine rollout, a smaller and more geographically concentrated population, and a more digitized health care system. Prasad also called for larger randomized controlled trials of Covid shots for children but did not explain how they could have been done late in the pandemic.
Many of the experts who STAT spoke with believed that Prasad had written the memo with the express purpose that it would be leaked. He made note in the lengthy email of the fact that there have been previous leaks from within CBER.
ACIP, the CDC’s key vaccine panel, will meet during the coming week. Goodman said that HHS “basically removed suitable expertise” when the ACIP committee was reconstituted. “So I hope the plan isn’t to suddenly dump these cases on the ACIP.”
Prasad took the opportunity in the email to comment on both his willingness to change his mind and his opposition to public leaks.
“I remain open to vigorous discussions and debate on these topics, as I have always been,” he wrote. “I am open minded to modifications or alterations.”
He then emphasized that the debates should be “private, internal to FDA, until they are ready to be made public.”
He added: “Some staff may not agree with these core principles and operating principles. Please submit your resignation letters to your supervisor and CC my deputy Katherine Szarama.”
Lizzy Lawrence and Daniel Payne contributed reporting.
