The nation’s top vaccine regulator on Friday laid out a stricter approach for federal vaccine approvals, citing his team’s conclusion that coronavirus vaccines had contributed to the deaths of at least 10 children, according to an internal Food and Drug Administration email obtained by The Washington Post.
Vinay Prasad, an FDA official whose approach to vaccine policy has been championed by Health Secretary Robert F. Kennedy Jr., told agency officials that the FDA will rethink its framework for annual flu shots, examine whether Americans should be receiving multiple vaccines at the same time and require vaccine makers to show far more data to prove the safety and value of their products. For instance, Prasad said that pneumonia vaccine makers must demonstrate that their products reduce pneumonia, rather than just generate antibodies to fight infections.
Prasad also wrote that the new approach means the agency will have strict requirements for authorizing new vaccines for pregnant women. He concluded his lengthy email by maintaining that he was open-minded about next steps.
“I remain open to vigorous discussions and debate,” Prasad wrote to his team, adding that staff who did not agree with the core principles of his new approach should submit their resignations.
Collectively, Prasad’s plans would transform the FDA’s decades-old process of approving vaccines by compelling pharmaceutical companies to run far larger studies, likely slowing them down, said current and former agency staff and outside public health experts, some of whom spoke on the condition of anonymity to discuss internal FDA operations or comment on a developing situation. The approach could also have a chilling effect on the development of novel vaccines, because manufacturers will need to undertake sweeping new studies when seeking most new approvals — even for expanding the population who can get the shot, they said.
Prasad’s continued questions about the value of administering multiple vaccines at the same time also represent a potential reversal of years of federal guidance. His team’s findings could have implications moving forward for vaccines that are placed on the Centers for Disease Control and Prevention’s recommended schedule for childhood vaccines, which calls for administering multiple vaccines at key milestones, such as a child’s birthday. Health officials also encourage Americans to receive multiple vaccines for respiratory illnesses, including flu, covid and RSV, in the same visit for convenience.
Jesse Goodman, one of Prasad’s predecessors leading the agency’s Center for Biologics Evaluation and Research, said that he believes current vaccine guidelines are “quite strict.” He added it was difficult to assess the new requirements from an email and that in cases where vaccines are approved based on an immune response, further studies are typically required.
“It’s not like these things are being approved without strong scientific evidence,” he said. “They’re being approved with strong scientific evidence.”
The Department of Health and Human Services, which oversees the FDA, did not respond to questions on Friday night about Prasad’s email. A PBS NewsHour correspondent first reported the contents of the email in an X post.
Prasad’s planned vaccine strategy reflects some changes long sought by Kennedy and his allies in the nation’s anti-vaccine movement who have demanded more evidence about the safety and efficacy of many vaccines. Prasad on Friday justified his new approach by focusing on his team’s finding that coronavirus vaccines were linked to the deaths of children after he and colleagues spent months reviewing data.
“This is a profound revelation,” Prasad wrote. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
Past FDA leaders, outside scientists and public health experts have countered that coronavirus vaccines have been extensively studied, including in children, and that the benefits of immunization far outweigh the risks. They also said that while the vaccines for covid-19 and other viruses have been sometimes linked with adverse events and even death, those outcomes were rare.
Peter Hotez, the director of the Center for Vaccine Development at Texas Children’s Hospital, said in a text message that he wanted to see Prasad’s statement about a link between covid-19 vaccines and children’s deaths supported with more data as well as information about any underlying health conditions.
“With almost one billion COVID immunizations administered to Americans during the pandemic, and perhaps close to 100 million for children and adolescents, it is conceivable that such a one in 10 million or 100 million event occurred,” such as a child’s death, Hotez wrote, later adding, “given the public health implications, this is not something one casually blurts out in an email.”
Kennedy, the founder of a prominent anti-vaccine group, has a lengthy history of disparaging vaccines, and once called the coronavirus shot “the deadliest ever made.” He and his deputies at the federal health agencies have spent months revisiting a debunked theory that vaccines in the childhood immunization schedule are linked to autism, drawing rebukes from medical groups, public health leaders and some GOP senators.
Tracy Beth Hoeg, who was a prominent critic of broad childhood coronavirus vaccination before becoming one of FDA Commissioner Marty Makary’s top deputies, this summer began investigating reports of children who had died after being administered a coronavirus vaccine, Prasad wrote in his email Friday. The reports were submitted to the federal Vaccine Adverse Event Reporting System, which contains unverified reports of side effects or bad experiences of vaccines submitted by anyone, such as doctors, patients or even someone who sees a report on social media. CDC emphasizes that the database alone is not designed to assess whether a shot caused a death.
Prasad said that he then asked FDA staff to perform an analysis of 96 deaths between 2021 and 2024, concluding that “no fewer” than 10 are related.
Prasad wrote the agency would take “swift action regarding this new safety concern.”
The Post previously reported the FDA was planning to link coronavirus vaccines to the deaths of 25 children in a presentation to federal vaccine advisers. The plan had alarmed public health experts who said that the vaccines have been extensively studied, including in children, and that the dangers of the virus are being underplayed.
The presentation did not happen. But CDC staff over the summer presented data showing that at least 25 children died who had had covid-associated hospitalizations since July 2023. The number was likely an undercount, according to staff, and of the 16 children old enough for vaccination, none was up to date.
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