FDA to impose strict new vaccine requirements, claiming child covid shot deaths

Source: Washington Post

FDA to impose strict new vaccine requirements, claiming child covid shot deaths

Vinay Prasad, the nation’s top vaccine regulator, said his team concluded that coronavirus shots were linked to children’s deaths, necessitating a new approach.

November 29, 2025 at 12:05 a.m. EST Today at 12:05 a.m. EST
6 min


Moderna coronavirus vaccines are displayed during a 2021 vaccination campaign in California. (Melina Mara/The Washington Post)

By Dan Diamond and Rachel Roubein

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.

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By Dan Diamond
Dan Diamond is a White House reporter for The Washington Post, with a focus on policy and public health. His email is dan.diamond@washpost.com and you can reach him on Signal at @dan_diamond.01.follow on X@ddiamond
https://www.washingtonpost.com/people/dan-diamond/

By Rachel Roubein
Rachel Roubein is a national health-care reporter for The Washington Post covering the Food and Drug Administration. Reach her securely on Signal: RachelRoubein.28follow on X@rachel_roubein
https://www.washingtonpost.com/people/rachel-roubein/

Read more: https://www.washingtonpost.com/health/2025/11/29/fda-vaccine-approval-child-covid-deaths/