Blaming some child deaths on covid shots, FDA vows stricter vaccine rules

The United States’ top vaccine regulator has laid out a stricter approach for federal vaccine approvals. Photo / Melina Mara, the Washington Post

The United States’ top vaccine regulator has laid out a stricter approach for federal vaccine approvals, citing his team’s conclusion, without detailing the evidence, that coronavirus vaccines contributed to the deaths of at least 10 American children.

According to an internal Food and Drug Administration (FDA) email obtained by the Washington Post, Vinay Prasad, an FDA official whose approach to vaccine policy has been championed by US Health Secretary Robert F Kennedy jnr, 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, at least after they become available in the market, rather than just generate antibodies to fight infections.

Prasad also wrote that the new approach means the agency will have strict requirements for authorising 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, probably 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. They also cautioned that the full implications are difficult to understand based on a single email that did not offer a detailed accounting of how the changes would be enacted.

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 for vaccines that are placed on the Centres 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.

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