FDA announces Stricter Vaccine Approval Process Following Claims of Child Deaths

The leading vaccine regulator at the Food and Drug Administration (FDA) has announced a far stricter course for federal vaccine approvals, following claims from his team that Covid vaccines were linked to the deaths of at least 10 children.

Experts suggest the announcement will make the vaccine approval process substantially more difficult.

Dr Vinay Prasad, whose vaccine policy direction has been supported by the US health secretary, Robert F Kennedy Jr, told FDA staff that the agency would rethink its approach to vaccination programs, according to an internal agency email circulated on Friday and later obtained by several media outlets.

Prasad said the agency plans to re-examine annual flu-shot policies,consider limits on simultaneous vaccinations,and require more robust safety and efficacy data from pharmaceutical manufacturers before approval.

The internal memo reportedly stated that a recent review determined at least 10 children had died “after and because of” receiving a covid vaccine.Prasad noted that these deaths appeared tied to myocarditis, or inflammation of the heart muscle.

“This is a profound revelation,” Prasad wrote in the memo to staff members. “For the first time, the US FDA will acknowledge that Covid-19 vaccines have killed American children.”

He also wrote that new rules would impose tight restrictions on vaccines for pregnant women, marking another meaningful change in the agency’s approval framework.

“I remain open to vigorous discussions and debate,” Prasad wrote, reportedly adding that staff who did not agree with the core principles of his new approach should submit their resignations.

A PBS NewsHour correspondent first reported on the memo’s contents on X. The New York Times noted that the document did not include identifying details such as the children’s ages, any existing health conditions, or how the causal relationship between vaccination and death was determined. the vaccine manufacturers involved were also not named.

Dr Paul Offit of Children’s Hospital of Philadelphia,who reviewed the memo,told MedPage Today that it’s a “risky and irresponsible thing to do”.

“[Prasad] says he has evidence that this vaccine killed 10 children, but that’s not the way it works,” Offit said. “If you think you have an extraordinary claim, you should back it up with extraordinary evidence. He should have submitted it to an excellent journal where it can be reviewed by subject matter experts who can say ‘Yes, this is clear evidence,’ then it can be published. That’s the way it effectively works.”

Prasad’s predecessor, Dr Peter Marks, who led the FDA division throughout the pandemic, told the new York Times that he was “shocked” by the memo.