Lead FDA vaccine regulator announced new approval process after claiming Covid vaccine had killed 10 children

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 significantly more difficult.

A PBS NewsHour correspondent first reported on the memo’s contents in a post 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 was a “dangerous 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 works.”