Article Summary:
The FDA’s top vaccine regulator, Vinay Prasad, has outlined a stricter approach for approving new vaccines. According to an internal email obtained by The Washington Post, Prasad claims his team found that coronavirus vaccines contributed to the deaths of at least 10 children, though he did not provide details on the evidence.
Prasad’s new framework would significantly transform the FDA’s vaccine approval process. He plans to require pharmaceutical companies to run much larger safety studies, likely slowing down vaccine development. Prasad also wants to examine whether Americans should receive multiple vaccines concurrently and will have strict requirements for authorizing new vaccines for pregnant women.
This represents a potential reversal of longstanding federal guidance on administering multiple vaccines at the same time. Prasad’s predecessor, Jesse Goodman, argues that current vaccine approvals are based on strong scientific evidence. However, Prasad, whose approach has been championed by Health Secretary Robert F. Kennedy Jr., believes more rigorous standards are needed.
Experts warn that Prasad’s changes could have a chilling effect on novel vaccine development, as companies will face more extensive study requirements. The full implications are unclear from a single email, but the plan reflects demands made by the anti-vaccine movement. The FDA commissioner has promised to provide more information on the child deaths allegedly linked to COVID-19 vaccines.