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FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff (apnews.com)

submitted 1 day ago by [email protected] to c/[email protected]

6 comments fedilink hide all child comments

The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government scientists, according to federal documents released Wednesday.

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and Moderna.

Both vaccines were approved by the FDA in May after months of analysis by rank-and-file FDA reviewers.

But internal correspondence show Prasad disagreed with staffers who planned to approve the shots for everyone 12 and older, similar to previous COVID vaccines. The scientists had concluded the benefit from the vaccines and the risk of COVID-19 outweighed the risk of possible side effects, which are rare.

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[–] [email protected] 1 points 1 day ago (2 children)

According to the linked in the article, the restriction is a requirement to revise the warnings

WASHINGTON (AP) — The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.

In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients.

I don't see any indication that the vaccines are not approved other than that the accompanying documentation must be changed. The companies have now had several months to make the required changes.

The linked article suggests that the conduct of the FDA and resulting requirement to change the documentation was inappropriate. But there is no restriction other than the requirement to update the documentation. Or am I missing something in the article?

[–] [email protected] 8 points 1 day ago* (last edited 1 day ago) (1 children)

The drug had already been previously approved, they were seeking approval for younger people to also be eligible for the vaccine. This was reviewed, and was going to be approved when the center director blocked the approval. Pure politics.

[–] [email protected] 1 points 1 day ago

Thanks. I see that is in the linked article. My mistake was to read the article linked in the first paragraph: with the link text 'restricted the approval', thinking that was the details of the restriction.