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Experts say strict new FDA protocol for vaccine approval is ‘dangerous and irresponsible’ (www.theguardian.com)

submitted 1 week ago by MicroWave@lemmy.world to c/health@lemmy.world

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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."

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[–] tangeli@piefed.social 1 points 1 week ago

I did a little more searching with similar conclusion: most of what's available is pretty extremely biased and unreliable. But it does seem there may be a connection beyond the vaccine he created being manufactured by Merck.

This CBS News article from 2008 says:

Offit holds in a $1.5 million dollar research chair at Children's Hospital, funded by Merck. He holds the patent on an anti-diarrhea vaccine he developed with Merck, Rotateq, which has prevented thousands of hospitalizations.

That appears to be a quote from a Couric & Co Blog entry but that is "the official blog of the CBS Evening News", so I guess CBS is quoting themselves and the information is as reliable as CBS. Unfortunately the linked blog entry no longer exists.

Offit is the current Chairholder of the Maurice R. Hilleman Chair of Vaccinology according to UPENN website. I guess that's a reliable source. CBS didn't name the chair funded by Merck but the Maurice R. Hilleman Chair of Vaccinology was established by Merck, according to UPENN.

On the other hand this UPMC Center for Continuing Education in the Health Sciences CME Information Sheet, which lists Offit as a speaker, says:

No members of the planning committee, speakers, presenters, authors, content reviewers and/or anyone else in a position to control the content of this education activity have relevant financial relationships with any entity producing, marketing, re-selling, or distributing health care goods or services, used on, or consumed by, patients to disclose.

I don't see anything about ongoing funding of the Maurice R. Hilleman Chair of Vaccinology by Merck. Only that Merck established it (presumably providing some endowment), and the possibly related report by CBS. Maybe $1.5million was the initial endowment.