Experts say strict new FDA protocol for vaccine approval is ‘dangerous and irresponsible’

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www.theguardian.com/society/2025/nov/29/regulat…

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.

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.

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.

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.

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Flu is miserable. As is, all we have to combat it after the fact is Tamiflu. Manufacturer hype aside, the data says, at best, Tamiflu shaves 16hrs off the duration of the flu, if any only if it is taken within 2 days of showing symptoms. Not after.

Flu can also kill old people.

I’m not even that old and I take the shot yearly. Worst case is a sore deltoid and possibly a weak parody of a fever on day 1. Way better than flu imo.

So what they are saying is that under RFK Jr, the FDA has taken a decisive stance on overpopulation.

So FDAs new rules are making vaccines unsafe? Maybe that was the plan from the start.

Data or it didn’t happen.

They can’t restrict vaccines and affect people’s choices about their own health without showing actual data. This is complete hearsay.

I predict this is the first step in making all drugs easier to get approved because the Democrats really want vaccines to not suffer through the standard procedure and Republicans hate the standard procedure

I predict this is the first step in making all drugs easier to get approved because the Democrats really want vaccines to not suffer through the standard procedure and Republicans hate the standard procedure health and safety guidelines really cut into our profits

FTFY

IMO people should research what they’re putting in their bodies anyway, putting a bit more poison on the market just makes that more important

Maybe, but when the national government runs a department explicitly to ensure people don’t die from ingesting medicines, I think it’s reasonable for the country’s populace to expect medicines issued in their country and authorized by that government department to be safe and effective.

People shouldn’t have to get sick or die, in order for current administrations to score political points.

but how else will they up their kill count?

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“Dangerous and Irresponsible” is also what it says on the front cover of the Project 2025 playbook.

Is there any truth to the allegation that Dr Paul Offit received $1.5million from Merck? I don’t see any disclosure of such conflict of interest in the The Guardian article but it comes up when I search for information about him.

That’s an ai generated website but the only other ones i could find about that seem to be really biased roght wing drivel. Offit receives royalty payments from merck for his vaccine that he created. It’s a vaccine against rotavirus, which he is an expert in.

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.

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.

So in other words, it’s pulled out of their asses

And even if it were real, as some point it becomes simple math. Are we going to risk 10 dead children or millions of dead men, women, and children?

But again, it’s not even true, it’s just another Cheeto government lie

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