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Elizabeth Jacobs, PhDPfizer has ended its large Phase III Trial of an updated COVID19 vaccine.
They were not able to enroll enough people to meet their goal.
A major problem is the FDA’s wholly unreasonable demand that people with chronic conditions, who benefit most from the vaccine, not be allowed to participate.
This is the result of the completely irrational demands of people like Vinay Prasad and Marty Makary.
I do not know what the final outcome of this debacle will be. The FDA had indicated that they won’t approve the vaccine without new Phase III Trials.
I do not know if an updated COVID19 vaccine will be available for Fall in the United States.
All because little men got their feelings hurt because their ideas are fucking dumb and thousands of scientists told them that.
firstwordpharma.com/story/7157141
firstwordpharma.com/story/7157141
firstwordpharma.com/story/7157141
“Pfizer and BioNTech's Comirnaty and Moderna's Spikevax and next-generation mNEXSPIKE are approved for adults aged 65-plus, as well as for younger people who are at higher risk of severe COVID-19…no COVID-19 vaccines have full FDA approval for healthy adults in the 50-to-64 age bracket.
Probably the best we can hope for is that these approvals for 65+ and people at high risk will allow for anyone to get a vaccine via off-label prescribing.
However, you may recall that last year RFK Jr. made a subtle threat to doctors who do this.
Veronica 🇺🇸 🇮🇹 🇺🇦 🇳🇴 🇲🇽 🇩🇪The companies decided to stop the trial, which aimed for 25,000 to 30,000 participants, because they were unable to recruit enough people to generate relevant post-marketing data. Enrollment was closed on March 6, 2026.
FDA required that participants for this trial not have chronic conditions (hypertension or diabetes. Finding healthy adults within that specific age range, without common chronic conditions, was difficult. 80% of volunteers failed pre-screening because they did not meet the "healthy" criteria.
eVOTErra – #RhRRMy wife and I were rejected from that clinical trial a month ago.
(Athsma her, anxiety/depression me.)
Dumb.
My camera shoots fascists@evoterra @elizabethjacobs.bsky.social
If I had had a chance to sign up for it I would have done so in a hot second. Probably best I didn't because I would be even more livid that it was canceled.
David@elizabethjacobs.bsky.social Pfizer will have to move its vaccine trials to another country, and create a partner business headquartered there, at least until the anti-facts regime falls in the USA.
it's B! Cavello 🐝@elizabethjacobs.bsky.social @SRDas I didn’t know this was something you could enroll in. I wish I’d heard about it!
Das@b_cavello @elizabethjacobs.bsky.social Same! I looked up the Moderna trial - it shows as still recruiting. Unfortunately not anywhere that close to me.
https://clinicaltrials.gov/study/NCT07266558?term=NCT07266558&viewType=Card&rank=1
@SRDas @elizabethjacobs.bsky.social Dang, yeah, it’s an hour of transit for me to get to the location in my city, but it’s good to know. I am tempted, but it’s a shame it’s not more convenient/in the center of town.
David PIt's clear under the current regime the FDA was never going to approve it anyway. Why were they doing the trial according to FDA guidelines?
I mean, the US is not the only market and I'll lay a bet that FDA approval doesn't carry the same weight overseas with other nations' regulatory bodies like it used to.
Meanwhile, that requirement is almost impossible to meet (as intended) as so many people have chronic conditions, especially since the pandemic started.