Why does it need a new name? Was “Pfizer Covid Vaccine” not descriptive enough?
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Emergency Use is nothing more than an unblinded Phase 3 study with no control group. Each dose during Emergency Use is part of the research phase.
‘Fully Approved’ is the designation given when the Marketing Application, in this case a Biologics Licensing Application (BLA), has been assessed and a positive opinion delivered. Fully Approved literally means that the request for a license to sell and market the product in the US has been granted by FDA.
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Any word on the Moderna vaccine getting full, non-emergency use approval?
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It was put in for approval 3 weeks after Pfizer, so that’s probably the time frame. I’m making assumptions of course.
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Don’t underestimate the skill of pharmaceutical marketers at convincing people to “talk to their doctor” and “try ____ today”
Raise the price to a couple hundred dollars a dose, and suddenly fox news viewers will be scrambling to get the shot.
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That sounds reasonable, though. Thanks for the info.
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If I recall correctly, it can now be made mandatory for the armed forces.
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As I said above, it has always had that name
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Practically it doesn’t make much difference in the short term. Both EUA and licensure in the are about showing the drug is safe and effective. As long a COVID-19 continues to be an emergency then the EUA will apply basically the same.
As a scientific matter it means quite a lot, that pfizer has completed more extensive and longer term study of safety and efficacy. That is important and we shouldn’t diminish that.
Longer term I assume that the availability of licensed vaccines is eventually going to make other vaccines no longer meet the emergency use criteria and they will either have to get full approval or be withdrawn from the market.
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Go ahead and suit up — it’s game time!
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Sure, but that’s not related to FDA regulations, that’s just local window dressing, as you rightly point out, to avoid vaccine mandates.
@Doctor_Faustus , I agree with you that we should keep BioNTech in the name of that vaccine. I think the trade name has not been used in the US yet because it has not been approved for marketing until now.
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YES it was rushed.
Their God-Emperor of the United States signed a bill that explicitly rushed it. We know exactly why it was rushed, and we saw the data as two of the trials were overlaid instead of run sequentially. This data’s still good, the trials are still good, and everything is okay. This might even be the new standard in how we develop vaccines.
But it absolutely was rushed, that was the whole fucking POINT.
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Note that full approval is only for patients 16 years old and up. It’s still (strikeout “experimental”) under emergency use authorization for ages 12 through 15.
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You’re right it was rushed but neither BioNTech nor Pfizer took any of the “warp speed” money. BioNTech were first out of the block anyway, possibly as they had done Sars vaccine before.
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That’s not exactly correct. They didn’t take any of the research funding money, but they did take around $3 billion dollars from Operation Warp Speed for 300 million doses. They confirmed in a press release that this DID make them part of Operation Warp Speed , which was why they got the EUA for their drug and produced 300 million doses for US citizens.
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“Wheels within wheels.” (Frank Herbert)
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Guys, I just started the Goalpost Moving Company, for anti-vaxxers who suddenly find themselves on the wrong side of FDA approval. I expect a lot of business soon, so if you can lift up to 5 words and love to work from home, please let me know. Lots of work incoming.
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So far I’ve seen people saying that FDA was bribed by Big Pharma, and/or it’s not “really” approved.
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One meaningful thing this does (beyond kicking one of the arguments of anti-vaxxers out from under them), it seems to me, is that it could make it legal for doctors to prescribe it for “off-label” use. Which suggests that a pediatrician could possibly prescribe it for an under 12 if they deemed it “medically appropriate”
Per the FDA: “From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.”
I am not a doctor or a medical regulator or a lawyer, so take this all with the hugest grain of salt.
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Does it mean that people can start asking their doctors for an unofficial third-dose?
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