Someone else answered correctly saying an EUA can't be issued if an already licensed drug can help. I would further that point by saying to actually go dig up the true source of that policy on the FDA's website in your country (not someone's summary or interpretation). It's a great exercise that will leave you with some sort of ground truth in this mess.
Same as in coding, you eventually reach a point where you learn that when in doubt, you must read the source.
FDA approval or not was not the statement I made. Even in your link it expressly says they are still being distributed under the EUA not under normal law
Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.
This is a myth that keeps getting passed around. The FDA actually had more than one therapeutic with eua for covid19 when they created the eua for the vaccine. There is no rule forbidding an EUA for a vaccine if a therapeutic exists.
As I stated in my comment, the difference may only be the label. But the FDA article clearly differentiates them and explicitly discusses how the approvals vs EUA are different for each.
Does full FDA approval make a meaningful difference, though?
If anything, it seems like if someone doesn’t want to rely on the current EUA (because of limited data, incentives, etc.) then they shouldn’t suddenly be okay with the FDA’s full authorization.
I had heard that the FDA rejected the outside the US data, stating it would not be sufficient for approval. They are supposed to be in constant communication with the regulators, so nobody is submitted EUA until its basically a sure thing.
> What is the difference between FDA approved and an emergency use authorization, from the perspective of the law?
> Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions[1]
The difference is that something pushed out under EUA is _not_ FDA approved. So any laws related to approved medicine, devices, vaccines, etc do not apply automatically to EUA products.
Why isn’t the EUA process the default then? It sounds like manufacturing being after approval would just be a cost thing producers could figure out without needing the FDA involved…?
Edit: also why is there such a large lag between EUA and full FDA approval? That flow chart seems misleading.
Funny how most people have zero idea what the difference between EUA and the "normal way" means. Buying FDA registered non-drugs and medical devices doesn't seem to bother as much so.
This suggests FDA approval doesn’t say much about whether something works—presumably it still says something about safety. At any rate, whether or not FDA approval means much, to a certain subset of people it ostensibly did, since the objection that there was only an EUA was fairly common.
I wasn't being literal. The point is the FDA is overly cautious to the point that they're harming the health of patients. Slight deviations between the US and EU are understandable, 10x is questionable.
"On October 19, 2022, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the September 12, 2022 letter of authorization in its entirety to authorize the use of Novavax COVID-19 Vaccine"
You are downplaying the role of an emergency use authorization. "Reasonable belief" sounds experimental to me. Otherwise they would've had all the information needed for FDA approval, it wouldn't have been predicated on belief, and it wouldn't have been labeled emergency use.
Why are you so adverse to accepting the reality of the situation?
"The process for issuing an EUA is different than an FDA approval. Under an EUA, the FDA authorizes uses of medical products based on a reasonable belief that the product may be effective based on the best evidence available at the time, without waiting for all the information that would be needed for an FDA approval."[1]
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