Because it does. https://beta.clinicaltrials.gov/study/NCT04848584
> Several hundred million people have already received their vaccine, unaware that it's part of a study
Because it's not. Use under the EUA and subsequent approval is separate from and in parallel with continuing studies.
That is misleading at best. It absolutely is part of an ongoing clinical trial regardless us if it is authorized for emergency use.
How many people who were given the vaccine were told that it is part of an ongoing clinical trial, authorized for emergency use, and the data from the trial won’t be available for years? I suspect a very small percent.
Individuals receiving drug under an EUA are not part of a clinical trial, regardless of what you think of the drug.
It is for the people enrolled in an actual clinical trial.
It's not for people outside of the clinical trial using it under either the EUA or the subsequent full authorization.
> How many people who were given the vaccine were told that it is part of an ongoing clinical trial,
100% of those for whom that was true. Which is a very small percentage of the population who has received it.
> authorized for emergency use
100% of those for whom that was true, who aren't the same people.
See section e-1-A-ii here: https://www.law.cornell.edu/uscode/text/21/360bbb-3
(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—
(I)that the Secretary has authorized the emergency use of the product;
(II)of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III)of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
That's very different than what you said before, and all of them who got it under the EUA.
> Since the trials are ongoing
The trials being ongoing is immaterial, it's required when under an EUA, not when the intervention is one for which trials are ongoing, which are different things.
Well, it is what I _meant_ and what I believe the op meant that you originally responded to.
> The trials being ongoing is immaterial
No, it is not immaterial, because people have to be notified of “the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown”. The fact that the clinical trial is ongoing means that many of those benefits and risks are, in fact, unknown.
You can spin this however you like, but my point is that most people who are receiving and have received shots have NO IDEA that clinical trials are ongoing and the actual data has not been made available to the public (even to their doctors who are likely recommending it). This is the reality whether you would like to believe it or not.
This is one of your many points of confusion; it is completely normal for even long approved interventions to have many clinical trials in varying stages. There are currently 92 trials for the Pfizer vaccine listed on clinicaltrials.gov, in stages from “not yet recruiting” to “completed”.
And also 1,761 between “Not Yet Recruiting” and “Active” for the notorious untested drug aspirin.
> many of those benefits and risks are, in fact, unknown
That's kind of expected with an EUA more than a fully approved intervention (but even for the latter it's always the case), and why disclosure of potential unlnown risks is required with EUAs.
You unsupported assertion that this requirement is routinely ignored would be a problem if it was true, but you offer exactly zero reason to believe it is true, surrounded by a lot of irrelevancies that show you don't understand the context.