Title. Just trying to prove a point to someone with official documentation.
EDIT: Thanks guys, been at work, so I appreciate the links. To explain, guy was asking why I wasn't getting the shot, and while I could have said something like my medical decisions are not your business, I thought I'd try and kill two birds with one stone and give him something to chew on with regards to their approval.
It's more accurate to say they are under an Emergency Use Authorization, which is a temporary approval process for pharmaceuticals and medical devices which haven't gone through the normal FDA approval process.
Pfeizer EUA
Moderna EUA
Also, FWIW, I had to sign a disclaimer that said exactly this (Emergency Use Authorization, not fully tested by FDA, etc.) before getting Moderna.
I typically link to the Federal Register when referring to documents like this. The Federal Register notice and the associated Regulations.gov docket frequently constitute most of the the statutorily-required public notice and comment procedure. For example:
Federal Register Posting
Docket No. FDA-2020-N-2358
Docket on Regulations.gov
To put it generally, I have some experience with the FDA application and approval process. People often misunderstand the risk-benefit calculus (I loathe this phrase) FDA uses when approving a new drug product. When dealing with conventional approvals on an accelerated pathway, there is reduced clinical, stability, and other data. FDA is willing to forgo this for either something that is already well-understood (there are special types of applications for this), or for something with an immediate medical need. Emergency Use takes this even further and side-steps much of the typical review process altogether, because the need is determined to be that dire. This doesn't necessarily mean something is or isn't safe, just that there is much less data and scrutiny than something that's actually approved.
I can say from experience that you should not trust FDA to have your personal interests in mind here. Equivalent products are treated differently even when dealing with conventional applications, because there is a significant amount of politics behind all FDA decisions. The legal terminology here would be "arbitrary and capricious". However, the judicial branch generally grants FDA extreme deference on all scientific matters, so they're frequently not held accountable for wrong decisions. It's all part of the game pharma companies play.
They do this for all government agencies under Chevron Deference. It's the official doctrine of the government to side with the government, which is kind of them to put in writing.
Here is a CNN article from April that states its still on clinical trial since Covididians tend to take that source as scripture
https://www.cnn.com/2021/04/01/health/pfizer-covid-vaccine-efficacy-six-months-bn/index.html