My first thought is that there are 329,000 pages of data related to the Pfizer vaccine alone and we are supposed to believe that the FDA read and evaluated them before granting authorization.
I'd expect that a lot of it is data that is gathered because it might be useful if certain things came to pass that did not come to pass.
For example, suppose in phase 3 they had found that the vaccine provides excellent COVID protection but it also has some terrible side effect in too many people to approve it for general use.
If they have extensive medical records on all the people in the trial they might be able to see some way to tell who is likely to have the bad reaction and who is not. Then they can try to find some way to mitigate that, or go for an approval for the vaccine for people other than those who are likely to react badly.
If things go smoothly on the other hand, there may be no need for anyone to look at much of that data.
That 0.25% is mostly known to subject matter experts. The rest is there to meet documentation requirements.
it is definitely NOT 329k pages of absolutely vital facts that can't be skipped.
besides, it can be split up among many people over the course of time.
experts know how to do this stuff.
However with this they should be fully transparent with any and all vaccine related data as they are already suffering from credibility concerns when it comes to vaccine.
this group is an EXTREMELY vocal micro-minority.
Here's literally the law on what goes into a New Drug Application: https://www.law.cornell.edu/cfr/text/21/314.50
The idea is that it serves as the "whole story" of a drug, and includes everything from preclinical data demonstrating how the drug works on a molecular level, up through the plans for actually manufacturing and administering it. Thus, it includes a lot of things "for the record". For example....
If the application relies on material published in another language, then you are required to submit the original and a translated copy. It is very unlikely that the FDA is going to retranslate each article.
Similarly, you need to include individual case reports for any trial participants who die/drop out from adverse events even if in the placebo group and the cause is unrelated to the drug. If Mrs Jones from the control group got eaten by a shark after getting the placebo, a bunch of her medical info will be in there. This a) bulks up the application and b) slows down redaction but c) takes a reviewer about two seconds to realize they can ignore that entire section.
Oh, yes.
>experts know how to do this stuff
https://www.americanbar.org/groups/judicial/publications/jud...
"One way to test the effectiveness of a redacted PDF document is by using a technique that nearly all word processing users know--copy and paste."
...nearly...all...