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Comment by mrfusion | Hacker News Reader

Does they mean they never read it before approving it?

I'd bet that no one person has read all 329,000 pages, but I would bet that somebody looked at almost any given page.

I'm hedging a bit on "any" because a New Drug Application is supposed to contain "the whole story of the drug." As a result, it includes the original and translated copies of any non-English publications related to the drug. It includes case reports for every participant who died during the trial, including in the placebo group. It includes information on related patents and licensing arrangements.

I'm assuming whoever made the decision read the summary. The majority of those "pages" are probably just raw data. Most of it is probably each experimental patient's temperature and blood pressure, each time they got checked, one page at a time.

I think that is a given

Why would it?

Should they have delayed the emergency authorization of the vaccines until these 330,000 pages had all been reviewed and redacted? It would have cost hundreds of thousands of lives, but I can't see any benefit from that course of action.

Should they delay the FOIA release until these 330,000 pages had all been reviewed and redacted? I don’t think the answer to either of these questions are “no”, though ofc the standard could vary.

emergency authorization != approval.

These shenanigans show that the approval can't have been based on all the information. They should have delayed the approval, at least until Phase III trial officially ended.

How many lives would that have cost, though, and for what benefit? The size of the sample that had already received the vaccine without issue made it basically impossible [0] for there to have been an unexpected danger. And without approval, the govt couldn't mandate federal employees take the vaccine, and that mandate has saved tens of thousands of lives.

[0] https://en.m.wikipedia.org/wiki/Power_of_a_test

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