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by tzs 1680 days ago
Why would it all need to be read?

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.

1 comments

getting approval for a brand new drug intended for millions of people and you don't think its important to read all submitted data? reminds me of Nancy Pelosi "we have to pass the bill so you can find out what's in it"