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To: semimojo
And they met those endpoints.

Agreed...the in-sample short-term VE was 90%+.

Since then we've learned that the protection from infection wanes

...more on that later...

but protection from severe disease remains pretty high.

Those learnings on severity are not from controlled, clinical trials and the attendant data. Those learnings are from statistical studies using databases that don't have the same rigor that comes with clinical trials. That is a very big differential. Indeed, vaccine clinical trials fail to make it to approval about 59% of the time. We don't know if this collection of shots granted EUA would make it to the 41% or 59% cluster.

And while I will grant that some follow-up studies show favorable VE and a statistical linkage between getting shots and saying out of the hospital, that linkage is over a very short window (a few months) and with no controlled data collection on the flip side/side effects of those getting the shots. Indeed, I've seen studies (and not garbage studies or sensational Gateway Pundit crapola) showing the fatality rate being the same between the shot and non-shot groups. Finally, vaccine clinical trials take a median of nine years...we aren't even out of the first inning of our little league game.

Why would you revoke a EUA for a drug that's proven to be safe and very effective in preventing severe disease?

1. Because the EUA approval is for prevention only, not severity. If we think the shots also guard against severity, let's run a proper clinical trial and trot it before the FDA.

2. Because the early evidence shows negative VE against Omicron after a few months and that the shots failed to protect people at a "super spreader" event in Oslo.

24 posted on 12/29/2021 10:15:53 AM PST by DoodleBob (Gravity's waiting period is about 9.8 m/s^2)
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To: DoodleBob
If we think the shots also guard against severity, let's run a proper clinical trial and trot it before the FDA.

Fine, but why revoke authorization for something that's working pretty well?

...the early evidence shows negative VE against Omicron after a few months...

Wrong link, but if it's the article I've seen it's a statistical model based on not much data. Let's wait until Omicron has at least been around a couple of months before we start predicting negative VE.

...the shots failed to protect people at a "super spreader" event in Oslo.

Failed to protect from infection, but from what I can find they were fully effective in preventing serious disease.

28 posted on 12/29/2021 10:45:43 AM PST by semimojo
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