important piece re: pfizer vaccine.https://twitter.com/GidMK/status/1326304265304903680 …
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Replying to @drvyom
@gidmk Too many things to correct, but a few things: the trial isn't at less half recruited - it might even be fully recruited. Original interim events wasn't 64: they were 32, 62, 92, 120. 94 infections weren't across the study - only Covid-free people 7 days after 2nd shot..1/2pic.twitter.com/MNykMegaix
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Replying to @hildabast @drvyom
Oh yep I should correct the 64 typo! Fully recruited possibly, but I didn't say half just that it wasn't done yet. I do specify the 28-day timepoint and the three week schedule so I'm confused about that?
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(1) It's not just a typo - 62 wasn't the original first interim analysis. (2) You did
(3) 7+ days after 2nd shot isn't exactly the same as 28-days (unspecified) & it's still not restricted to the people who were known to be Covid-free.pic.twitter.com/JjwgwMGxau
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Replying to @hildabast @drvyom
I'm not sure I'd agree that's an error as such, I was more focused on the meaning of such an analysis to people rather than the discussion with the FDA about the initially planned interim analysis. I don't see where I say half? I'm very confused?
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And I did say: first shot 0 days, second shot 21 days, primary endpoint 28 days. You're right that I didn't go into the serological and other screenings at the start of the study to exclude people with previous COVID-19, but honestly I thought it was implied. My mistake!pic.twitter.com/DaOgsvND3K
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It's not implied: that's why it was specified in the press release. It wasn't an exclusion criterion because they have to show it's safe for people who've already had Covid-19 without knowing it. See the protocolpic.twitter.com/bdSdVZOyYQ
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Replying to @hildabast @drvyom
Sorry, you're right - I was thinking about people with symptomatic disease
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?? Sorry, that doesn't make sense since it wasn't an exclusion criterion & differentiating between these people is a high-level objective of the trial.
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Wait now I'm confusing myself. The exclusion criteria specify that people with previous COVID-19 are not included in the studypic.twitter.com/ltxMvjIURJ
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Yes, from the way you described it. (Need to spend more time with the protocol.)
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Replying to @hildabast @drvyom
Protocol is somewhat unclear tbh. People with current infections definitely 'delayed' recruitment until they got better. Exclusion criteria also quite specific. But as you point out, this seems in conflict with the specified outcomes unless 'infection' does not mean COVID-19
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