These vaccine announcements tell us how it's virtually impossible to have Phase 3 complete by November 3rd
23,000 of 30,000 currently enrolled @Pfizer/@BioNTech_Group program
1/
23,000 of 30,000 currently enrolled @Pfizer/@BioNTech_Group program
1/
That means another 24,000 participants need to get their 2nd dose still, which occurs a month after the 1st.
Then 2-3 weeks to get the full immune response.
Then exposure to infections
Then moderate or severe infections as events
2/
Then 2-3 weeks to get the full immune response.
Then exposure to infections
Then moderate or severe infections as events
2/
Pfizer CEO: "We expect by end of October, we should have enough...to say whether the product works or not."
The 1st interim analysis is at 32 events
statnews.com/2020/09/02/exp… @matthewherper @statnews
Even 32 events for placebo, 0 vaccine (likelihood ~0) wouldn't cut it to stop 3/
The 1st interim analysis is at 32 events
statnews.com/2020/09/02/exp… @matthewherper @statnews
Even 32 events for placebo, 0 vaccine (likelihood ~0) wouldn't cut it to stop 3/
150 events has been suggested as minimum required for determining efficacy. Even if 100 events for placebo v 50 in the vaccine group, that's 0.66% vs 0.33% (w/o 95% CI).
Hard to imagine any trial would be stopped or confirmation of Pfizer's "We expect by end of October..."
Hard to imagine any trial would be stopped or confirmation of Pfizer's "We expect by end of October..."
This new draft pledge/statement expected from @Pfizer @moderna_tx @JNJNews is encouraging and further argues against Oct/early November
by @Loftus @JaredSHopkins
wsj.com/articles/covid…
by @Loftus @JaredSHopkins
wsj.com/articles/covid…
