@US_FDA Fantastic discussion of Pfizer/BioNtech vaccince - listen in :
1) Possible that social distancing contributed some to great efficacy data in the intervention arm.
2) Reverse transcript data unavailable. But Limited RNA in cells.

@OncoAlert

https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement

2/ FDA Vaccine Review - Pfizer / BioNTech: Study design and antibodies tested:
@OncoAlert @gary_lyman

3/ FDA Vaccine Review - Pfizer / BioNTech: COVID19 Case definition and Outcomes definition
@OncoAlert @gary_lyman @ADesaiMD @arkhaki

4/ FDA Vaccine Review - Pfizer / BioNTech: Statistical considerations, various patient populations, follow-up duration (median 2 months) & monitoring of vaccine-induced respiratory illnesses:

5/ FDA Vaccine Review - Pfizer / BioNTech:
Patient population, patient disposition, various patient population efficacy data:
Results: 95% Efficacy (8 vs 162 #COVID19 diagnoses)

6/ FDA Vaccine Review - Pfizer / BioNTech:
Efficacy results by race / ethnicity, comorbid conitions, and secondary outcomes data (severe #COVID19)