FDA Review of Efficacy and Safety of Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Request
Advisory committee deck review
Comments
3 open comments
DE
Dr. Elena BrooksChange request · May 20, 2026, 12:14 PM
Please add a final review note that this December 10, 2020 public FDA deck is historical source material, not current medical guidance.
Deck title
JD
Jordan DiazChange request · May 20, 2026, 12:36 PM
The efficacy summary should preserve the first primary endpoint detail: 8 vaccine cases vs 162 placebo cases, VE 95.0%, assessed from 7 days after Dose 2.
Primary efficacy analysis
DP
Dr. Priya ShahChange request · May 20, 2026, 12:52 PM
For safety, mention the median follow-up was about 2 months and avoid implying causality for Bell's palsy; the slide says there was no clear basis to conclude causality at that time.
Unsolicited adverse events
MC
Mara ChenResolved · May 20, 2026, 12:40 PM
Source page, FDA media download, title slide, and hash are verified for the bundled presentation.
Please add a final review note that this December 10, 2020 public FDA deck is historical source material, not current medical guidance.
Deck titleThe efficacy summary should preserve the first primary endpoint detail: 8 vaccine cases vs 162 placebo cases, VE 95.0%, assessed from 7 days after Dose 2.
Primary efficacy analysisFor safety, mention the median follow-up was about 2 months and avoid implying causality for Bell's palsy; the slide says there was no clear basis to conclude causality at that time.
Unsolicited adverse eventsSource page, FDA media download, title slide, and hash are verified for the bundled presentation.
FDA source