FDA Review of Efficacy and Safety of Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Request
Audit trail
Review versions, decisions, comments, and exports.
Current versionv1fda-pfizer-biontech-covid19-vaccine-eua-review-2020.pdf
Approvals1/4Version-specific
Open changes31 closed
Document verificationCaptured
Technical details
SHA-256: 64bd5bbeee73485892b729b61948f53780c3b0166e789cc3b56ac9545a5c5c51People and decisions
4 peopleMara Chenmara.chen@example.orgEditor
Source verification approved; safety wording still open
Dr. Elena Brookselena.brooks@example.orgReviewer
Requested historical-source note
Jordan Diazjordan.diaz@example.orgReviewer
Requested primary efficacy details
Dr. Priya Shahpriya.shah@example.orgReviewer
Requested safety-context wording
Comments and change requests
4 totalDr. Elena BrooksPlease add a final review note that this December 10, 2020 public FDA deck is historical source material, not current medical guidance.Deck title
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Jordan DiazThe 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
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Dr. Priya ShahFor 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
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Mara ChenSource page, FDA media download, title slide, and hash are verified for the bundled presentation.FDA source
Resolved