Emergency Use Authorization


Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum

Identifying Information Application Type EUA (Event-driven EUA request) Application Number 27034 Sponsor Pfizer, Inc., on behalf of Pfizer and BioNTech Submission Date November 20, 2020 Receipt Date November 20, 2020 Signatory Authority Marion F. Gruber, Ph.D., Director, CBER / OVRR

Review Team

Ramachandra Naik, Ph.D., Chair, OVRR/DVRPA;

CAPT [:Michael Smith]], Ph.D., Regulatory Project Manager, OVRR/DVRPA;

Susan Wollersheim, M.D., Clinical reviewer, OVRR/DVRPA;

Nabil Al-Humadi, Ph.D., Toxicology reviewer, OVRR/DVRPA;

Lei Huang, Ph.D., Biostatistics reviewer, OBE/DB;

Haruhiko Murata, Ph.D., CMC/Product reviewer, OVRR/DVP;

Xiao Wang, Ph.D., CMC/Product reviewer, OVRR/DVP;

Laura Fontan, Ph.D., CMC/Facility reviewer; OCBQ/DMPQ;

Kathleen Jones, Ph.D., CMC/Facility reviewer, OCBQ/DMPQ;

Kerry Welsh, M.D., Pharmacovigilance reviewer, OBE/DE;

Narayan Nair, M.D., Pharmacovigilance reviewer, OBE/DE;

Brenda Baldwin, Ph.D., Data Integrity reviewer, OVRR/DVRPA;

Bhanumathi Kannan, Ph.D., BIMO reviewer, OCBQ/DIS/BMB;

Oluchi Elekwachi, Ph.D., Labeling reviewer, OCBQ/DCM/APLB

Review Completion Date December 11, 2020

Established Name/Other names used during development Pfizer-BioNTech COVID-19 Vaccine/ BNT162b2

Dosage Forms/Strengths and Route of Administration A 0.3 mL Suspension for intramuscular injection

Intended Use for EUA Active immunization to prevent coronavirus disease 2019

(COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Intended Population Individuals 16 years of age and older


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