===== Emergency Use Authorization =====

==== USA - FDA ====
Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum

{{ ::covid_jab_eua_contract_-_stop_transmission.png?800|}}

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

((https://web.archive.org/web/20201217133250/https://www.fda.gov/media/144416/download))