125742 S1 M2 22 introduction

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BNT162b2
2.2 Introduction
CONFIDENTIAL
Page 12.2 INTRODUC TION
1. Drug Name
Company  code: BNT162b2
Dosage form: BNT162b2 is formulated as concentrate for dispersion for injection. Each vial 
contains 6doses of 30 micrograms of COVID -19 mRNA  Vaccine, embedded in lipid 
nanoparticles (total volume: 0.45 mL ). 
2. Pharmacological Class
BNT162b2 is ahighly purified single -stranded, 5’- capped messenger RNA produced using a 
cell-free in vitro transcription f rom the corresponding DNA  templates, encoding the viral 
spike (S) protein of SARS -CoV-2.
3. Mode of Action
Upon intramuscular administration, the RNA  is translated to the S protein, which in turn 
induces a protective immune response in the vaccinated orga nism. 
4. Proposed Clinical Use
The proposed indication is active immunization to prevent coronavirus disease 2019 
(COVID-19) caused by severe acute respiratory  syndrome coronavirus 2 (SARS -CoV-2) in 
individuals 16 years of age and older .
BNT162b2 is administered intramuscularly after dilution as a course of 2 doses (0.3 mL  
each). It is recommended to administer the second dose 3 weeks after the first dose .
090177e196ee1ea3\Approved\Approved On: 01-May-2021 17:31 (GMT)
FDA-CBER-2021-5683-0013859
Document Approval Record
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090177e196ee1ea3\Approved\Approved On: 01-May-2021 17:31 (GMT)
FDA-CBER-2021-5683-0013860