125742 45 S211 M2 introduction

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 12 15 Documents

2

Download PDF ↗ Live URL (may be dead)

Document text

BNT162b2
2.2 Introduction
CONFIDENTIAL
Page 12.2 INTRODUC TION
1. Drug Name
Trade N ame: COMIRNA TY
Product Name: COVID -19Vaccine, mRNA
Company  code: BNT162b2 
Dosage form:
COMI RNA TY is formulated as a suspension for injection. Each vial contains 6 doses of 30 
micrograms of COVID -19 mRNA  Vaccine, embedded in lipid nanoparticles (total volume: 
0.45 mL ).
2. Pharmacological Class
COMI RNA TYis ahighly  purified single -stranded, 5’-capped messenger RNA  produced 
using a cell -free in v itro transcription from 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 organism. 
4. Pr oposed Clinical Use
Therapeutic indication:
The proposed indication for COMI RNATY is active immunization to prevent coronavirus 
disease 2019 ( COVID -19) caused b y severe acute respiratory  syndrome coronavirus 2 
(SARS -CoV -2)in individuals ≥12years of age.
COMI RNATY is administered intramuscularly  as a series of 2 doses (0.3 mL  each) 3 weeks 
apart.
090177e198ce090c\Approved\Approved On: 07-Dec-2021 22:54 (GMT)
FDA-CBER-2022-5812-0071519
Document Approval Record
Document Name:	







 !
"#$%	&'(
Document Title:	







 !
"#$%	&'(
Signed By: Date(GMT) Signing Capacity
)
*+,-
 '.
	
'/0/00 12
$
$!!3

090177e198ce090c\Approved\Approved On: 07-Dec-2021 22:54 (GMT)
FDA-CBER-2022-5812-0071520