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BNT162b2
Module 2.6.1. Introduction
CONFIDENTIAL
Page 1MODULE 2.6.1. INTRODUCTION
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090177e19630e2b2\Approved\Approved On: 08-Feb-2021 15:28 (GMT)
FDA-CBER-2021-5683-0708841
BNT162b2
Module 2.6.1. Introduction
CONFIDENTIAL
Page 22.6.1. INTRODUCTION
There is an urgent need for the development of a new proph ylactic vaccine given the threat
posed by the increasing number of globall y distributed outbreaks of Severe Acute
Respiratory Syndrome (SARS) -CoV -2 infection and thus its associated disease Coronavi rus
Disease 2019 (COVID -19). A L ipid Nanoparticle (LNP) -formulated ribonucleic acid (RNA )-
based vaccine would provide one of the most flexible, scalable, and fastest approaches to
provide protection against new, fast spreading, virus infection. The develop ment of a n
RNA -based vaccine encoding a viral antigen that is translated by the vaccinated organism to
protein to induce a protective immune response provides significant advantages over more
conventional vaccine approaches.
BNT162b2 (BioNTech code number BNT162, Pfizer code number PF -07302048) is a
vaccine intended toprevent COVID -19, which is caused bySARS -CoV -2.BNT162b2,
otherwise known as BNT162b2 (V9), is a nucleoside modified mRNA (modRNA)
expressing full -length spike (S) protein with two proline mutations (P2) to lock the
transmembrane protein in an antigenicall y optimal prefusion conformation . The vaccine is
formulated in lipid nanoparticles. The LNP is composed of 4 lipids: AL C-0315, AL C-0159,
DSPC, and cholesterol. Other excip ients in the formulation include sucrose, NaCl, KCL,
Na2HPO 4, and KH 2PO 4. The drug product is a preservative -free, sterile dispersion of RNA
formulated in LNP in aqueous cry oprotectant buffer for intramuscular ( IM)administration.
The RNA drug substance is the only active ingredient in the drug product. The drug product
is a concentrate for injection and filled a mg/mL in glass vials and closed with
stoppers and flip off crimping cap.
2.6.1.1. Proposed Indications
BNT162b2 is indicated for a ctive immuniz ation to prevent COVID -19caused by SARS -
CoV -2 virus, in individuals 16years of age and older .The dose selected for BNT162b2 for
commercial use i s 30 ug RNA administered IM on Day s1 and 22.
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