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2.4 NONCLINICAL OVERVIEW

BNT162b2. Module NONCLINICAL OVERVIEW NONCLINICAL OVERVIEW . 090177e1962c108d\Approved\Approved On: 08-Feb-2021 15:26 (GMT). CONFIDENTIAL. Page 1. FDA-CBER-2021-5683-0013861. BNT162b2. Module NONCLINICAL OVERVIEW TABLE OF CONTENTS. NONCLINICAL OVERVIEW .. 1. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .. 4. OVERVIEW OF NONCLINICAL TESTING STRATEGY .. 6. Table Nomenclature of the Vaccine Candidates .. 6. Table NONCLINICAL Studies .. 8. PHARMACOLOGY ..10. Primary Pharmacodynamics ..10. Summary ..10. BNT162b2, A Lipid Nanoparticle Encapsulated RNA Vaccine Encoding the SARS-CoV-2 P2 S as a Vaccine Figure Schematic of the Organization of the SARS-CoV-2 S Glycoprotein.

BNT162b2 is a nucleoside modified mRNA (modRNA) expressing full-length S with two proline mutations (P2) to lock the transmembrane protein in an antigenically optimal prefusion conformation (Pallesen et al, 2017; Wrapp et al, 2020). The vaccine is formulated in lipid nanoparticles (LNPs). The LNP is composed of 4 lipids: ALC-0315, ALC-0159,

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