125742 S1 M2 2.6.3.1 pharmacol tabulated summary
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BNT162b2 2.6.3 Pharmacology Tabulated Summary PFIZER CONFIDENTIAL Page 12.6.3.1 Pharmacology: Overview Test Article: BNT162b2 Type of Study Test System Method of AdministrationTesting Facility Study Number Prim ary Pharmacodynamics Qualification Report for a Single -plex Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS -CoV -2 S1 Protein in Human Sera Direct Luminex immunoassayNA PWRD VR-MQR -10211 Qualification of the SARS -CoV -2 mNeonGreen Virus Microneutralization AssayIn vitro cell culture NA University of Texas Medical Branch (Galveston, TX)VR-MQR -10214 BNT162b2 (V9) Immunogenicity and Evaluation of Protection against SARS -CoV- 2 Challenge in Rhesus MacaquesRhesus macaques IM PWRD New Iberia Research Center (New Iberia, LA) SNPRC (San Antonio, TX)VR-VTR -10671 In Vitro Expression of BNT162b2 Drug Substance and Drug ProductIn vitro cell culture IM BioNTech (Mainz, Germany)R-20-0211 COVID -19: Immunogenicity Study Of The LNP-Form ulated Mod RNA Encoding The Viral S Protein -V9BALB /c mice IM BioNTech (Mainz, Germany)R-20-0085 Characterizing the Immunophenotype In Spleen And Lymph Node Of Mice Treated With S ARS -CoV-2 Vaccine CandidatesBALB/c mice IM BioNTech (Mainz, Germany)R-20-0112 Structural and Biophysical Characterization of SARS -CoV -2 Spike Glycoprotein (P2 S) as a Vaccine AntigenIn vitro cell culture NA PWRD VR-VTR -10741 Secondary Pharm acodynamics Studies not conducted Safety Pharm acology Studies not conducted Pharm acodynamic Drug Interactions Studies not conducted COVID -19 –Coronavirus disease 2019; dLIA –Direct Luminex Assay ;IgG –immunoglobulin G; SARS -CoV -2 –severe acute respiratory syndrome coronavirus 2 ;NA –not applicable; PWRD –Pfizer Worldwide Research & Development; IM - intramuscular; SNPRC –Southwest National Primate Research Center . 090177e196169b72\Approved\Approved On: 22-Jan-2021 20:22 (GMT) FDA-CBER-2021-5683-0708885