Pfizer Documents (PHMPT/FDA)

The court-ordered FDA release of Pfizer's COVID-19 vaccine BLA submission (~450K pages across 4 sub-collections), mirrored from PHMPT.org. Searchable with AI explain.

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2373 documents

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech RNA Pharmaceuticals GmbH 08/25/2020 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 18 years of age 0 0 6 8 3 FDA-CBER-2021 5683-1072450 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines 215-280-5503 (845) 474-3500 500 Arcola Road …

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech RNA Pharmaceuticals GmbH 07/10/2020 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 18 years of age 0 0 3 0 3 FDA-CBER-2021 5683-1072441 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines 215-280-5503 (845) 474-3500 500 Arcola Road …

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 2 pages

Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 07 May 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 08/30/2021 An der Goldgrube 12 Mainz N/A Germany 55131214-918-5262 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Active immunization to prevent COVID-19 caused by SARS-CoV-2 Phase 4 BB-IND 013812, BB-IND 013278, BLA 125549 0 4 6 9 3 FDA-CBER-2021 5683-1072534 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Amit Patel, Director, Global Regulatory Affairs - Vaccines 214-918-5262 845-474-3500 235 East 42nd Street New York NY…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 09/14/2021 An der Goldgrube 12 Mainz N/A Germany 55131214-918-5262 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Active immunization to prevent COVID-19 caused by SARS-CoV-2 BB-IND 013812, BB-IND 013278, BLA 125549 0 4 8 7 Informed Consent Documents for Study C4591007 3 FDA-CBER-2021 5683-1072540 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Amit Patel, Director, Global Regulatory Affairs - Vaccines 214-918-5262…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 09/15/2021 An der Goldgrube 12 Mainz Rhineland-Palatinate Germany 55131(214) 918-5262 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Active immunization to prevent COVID-19 caused by SARS-CoV-2 BB-IND 013812, BB-IND 013278, BLA 125549 0 4 9 1 3 FDA-CBER-2021 5683-1122587 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Amit Patel, Director, Global Regulatory Affairs - Vaccines 214-918-5262 (845) 474-3500 235 East 42nd…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 06/15/2021 An der Goldgrube 12 Mainz Rhineland-Palatinate Germany 55131(212) 733-2613 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age 0 3 6 5 3 FDA-CBER-2021 5683-1095406 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Director, Pfizer Global Regulatory Affairs - Vaccines (212) 733-2613 (845) 474-3500 235 East 42nd Street New York…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 05/14/2021 An der Goldgrube 12 Mainz Rhineland-Palatinate Germany 55131(212) 733-2613 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age 0 3 3 4 3 FDA-CBER-2021 5683-1089418 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Director, Pfizer Global Regulatory Affairs - Vaccines (212) 733-2613 (845) 474-3500 235 East 42nd Street New York…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 04/16/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age BB-IND 013812, BB-IND 013278, BLA 125549 0 2 9 5 3 FDA-CBER-2021 5683-1078309 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Director, Pfizer Global Regulatory Affairs - Vaccines 212-733-2613 (845) 474-3500 235…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 07/06/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Active immunization to prevent COVID-19 caused by SARS-CoV-2 BB-IND 013812, BB-IND 013278, BLA 125549 0 3 9 7 3 FDA-CBER-2021 5683-1072506 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Director, Pfizer Global Regulatory Affairs - Vaccines 212-733-2613 (845) 474-3500 235 East 42nd…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 06/16/2021 An der Goldgrube 12 Mainz Rhineland-Palatinate Germany 55131(212) 733-2613 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age 0 3 6 8 3 FDA-CBER-2021 5683-1102861 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Senior Manager, Pfizer Global Regulatory Affairs - Vaccines (212) 733-2613 (845) 474-3500 235 East 42nd Street New…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 07/15/2021 An der Goldgrube 12 Mainz Rhineland-Palatinate Germany 55131(212) 733-2613 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age 0 4 0 8 3 FDA-CBER-2021 5683-1103443 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Director, Pfizer Global Regulatory Affairs - Vaccines (212) 733-2613 (845) 474-3500 235 East 42nd Street New York…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 03/15/2021 An der Goldgrube 12 Mainz Rhineland-Palatinate Germany 55131(212) 733-2613 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age 0 2 4 2 Summary Monthly Safety Report (SMSR) 3 FDA-CBER-2021 5683-1081176 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Senior Manager, Pfizer Global Regulatory Affairs - Vaccines (212) 733-2613 (845)…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 04/15/2021 An der Goldgrube 12 Mainz Rhineland-Palatinate Germany 55131(212) 733-2613 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age 0 2 8 8 Summary Monthly Safety Report (SMSR) 3 FDA-CBER-2021 5683-1084590 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Senior Manager, Pfizer Global Regulatory Affairs - Vaccines (212) 733-2613 (845)…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 08/14/2021 An der Goldgrube 12 Mainz Rhineland-Palatinate Germany 55131(212) 733-2613 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age 0 4 5 2 3 FDA-CBER-2021 5683-1112216 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Director, Pfizer Global Regulatory Affairs - Vaccines (212) 733-2613 (845) 474-3500 235 East 42nd Street New York…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 01/29/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age Phase 4 BB-IND 013812, BB-IND 013278, BLA 125549 0 1 9 5 3 FDA-CBER-2021 5683-1072480 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Senior Manager, Pfizer Global Regulatory Affairs - Vaccines 212-733-2613 (845)…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 03/31/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age Phase 4 BB-IND 013812, BB-IND 013278, BLA 125549 0 2 6 7 3 FDA-CBER-2021 5683-1072490 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Senior Manager, Pfizer Global Regulatory Affairs - Vaccines 212-733-2613 (845)…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 07/28/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Active immunization to prevent COVID-19 caused by SARS-CoV-2 BB-IND 013812, BB-IND 013278, BLA 125549 0 4 2 6 3 FDA-CBER-2021 5683-1078312 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Director, Pfizer Global Regulatory Affairs - Vaccines 212-733-2613 (845) 474-3500 235 East 42nd…

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Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 08/10/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Active immunization to prevent COVID-19 caused by SARS-CoV-2 BB-IND 013812, BB-IND 013278, BLA 125549 0 4 4 3 Informed Consent Document for C4591007 3 FDA-CBER-2021 5683-1072528 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Director, Pfizer Global Regulatory Affairs - Vaccines…

019736 S325 M1 1571

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 3 pages

BioNTech SE 05/07/2021 An der Goldgrube 12 Mainz N/A Germany 55131215-280-5503 COVID-19 Vaccine (BNT162, PF-07302048) 019736 Prophylactic immunization against COVID-19 in adults 16 years of age BB-IND 013812, BB-IND 013278, BLA 125549 0 3 2 4 3 FDA-CBER-2021 5683-1072496 Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Özlem Türeci, MD, Chief Medical Officer, BioNTech SE Neda Aghajani Memar, Pharm.D., Director, Pfizer Global Regulatory Affairs - Vaccines 212-733-2613 (845) 474-3500 235…