Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
05/09/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 45 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
05/04/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 45 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
05/02/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 45 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
04/29/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 45 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
03/18/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 0045 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
03/16/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 0045 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
03/15/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 0045 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
03/11/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 0045 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
03/01/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 0045 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
02/02/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 0045 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
01/28/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Adrienne Stafford, Director, Pfizer Global CMC - Vaccines 4300 Oak Park Road Sanford NC 27330919-708-6173 [email protected] 125742 0045 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 7 pages
12/16/2021 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Amit Patel, Director, Pfizer Global Regulatory Affairs - Vaccines 235 East 42nd Street New York NY 10017214-918-5262 845-474-3500 [email protected] 125742 0045 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY COVID-19 Vaccine (BNT162, PF-07302048) Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 02May 2022 Peter Marks , M.D., Ph.D. Active Office Director Office of Vaccines Research and Review Food and Drug Administr ation Center for Bi ologics Evaluation and Research DocumentControl 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 29April2022 Peter Marks , M.D., Ph.D. Active Office Director Office of Vaccines Research and Review Food and Drug Administr ation Center for Bi ologics Evaluation and Research DocumentControl 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 18March2022 Peter Marks , M.D., Ph.D. Active Office Director Office of Vaccines Research and Review Food and Drug Administr ation Center for Bi ologics Evaluation and Research DocumentControl 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 16March2022 Peter Marks , M.D., Ph.D. Active Office Director Office of Vaccines Research and Review Food and Drug Administr ation Center for Bi ologics Evaluation and Research DocumentControl 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 15March 2022 Peter Marks , M.D., Ph.D. Active Office Director Office of Vaccines Research and Review Food and Drug Administr ation 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 …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 11March2022 Peter Marks , M.D., Ph.D. Active Office Director Office of Vaccines Research and Review Food and Drug Administr ation Center for Bi ologics Evaluation and Research DocumentControl 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 01March2022 Peter Marks , M.D., Ph.D. Active Office Director Office of Vaccines Research and Review Food and Drug Administr ation Center for Bi ologics Evaluation and Research DocumentControl 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 227 pages
Page 1 of 227 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1260 Site Name: (1260) UMass Memorial Medical Center Subject No: 12601108 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…