Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 3 pages
file:///J/...45-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-addv-sas.txt[7/5/2023 7:39:06 AM]***********************************************************************************************; ** Program Name : addv.sas **;** Date Created : 09Mar2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 7 pages
file:///J/...-45-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adds-sas.txt[7/5/2023 7:39:08 AM]***********************************************************************************************; ** Program Name : adds.sas **;** Date Created : 07Mar2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 80 pages
file:///J/...)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adds-s002-ped-rand-sas.txt[7/5/2023 7:39:13 AM]***********************************************************************************************; ** Program Name : adds-s002-ped-rand.sas **;** Date Created : 21Mar2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 17 pages
file:///J/...45-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adcm-sas.txt[7/5/2023 7:39:21 AM]***********************************************************************************************; ** Program Name : adcm.sas **;** Date Created : 09Mar2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 18 pages
file:///J/...-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adcevd-sas.txt[7/5/2023 7:39:19 AM]***********************************************************************************************; ** Program Name : adcevd.sas **;** Date Created : 10Mar2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 165 pages
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adce-s020-se-sev-ped-saf-sas.txt[7/5/2023 7:38:53 AM]***********************************************************************************************; ** Program Name : adce-s020-se-sev-ped-saf.sas **;** Date Created : 11Mar2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 67 pages
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adce-s010-lr-sev-ped-saf-sas.txt[7/5/2023 7:39:26 AM]***********************************************************************************************; ** Program Name : adce-s010-lr-sev-ped-saf.sas **;** Date Created : 22Mar2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 6 pages
file:///J/...sets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adc19ef-ve-cov-7pd2-peds-wo-eval-sas.txt[7/5/2023 7:39:01 AM]***********************************************************************************************; ** Program Name : adc19ef-ve-cov-7pd2-peds-wo-eval.sas **;** Date Created : 22Mar2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 5 pages
file:///J/...atasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adc19ef-ve-cov-7pd2-peds-eval-sas.txt[7/5/2023 7:38:39 AM]***********************************************************************************************; ** Program Name : adc19ef-ve-cov-7pd2-peds-eval.sas **;** Date Created : 22Mar2021 **;** Programmer Name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 41 pages
file:///J/...-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adc19ef-sas.txt[7/5/2023 7:39:17 AM]************************************************************************************************ *****************;** Program Name : adc19ef.sas **; ** Date Created : 28Mar2021 **; ** Programmer Name: **; ** Purpose : Create adc19ef dataset **; ** Input…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 17 pages
file:///J/...-45-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adae-sas.txt[7/5/2023 7:39:10 AM]************************************************************************************************ *****************;** Program Name : adae.sas **; ** Date Created : 07Mar2021 **; ** Programmer Name: **; ** Purpose : Create adae dataset **; ** Input data : ae suppae ex adsl **; ** Output data : adae.sas7bdat **;…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 14 pages
file:///J/...211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adae-s091-pd2-ped-saf-sas.txt[7/5/2023 7:39:03 AM]***********************************************************************************************; ** Program Name : adae-s091-pd2-ped-saf.sas **;** Date Created : 24Mar2021 **; ** Programmer Name : **; ** Purpose : Create adae-s091-pd2-ped-saf **; ** Input data : …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 13 pages
file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adae-s091-d1-cut-ped-saf-sas.txt[7/5/2023 7:38:46 AM]***********************************************************************************************; ** Program Name : adae-s091-d1-cut-ped-saf.sas **;** Date Created : 22Mar2021 **; ** Programmer Name : **; ** Purpose : Create…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 13 pages
Research paper Factors associated with deaths due to COVID-19 versus other causes: population-based cohort analysis of UK primary care data and linkednational death registrations within the OpenSAFELY platform Krishnan Bhaskarana,1,*, Sebastian Baconb,1, Stephen JW Evansa,1, Chris J Batesc, Christopher T Rentscha, Brian MacKennab, Laurie Tomlinsona, Alex J Walkerb, Anna Schultzea, Caroline E Mortonb, Daniel Grinta, Amir Mehrkarb, Rosalind M Eggoa, Peter Inglesbyb, Ian J Douglasa, Helen I…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 9 pages
Assessment of 135 794 Pediatric Patients Tested for Severe Acute Respiratory Syndrome Coronavirus 2 Across the United States L. Charles Bailey, MD, PhD; Hanieh Razzaghi, MPH; Evanette K. Burrows, MPH; H. Timothy Bunnell, PhD; Peter E. F. Camacho, MS; Dimitri A. Christakis, MD, MPH; Daniel Eckrich, MLIS; Melody Kitzmiller, BS; Simon M. Lin, MD, MBA; Brianna C. Magnusen, MD;Jason Newland, MD; Nathan M. Pajor, MD, MS; Daksha Ranade, MPH, MBA; Suchitra Rao, MD, MSCS; Olamiji Sofela, MBChB,…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
BNT162b2 2.2 Introduction CONFIDENTIAL Page 12.2 INTRODUC TION 1. Drug Name Trade N ame: COMIRNA TY Product Name: COVID -19Vaccine, mRNA Company code: BNT162b2 Dosage form: COMI RNA TY is formulated as a suspension for injection. Each vial contains 6 doses of 30 micrograms of COVID -19 mRNA Vaccine, embedded in lipid nanoparticles (total volume: 0.45 mL ). 2. Pharmacological Class COMI RNA TYis ahighly purified single -stranded, 5’-capped messenger RNA produced using a cell -free in v…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 13 pages
BNT162b2 1.2 Request for Priority Review CONFIDENTIAL Page 1REQUEST FOR PRIORITY REVIEW COVID -19 Vaccine (BNT162, PF -07302048) sBLA 125742/45 DECEMBER 2021 FDA-CBER-2022-5812-0071506 BNT162b2 1.2 Request for Priority Review CONFIDENTIAL Page 2TABLE OF CONTENTS LIST OF FIGURES ................................ ................................ ................................ ................... 2 ABBREVIAT IONS ................................ ................................…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 4 pages
Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 16December 2021 Peter Mark, M.D., Ph.D. Office of Vaccines Research and Review Food and Drug Administration Center for Biologics 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 AN…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
Pfizer FDA submission document — 2 pages. PHMPT court-ordered release. Open the PDF to read.
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 6 pages
file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adxb-sas.txt[7/5/2023 10:22:52 AM]************************************************************************************************ ****************;** Program Name : adxb.sas **;** Date Created : 17Nov2021 **;**…