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.
Get an AI answer drawn only from the Pfizer Documents (PHMPT/FDA) documents indexed here — every claim cited back to the filing or proceeding it came from. It will tell you plainly when the record doesn't cover your question, rather than guessing.
file:///J/...1)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adsl-fu-d2-ped-saf-sas.txt[7/5/2023 7:39:00 AM]***********************************************************************************************; ** Program Name : adsl_fu_d2_ped_saf.sas **;** Date Created : 10Mar2021 **;** Programmer Name…
file:///J/...45-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-admh-sas.txt[7/5/2023 7:39:05 AM]***********************************************************************************************; ** Program Name : admh.sas **;** Date Created : 09Mar2021 **;** Programmer Name…
file:///J/...20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adfacevd-sas.txt[7/5/2023 10:07:45 AM]/* ********************************************************************************************/ ** Program Name : adfacevd.sas **;** Date Created : 10Mar2021 **;** Programmer Name…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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 **;…
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 : …
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…
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…
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,…
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…
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 ................................ ................................…