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/...tasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-ve-cov-7pd2-peds-eval-sas.txt[7/5/2023 10:22:59 AM]************************************************************************************************ *****************;** Program Name : adc19ef-ve-cov-7pd2-peds-eval.sas **;** Date Created : 15Nov2021 **; ** Programmer Name: **; ** Purpose : Create…
file:///J/...%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-sas.txt[7/5/2023 10:22:58 AM]************************************************************************************************ **;** Program Name : adc19ef.sas **; ** Date Created : 17Nov2021 **; ** Programmer Name : **; ** Purpose : Create adc19ef dataset **; ** Input data : ADSYMPT and ADSL …
file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adae-sas.txt[7/5/2023 10:22:57 AM]************************************************************************************************ *****************;** Program Name : adae.sas **;** Date Created : 17Nov2021 **;**…
file:///J/.../m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adae-s130-sae-unb2-ped6-sas.txt[7/5/2023 10:22:56 AM]***********************************************************************************************; ** Program Name : adae-s130-sae-unb2-ped6.sas **;** Date Created : 15Nov2021 **;** Programmer Name : **; ** Purpose : Create…
Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 02February 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…
Pfizer Global Regulatory Affairs Pfizer Inc. 4300 Oak Park Road /Sanford, NC27330 Global Product Developm ent 28January2022 Peter Marks , M.D.Ph.D. Acting 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 S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING …
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 01 July 2022 Peter Marks , M.D., Ph.D. Acting Director Office of Vaccines Research and Review Food and Drug Administr ation Center for Biologics 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 TH E…
Pfizer Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 13 May2022 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 Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 09 May2022 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 Global Regulatory Affairs Pfizer Inc. 235 East 42ndStreet/New York , NY 10017 -5755 Global Product Developm ent 04May2022 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…
Copyright © 2021 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.The Pediatric Infectious Disease Journal • Volume 40, Number 4, April 2021 www.pidj.com | e137ISSN: 0891-3668/21/4004-e137 DOI: 10.1097/INF .0000000000003043Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.Original Studies Accepted for publication December 12, 2020 *Department of Pediatrics, School of Medicine, University of Colorado, Aurora, CO; †Department of Pathology and…
Morbidity and Mortality Weekly Report 382 MMWR / March 19, 2021 / Vol. 70 / No. 11 US Department of Health and Human Services/Centers for Disease Control and Preventi onRacial and Ethnic Disparities in COVID-19 Incidence by Age, Sex, and Period Among Persons Aged <25 Years — 16 U.S. Jurisdictions, January 1–December 31, 2020 Miriam E. Van Dyke, PhD1,2,*; Maria C.B. Mendoza, PhD2,*; Wen Li, PhD2; Erin M. Parker, PhD2; Brook Belay, MD2; Elizabeth M. Davis, MA3; Joshua J. Quint, PhD4; Ana…
Severe COVID-19 Infection and Pediatric Comorbidities: A Systematic Review and Meta-Analysis Boyan K. Tsankova,b,d,e, Joannie M. Allairea,b,d, Michael A. Irvined, Alison A. Lopeza,c,d, Laura J. Sauvéa,c,d, Bruce A. Vallancea,b,d, Kevan Jacobsona,b,d,f,* aDepartment of Pediatrics, BC Children ’s Hospital, Vancouver, BC, Canada bDivision of Gastroenterology, Hepatology and Nutrition, BC Children ’s Hospital, Vancouver, BC, Canada cDivision of …
Systematic Review/Meta analysis The Prevalence of Olfactory and Gustatory Dysfunction in COVID-19 Patients: A Systematic Review and Meta-analysisOtolaryngology– Head and Neck Surgery 2020, Vol. 163(1) 3–11 /C211American Academy of Otolaryngology–Head and NeckSurgery Foundation 2020Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599820926473http://otojournal.org Jane Y . T ong1*, Amanda Wong2*, Daniel Zhu2*, Judd H. Fastenberg, MD2,3, and Tristan Tham, MD2,3…
Articles www.thelancet.com Vol 398 October 16, 2021 1407Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study Sara Y Tartof, Jeff M Slezak, Heidi Fischer, Vennis Hong, Bradley K Ackerson, Omesh N Ranasinghe, Timothy B Frankland, Oluwaseye A Ogun, Joann M Zamparo, Sharon Gray, Srinivas R Valluri, Kaije Pan, Frederick J Angulo, Luis Jodar, John M McLaughlin Summary Background Vaccine effectiveness studies…
090177e19669cdfe\Final\Final On: 02-Mar-2021 22:00 (GMT)…
Pediatric Pulmonology. 2021;56:1342 1356. wileyonlinelibrary.com/journal/ppul 1342 |© 2021 Wiley Periodicals LLCReceived: 10 November 2020 |Revised: 9 January 2021 |Accepted: 19 February 2021 DOI: 10.1002/ppul.25344 REVIEW COVID ‐19 in childhood: Transmission, clinical presentation, complications and risk factors Melissa K. Siebach RN, BSN1,2|Giovanni Piedimonte MD3|Sylvia H. Ley PhD, RD1 1Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans,…
Correspondence www.thelancet.com/child-adolescent Vol 5 June 2021 e22Post-acute COVID-19 outcomes in children with mild and asymptomatic disease Data on the clinical outcomes of children with COVID-19 are scarce, particularly in those with asymptomatic and mild disease. 1,2 Studies involving adults suggest that long-term multisystem sequelae and complications can occur, even with mild COVID-19. 3 We aimed to describe medium-term clinical outcomes 3–6 months after diagnosis in…
Asymptomatic SARS-CoV-2 infection: A systematic review and meta-analysis Pratha Saha, Meagan C. Fitzpatricka,b, Charlotte F. Zimmera, Elaheh Abdollahic, Lyndon Juden-Kellyc, Seyed M. Moghadasc, Burton H. Singerd,1, and Alison P. Galvania aCenter for Infectious Disease Modeling and Analysis, Yale School of Public Health, New Haven, CT 06520;bCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD 21201;cAgent-Based Modelling Laboratory, York…
The new england journal of medicine n engl j med 385;22 nejm.org November 25, 2021Correspondence Effectiveness of BNT162b2 Vaccine against Delta Variant in Adolescents To the Editor: The B.1.617.2 (delta) variant of seve re acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as the dominant strain circulating in many regions worldwide. The BNT162b2 mRNA vaccine against coronavirus disease 2019 (Covid-19) was found to be effective in preventing infection with the delta…