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.
From: Smith, Michael (CBER) Sent: Friday, August 6, 2021 7:26 PM To: 'Harkins Tull, Elisa' <[email protected]>; 'Aghajani Memar, Neda' <[email protected]>; 'Devlin, Carmel M' <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected] ov> Subject: STN 125742.0: 3 questions RE measurement of endotoxins using the LAL procedures Elisa, The review team has the below three question for you…
From: Smith, Michael (CBER) Sent: Friday, August 6, 2021 11:31 AM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: RE: STN 125742.0: IR RE two DP documents Elisa, The review team has the below questions regarding the following two drug product (DP) documents 1)…
Department of Health and Human Services Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Biostatistics and Epidemiology (OBE) Division of Epidemiology (DE) PHARMACOVIGILANCE PLAN REVIEW MEMORANDUM From: Deborah L. Thompson, MD, MSPH Medical Officer, Analytic Epidemiology Branch (AEB) DE, OBE, CBER, FDA To: Ramachandra Naik, PhD Chair, Review Committee Office of Vaccines Research and Review (OVRR),…
PFIZER CONFIDENTIAL Page 1Global Regulatory Affairs -Vaccines Pfizer Inc. 500 Arcola Road Collegeville , PA19426 -3982 Global Product Developm ent 15 February 2021THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONL Y IN CONNECTION WITH THE LICENSING AND/OR REGI STRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, I N WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN…
FDA-CBER-2021-5683-1072424
Listing 7.7.2 Page 1of 1 BNT162b2 Protocol C4591008 Participant Reported Death PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL Generated from /dcri/ct/hero_together/lists/l_death.sas on 24MAY2021 12:45 Page 5of 1689 Subject ID Age/Sex/Race Vaccination DateDays since 1st Vaccine to Death Covid -19 Related C4591008 -6872706624 73/M/WHITE 2020 -12-16 52 Not Covid -19 Related C4591008 -7271517760 54/M/WHITE 2021 -01-14 50 Not Covid -19…
Dear, You will be travelling to Belgium soon to visit and work on the Pfizer Puurs plant. As of April 19th,there are a few conditions for travel to Belgium from abroad, to which the traveller must comply. In your specific situation, it is important to notice the following: As a non-resident , only essential trips are allowed; in this case it’s a professional reason so this will be allowed. A PLF ( Passenger Locator Form ) will need to be completed, via this form: Passenger Locator Form |…
COVID -19 Vaccine (BNT162, PF-07302048) BLA 125742/0 3.2.R Guidelines for Business Travel from a Red Zone to Belgium GUIDELINES FOR BUSINESS TRAVEL FROM A RED ZONE TO BELGIUM Residents returning to Belgium Non-residents travelling to Belgium Bycarortrain Byboat orplane Bycarortrain Byboat orplanePfizer as employer Traveller<48 hrs abroad >48 hrs abroad<48 hrs abroad >48 hrs abroad<48 hrs in BE >48 hrs ≤5d in BE>5d in B E <48 hrs in BE >48 hrs ≤5d in BE>5d in BE As the employer, Pfizer…
SARS-CoV-2 dLIA Linearity Qualification Data re VR-MQR-10211 and VR-MQR-10212 Experimental Data Listing - Linearity PFIZER CONFIDENTIAL Page 1 090177e194aedf59\Approved\Approved On: 18-Aug-2020 21:20 (GMT) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1072704 SARS-CoV-2 dLIA Linearity Qualification Data re VR-MQR-10211 and VR-MQR-10212 Experimental Data Listing - Linearity PFIZER CONFIDENTIAL Page 2 090177e194aedf59\Approved\Approved On: 18-Aug-2020 21:20 (GMT) (b) (4) (b) (4) (b) (4)…
APPENDIX 1. SIGNATURES PROTOCOL NUMBER: C4591012 TITLE OF STUDY: Post-Emergency Use Authorization Active Safety Surveillance Study among Individuals in the Veteran’s Affairs Health System Receiving Pfizer -BioNTech Coronavirus Disease 2019 (COVID -19) Vaccine FINAL STUDY REPORT VERSION: 1.0 Confirmation: I confirm that this non -interventional (NI) study final report, which is final in content and has been printed from its definitive source, is a complete…
file:///J/...211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adae-s092-cut1-ped6-sas.txt[7/5/2023 10:22:56 AM]***********************************************************************************************; ** Program Name : adae-s092-cut1-ped6.sas **;** Date Created : 15Nov2021 **; ** Programmer Name : **; ** Purpose : Create adae-s092-cut1-ped6 **; ** Input data : adae…
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file:///J/.../m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adae-s091-all-unb2-ped6-sas.txt[7/5/2023 10:22:57 AM]***********************************************************************************************; ** Program Name : adae-s091-all-unb2-ped6.sas **;** Date Created : 15Nov2021 **;** Programmer Name : **; ** Purpose : Create…
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file:///J/...m5/datasets/c4591001/analysis/adam/programs-1mth/125742-45_S211_M5_c4591001-A_1mth-P-adva-s001-gmr-ped-ev-eval-sas.txt[7/5/2023 7:39:23 AM]***********************************************************************************************; ** Program Name : adva-s001-gmr-ped-ev-eval.sas **;** Date Created : 23Mar2021 **;** Programmer Name…
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