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.
FDA-CBER-2022-5812-0236383 Confirming receipt. We will discuss with the review team regarding your proposal to provide the 508- compliant tables. As suggested, we will continue to include Elisa and Carmel in any correspondence in your absence. Regards, Ram From: Patel, Amit < [email protected] > Sent: Thursday, November 11, 2021 4:31 PM To: Naik, Ramachandra < [email protected] > Cc: Smith, Michael (CBER) < [email protected] >; Gottschalk, Laura …
FDA-CBER-2022-5812-0236386
Table.A Follow -up Duration After Dose 2 – Participants 12 Through 15 Years of Age – Safety Population (Data Cutoff September 2, 2021) Vaccine Group (as Administered) BNT162b2 (30 μg) (Na=1131) nb (%) Placebo (Na=1129) nb (%) Total (Na=2260) nb (%) Length of Blinded Placebo -controlled Follow -up <4 Months 345 (30.5) 356 (31.5) 701 (31.0) ≥4-<5 Months 528 (46.7) 532 (47.1) 1060 (46.9) ≥5-<6 Months 106 (9.4) 97 (8.6) 203 (9.0) …
Number (%) of Subjects Reporting at Least 1 Non -Serious Adverse Event From Dose 1 Through 1 Month After Dose 2, by System Organ Class and Preferred Term – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenic ity Subset) – Safety Populatio n Vaccine Group (as Administered) BNT162b2 (30 μg) Placebo 12-15 Years (Na=1131) 16-25 Years (Na=536) 12-15 Years (Na=1129) 16-25 Years (Na=561) System Organ Class Preferred Term nb (%) (95% CIc) nb…
FDA-CBER-2022 5812-0236052 FDA-CBER-2022-5812-0236053 FDA-CBER-2022-5812-0236054
Pfizer Global Regulatory Affairs Pfizer Inc . 235 East 42ndStreet /New York , NY 10017 -5755 Global Product Developm ent 03August 2021 Marion Gruber, Ph.D. 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 SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING…
COVID -19 Vaccine (BNT162, PF -07302048) BB-IND 19736 M 1.12.4 Requests for Comments and Advice PFIZER CONFIDENTIAL Page 1COVID -19 Vaccine (BNT162, PF- 07302048) IND 19736 Request for Comments and Advice Regarding Adolescent (12- 15 Years of Age) Supplemental BLA Propos ed Clinical Package August 2021 090177e197b81544\Approved\Approved On: 03-Aug-2021 12:37 (GMT) FDA-CBER-2022-5812-0236057 COVID -19 Vaccine (BNT162, PF -07302048) BB-IND 19736 M 1.12.4 Requests for Comments and Advice …
BNT162b2 C4591014 NON -INTERVENTIONAL STUDY PROTOCOL Version 2.0, 01 December 2021 PFIZER CONFIDENTIAL CT24- WI-GL02 -RF02 2.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 15-Aug-2018 Page 1 of 47NON -INTER VENTIONAL (NI) STUDY PROT OCOL This document contains confidential information belonging to Pfizer. Except as otherw ise agreed to in w rit- ing, by accepting or reviewing this document, you agree to hold this information in confidence and not copy or …
BNT162b2 C4591014 NON -INTERVENTIONAL STUDY PROTOCOL Version 2.0, 01Oct 3 01 D ecember 2021 PFIZER CONFIDENTIAL CT24- WI-GL02 -RF02 2.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 15-Aug-2018 Page 1 of 48NON -INTER VENTIONAL (NI) STUDY PROT OCOL This document contains confidential information belonging to Pfizer. Except as otherw ise agreed to in w rit- ing, by accepting or reviewing this document, you agree to hold this information in confidence and not…
Protocols C4591014, WI255886, and WI235284 Statistical Analysis Plan PFIZER CONFIDENTIAL CT24- WI-GL03 -RF03 2.0 Non-Interventional Statistical Analysis Plan For Secondary Data Collection Study 01-Jun-2020 Page 1of 27Statistical Analysis Plan (SAP) for BNT162b2 Vaccine Effecti veness (VE) Version: 1 Author s: Srinivas Rao Valluri Laura Puzniak MDSCA, Pfizer I nc, New York, NY Heidi Fischer Jeff Slezak Department of Research & Evaluation, Kaiser Permanente Southern California Date : …
Pfizer -BioNTech COVID -19 Vaccine C4591022 NON -INTERVENTIONAL STUDY PROTOCOL Version 4.0, 09 May 2022 PFIZER CONFIDENTIAL CT24- WI-GL02 -RF02 3.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 20-May-2021 Page 1 of 50NON -INTERVENTIONAL (NI) STUDY PROTOCOL Study information Title Pfizer -BioNTech COVID -19 Vaccine Exposure during Pregnancy : A Non- Interventional Post -Approval Safet y Study of Pregnancy and Infant Outcomes in the Organization of…
Pfizer -BioNTech COVID -19 Vaccine C4591022 NON -INTERVENTIONAL STUDY PROTOCOL Version 34.0, 29 November 2021 09 May 2022 PFIZER CONFIDENTIAL CT24 -WI-GL02 -RF02 3.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 20-May-2021 Page 1 of 50 NON -INTERVENTIONAL (NI) STUDY PROTOCOL Study information Title Pfizer -BioNTech COVID -19 Vaccine Exposure during Pregnancy: A Non - Interventional Post -Approval Safety Study of Pregnancy and…
Pfizer -BioNTech COVID -19 Vaccine C4591022 NON -INTERVENTIONAL STUDY STATISTICAL ANALYSIS PLAN Version 2.0, 05 May 2022 PFIZER CONFIDENTIAL Page 1NON -INTERVENTIONAL (NI) STUDY STATISTICAL ANALYSIS PLAN (SAP) Study Information Title Pfizer -BioNTech COVID -19 Vaccine Exposure during Pregnancy : A Non- Interventional Post -Approval Safet y Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTI S)/MotherToBaby Pregnancy Registry Protocol…
Pfizer -BioNTech COVID -19 Vaccine C4591022 NON -INTERVENTIONAL STUDY STATISTICAL ANALYSIS PLAN Version 12.0, 30 November 2021 05 May 2022 PFIZER CONFIDENTIAL Page 1 NON -INTERVENTIONAL (NI) STUDY STATISTICAL ANALYSIS PLAN (SAP) Study Information Title Pfizer -BioNTech COVID -19 Vaccine Exposure during Pregnancy: A Non - Interventional Post -Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists…
BNT162b2 1.3.3 Debarment Certification CONFIDENTIAL Page 1 BLA 125742 COVID-19 VACCINE DEBARMENT CERTIFICATION [FD&C Act 306(k)(1)] BioNTech Manufacturing GmbH hereby certifies that it did not and will not use in any capacity the services of any person debarred under Section 306 of the Federal Food Drug and Cosmetic Act in connection with this application. _____________________________________ _________________ Signature of Applicant Date Ruben Rizzi …
BNT162b2 1.3. Administrative Information CONFIDENTIAL Page 1of 21.3.5.3 EXCLUSIVITY REQUEST The Sponsor included a claim forreference product exclusivity under section 351(k)(7) of the Public Health Service Act (PHSA) in the original BLA 125742 for COMIRNATY (COVID-19 Vaccine, mRNA) . The Sponsor requests that the FDA applythereference product exclusivity that was claimed in connection with the first licensure of COMIRNATY to the changes proposed in the COMI RNATY supplemental BLA, which…
sBLA BNT162b2 Section 1.3.4 Financial Disclosure PFIZER CONFIDENTIAL Page 1 1.3.4 FINANCIAL CERTIFICATION AND DISCLOSURE – SUMMARY N OTE In accordance with 21 CFR Part 54 and Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators (Final , February 2013 ), Pfizer Inc . is submitting financial disclosure information on the Covered Studies listed in Table 1 . The financial disclo sure information covers the time period from…
FDA-CBER-2022-5812-0220469 FDA-CBER-2022-5812-0220470 3 THAWING PRIOR TO DILUTION • Thaw vial(s) of COMIRNATY before dilution either by: o Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month. o Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes. • Using either thawing method, vials must reach room temperature before…
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID- 19 Vaccine , mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- RECENT MAJOR CHANGES --------------------------- Indications and Usage (1) ---------------- ----------------------------------- X/ XXXX …
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COM IRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY® (COVID- 19 Vaccine , mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021 --------------------------- RECENT MAJOR CHANGES --------------------------- Indications and Usage (1) ---------------- ----------------------------------- X/ XXXX …