Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 38 pages
1HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRADENAME safely and effectively. See full prescribing information for TRADENAME. TRADENAME (COVID-19 Vaccine, mRNA) suspension for r injection, for intramuscular use Initial U.S. Approval: YYYY -------------------------------INDICATIONS AND USAGE ------------------------------ TRADENAME is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19)…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 5 pages
Memorandum Date: July 2, 2021 From: Oluchi Elekwachi, PharmD, MPH, Regulatory Review Officer OCBQ/DCM/APLB Through: Lisa Stockbridge, PhD, Branch Chief OCBQ/DCM/APLB Robert A. Sausville, Division Director OCBQ/DCM To: Michael Smith, RPM,OVRR\DVRPA\CMC3 Susan Wollersheim, Medical Officer, CBER/OVRR/DVRPA/CRB1 Subject: Review of Proposed Proprietary Name COMIRNATY (Pfizer-BioNTech COVID-19) Vaccine STN: BLA 125742 Applicant: Pfizer, Inc. Recommendation: COMIRNATY –Acceptable _ Executive…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 9 pages
1FILING MEETING SUMMARY Application number: BLA STN 125742/0 Product name: COVID-19 mRNA Vaccine (COMIRNATY) Proposed Indication: Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older Applicant: BioNTech Manufacturing GmbH Meeting date & time: June 29, 2021; 2:00 - 3:30 PM EDT Committee Chair: Ramachandra Naik, Ph.D. Meeting Recorders: CAPT Michael Smith, Ph.D. and Laura Gottschalk, Ph.D. Background:This meeting was to discuss the new original…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 www.fda.gov Date: June 17, 2021 From: Christopher Joneckis, Associate Director For Review Management Subject: Issuance of BLA License Number in Advance of Approval To: STN 125742, COVID -19 mRNA Vaccine I am authorizing release of the BLA license number for Pfizer/ BioNtech Covid v accine in advance of the typical notification in the approval letter. A significant consideration in…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 9 pages
First Committee Meeting Summary Application number: BLA STN 125742.0 Product name: COVID -19 mRNA Vaccine (COMIRNATY) Proposed Indication: Active immunization to prevent COVID -19 caused by SARS - CoV-2 in individuals ≥16 years of age Applicant: BioNTech Manufacturing GmbH Meeting date & time: June 3, 2021; 4:00PM - 5:30PM EDT Committee Chair: Ramachandra Naik, Ph.D. Meeting Recorder s: CAPT Michael Smith, Ph.D. and Laura Gottschalk, Ph.D. Table 1:…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 6 pages
1 LABELING REVIEW MEMORANDUM To: The File Date: September 1, 2021 STN: 125742/0 Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer, Inc.) Product: COVID -19 Vaccine, mRNA (COMIRNATY) From : Laura Gottschalk, Ph.D . OVRR/DVRPA/RRB3 Through: Elizabeth M. Sutkowski, Ph.D. OVRR/DVRPA/RRB3 Summary : This memorandum outlines the labeling review of the original BLA (STN 125742/0) from BioNTech Manufacturing GmbH (in partnership with…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
GS1 DataBar Code Scans as: (01)10300691000011After dilution, vial contains 6 doses of 0.3 mL FPO GS1 Data BarFor ntramuscular use Contains no preservative DILUTE BEFORE USE D scard 6 hours after d lu ion when stored at 2 to 25º C (35 to 77º F) Di ut on date and ime: US L cense No XXXX B oNTech Manufacturing GmbH & Pfizer Inc NDC 0069-1000-01Rx onlyTM LOT/EXP:COMVLABPComirnaty Label COMVLABP - Puurs 14P March 22, 2021 am Black PMS 7671 Body text point size -…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
LOT/EXP:LOT/EXP: NOTE: Area around QR Code is a requiredquiet zone. Nothing is to print within this space.Code to scan as: https://www.pfi.sr/comirnaty COM195LPUS COM195LPUSManufactured for BioNTechManufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany Manufactured by Pfizer Inc.New York, NY 10017 US License No. XXXX 195 Multiple Dose Vials (after dilution each vial contains 6 doses of 0.3 mL)Suspension for Intramuscular Injection STORAGE: Prior to dilution, store at -90°C to -60°C (-130°F…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
LOT/EXPCOMVLABKZ GS1 DataBar Code Scans as: (01)10300691000011 FPO GS1 Data BarNDC 0069-1000-01Af er d lution, vial contains 6 doses of 0 3 mLRx onlyTM For in ramuscular use Con ains no preserva ive D LUTE BEFORE USE Discard 6 hours after dilution when s ored at 2 to 25º C (35 o 77º F) D lution date and time: US License No XXXX BioNTech Manufacturing GmbH & Pfizer IncComirnaty Label - Kzoo COMVLABKZ 14P March 22, 2021 am Black PMS 7671 Body text point size -…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
MUST BE DILUTED BEFORE USE with sterile 0.9% Sodium Chloride Injection, USP (supplied separately). After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F). Discard after 6 hours.25 Multiple Dose Vials (after dilution each vial contains 6 doses of 0.3 mL)Suspension for Intramuscular Injection Rx onlyNDC 0069-1000-03 STORAGE: Prior to dilution, store at -90°C to -60°C (-130°F to -76°F).Store in this carton to protect from light. DOSAGE AND ADMINISTRATION: After dilution, each vial…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
NO COPY NO COPY NO COPYNO COPY XXXXXX MM/YYYYGS1 Data Matrix (GTIN, Lot, Exp)XXXXXXMM/YYYYGS1 Data Matrix (GTIN, Lot, Exp)NOTE: Area around QR Code is a requiredquiet zone. Nothing is to print within this space.Code to scan as: https://www.pfi.sr/comirnaty LOT: EXP: LOT: EXP:195 Multiple Dose Vials (after dilution each vial contains 6 doses of 0.3 mL)Suspension for Intramuscular Injection195 Multiple Dose Vials (after dilution each vial contains 6 doses of 0.3 mL)Suspension for Intramuscular…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
MUST BE DILUTED BEFORE USE with sterile 0.9% Sodium Chloride Injection, USP (supplied separately). After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F). Discard after 6 hours.NDC 0069-1000-03 25 Multiple Dose Vials (after dilution each vial contains 6 doses of 0.3 mL)Suspension for Intramuscular Injection See prescribing information or scan QR code.STORAGE: Prior to dilution, store at -90°C to -60°C (-130°F to -76°F).Store in this carton to protect from light. DOSAGE AND…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 96 pages
Protocol C4591001 (PF-07302048 ) Statistical Analysis Plan CONFIDENTIAL Page 1 TMF Doc ID: 98.03Protocol C4591001 A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED, OBSERVER -BLIND , DOSE -FINDING STUDY T O EVALUATE THE SAFETY, TOLERAB ILITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2RNA VACCINE CANDIDATES AGAINST C OVID -19 IN HEALTHY INDIVIDUALS Statistical Analysis Plan (SAP) Version: 5 Date: 17Mar 2021 090177e196897024\Approved\Approved On: 17-Mar-2021 16:05 (GMT) …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 68 pages
16.2.2 Listing of Important Protocol Deviations – All Subjects ≥16 Years of Ag e Protocol Deviation Category Protocol Deviation Subcategory Number of Subjects Subject (Number of Deviations if >1) Dosing/admini stration error, subject did not receive correct dose of vaccine 1 C4591001 1231 12313428 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. 462 C4591001 1001 10011005^ (2) C4591001 1001 …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 430 pages
16.2.8.1 Listing of Subjects With Fir st COVID-19 Occurrence After Dose 1 – Blinded Placebo-Controlled Follow-up Period – Dose 1 All-Availa ble Efficacy Population Subject (Country/Age in Years/Sex) Vaccine Group (as Randomized) Dose/Rel DayaStart Date of First Symptom Stop Date of Last Symptom Visit 1 N-Binding Assay/ Visit 1 NAAT/ Visit 2 NAAT Signs and Symptoms SARS-CoV-2 NAAT Result (Central Lab/Local Labb), Swab Date C4591001 1003 10031122 (USA/48/M)* Placebo Dose 2/77…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 198 pages
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population – Blinded Placebo-Controlled Follow-up Period Vaccine Group (as Randomized) Age Group (Years) Subject Population Reason for Exclusion BNT162b2 (30 μg) 12-15 C4591001 1006 10061272 Dose 2 all-available efficac yDid not receive 2 vaccinations. Evaluable efficacy (7 days) Randomized but did not meet all…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 6 pages
16.2.3.2 Listing of Subjects Excluded From Immunogenicity Popul ations – Phase 1, 2 Doses, 21 Days Apart – BNT162b2 (30 μg)/Placebo Age Group (Years) Vaccine Group (as Randomized) Subject Population Reason for Exclusion 18-55 BNT162b2 (30 μg) C4591001 1007 10071050Dose 2 evaluable Did not have blood collection within 6-8 days after Dose 2. Placebo C4591001 1003 10031070Dose 1 evaluable Not eligible for the study at ra ndomization; had important prot ocol deviation(s) as …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
CLINICAL STUDY REPOR T ERRATA Protocol Nu mber: C4591001 CONFIDENTIAL Page 1Study Report Title: Interim Report –6 Month Update: A Phase 1/2/3, Placebo- Controlled, Randomized, Observer -Blind, Dose -Finding Study to Evaluate the Safety , Tolerability , Immunogenicity , and Efficacy of SARS -COV -2 RNA Vaccine Candidates Against COVID -19 in Healthy Individuals Minor errors were identified in the Clinical Study Report. Those errors are listed below. Although these errors do not…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 5 pages
16.2.6 Listing of Assay Data – Phase 1, 2 Doses, 21 Days Apart – BNT162b2 (30 µg)/Placebo Assay Age Group (Years) Vaccine Group (as Randomized) Subject Dose/ Sampling Time Point Date of Sample Rel DayaNT50 (Titer) S1-Binding IgG Level (U/mL) 18-55 BNT162b2 (30 μg) C4591001 1003 10031057 1/Prevax 24JUN2020 1 10.00 BLQ 1/Da y 21 15JUL2020 22 127.84 530.363 2/1 Month 14AUG2020 31 135.45 2786.473 2/6 Months 13JAN2021 183 28.02 463.85 C4591001 1003 10031059 1/Prevax…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 232 pages
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e Age Group (Years) Subject Dose No. Rel Daya Withdrawal Date Study Phase Withdrawal Reason Commentb 16-55 C4591001 1001 10011125 1 37 09SEP2020 VACCINATION WITHDRAWAL BY SUBJECT Withdrew consent and decided not to continue in study. 1 37 09SEP2020 FOLLOW -UP WITHDRAWAL BY SUBJECT patient withdrew consent C4591001 1003 10031140 …