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Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Developm ent
18May2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologicsEvaluation 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 THE LICENSING AND/OR
REGISTRATION OF PRODUCTS FOR PFIZER
INC OR ITS AFFILIATED COMPANIES. THIS
DOCUMENT SHOULD NOT BE DISCLOSED OR
USED, IN WHOLE OR IN PART, FOR ANY
OTHER PURPOSE WITHOUT THE PRIOR
WRITTEN CONSENT OF PFIZER INC.
Re:BLA 125742
COVID-19 mRNA Vaccine ( BNT162/PF-07302048)
Part 2, final,of the Origin al Submission – Rolling Biologics License Application
(BLA)
Dear Dr. Gruber ,
Please find enclosed Part 2 of the Original Submission of the rolling Biol ogics License
Applicatio n (BLA) for the BNT162b2 vaccine candi date developed by BioNTech and Pfizer
under BB -IND 19736 for the prevention of COVID -19caused by SARS-CoV-2in
individuals ≥16 years of age. This vaccine was granted Fast Track D esignation for
individuals >18 years of age on 07July2020 (Grant Fast Track Designation Letter).
Part 1 of the rolling BLA, containing the complete non -clinicaland clinical contents of the
application and PriorityReviewDesignation Request, was submitted on 06 May 2021. FDA
acknowledgement of receipt of that submi ssion was received on 13 May 2021, and the
submission was assigned tracking number BL 1 25742. This submission (Part 2 of the roll ing
submission) completes the Biologics License Application.
The User Fee for this application was paid prior to submission of roll 1 of the BLA (05 May
2021; User Fee ID# PD3017966), and the user fee cover shee t (Form 3397) was submitted
with the first submission on 06 May 2021.
FDA-CBER-2021-5683-0779722
Marion Gru ber, Ph.D. , Director Page 2of 5
BLA125742 18May2021
Pfizer Confid ential
Page 2The purpose of this submissi on is tocomplete the application . This submission is provided in
electronic Com mon Technical Document (eCTD) for mat. The Table of Contents isattached.
As agreed during the te leconference of 16 A pril 2016, sequencing data requested by the
Agency on 09 March 2021 will be provided during the course of review of the BLA by 07
June 2021.
Any reference not included with thi s submission is available upon requ est.
A Request for Proprietary NameReview will be submitted separatel y to this BLA as an
amendment following this submission.
On 10August 2020 it was agreed that BioNTech co uld beprovided their US License
Number upon submission of the BLA (as opposed to at approval ). We kin dly request the US
License Number for Bio NTech with agreement that they will not use it until after the BLA is
approved.
Should you have any questions re garding this submission, or requi re additionalinformation,
pleasecontact me vi aphone at 215-280-5503; via facsimile at 845-474-3500; or via e-mail at
elisa.hark [email protected] .
Sincerely,
Elisa Harkins
Global Regulatory Lead
Global Regulatory Affairs – Vaccines
CC: Ramac handra S. Naik, Ph.D.
FDA-CBER-2021-5683-0779723
Marion Gru ber, Ph.D. , Director Page 3of 5
BLA125742 18May2021
Pfizer Confid ential
Page 3BLA 125742 Part 2Table of Contents
MODULE 1
1 Administrative Inform ation and Prescribing Inform ation
1.1 Forms
FDA 356h Form: Application Form
1.2 Cover Letters
Cover Letter
1.4 References
1.4.2Statement of Right to Reference
DMF Letters of Authorization
1.12 Other Correspondence
1.12.14Environmental Analysis
Environmental Analysis
1.14 Labeling
1.14.1 Draft Labeling
1.14.1.1 Draft Carton and Container Labels
Diluent Labeling Proposal
Fresenius Kabi Diluent Carton (Attachment 1)
Fresenius Kabi Diluent Stamp (Attachment 2)
Hospira Diluent Carton (Attachment 3)
Hospira Diluent Label (Attachment 4)
Carton COM25CTPUS -Puurs
Carton COM25CTKZ -Kzoo
Carton Label COM1 95LPUS -Puurs
Carton Label COM195LKZ -Kzoo
VialCOMVLABP -Puurs
VialCOMVLABKZ -Kzoo
1.14.1.2 Annotated Draft Labeling Text
Annotated Draft Labeling Text
1.14.1.3 Draft Labeling Text
Draft Labeling Text (Word, PDF , SPL)
1.14.1.5Labeling History
Summary of Literature Search on Pregnancy, Lactation and Fertility
Pregnancy and Lactation Cumulative Review
Waiver Request for Summary of Drug Utilization Rates
Waiver Request for Pregnancy Registry Report
1.16 Risk Manage ment Plans
1.16.1 Risk Managem ent (Non-REMS)
Pharmacovigilance Plan
COVID-19 Vaccine VAED Data Capture Aid
COVID-19 Vaccine Anaphylactic Reaction Data Capture Aid
MODULE 2
FDA-CBER-2021-5683-0779724
Marion Gru ber, Ph.D. , Director Page 4of 5
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Pfizer Confid ential
Page 42 CTD SUMMARIES
2.3 Quality OverallSummary
Quality Overall Summary
MODULE 3
3 QUALITY
3.2 Body of Data
3.2.S Drug Substance
3.2.S.1 General Information
3.2.S.2 Manufacture
3.2.S.3 Characterization
3.2.S.4 Control of Drug Substance
3.2.S.5 Reference Standards or Materials
3.2.S.6 Container Closure System
3.2.S.7Stability
3.2.P Drug Product
3.2.P.1 Description and Composition of the Drug Product
3.2.P.2 Pharmaceutical Development
3.2.P.3 Manufacture
3.2.P.4 Control of Excipients (compendial)
3.2.P.4 Control of Excipients (non-compendial)
3.2.P.5 Control of Drug Product
3.2.P.6 Reference Standards or Materials
3.2.P.7 Container Closure System
3.2.P.8 Stability
3.2.A Appendices
3.2.R Regional Inform ation
3.3 Literature References
MODULE 5
5 CLINICAL STUDY REPORTS
5.3 Clinical Study Reports
5.3.5 Reports of Efficacy and Safety Studies
5.3.5.1 Reports of Controlled Clinical Studies Pertinent to the Claim ed Indication
C4591007 Protocol -A Phase 1, Open -Label Dose -Finding Study to Evaluate Safety, Tolerability,
and Immunogenicity and Phase 2/3 Placebo Controlled, Observer -Blinded Safety, Tolerability, and
Immunogenicity Study of a SARS -CoV-2 RNA Vaccine Candidate Against COVID -19 in Healthy
Children <12 Years of Age
C4591015 Protocol -A Phase 2/3, Placebo -Controlled, Randomized, Observer -Blind Study to
Evaluate the Safety, Tolerability, and Immunogenicity of A SARS -CoV-2 RNA Vaccine Candidate
(BNT162b2) Against COVID -19 in Healthy Pregnant Women 18 Years of Age and Older
5.3.5.4 Other Clinical Study Reports
C4591008 Protocol -HERO Together: A Post -Emergency Use Authorization Observational Cohort
Study to Evaluate the Safety of the Pfizer -BioNTech COVID -19 Vaccine in US Healthcare
Workers
C4591009 Protocol Synopsis -A Non-Interventional Post -Approval Safety Study of the Pfizer -
BioNTech COVID -19 mRNA Vaccine in the United States
FDA-CBER-2021-5683-0779725
Marion Gru ber, Ph.D. , Director Page 5of 5
BLA125742 18May2021
Pfizer Confid ential
Page 5C4591011 Protocol-Active Safety Surveillance of the Pfizer -BioNTech COVID -19 Vaccine in the
United States Department of Defense Population Following Emergency Use Authoriza tion
C4591012 Protocol -Post-Emergency Use Authorization Active Surveillance Study among
Individuals in the Veteran’s Affairs Health System Receiving Pfizer -BioNTech Coronavirus
Disease 2019 (COVID -19) Vaccine
C4591014 Protocol -Pfizer-BioNTech COV ID-19 BNT162b2 Vaccine Effectiveness Study -
Kaiser Permanente Southern California
C4591022 Protocol Synopsis -A Non-Interventional Post -Approval Safety Study of Pregnancy
and Infant Outcomes in the Organization of Teratology Information Specialists
(OTIS)/MotherToBaby Pregnancy Registry
WI235284 Protocol -Determining RSV Burden and Outcomes in Pregnant Women and Older
Adults Requiring Hospitalization
WI255886 Protocol -Avon Community Acquired Pneumonia Study (Avon CAP): A Pan -
pandemic Acute Low er Respiratory Tract Disease Surveillance Study
5.4 Literature References
FDA-CBER-2021-5683-0779726