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Pfizer Global Regulatory Affairs
Pfizer Inc.
235 East 42ndStreet/New York , NY 10017 -5755
Global Product Developm ent
14September 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review 
Food and Drug Administration
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 THE LICENSING AN D/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.
SN0487
Re:COVID-19Vaccine(BNT162/ PF-07302048)BB-IND 19736
IND Amendment –
Clinical: Study C45910 07Protocol Amendment
Informed Consent Documentsfor StudyC4591007
Dear Dr. Gruber ,
Reference is made to BB- IND 19736 for the COVID -19 Vaccine (BNT162; PF -07302048), 
which Pfizer and BioNTech are developing for the indication of acti ve immunization to 
prevent coronavirus disease 2019 (COVID -19) caused by  severe acute respiratory  syndrome 
coronavirus 2 (SARS -CoV-2). The IND was effective on 29 April 2020.
Reference is also made to Study C4591007 protocol enti tled, “A Phase 1, Open- Label Dose-
Finding Study to Evaluate Safety, Tolerabili ty, and Immunogenicity and Phase 2/3 Placebo -
Controlled, Observer-Blinded Safety, Tolerability, and Immunog enicity Study of a 
SARSCOV -2 RNA Vaccin e Candidate Again st COVID-19 in Healthy Children and Young
Adults,”initially submitted to th e IND on 08 February  2021 (SN 0203) and the current 
C4591007 Clinical Protocol incorporating Amendment 2submitted to the IND on 10August
2021 (SN 0443).
The present submission pr ovides C45910 07Clinical Protocol Amendme nt 3, Clean cop yand
Tracked change copy.
ProtocolAmendme nt 3includesthe following key changes:
FDA-CBER-2021-5683-1072543
Marion Gr uber, Ph.D. , Director Page 2of 3
BB-IND 19736 14Septembe r2021
Pfizer Confidential
Page 2Updated to allow an additional 2250 Phase 2/3 selected -dose participants <5 y ears of 
age, to enlarge the size of t he pediatric safet y database.  This has resulted in the total 
number of participants in this portion of the study  increasing to approximately  9000 
participants
Included blood draws, procedures , and objecti ves for potential troponin I testing in 
participant s5 to <12 and 12 to <16 y ears
Added the rationale for collecting serum samples for potential troponin I testing.
Revised the objective and corresponding endpoints to describe severe COVID -19 
cases in participants in selected -dose portion of the study
Clarified the process for participants who become eligiblefor receipt of BNT 162b2 or 
another COVID -19 vaccine prior Visit 5 (6 -month follow -up visit)
Added a second definition of sy mptoms of severe COVID-19 disease per CDC 
definition
Clarified instruction s onhow tounblind participants at the 6 -month follow -up visit.
Updated information on the recording ofnon -study vaccination and concomitant 
medications
Additionally , theInformed Consent Do cumentshave been revised and are included in
Module 5.3.5.1 :
C4591007 PA3 Phase 2/3 Older Children Assent Obtaining Serum Samples for 
Potential Troponin I  TestingV113 Sep 2021 ,version1(original) -Cleancopy
C4591007 PA3 Phase 2/ 3 Younger Children Assent Obtaining Serum Samples for 
Potential Troponin I  TestingV113 Sep 202 1,version1(original) -Cleancopy
C4591007 PA3 Phase 2/ 3 Parent ICD Obtaining Se rum Samples for Potential 
Troponin I Testing V1 13 Sep 2021, version1(original) –Clean copy
C4591007 PA3 Phase 2/ 3 Parent ICD Addendum Placebo -Controlled Selec ted Dose 
V1 13 Sep 2021 ,version1(original) –Clean cop y
C4591007 PA3 Phase 2/ 3 Parent ICD Placebo -Controlled Selected Dose V613 Sep 
2021,version 6 – Clean copy &track changes copy
This submission has been scanned for vir uses using McAfee VirusS can EnterpriseVersion
8.8 and is virus free . The submission is be ingsent via the Gateway .
Shouldyou have any questions regarding t his submission, or requ ire additionalinformation, 
pleasecontact me via phone a t 214-918-5262or via e-mail [email protected] .
Sincerely,
Amit Patel
Director
Global Regulatory  Affairs
FDA-CBER-2021-5683-1072544
Marion Gr uber, Ph.D. , Director Page 3of 3
BB-IND 19736 14Septembe r2021
Pfizer Confidential
Page 3CC: Ramachand ra S. Naik,Ph.D.
CC: Laura Go ttschalk, Ph.D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2021-5683-1072545