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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
10August 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Biolo gics 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 AN D/OR
REG ISTRATION 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.
SN0443
Re: Covid-19 Vaccine (BNT162/PF -07302048) BB- IND 19736
IND Amendment –
Clinical: Study C45910 07 Protoc ol Amendment
Informed Consent Document for Study C4591007
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 active immuniza tion 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 C459100
7 wh ich was initially submitted to th e IND on 08
February 2021 ( SN 0203) and the current C4591 007 Clinica l Protoc ol incorporating
Amendment 1 submitted to the I ND on 09 March 2021 (SN 0236).
The present submission provides C45910 07 Protocol Amendment 2 and thestudy title has
been updated as follows, in alignment with Amendment 2 “A Phase 1, Open-Label Do se-
Finding Study to Evaluate Safety, Tolerabili ty, and Immunogenicity and Phase 2/3 Placebo -
Controlle d, Obser ver-Blinded Safety, Tolerability, and Immunog enicity Study of a
SARSCOV -2 RNA Vaccin e Candidate Against COVID- 19 in Healthy Children and Young
Adults” , Clean copy andTracked change cop y.
Protocol Amendme nt 2includes the follo wing ke y changes:
FDA-CBER-2021-5683-1072531
Marion Gruber, Ph.D. , Director Page 2of 3
BB-IND 19736 10August 2021
Pfizer Confid ential
Page 2Made the following updates in response to commitments m ade to CBER concerning
myocarditis and pericarditis:
oInsertion of a dditional row in risk assessment table in risk assessment section
oAddition of myocarditis and pericarditis in Adverse E vents of S pecial Interest
section.
oAddition of a procedure to any visit th at occurs soone r than 1 month after any
vaccination .
oAddition of an unplanned visit to capture data pertaining to my ocarditis and
pericarditis.
Revised protocol title to reflect the changes in age and dose evaluation.
Updated to allow an additional 2250 P hase 2/3 selected-dose participants to enlarge
the size of the pediatric safet y database.
Added Phase 1/2/3 evaluation of lower dose levels for children and y oung adults with
corresponding objectives.
Revised the order of Visit 1 activities to clari fy whe n procedures should be conducted
in relation to study intervention administration when the visit occurs over 2
consecutive day s.
Added updates and reformatted activities in th e Schedule of Activities.
Removed the requirement to conduct a potential COVID 19 convalescent visit
following each potential COVID 19 illness visit. The collection of the blood sample
was to support an exploratory endpoint, which will be addressed with external data
and ther eby reduce burden to participants and caregivers.
Added a co untry -specifi c appendix that allows flexibility to conduct scheduled visits
in the participant’s home, ie, site -arranged home health visits, as permitted per local
guidelines (applicable to Polan d only ).
Additionally , thefollowing Informed Consent Do cumentshave been revised and are included
inModule 5.3.5.1 :
C4591007 PA2 Phase 2/ 3 Children Assent Placebo-Controlled Selected Dose 06 Aug
2021 version 3 - Clean copy &track changes copy
C4591007 PA2 Phase 2/ 3 Parent ICD Placebo -Controlled Selected Dose 06 Aug
2021 version 5 - Clean copy &track changes copy
Final ly, the following new Informed Consent Do cument sare bein g added to Study
C4591007 and are included inModule 5.3.5.1 :
C4591007 PA2 Phase 1 Younger Children Assent L ower Dose Evaluation 09 Aug
2021 version 1 –Clean copy
C4591007 PA2 Phase 1 Older Children Assent Lower Dose Evaluation 09 Aug 2021
version 1 –Clean cop y
C4591007 PA 2 Phase 1 Parent I CD Lower Dose Evaluation 09 Aug 2021 version 1 –
Clean cop y
C4591007 PA2 Phase 1 Adult Participant I CD Lower Dose Evaluation 09 Aug 2021
version 1 –Clean cop y
C4591007 PA2 Phase 2/ 3 Younger Children Assent L ower Dose Evaluation 09 Aug
2021 version 1 –Clean copy
FDA-CBER-2021-5683-1072532
Marion Gruber, Ph.D. , Director Page 3of 3
BB-IND 19736 10August 2021
Pfizer Confid ential
Page 3C4591007 PA2 Phase 2/ 3 Older Children Assent Lower Dose Evaluation 09 Aug
2021 version 1 –Clean copy
C4591007 PA2 Phase 2/3 Parent ICD Lower Dose Evaluation 09 Aug 2021 version 1
–Clean cop y
C4591007 PA2 Phase 2/ 3 Adult Participant I CD Lower Dose Evaluation 09 Aug
2021 version 1 –Clean copy
This submission has been scanned for vir uses us ing McAf ee VirusS can Ente rpriseVers ion
8.8 and is virus free . The submission is be ing sent via t he Gateway .
Should you have an y questions regarding t his submi ssion, or requ ire additionalinformation,
pleasecontact me via phone a t 212-733-2613 ; via fac simile a t 845-474-3500; or via e -mail at
neda.ag [email protected].
Sincerel y,
Neda Aghajani Memar, Pharm. D.
Directo r
Pfizer G lobal Regulatory Affairs
CC: Ramac handra S . Naik, Ph.D.
CC: Laura Gottschalk, Ph.D.
CC: Captain Michael Smith, Ph.D.
FDA-CBER-2021-5683-1072533