Document text
Pfizer-BioNTech COVID -19 Vaccine
EUA 27034
M 1.11.3 Response to FDA Information Request
Pfizer-BioNTech COVID -19 Vaccine
Response to CBER04May2022 Information Request Regarding Package Insert
Information for ReportedNauseain Placebo Recipients 12 -15 Years of Age
09May2022
090177e19a256afd\Approved\Approved On: 09-May-2022 08:22 (GMT)
FDA-CBER-2022-5812-0235944
COVID-19 Vaccine (BNT162, PF -07302048)
BB-IND 19736
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 2LIST OF ABBREVIATIONS
CBER Center for Biologics Evaluation and Research
COVID-19 Coronavirus Disease 2019
FDA (US)Food and Drug Administration
EUA Emergency Use Authorization
PI package insert
sBLA supplemental Biologics License Application
USPI United States package insert
090177e19a256afd\Approved\Approved On: 09-May-2022 08:22 (GMT)
FDA-CBER-2022-5812-0235945
COVID-19 Vaccine (BNT162, PF -07302048)
BB-IND 19736
M 1.11.3 Response to FDA Information Request
PFIZER CONFIDENTIAL
Page 31.INTRODUCTION
Reference is made to the EUAfor thePfizer-BioNTech COVID -19 Vaccine granted on
10May2021 to expand use to individuals 12- 15 years of age , and to the sBLA submitted on
16December 2021 (STN12542.45), for the expansion of licensure to individuals 12- 15 years of
age.
Reference is also made to an email received from Mi ke Smith, Ph.D. (CBER) by Kathleen
Collins(Pfizer) on 04May2022 regarding placebo recipient information contained in the PI that
was submitted to STN125 42.45, based on the dataset (02September 2021 data cutoff) submitted
in the referenced sBLA for the par ticipants 12- 15 years of age who received 2 doses of
BNT162b2 30 µg.
CBER’srequestsare shown below in bold italics followed b y Pfizer/BioNTech’s response s.
2.COMMENTS AND REQUEST S
2.1.Request 1
The review team has the below information request regarding place bo recipient information
contained in the Package Insert (PI) that was submitted to STN 125742.45 and they requested
a response by Monday, May 9th.
Please confirm the number of placebo recipients who reported nausea from Dose 1 through
1month after Dose 2, based on the September 2, 2021 data cutoff. There appears to be
2 placebo recipients who reported nausea from Dose 1 through 1 month post Dose 2, based on
our analysis of the 6 -mo ADAE dataset.
Response
The referenced PI cites 1 participant in the placebo group that reported nausea from Dose 1 to
1month post Dose 2 based on the 13 March 2021 data cutoff date forthe referenced12 -15 years
EUAamendment .
Upon review of the dataset based on the 02 September 2021 cutoff, it was determined that the
updatesreported afterthe EUA snapshot would not impact the interpretation of the data included
in the EUAsubmission. The additional AEs reported sincethe13March 2021 cutoff were
summarized in the sBLAsubmission.
In the dataset based on the 02September 2021cutoff, an additional AE of nausea was reported in
the placebo group (the AE occurred within 1 month post Dose 2 but was entered to the database
after the EUA snapshot ); thus, a total of 2 placebo recipients reported nausea from Dose 1 to
1month post Dose 2 .
The Sponsor will update the USPI to reflect the 2 participants in the placebo group that reported
nausea from Dose 1 to 1 month post Dose 2, atthe next round of FDA labeling comments.
090177e19a256afd\Approved\Approved On: 09-May-2022 08:22 (GMT)
FDA-CBER-2022-5812-0235946
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