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COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125 742
1.12.4 Request for Comments and Advice
PFIZER CONFIDENTIAL
Page 1REQUEST FOR COMMENTS AND ADVICE
COVID-19 VACCINE ( PF-07302048 )
POSTMARKETING ADVERS E EVENT REPORTING
SEPTEMBER 2021
090177e197fb0030\Approved\Approved On: 03-Sep-2021 13:06 (GMT)
FDA-CBER-2021-5683-0951451
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125 742
1.12.4 Request for Comments and Advice
PFIZER CONFIDENTIAL
Page 21.INTRODUCTION
Reference is made to the Biologics License Application (BLA 125742) for COMIRNATY
(COVID-19 mRNA Vaccine ) approved 23 August 2021 for the prevention of COVID -19
caused by SARS-CoV-2in individuals ≥16 years of age. Reference is also made to the
Emergency Use Authorization (EUA 27034) for Pfizer -BioNTech COVID -19 Vaccine for
the indication of active immunization to prevent coronavirus disease 2019 (COVID -19)
caused by severe acute respiratory s yndrome coronavirus 2 (SARS -CoV-2) in individuals
≥12 years of age issued on 23 August2021.
Pfizer acknowledges the requirements for reporting adverse events following the recent BLA
approval. However, we respectfull y need time to make the changes in the safet y database
whilealso seeking clarification and verification for specific aspects to reporting below. In
the meantime, Pfizer continues to submit cases to the EUA. We are asking for guidance and
confirmation from the Agency for the below questions and scenarios .
The purpose of this communication is to obtain FDA agreement and advice regarding the
scenarios
presented in S ection 2.
2. Pfizer’s Plan for Reporting Adverse Events
1. Cases where the patient age or age group is reported as le ss than 16 y ears, Pfizer will
report to the EUA, and if the age or age group is equal to or greater than 16 or is
unknown/not reported, Pfizer will report these cases to the BLA.
2.Similarly, cases involving an adverse event where a third dose is administered to
immunocompromised patients will be report edto the EUA . If the dose number is not
reported or unknown, Pfizer will report those adverse events to the BLA .
3.Per the BLA reporting requirements, cases reported in associati on with BLA number will
beincluded in PAER.
4.In order to simplify reporting and ensure consistency , if and when additional
indications/populations are authorized under the EUA, Pfizer would propose to use the
same EUA number .
5. Existing and future Pfizer Int erventional studies will be reported to the IND, as well as to
the BLA or EUA, depending on the population under investigation .
Pfizer proposes to make these reporting requirement sand product configuration changes to
the safety system and begin reporting as described above by 24September 2021 . In addition,
we would appreciate an y additional guidance or clarification from the Agency regarding
reporting under the BLAand EUA.
Does CBER agree with Pfizer’s proposed plan for reporting adverse events ?Pfizer would
appreciate a response by 10September 2021.
090177e197fb0030\Approved\Approved On: 03-Sep-2021 13:06 (GMT)
FDA-CBER-2021-5683-0951452
Document Approval Record
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