125742 S105 M1 req comments advice bpdr

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

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BNT162b2
1.12.4 Request for Comments and Advice –BPDR Reporting
PFIZER CONFIDENTIAL
Page 1BIOLOGIC PRODUCT DEV IATION REPORTING ( BPDR) –COMPANY 
POSITION
In line with the BLA licenseapproval, 21 CFR 600.14 regulations, and previous 
communication that Biologic Product Deviation Reports (BPDRs) were not required for the 
Pfizer-BioNTech COVID- 19 Vaccine authorized under the EUA the following approach will 
be taken:
A BPDR is required and would be issued for COVID -19 Vaccine lots manufactured 
and released in accordance with the approved BLA and certified by  CBER (lot has 
received an approved CBER lot release certificate).
A BPDR is not required and will not be issued for COVID- 19 Vaccine lots 
manufactured and released in accordance with the EUA only . As noted by Dr. 
Ramachandra Naik, FDA, in email correspondence to Donna Boy ce on December, 
17, 2020, FDA indicated that Biologic Product Deviation Reports (BPDRs) are not 
required to be submitted for the Pfizer- BioNTech COVID -19 Vaccine authorized 
under EUA, as they  are for lic ensed products under 21 CFR 600.14.
If a COVID -19 Vaccine lot manufactured and released in accordance with the EUA is 
included in the scope of a deviation requiring a BPDR for a COVID -19 Vaccine lot 
manufactured and released in accordance with the approve d BLA, then the EUA lot 
number will be included in the Additional Comments section of the BPDR to ensure 
transparency . 
090177e19813a712\Approved\Approved On: 15-Sep-2021 15:47 (GMT)
FDA-CBER-2021-5683-0951553