Document text
BNT162b2
1.12.5 Request for a Waiver –Lot Distribution Reports
PFIZER CONFIDENTIAL
Page 1WAIVER REQUEST –LOT DISTRIBUTION REPORTS
Per 21 CFR 600.81 a Lot Distribution Report (L DR) is to be provided in electronic format
every six months or at times other than every 6 months as determined at the time of approval.
For COMIRNATY, the LDR was requested monthly per the BLA approval issued on 23
August 2021. The purpose of this General C orrespondence is to request an extension of the
first reporting period from September 2021 to January 2022. A waiver is also requested to
align the LDR reporting requirement with quarterly reporting per the Emergency Use
Authorization (EUA) as outlined in the re -authorization issued on 23 August 2021. A January
2022 L DR report would align with the quarterl y EUA report next due after the October 2021
report .
Justification for th e Request
Due to the rapid approval of COMIRNATY, Pfizer/BioNTech request a tem porary waiver of
four months (from September 2021 to January 2022) to allow additional time needed to set
up required electronic s ystems needed for submission of the LDR in SPL format. The
monthly LDR reporting requirement requires specific electronic repo rting format and license
holder product distribution information. This information must be provided to a third -party
contractor for conversion into the correct reporting format. As Pfizer and BioNTech have
different inventory and quality systems to report lot distribution information , additional time
is needed to enable routine reporting in the appropriate format.
In addition , some information under an LDR is also required to be reported under the EUA.
The EUA states the following:
“Pfizer I nc. will submit to the EUA file quarterl y manufacturing reports, starting in July
2021, that include a listing of all Drug Substance and Drug Product lots produced after
issuance of this authorization. This report must include lot number, manufacturing site, date
of manuf acture, and lot disposition, including those lots that were quarantined for
investigation or those lots that were rejected. Information on the reasons for lot quarantine or
rejection must be included in the report.”
As information needed to support both the BLA and EUA reports is similar, it is expected
that the same organizational groups will be needed to support both reports. As a result,
alignment between the reporting period for the BLA and EUA is requested. The first EUA
quarterl y report was provided t o the Agency inJuly 2021 as per the initial authorization. As
indicated above, the next report is scheduled for October 2021. If a waiver is granted, the
first BLA LDR would coincide with the January 2022 EUA report.
090177e198115985\Approved\Approved On: 14-Sep-2021 19:23 (GMT)
FDA-CBER-2021-5683-0951550