6 PM S102 2 BLA 125742 8 09 21 2021 Memo 600.81 Lot Distributi

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Template updated_v4_20180901_lahCBER/OBE/DE
Waiver Request Review Memo 
I. Completed by Waiver Coordinator
Product/STN/Reviewer:
Product Name STN/NDA Approval Date Reviewer
COMIRNATY125742/823-Aug-2021 D. Thompson
CBER Submission Receipt Date: September15, 2021
Review Memo Action Due Date: October 18, 2021
Type of request :
PBRER Waiver Request 
Request to Change Reporting Period 
Other:  Lot distribution Waiver Request
     II. Completedby Medical Officer
Reviewsummary:The sponsor requested awaiverto submit quarterly 
BLA LotDistribution Reports (LDR)in lieu of monthly LDR with the justification 
to align the BLA LDRreporting requirementswith the quarterly reporting per the 
Emergency Use Authorization (EUA) asoutlined in the re-authorizationissued 
on August 23, 2021. The Comirnaty BLA approval letter issuedon August 23, 
2021 requested submission of LDRat monthly intervals.
Note: The sponsor also requested an extension of the first reporting period 
for the BLA LDRfrom September 2021 to January 2022 in order to allow for
additional time needed to set up required electronic systems needed for 
submission of the LDR in SPL formatand to coincidewith the January 2022 EUA 
report. Therequest to delay the first reporting period will be granted.
Decision:
Waivergranted 
Waiver declined
Request additional informationfrom Licensed Manufacturer
FDA-CBER-2021-5683-1072430
Template updated_v4_20180901_lahMedical Officer Stamp Date
9/21/2021
Reference Documents
21 CFR 600.80
Guidance for Industry:Safety Reporting for Human Drug and Biological 
Products Including Vaccines
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/Vaccines/ucm092257.pdf
Guidance for Industry: Providing Postmarketing Periodic Safety Reports in the 
ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) 
https://www.fda.gov/downloads/drugs/guidances/ucm346564.pdf
Guidance for Industry: Providing Submissions in Electronic Format —
PostmarketingSafety Reports
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat
ion/Guidances/UCM072369.pdf
Guidance for Industry: Addendum to E2C Clinical Safety Data Management: 
Periodic Safety Update reports for Marketed Drugs, February 2004:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm129444.htm
Guidance for Industry: Postmarketing Adverse Experience Reporting for Human 
Drug and Licensed Biological Products: Clarification ofWhat to Report, August
1997:
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/G
uidances/UCM071981.pdf
21 CFR 600.81
Electronic Submission of Lot Distribution Reports:Guidance for Industry: 
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance
RegulatoryInformation/Guidances/Blood/UCM412006.pdf
21 CRF 600.90
FDA-CBER-2021-5683-1072431
Template updated_v4_20180901_lahhttp://www.gpo.gov/fdsys/granule/CFR-2011-title21-vol7/CFR-2011-title21-
vol7-sec600-90
CFR -Code of Federal Regulations Title 21:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm
ICH E2C(R2)-PeriodicBenefit-Risk Evaluation Report 
http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html
CFR -Code of Federal Regulations Title 21:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=60
0.80
FDA-CBER-2021-5683-1072432