Document text
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
MEMORANDUM
Date: August 18, 2021
From: Marie J. Anderson, MS, PhD
Division of Biological Standards and Quality Control (DBSQC)
Office of Compliance and Biologics Quality (OCBQ)
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration (FDA)
To: Biologics License Application Submission Tracking Number 125742
Subject: Review of Lot Release Protocol (LRP) Template for COVID- 19 mRNA
Vaccine
Through: Maryna Eichelberger, PhD , Director DBSQC/OCBQ/CBER/FDA
Mary A. Malarkey, Director OCBQ/CBER/FDA
Cc: Ramachandra Naik, PhD, Chair , BLA Review Committee,
DVP/OV RR/CBER/FDA
Michael Smith , PhD, RPM , DVRPA/OVRR/CBER/FDA
Laura Gottschalk, PhD, RPM, DVRPA/OVRR/CBER/FDA
Applicant : BioNTech Manufacturing GmbH (BioNTech)
Product: COVID- 19 mRNA Vaccine
Trade Name: COMIRNATY
Executive Summary: The LRP template for COVID- 19 mRNA Vaccine submitted in
amendment 125742/0.50 on August 16, 2021 is acceptable for use.
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1 General Information
1.1 CMC Review Identifiers and Dates
1.1.1 Biologics License Application (BLA) Submission Tracking Number (STN):
125742
1.1.2 Submission received by CBER: May 18, 2021
1.1.3 Review completed: August 17, 2021
Material Reviewed: BLA 125742
1.1.4 Related Master File, INDs and BLAs: N/A
2 Review
2.1 Documents Reviewed
Lot release documentation package submitted on May 18, 2021 in amendment
125742/0.1
Response and l ot release documentation submitted on July 9 , 2021 in
amendment 125742/0.10
Response and LRP template submitted on July 20, 2021 in amendment
125742/0. 14
Response and LRP template submitted on August 11, 2021 in amendment
125742/0. 40
LRP template received via e- mail on August 14, 2021
Response and LRP template (identical to template submitted August 14, 2021)
submitted on August 16, 2021 in amendment 125742/0. 50
2.2 Review
BioNTech submitted BLA 125742 on May 6, 2021. A lot release documentation
package was submitted in amendment 125742/0.1 on May 18, 2021.
This documentation did not qualify as an LRP template. An IR for a n LRP
template was sent on June 25 , 2021. A response was submitted in amendment
125742/0.10 on July 9, 2021. The response stated the LRP that included the
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assays performed and acceptance criteria was previously provided with the
initial submission. The same l ot release documentation was submitted.
An IR for a LRP template (additional information provided) was requested on
July 16, 2021. A response was submitted in amendment 125742/0.14 on July
20, 2021. The LRP template was reviewed by OVRR/DVP, OCBQ/DBSQC and
OCBQ/DMPQ/PRB with comments.
An IR for a revised LRP template was sent to Pfizer/BioNTech on August 4 ,
2021. This IR also included templates to document assay results. A response
was submitted in amendment 125742/0. 40 on August 11, 2021. The response
and LRP template were reviewed by OVRR/DVP, OCBQ/DBSQC and
OCBQ/DMPQ/PRB.
The majority of CBER’s requested revisions were made to the LRP template.
However , Pfizer/BioNTech requested clarifications to some CBER comments
and issues regarding the submission of requested
.
An IR for a dditional revis ions to the LRP template and clarifications was sent to
Pfizer/BioNTech on August 13, 2021. A revised LRP template was submitted
via e -mail on August 14, 2021. This template was reviewed by OCBQ/DBSQC
with no comments.
An e-mail stating the LRP tem plate was acceptable for use was sent via e-mail
to Pfizer/BioNTech on August 14, 2021. This message also stated
for each lot must be provided as
previously requested.
An amendment (containing the identical lot release protocol template and
information in the body of the e- mail) was submitted to 125742/0. 50 on August
16, 2021. This response and LRP template were reviewed by DBSQC. There
were no changes from the e- mail submission of August 14, 2021.
3 Conclusions
The LRP template for COVID- 19 mRNA Vaccine submitted in amendment
125742/0. 50 on August 16, 2021 is acceptable for use. This template may be
used for future lot release submissions. This BLA was under an expedited
review and the LRP template may require additional revisions in the future.
(b) (4)
(b) (4)
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