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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administrat ion
Silver Spring MD 209 03
MEMORANDUM
Date: September 23, 2021
From: Anil Choudhary, Ph.D. , MBA.
CMC Reviewer
Laboratory of Biochemistry, Virology and Immunochemistry (LBVI)
Division of Biological Standards and Quality Control (DBSQC)
Office of Compliance and Biologics Qualit y (OCBQ)
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration (FDA)
To: Biologics License Application Submission Tracking Number # 125742 /0
Subject: Total RNA content determination for COMIRNATY® final container lots
for BLA I n-Support Testing.
Through: Muhammad Shahabuddin, Ph.D., Lab Chief, LBVI, DBSQC/OCBQ/CBER
Maryna Eichelberger , Ph.D., Director, DBSQC/OCBQ/CBER
Mary A. Malarkey, Director, OCBQ/CBER
Cc: Laura Gottschalk, Ph.D., BLA Review Committee, DVRPA/OVRR
Mich ael Smith, Ph.D., BLA Review Committee, DVRPA/OVRR
Ramachandra Naik, Ph.D. , Chair, BLA Review Committee, DVRPA/OVRR
Applicant : BioNTech
Product: COMIRNATY
®, COVID -19 mRNA Vaccine
___________________________________________________________________
Summary :
BioNTech submitted three lots of COMIRNATY® vaccine for in-support testing to
determine the total RNA cont ent of drug product (DP) . The DP lots - FC3181, FC3184
and FD0809 met the total RNA specifications.
FDA-CBER-2021-5683-1150738
BLA 125742/0
Pa ge 2
Test Results
The total RNA content of COM IRNATY®, COVID -19 mRNA Vaccine (three DP lots-
FC3181, FC3184 and FD0809) was determined using the manufacturer ’s pro cedure
for the fluorescence assay . This procedure is described in sponsor ’s Test Method #
00-08940A-00 entitled: Quantification of total and percent encapsulated RNA in PF -
07302048 by fluorescence using . The tests were performed in
LBVI, DBSQC , OCBQ . Results from these tests are listed in Tables 1 below :
Table 1: Total RNA cont ent results for three DP lots performed at DBSQC, CB ER
Date Lot# Total
RNA
(mg/mL)
(DBSQC) Percent RNA
Encap sulation
(DBSQC) Sponsor
Results
Total RNA
mg/mL Sponsor
Results
Precent RNA
Encap sulation *Pass/Fail
9/15/2021 FC3181 Pass
9/15/2021 FC3184 Pass
9/15/2021 FD0809 Pass
*Specification for DP lot : Total RNA = mg/mL and Percent E ncapsulation=
%
Conclusions
The test results obtained at LBVI , DBSQC, CBER for these COMIRNATY® Final
Container DP lots demonstrate that lots FC3181, FC3184 and FD0809, met the
specifications for Total RNA cont ent. The assay met the system suitability criteria for
R2 value for the reference standard (Lot# ) of
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150739