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DEPARTMENT OF HEALTH AND HUMAN SERV ICES
Food and Drug Administration
Silver Spring MD 20993
MEMORANDUM FOR RECORD
To STN # 125 742/0 August 20, 2021
From Hyesuk Kong, Ph. D.
Karla Garcia, M.S.
Seth Schult e, M.S.
Laboratory of Microbiology, In -vivo Testing & Standards (LMIV TS)
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)
Through Mary A. Malarkey, Director, OCBQ Mary na Eich elberger, Ph. D., Director, DBSQC
James L. Kenney, D. Sc., Chief , LMIVTS
Cc Michael Smith, RPM, OVRR
Laura Gottschalk , RPM, OVRR
R amachandra Naik , Chair, BLA Review Committee
Subject CBER I n-support Sterility and Bacterial Endotoxin Test (BET) Result s for
COVID- 19 mRNA Vaccine, COMIRNATY
The DBSQC’s Labor atory of Microbiology, In-vivo Testing and Standards tested three
lots of COVID- 19 mRNA Vaccine final drug product for sterility using the membrane
filtration test method (TM: 000388, v 10) and bacter ial endotoxin using the
test method (TM: 000575, v04), to support approval of STN 125742/0
submitted by BioNTech Manufacturing GmbH, in partnership with Pfizer, Inc . (Pfizer ).
The sterility and bacterial endotoxin results obtained by CBER along with those of Pfizer
are listed below:
Sterility and BET Results
Lot
Number CBER &
Pfizer Sterility
Test Results*1 BET
Test
Dilution CBER
% Spike
Recovery CBER
Results *2
(EU/mL) Pfizer ’s
Results
(EU/mL) Proposed
Specificatio n
(EU/mL)
FC3181 Passed
FC3184 Passed
FD0809 Passed
*1 Sterility lot -release specification is No growth of bacteria and fungi
*2 Test Kit
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150329
BLA 125742 /0
Page 2
CBER pe rformed the compendial sterility test per TM 000388 to confirm Pfizer’s
sterility test results, as CBER does not have the s terility testing system in -
house. No microorganism growth was obser ved in the lots tested by CBER using the
compendial sterility test , confirming the test result s obtained by Pfizer using the
system. CBER’s in -support sterility test results for all lots met the specification required
to report the result as a pass .
The BET p erformed at C BER followed the firm’s S tandar d
Operating Procedure ( SOP) TM-8914A and analytical method validation report (BET -
102720- R0-HC Version 003), including a followed by sample
dilution in . A dilution of was used and t hese three test samples
showed no inhibition or enhancement as the spike recoveries for the p ositiv e product
control were 77- 106% (acceptance criteria CBER ’s in- support test r esults
indicate the bacterial endotoxin concent ration met the specification of for
all conformance lots.
In conclusion, the sterility and bact erial endotoxin results from tests performed by CBER
are comparable to the values reported in Pfiz er’s Certificat e of Anal ysis and were within
the proposed speci fication .
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150330