Document text
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 1 BLA 125 742/0 COMIRNATY : Documentation Review Memo
Product Information: COMIRNATY
Indication and Use: Active immunization to prevent coronavirus disease 2019 ( COVID -19) caused by severe acute respiratory
syndrome coronavirus 2 ( SARS -CoV-2) in individuals 16 years of age and older.
Communications (IRs) from CBER:
IR # Request
Date CBER
Rep(s) Request CBER
Requester
for Information BLA
Amendment
Response
1 5/18/21 Mike Smith Three clinical questions regarding the datasets. Clinical team and
Lei Huang STN 125742/0. 3
2 5/20/21 Mike Smith Four facilities questions and a request for a t -con on May 25 or
26, 2021, to discuss production schedules and
for the Puurs, Belgium site. Iryna Zubkova STN 125742/0.4
3 6/8/2021 Mike Smith Three clinical questions regarding datasets and the PI. Clinical team STN 12 5742/0.6
4 6/9/2021 Mike Smith Clinical IR requesting dates for PREA deferred studies. Clinical team STN 12 5742/0.7
5 6/25/2021 Mike Smith DBSQC IR regarding the lot release protocol (LRP) template
and samples & reagents. Marie Anderson STN 125742/0.10
6 6/25/2021 Mike Smith Clinical IR regarding the document titled “bnt162 -01-interim3 -
report -body .” Clinical team STN 127742 /0.9
7 6/29/2021 Mike Smith Clinical IR RE latest date of randomization for participants
included in the reactogenicity subset for Study C4591001 . Clinical team STN 127742 /0.8
8 7/2/2021 Ram Naik 18 question from DVP on product related issues and categorical
exclusion for an environmental assessment. Xiao Wang
STN 127742 /0.19
9 7/6/2021 Mike Smith Clinical IR RE the document titled “c4591001 -interim -mth6 -
report -body.pdf .” Clinical team STN 127742 /0.12
10 7/9/2021 Mike Smith IR RE the validation of the RNA Integrity by capillary gel
electrophoresis method. DBSQC and
DVP STN 125742/0.16
11 7/13/2021 Mike Smith OBE IR to add myocarditis and pericarditis to the PVP and
submit to the BLA by July 19, 2021. Deb Thompson STN 125742/0.20
12 7/13/2021 Ram Naik DVP IR regarding exception or alternative to the requirement
that products in multiple -dose vials include a preservative. Xiao Wang STN 125742/0.11
13 7/15/2021 Mike Smith Clinical IR RE study C4591007 to provide updated goal dates
for final protocol submission . Clinical team STN 12 5742/0.15
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150383
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 2 14 7/15/2021 Mike Smith Updated advice to submit PVP to BLA by July 29, 2021. Deb Thompson STN 125742/0.20
15 7/16/2021 Laura
Gottschalk DBSQC IR regarding lot release protocol template and drug
substance handling instructions. Marie Anderson STN 125742/0 .14
16 7/16/2021 Laura
Gottschalk DBSQC IR regarding sterility and endotoxin test methods. Karla Garcia STN 125742/0.21
17 7/20/2021 Ram Naik Clinical IR for a revised pediatric plan to include study
C4591007 for children 6 months to 11 years of age and
proposal for another study t o enroll infants <6 months of age. Clinical team STN 125742/0.15
18 7/22/2021 Laura
Gottschalk Clinical and stats IR regarding shell tables to include safety and
efficacy data from study C4591001 and other clinical
comments. (Pfizer informed us that shell tables will be provided
by Aug 13. On July 26 we told them to submit the shell tables
ASAP. ) Clinical team ,
Lei Huang and
Ye Yang STN 125742/0.17
STN 125742/0.18
STN 125742/0.28
STN 125742/0.32
STN 125742 /0.37
19 7/26/2021 Laura
Gottschalk Clinical IR regarding the disposition of participants in safety
populations who experienced pregnancy. Clinical team STN 125742/0.23
20 7/26/2021 Laura
Gottschalk DMPQ IR regarding manufacturing and equipment. (Remaining
response to be submitted week of Aug 2 .) Laura Fontan STN 125742/0.24
STN 125742/0.29
21 7/27/2021 Mike Smith Two Clinical IR’s RE vaccine effectiveness. Clinical team STN 125742/0.22
22 7/27/2021 Mike Smith Third clinical IR RE vaccine effectiveness. Clinical team STN 125742/0.22
23 7/28/2021 Ram Naik First set of labeling comments regarding the PI. Clinical team and
RPM labeling
memo STN 125742/0.27
24 7/28/2021 Ram Naik OBE IR regarding postmarketing safety study(ies) Clinical team and
Yun Lu STN 125742/0.30
&
STN 125742/0.42
25 7/29/2021 Laura
Gottschalk Clinical IR regarding safety analysis for two age groups. Clinical team STN 125742/0. 26
26 8/2/2021 Mike Smith DVP and stats questions regarding the Validation Report VR -
MVR -10077. Xiao Wang and
Xinyu Tang STN 125742 /0.31
27 8/2/2021 Mike Smith Five questions regarding validation of assay methods and lot
release. DBSQC and
Xiao Wang STN 125742 /0.35
28 8/3/2021 Mike Smith Six CMC -related questions. Xiao Wang STN 125742 /0.33
29 8/3/2021 Mike Smith Two clinical/stats questions regarding July 26, 2021,
submission and SAS program. Lei Huang and
Clinical team STN 125742 /0.32
(b) (4)
FDA-CBER-2021-5683-1150384
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 3 30 8/4/2021 Mike Smith Two questions regarding the potency assay for determination of
in vitro expression (IVE) by flow cytometry. Xinyu Tang
and Xiao Wang STN 125742 /0.34
31 8/4/2021 Mike Smith F/U IR RE the LRP that was submitted to BLA 125742/0.14 on
July 20, 2021. Marie Anderson STN 125742 /0.40
32 8/4/2021 Mike Smith Secondary F/U IR with attachment RE the LRP that was
submitted to BLA 125742/0.14 on July 20, 2021. Marie Anderson STN 125742 /0.40
33 8/5/2021 Mike Smith 11 facilities questions. Kathy Jones STN 125742 /0.43
34 8/5/2021 Mike Smith Four questions regarding the diluent. RPM labeling
memo STN 125549 /0.36
35 8/5/2021 Mike Smith Second round of PI labeling comments. Clinical and
RPM labeling
memo STN 125549 /0.38
36 8/6/2021 Mike Smith Two questions from DVP regarding two drug product (DP)
documents . Xiao Wang STN 125742/0.39
37 8/6/2021 Mike Smith Three DBSQC questions RE measurement of endotoxins using
the LAL procedures . DBSQC STN 125742/0.48
38 8/9/2021 Mike Smith Clinical IR RE sequencing data . Clinical team STN 125742/0.45
39 8/9/2021 Mike Smith Carton and Container labeling comments. Daphne Stewart
and RPM
labeling memo STN 125742/0.46
40 8/10/2021 Ram Naik Second OBE IR regarding safety -related postmarketing studies . Yun Lu STN 125742/0.42
41 8/10/2021 Mike Smith One testing related question from DBSQC. Hsiaoling Wang STN 125742/0.41
42 8/11/2021 Mike Smith One diluent IR from DMPQ. DMPQ STN 125742/0.47
43 8/13/2021 Mike Smith Three clinical questions. Clinical team STN 125742/0.52
44 8/13/2021 Mike Smith DBSQC IR RE LRP and testing. DBSQC STN 125742/0.50
45 8/13/2021 Mike Smith Pfizer asked a clarification question regarding one of the three
clinical questions for August 13, 2021, and this IR was a
response to the clarification question. Clinical team STN 125742 /0.52
46 8/13/2021 Mike Smith 7 facility questions from the DMPQ team . DMPQ STN 125742 /0.57
47 8/13/2021 Mike Smith 3rd set of PI labeling comments. Clinical team and
RPM labeling
memo STN 125742/0.49
48 8/13/2021 Mike Smith One clinical question. Clinical team STN 125742/0.52
(b) (4)
FDA-CBER-2021-5683-1150385
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 4 49 8/13/2021 Ram Naik Safety -related Postmarketing Requirement/Postmarketing
Commitment studies Clinical team ,
and
Yun Lu STN 125742 /0.51
50 8/16/2021 Mike Smith DMPQ IR RE diluent suppliers and removing Pfizer Healthcare
India Pvt. Ltd. as a supplier of diluent for the BLA. DMPQ STN 125742 /0.56
51 8/16/2021 Mike Smith Second set of comments and questions on the carton and
container labels. Daphne Stewart
and RPM
labeling memo STN 125742 /0.53
52 8/16/2021 Ram Naik Request to submit th e same CMC stability information that was
submitted to EUA 27034.260 to the BLA STN 125742/ 0 so that
we can consider a 9 -month shelf -life for the licensed product. Xiao Wang STN 125742 /0.55
53 8/17/2021 Mike Smith Two questions regarding the drug substance. Xiao Wang STN 125742 /0.62
54 8/17/2021 Mike Smith 4th set of PI labeling comments Clinical team and
RPM labeling
memo STN 125742 /0.58
55 8/17/2021 Mike Smith Two questions for DVP regarding shelf life and date of
manufacture. Xiao Wang STN 125742 /0.61
56 8/17/2021 Ram Naik Follow up IR RE PMR & PMC studies that were received in
amendment 51 dated August 16, 2021. Clinical team STN 125742 /0.59
57 8/18/2021 Mike Smith Pfizer asked clarification question on DVP’s two questions
from August 17, 2021, on DS. This e -mail was guidance in
response to their clarification questions. Xiao Wang STN 125742 /0.62
58 8/18/2021 Mike Smith Two DBSQC questions on amendments 54 and 50 RE
endotoxin testing and specific parameters/instructions for
in the CGE integrity test method. DBSQC STN 125742 /0.65
59 8/18/2021 Mike Smith DVP follow -up response to Pfizer ’s August 18, 20 21,
clarification questions regarding DVP's August 17, 2021, IR on
shelf life and date of manufacture. Xiao Wang STN 125742 /0.61
60 8/18/2021 Mike Smith 5th set of PI labeling comments . Clinical team
and RPM
labeling memo STN 125742 /0.66
61 8/18/2021 Laura
Gottschalk Third set of comments and questions on the carton and
container labels. Daphne Stewart
and RPM
labeling memo STN 125742 /0.63
(b) (4)
FDA-CBER-2021-5683-1150386
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 5 62 8/18/2021 Ram Naik IR RE identification of BLA -compliant lots and Letter to HCP RPM labeling
memo /SBRA STN 125742/0.64
63 8/19/2021 Mike Smith IR RE PMR’s and PMC’s that were submitted in amendment
51. Clinical team STN 125742 /0.67
STN 125 742/0.69
64 8/19/2021 Laura
Gottschalk 6th set of PI labeling comments . (Response requested by COB
8/19/21. ) Clinical team and
RPM labeling
memo STN 125742/0.68
65 8/20/2021 Laura
Gottschalk 7th set of PI comments and shell table. Clinical team and
RPM labeling
memo STN 125742 /0.71
STN 125742/0.72
66 8/20/2021 Ram Naik CBER comments regarding identification of BLA lots/Dear
HCP Letter RPM labeling
memo/SBRA STN 125742 /0.73
67 8/21/2021 Mike Smith IR RE PMR’s and PMC’s to be submitted in one amendment
and revised final protocol submission date for PMC study
C4591007. Clinical team STN 125742/0.75
68 8/21/2021 Laura
Gottschalk 8th set of PI labeling comments . Clinical team and
RPM labeling
memo STN 125742/0.74
69 8/21/2021 Ram Naik Second set of comments regarding identification of BLA
lots/Dear HCP Letter RPM labeling
memo /SBRA STN 125742/0.76
FDA-CBER-2021-5683-1150387
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 6 Amendments:
Date/STN Summary Reviewed by and date reviewed:
5/18/ 2021
125742/ 0.1 Second roll and final piece of the BLA, the review clock has started. This
amendment was not submitted in response to an IR . Clinical team (September 2 , 2021)
Ye Yang (August 19, 2021)
Xiao Wang (August 21, 2021)
Deborah Thompson (August 6, 2021 )
Marie Anderson (August 18, 2021 )
Oluchi Elekwachi (August 6, 2021)
DMPQ team (August 2 2, 2021)
5/19/ 2021
125742 /0.2 Request for Proprietary Name Review . This amendment was not
submitted in response to an IR. Oluchi Elekwachi (July 2, 2021)
Clinical team (September 2 , 2021)
5/19/ 2021
125742/ 0.3 Response to May 18, 2021 , clinical IR RE three dataset questions. Clinical team (September 2 , 2021)
Lei Huang (August 19, 2021)
Ye Yang (August 19, 2021 )
5/24/ 2021
125742/ 0.4 Response to May 20, 2021, DMPQ IR RE four facilities questions and a
request for a t -con on May 25 or 26, 2021, to discuss production schedules
and for the Puurs, Belgium site. DMPQ team (August 2 2, 2021)
6/7/2021
125742 /0.5 COVID -19 case strain sequencing dat a. This amendment was not
submitted in response to an IR. Clinical team (September 2 , 2021)
6/16/2021
125742 /0.6 Response to June 8, 2021, clinical IR on t hree clinical questions regarding
datasets and the PI. Clinical team (September 2 , 2021)
6/17/2021
125742 /0.7 Response to June 9, 2021, clinical IR requesting dates for PREA deferred
studies. Clinical team (September 2 , 2021)
7/2/2021
125742 /0.8 Response to June 29, 2021, clinical IR RE latest date of randomization for
participants included in the reactogenicity subset for Study C4591001. Clinical team (September 2 , 2021)
7/2/2021
125742 /0.9 Response to June 25, 2021, clinical IR regarding IR regarding the document
titled “bnt162 -01-interim3 -report -body .” Clinical team (September 2 , 2021)
7/9/2021
125742 /0.10 Response to June 25, 2021, DBSQC IR regarding the lot release protocol
(LRP) template and samples & reagents. Marie Anderson (August 18, 2021 )
Xiao Wang (August 21, 2021)
7/15/ 2021
125742 /0.11 Response to July 13, 2021, DVP IR regarding exception or alternative to the
requirement that products in multiple -dose vials include a preservative. Xiao Wan g (August 21, 2021)
07/16/2021
125742 /0.12 Response to July 6, 2021, clinical IR regarding IR regarding the document
titled “c4591001 -interim -mth6 -report -body.pdf.” Clinical team (September 2 , 2021)
(b) (4)
FDA-CBER-2021-5683-1150388
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 7 Date/STN Summary Reviewed by and date reviewed:
07/19/ 2021
125742/ 0.13 The applicant waives their rights to the mid - and late -cycle review meetings
for BLA 125742. This amendment was not submitted in response to an
IR. N/A
07/20/2021
125742/0.14 Response to July 16, 2021, DBSQC IR regarding lot release protocol
template and drug substance handling instructions. Marie Anderson (August 18, 2021 )
7/23/2021
125742/ 0.15 Response to July 15, 2021, Clinical IR RE study C4591007 to provide
updated goal dates for final protocol submission and July 20, 2021 follow -
up Clinical IR for a revised pediatric plan to include study C4591007 for
subject 6 months to 11 years of age and proposal of another study to enroll
infants <6 months of age. Clinical team (September 2 , 2021)
7/23/2021
125742/ 0.16 Response to July 9, 2021 , IR RE the validation of the RNA Integrity by
capillary gel electrophoresis method. DBSQC team (August 21, 2021)
Xiao Wang (August 21, 2021)
7/26/2021
125742/ 0.17 Responses to questions 3 -5 of July 22, 2021 , clinical and stats IR regarding
shell tables to include safety and efficacy data from study C4591001 and
other clinical comments.
Clinical team (September 2 , 2021)
Lei Huang (August 19, 2021)
7/28/2021
125742/0.18 Responses to questions 1-2 of July 22, 2021 , clinical and stats IR regarding
shell tables to include safety and efficacy data from study C4591001 and
other clinical comments. Clinical team (September 2 , 2021)
Lei Huang (August 19, 2021)
7/28/2021
125742/0.19 Response to July 2, 2021 , DVP IR regarding 18 question on product related
issues and categorical exclusion for an environmental assessment. Xiao Wang (August 21, 2021)
Xinyu Tang (August 18, 2021)
DMPQ team (August 22, 2021)
7/29/2021
125742/0.20 Response to July 13, 2021 , OBE IR to add myocarditis and pericarditis to
the PVP . Deborah Thompson (August 6, 2021 )
Yun Lu (August 22, 2021)
7/30/2021
125742/0.21 Response to July 16, 2021 , DBSQC IR regarding sterility and
endotoxin test methods. DBSQC team (August 21, 2021 )
07/30/2021
125742/0.22 Response to July 27, 2021 , clinical three questions RE vaccine
effectiveness. Clinical team (September 2 , 2021)
07/30/2021
125742/0.23 Response to July 26, 2021 , clinical IR regarding the disposition of
participants in safety populations who experienced pregnancy. Clinical team (September 2 , 2021)
07/30/2021
125742/0. 24 Response to July 26, 2021 , DMPQ IR regarding manufacturi ng and
equipment. DMPQ team (August 22, 2021)
(b) (4)
FDA-CBER-2021-5683-1150389
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4/14/2022 8 Date/STN Summary Reviewed by and date reviewed:
8/2/2021
125742/ 0.25 Response to the observations contained in the FDA form 483 that was
issued for the pre -approval inspection of the Pfizer Andover facility. This
amendment was not submitted in response to an IR. N/A
8/2/2021
STN
125742 /0.26 Response to July 29, 2021 , clinical IR regarding s afety analysis for two age
groups. Clinical team (September 2 , 2021)
Ye Yang (August 19, 2021)
8/2/2021
125742/ 0.27 Response to July 28, 2021, first set of labeling comments regarding the PI. Clinical team (September 2 , 2021)
Xiao Wang (August 21, 2021)
Lei Huang (August 19, 2021)
Oluchi Elekwachi (August 6, 2021)
RPM labeling memo (September 1 , 2021)
8/2/2021
125742/0.28 Response to comment 5b of July 22, 2021 , clinical -statistical IR Clinical team (September 2 , 2021)
Lei Huang (August 19, 2021 )
8/3/2021
125742/0.29 Follow -up response (remaining supporting documents to response 10) to
July 26, 2021 , DMPQ IR regarding manufacturing and equipment . DMPQ team (August 22, 2021)
8/3/2021
125742/0.30 Response to OBE’s July 28, 2021 , comments regarding post marketing
observational safety study(ies) to assess myocarditis/pericarditis following
administration of COMIRNATY as well as providing plans to characterize
subclinical cases of myocarditis Yun Lu (August 22, 2021)
Clinical team (September 2 , 2021)
8/5/2021
125742/0.31 Response to DVP and stats August 2, 20 21, q uestions regarding the
Validation Report VR -MVR -10077. Xiao Wang (August 21, 2021)
8/5/2021
125742/0.32 Response to clinical and stats IR’s from July 22 , 2021, and August 3, 2021,
regarding shell tables and two additional clinical/stats questions regarding
July 26, 2021, submission and SAS program. Clinical team (September 2 , 2021)
Lei Huang (August 19, 2021)
8/6/2021
125742/0.33 Responses to DVP’s s ix CMC -related questions from August 3 , 2021 . Xiao Wang (August 21, 2021)
8/6/2021
125742/0.34 Responses to August 4 , 2021, IR RE two questions regarding the potency
assay for determination of in vitro expression (IVE) by flow cytometry. Xinyu Tang (August 18, 2021)
Xiao Wang (August 21, 2021)
8/9/2021
125742 /0.35 Response to DBSQC and Xiao Wang's August 2, 2021, questions regarding
validation of assay methods and lot release. DBSQC team (August 2 0, 2021)
Xiao Wang (August 21, 2021)
8/9/2021
125742 /0.36 Response to four questions regarding the diluent dated August 5, 2021. Xiao Wang (August 21, 2021)
RPM labeling Memo (September 1, 2021)
FDA-CBER-2021-5683-1150390
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 9 Date/STN Summary Reviewed by and date reviewed:
8/9/2021
125742/ 0.37 Response to July 22 , 2021, Clinical and stats IR regarding shell tables to
include safety and efficacy data from study C4591001 and other clinical
comments. Clinical team (September 2 , 2021)
Ye Yang (August 19, 2021)
8/9/2021
125742/ 0.38 Revised PI labeling in response to August 5, 2021, second round of labeling
comments. Clinical team (September 2 , 2021)
Lei Huang (August 19, 2021)
RPM labeling memo (September 1 , 2021)
8/10/2021
125742 /0.39 Response to Xiao Wang’s August 6, 2021, questions regarding two drug
product (DP) documents. Xiao Wang (August 21, 2021)
DMPQ team (August 22, 2021)
8/11/2021
125742 /0.40 Response to August 4, 2021, F/U IR RE the LRP that was submitted to
BLA 125742/0.14 on July 20, 2021. Marie Anderson (August 18, 2021 )
8/11/2021
125742 /0.41 Response to one testing related question from DBSQC on August 10, 2021 . Hsiaoling Wang (August 30, 2021)
8/11/2021
125742 /0.42 Response to August 10, 2021, s econd OBE IR regarding safety -related
postmarketing studies. Yun Lu (August 22, 2021)
8/11/2021
125742 /0.43 Responses to DMPQ ’s August 5, 2021 11 facilities questions .
DMPQ team (August 22, 2021)
125742 /0.44 This amendment was skipped . N/A
8/12/2021
125742 /0.45 Response to August 9, 2021, c linical IR RE sequencing data. Clinical team (September 2 , 2021)
8/13/2021
125742 /0.46 Response to August 9, 2021 IR RE Carton and Container labeling .
comments. Daphne Stewart (August 20, 2021 )
RPM labeling Memo (September 1 , 2021)
8/13/2021
125742 /0.47 Response to D MPQ’s August 11, 2021, diluent IR and amended response to
August 5, 2021, IR regarding diluent. DMPQ team (August 22, 2021)
Xiao Wang (August 21, 2021)
8/13/2021
125742/ 0.48 Response to DBSQC’s August 6, 2021, three questions RE measurement of
endotoxins using the LAL
procedures. DBSQC team (August 21, 2021)
8/16/2021
125742 /0.49 Response to 3rd set of PI labeling comments that were sent on August 13,
2021. Clinical team (September 2 , 2021)
RPM labeling memo (September 1 , 2021)
8/16/2021
125742 /0.50 Response to DBSQC’s August 13, 2021, IR RE LRP and testing. Marie Anderson (August 18, 2021)
DBSQC team (August 21 , 2021)
8/16/2021
125742 /0.51 Response to August 13, 2021, IR RE Safety -related Postmarketing
Requirement/Postmarketing Commitment studies . Clinical team (September 2 , 2021)
Yun Lu (August 22, 2021)
(b) (4)
FDA-CBER-2021-5683-1150391
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 10 Date/STN Summary Reviewed by and date reviewed:
8/16/2021
125742/ 0.52 Response to three clinical questions dated August 13, 2021, plus an
additional clinical question dated August 13, 2021 (four total clinical
questions dated August 13, 2021) . Clinical team (September 2 , 2021)
8/17/2021
125742 /0.53 Response to August 16, 2021 IR RE Carton and Container labeling
comments. Daphne Stewart (August 20, 2021 )
RPM labeling Memo (September 1 , 2021)
8/17/2021
125742/ 0.54 Response to f ollow -up to August 13, 2021, endotoxin IR and August 16,
2021, teleconference on this subject containing an agreement to implement
an endotoxin method on DP. DBSQC team (August 21, 2021)
8/17/2021
125742/ 0.55 Response to Xiao Wang’s August 16, 2021, IR to please submit th e same
CMC stability information that was submitted to EUA 27034.260 to this
BLA STN 125742 .0 . Xiao Wang (August 21, 2021)
DMPQ team (August 22, 2021)
8/17/2021
125742 /0.56 Response to DMPQ’s August 16, 2021, IR to remove Pfizer Healthcare
India Pvt. Ltd. as a supplier of diluent for the BLA. DMPQ team (August 22, 2021)
8/17/2021
125742 /0.57 Response to DMPQ’s 7 facility questions dated August 13, 2021 . DMPQ team (August 22, 2021)
8/18/2021
125742 /0.58 Response to August 17, 2021, 4th set of PI labeling comments. Clinical team (September 2 , 2021)
RPM labeling memo (September 1 , 2021)
8/18/2021
125742 /0.59 Response to August 17, 2021 , follow up IR RE PMR & PMC's that were
received in amendment 51 dated August 16, 2021 . Clinical team (September 2 , 2021)
8/18/2021
125742 /0.60 Updated response to FDA form 483 for the Andover site based off of
teleconference with CBER on August 17, 2021. DMPQ team (August 22, 2021, Andover Inspection
Closeout Memorandum )
8/19/2021
125742 /0.61 Responses to DVP’s August 17, 2021, two questions regarding expiry
dating period and date of manufacture. Xiao Wang (August 21, 2021)
8/19/2021
125742 /0.62 Responses to DVP’s August 17, 2021, two questions regarding the drug
substance. Xiao Wang (August 21, 2021)
DMPQ team (August 22, 2021)
8/19/2021
125742 /0.63 Responses to August 18, 2021, third set of comments and questions on the
carton and container labels . Daphne Stewart (August 20, 2021 )
RPM labeling Memo (September 1, 2021)
8/19/2021
125742 /0.64 Response to August 18, 2021, IR RE identification of BLA -compliant
lots/Letter to HCP . RPM labeling memo (September 1 , 2021)
SBRA (August 22, 2021)
8/19/2021
125742 /0.65 Responses to DBSQC’s August 18, 2021, IR. DBSQC team (August 21, 2021)
8/19/2021
125742 /0.66 Response to August 18, 2021, 5th set of PI labeling comments. Clinical team (September 2 , 2021)
RPM labeling memo (September 1 , 2021)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150392
STN 125742/0: BioNTech Manufacturing GmbH ’s COMIRNATY BLA Documentation Review Memo
4/14/2022 11 Date/STN Summary Reviewed by and date reviewed:
8/19/2021
125742 /0.67 Response to August 19, 2021, IR RE PMR’s and PMC’s that were
submitted in amendment 51. Clinical team (September 2 , 2021)
8/20/2021
125742 /0.68 Response to August 19, 2021, 6th set of PI labeling comments. Clinical team (August 2 3, 2021)
RPM labeling memo (September 1 , 2021)
8/20/2021
125742 /0.69 Additional Response to August 19, 2021 , IR RE PMR’s and PMC’s that
were submitted in amendment 51. Clinical team (September 2 , 2021)
8/20/2021
125742 /0.70 Letter of authorization for a new Point of contact in the U.S. agent. This
amendment was not in response to an information request. David Dickerson (no memo required)
8/20/2021
125742 /0.71 Response to August 20, 2021, 7th set of comments on the PI. Clinical team (September 2 , 2021)
RPM labeling memo (September 1 , 2021)
8/20/2021
125742 /0.72 Response to August 20, 2021, IR regarding an additional shell table. Clinical team (September 2 , 2021 )
8/20/2021
125742.0.73 Response to August 20, 2021, CBER comments regarding identification of
BLA lots /Dear HCP Letter . RPM labeling memo (September 1 , 2021)
SBRA (August 22, 2021)
8/21/2021
125742 /0.74 Response to August 2 1, 2021, 8th set of comments on the PI. Clinical team (September 2, 2021)
RPM labeling memo (September 1 , 2021)
8/21/2021
125742 /0.75 Response to August 21, 2021, IR RE PMR’s and PMC’s and final study
protocol date for study C4591007 Clinical team (September 2 , 2021)
8/21/2021
125742 /0.76 Response to August 21, 2021, IR RE regarding identification of BLA
lots/Dear HCP Letter . RPM labeling memo (September 1 , 2021)
SBRA (August 22, 2021)
8/23/2021
125742/0.77 Final PI (when compared to the PI received in STN 125.0.74 it was the
same EXCEPT Pfizer’s ver sion number at the very end of the PI was
changed from LAB -1448 -.9 to LAB -1448 -1.0). Received aft er the BLA was approved but sent to
clinical team, APLB reviewer and RPMs.
RPM labeling memo ( September 1 , 2021)
8/24/2021
125742/0.78 Final PI which has been revised to include the license number Received after the BLA was approved but sent to
APLB reviewer and RPMs.
RPM labeling memo ( September 1 , 2021) (Note: this
last version of the PI w as also sent to OCOD to post
to the web in place of the previous version that had
been sent on the day of approval .)
FDA-CBER-2021-5683-1150393