Document text
Section 1 - 125742/0/0
Section 2 - 125742/0/0
Section 5.3.1 - 125742/0/0
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***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM
***FOR OFFICIAL USE ONLY*** Exclude Inspection Related
Order: FDA/Appl, Then Date Ascending
L 125742/0STN:
BioNTech Manufacturing GmbH #2229 Applicant:
13-MAY-2021
18-MAY-2021
20-MAY-2021
03-JUN-2021
08-JUN-2021
09-JUN-2021
17-JUN-2021
25-JUN-2021
25-JUN-2021
29-JUN-2021
29-JUN-2021
01-JUL-2021
02-JUL-2021
02-JUL-2021
02-JUL-2021
06-JUL-2021
06-JUL-2021
09-JUL-2021
13-JUL-2021
13-JUL-2021
15-JUL-2021
15-JUL-2021
15-JUL-2021
15-JUL-2021
16-JUL-2021Date
Letter. Acknowledgement Letter - Rolling Review ( DICKERSON, DAVID )
Telecon. Information Request - IR RE datasets. ( SMITH, MICHAEL )
Telecon. Information Request - Four facility questions from DMPQ and a
request for a t-con on 5/25/21 or 5/26/21 to discuss production schedules and
the shutdown activities planned for the Puurs, Belgium site. ( SMITH,
MICHAEL )
Meeting Summary. First Committee Meeting - First Committee Meeting
Summary ( NAIK, RAMACHANDRA )
Telecon. Information Request - Three clinical questions. ( SMITH,
MICHAEL )
Telecon. Information Request - IR for PREA dates for deferred pediatric
studies. ( SMITH, MICHAEL )
Memo. Other - Permission to release License number to applicant prior to
approval. ( JONECKIS, CHRISTOPHER )
Telecon. Information Request - IR from DBSQC regarding the lot release
protocol (LRP) template and samples & reagents. ( SMITH, MICHAEL )
Telecon. Information Request - IR regarding the document titled ¿bnt162-
01-interim3-report-body¿. ( SMITH, MICHAEL )
Meeting Summary. Filing Meeting Summary - Summary of the June 29, 2021
Filing Meeting. The BLA is fileable. ( NAIK, RAMACHANDRA )
Telecon. Information Request - Clinical IR regarding Study C4591001. (
SMITH, MICHAEL )
Memo. Filing Checklist/RPM - RPM Filing Checklist - the application is
fileable. ( GOTTSCHALK, LAURA )
Memo. Committee Memo/APLB - PNR COMIRNATY: ACCEPTABLE (
ELEKWACHI, OLUCHI )
Telecon. Advice - Advice: Pfizer¿s assumption as outlined in Elisa Harkins
June 29, 2021 e-mail RE the bnt162-01-interim3-report-body are correct. (
SMITH, MICHAEL )
Telecon. Information Request - Comments regarding CMC information and
categorical exclusion for an environment analysis ( NAIK, RAMACHANDRA
)
Telecon. PNR Acceptance / Advice - The Applicant was informed that their
proprietary name "COMIRNATY" is acceptable. ( SMITH, MICHAEL )
Telecon. Information Request - Clinical IR RE the document titled
¿c4591001-interim-mth6-report-body.pdf." ( SMITH, MICHAEL )
Telecon. Information Request - IR RE the validation of the RNA Integrity by
capillary gel electrophoresis (CGE) method. ( SMITH, MICHAEL )
Telecon. Information Request - OBE IR RE adding myocarditis and
pericarditis to the PVP. ( SMITH, MICHAEL )
Telecon. Information Request - DVP IR regarding exception or alternative to
the requirement that products in multiple-dose vials include a preservative (
NAIK, RAMACHANDRA )
Letter. Filing Notification Letter / No Deficiencies Identified - Filing
Notification
No Deficiencies Identified ( SMITH, MICHAEL )
Telecon. Information Request - IR RE Study C4591007; please provide
updated goal dates for final protocol submission. ( SMITH, MICHAEL )
Meeting Summary. Committee Meeting Summary - Summary of the July 15,
2021 Monthly Committee Meeting. ( GOTTSCHALK, LAURA )
Telecon. Information Request - F/U IR RE updated PVP by 7/29/21. ( SMITH,
MICHAEL )
Telecon. Information Request - DBSQC IR regarding lot release protocol
template and drug substance handling instructions. ( GOTTSCHALK, LAURA
)DescriptionCOVID-19 Vaccine, mRNA Product:
For active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 16 years of age and older. Short Summary:
FDA Recd Date Login ID
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
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2 Page
***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM
***FOR OFFICIAL USE ONLY*** Exclude Inspection Related
Order: FDA/Appl, Then Date Ascending
L 125742/0STN:
BioNTech Manufacturing GmbH #2229 Applicant:
16-JUL-2021
19-JUL-2021
20-JUL-2021
20-JUL-2021
22-JUL-2021
26-JUL-2021
26-JUL-2021
27-JUL-2021
27-JUL-2021
28-JUL-2021
28-JUL-2021
29-JUL-2021
02-AUG-2021
02-AUG-2021
03-AUG-2021
03-AUG-2021
04-AUG-2021
04-AUG-2021
04-AUG-2021
05-AUG-2021
05-AUG-2021
05-AUG-2021
05-AUG-2021
06-AUG-2021
06-AUG-2021Date
Telecon. Information Request - DBSQC IR regarding and
test methods ( GOTTSCHALK, LAURA )
Telecon. Advice - US license number 2229 was provided to the applicant
prior to approval in response to the request included in the cover letter of the
first roll of their BLA on May 6, 2021. ( NAIK, RAMACHANDRA )
Memo. Review - CDISC validation results and discussion ( BALDWIN,
BRENDA )
Telecon. Information Request - 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. ( NAIK,
RAMACHANDRA )
Telecon. Information Request - Clinical and stats IR regarding shell tables to
include safety and efficacy data from study C4591001 and other clinical
comments ( GOTTSCHALK, LAURA )
Telecon. Information Request - Clinical IR regarding the disposition of
participants in safety populations who experienced pregnancy. (
GOTTSCHALK, LAURA )
Telecon. Information Request - DMPQ IR regarding manufacturing and
equipment ( GOTTSCHALK, LAURA )
Telecon. Information Request - Clinical IR RE vaccine effectiveness (
SMITH, MICHAEL )
Telecon. Information Request - Third clinical IR RE vaccine effectiveness. (
SMITH, MICHAEL )
Telecon. Labeling Target Closure / Labeling via FAX/e-mail - First set of
labeling comments regarding the PI ( NAIK, RAMACHANDRA )
Telecon. Information Request - OBE IR regarding postmarketing safety
study(ies) ( NAIK, RAMACHANDRA )
Telecon. Information Request - Clinical IR regarding safety analysis for two
age groups ( GOTTSCHALK, LAURA )
Telecon. Information Request - Questions regarding the Validation Report
VR-MVR-10077 ( SMITH, MICHAEL )
Telecon. Information Request - Five questions regarding validation of assay
methods and lot release. ( SMITH, MICHAEL )
Telecon. Information Request - Six CMC-related questions. ( SMITH,
MICHAEL )
Telecon. Information Request - Two clinical/stats questions regarding July 26,
2021, submission and SAS programs. ( SMITH, MICHAEL )
Telecon. Information Request - Two questions regarding the potency assay
for determination of by . ( SMITH,
MICHAEL )
Telecon. Information Request - F/U IR RE the LRP that was submitted to
BLA 125742/0.14 on July 20, 2021. ( SMITH, MICHAEL )
Telecon. Information Request - Secondary e-mail with attachment RE 8/4/21
F/U LRP comments. ( SMITH, MICHAEL )
Telecon. Advice - Informed the applicant regarding the PROPER NAME for
their product in this BLA. ( GOTTSCHALK, LAURA )
Telecon. Information Request - 11 facility questions. ( SMITH, MICHAEL )
Telecon. Information Request - Four questions regarding the diluent. (
SMITH, MICHAEL )
Telecon. Labeling via FAX/e-mail - 2nd round of PI labeling comments. (
SMITH, MICHAEL )
Letter. UNII Code Notification - Unique Ingredient Identifier (UNII) Code
Assignment ( SMITH, MICHAEL )
Memo. Committee Memo/APLB - APLB BLA LR ( ELEKWACHI,
OLUCHI )DescriptionCOVID-19 Vaccine, mRNA Product:
For active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 16 years of age and older. Short Summary:
FDA Recd Date Login ID
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
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YElec Post
(b) (4)
(b) (4)
(b) (4)
(b) (4)
3 Page
***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM
***FOR OFFICIAL USE ONLY*** Exclude Inspection Related
Order: FDA/Appl, Then Date Ascending
L 125742/0STN:
BioNTech Manufacturing GmbH #2229 Applicant:
06-AUG-2021
06-AUG-2021
06-AUG-2021
09-AUG-2021
09-AUG-2021
09-AUG-2021
10-AUG-2021
10-AUG-2021
11-AUG-2021
11-AUG-2021
12-AUG-2021
12-AUG-2021
13-AUG-2021
13-AUG-2021
13-AUG-2021
13-AUG-2021
13-AUG-2021
13-AUG-2021
13-AUG-2021
13-AUG-2021
13-AUG-2021
16-AUG-2021
16-AUG-2021
16-AUG-2021Date
Memo. Review - OBE/DE Pharmacovigilance Review ( THOMPSON,
DEBORAH )
Telecon. Information Request - IR RE two DP documents. ( SMITH,
MICHAEL )
Telecon. Information Request - Three DBSQC questions RE measurement of
using the procedures. (
SMITH, MICHAEL )
Telecon. Advice - Advice RE submitting samples, LRP and distribution of
EUA and BLA labeled product after COMIRNATY is licensed. ( SMITH,
MICHAEL )
Telecon. Information Request - Clinical IR RE sequencing data. ( SMITH,
MICHAEL )
Telecon. Labeling via FAX/e-mail - Comments on the Carton and Container
labels ( SMITH, MICHAEL )
Telecon. Information Request - Second OBE IR regarding safety-related
postmarketing studies. ( NAIK, RAMACHANDRA )
Telecon. Information Request - One testing related question from DBSQC. (
SMITH, MICHAEL )
Telecon. Information Request - One question from DMPQ regarding the
diluent that is to be provided with the vaccine. ( SMITH, MICHAEL )
Telecon. Other - This teleconference between CBER and Pfizer was to seek
clarity on availability of EUA and BLA products and plans for distribution after
licensure of COMIRNATY. ( SMITH, MICHAEL )
Memo. Committee Memo/Require Pre-Approval Inspection ( CHEUNG,
ANISSA )
Telecon. Other - Teleconference between CBER and Pfizer to receive
clarification on how EUA lots and BLA lots will be indentified. ( NAIK,
RAMACHANDRA )
Memo. Committee Memo/BIMO - BIMO Discipline Review Memo ( CHUN,
HAECIN )
Memo. Request For Compliance Check - Request for Compliance check. (
ZUBKOVA, IRYNA )
Telecon. Information Request - Three clinical questions. ( SMITH,
MICHAEL )
Telecon. Information Request - DBQSC IR LRP and testing. ( SMITH,
MICHAEL )
Telecon. Information Request - 7 facility questions from the DMPQ team. (
SMITH, MICHAEL )
Telecon. Information Request - A clinical IR was sent on 13AUG21 and
Pfizer had a clarification question. This IR t-con was in response to the F/U
clarification question. ( SMITH, MICHAEL )
Telecon. Labeling via FAX/e-mail - 3rd set of PI labeling comments. (
SMITH, MICHAEL )
Telecon. Information Request - One clinical question. ( SMITH, MICHAEL )
Telecon. Information Request - IR RE PMR's and PMC's. ( SMITH,
MICHAEL )
Telecon. Information Request - DMPQ IR RE
. ( SMITH,
MICHAEL )
Telecon. Labeling via FAX/e-mail - Second set of comments and questions
on the carton and container labels. ( SMITH, MICHAEL )
Telecon. Information Request - Teleconference regarding measurement of
.
Pfizer commits to implement testing method on
. ( SMITH, MICHAEL )DescriptionCOVID-19 Vaccine, mRNA Product:
For active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 16 years of age and older. Short Summary:
FDA Recd Date Login ID
Y
Y
Y
Y
Y
Y
Y
Y
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4 Page
***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM
***FOR OFFICIAL USE ONLY*** Exclude Inspection Related
Order: FDA/Appl, Then Date Ascending
L 125742/0STN:
BioNTech Manufacturing GmbH #2229 Applicant:
16-AUG-2021
17-AUG-2021
17-AUG-2021
17-AUG-2021
17-AUG-2021
17-AUG-2021
17-AUG-2021
17-AUG-2021
18-AUG-2021
18-AUG-2021
18-AUG-2021
18-AUG-2021
18-AUG-2021
18-AUG-2021
18-AUG-2021
18-AUG-2021
19-AUG-2021
19-AUG-2021
19-AUG-2021
19-AUG-2021
19-AUG-2021
19-AUG-2021
20-AUG-2021Date
Telecon. Information Request - Please submit this same CMC stability
information that was submitted to EUA 27034.260 to your BLA STN 125742
.0 so that we can consider a 9-month shelf-life for the licensed product. (
NAIK, RAMACHANDRA )
Memo. Lot Release Clearance Memo / Lot Release Clearance Request - Lot
Release Clearance Request and Lot Release Clearance Memo. ( BESHIR,
LEYLA )
Memo. Other; Non-proprietary name does not include a suffix - Justification
memo regarding approving non-proprietary name without a suffix ( GRUBER,
MARION )
Telecon. Other - The purpose of the teleconference between DMPQ and
Pfizer was to discuss items 2b, 2c, 6 and 9c from the FDA form 483 for the
Andover site. ( SMITH, MICHAEL )
Telecon. Information Request - Two questions from Xiao Wang regarding
drug substance. ( SMITH, MICHAEL )
Telecon. Labeling via FAX/e-mail - 4th set of PI labeling comments. (
SMITH, MICHAEL )
Telecon. Information Request - Follow up IR RE PMR & PMC's
commitments that were received in amendment 51 dated August 16, 2021. (
NAIK, RAMACHANDRA )
Telecon. Information Request - DVP IR regarding two questions on shelf life
and date of manufacture. ( SMITH, MICHAEL )
Memo. Committee Memo/Review - DBSQC LRP template review memo (
ANDERSON, MARIE )
Memo. Committee Memo/Statistical Non-Clinical - Statistical review memo
for non-clinical data ( TANG, XINYU )
Telecon. Advice - Pfizer e-mailed clarification questions on August 18, 2021,
to DVP's two DS questions dated August 17, 2021. This e-mail was guidance
in response to their clarification questions. ( SMITH, MICHAEL )
Telecon. Information Request - Two DBSQC questions on amendments 54
and 50 RE testing and specific parameters/instructions for
test method. ( SMITH, MICHAEL )
Telecon. Information Request - DVP follow-up response to Pfizer August 18,
2021, clarification questions regarding DVP's August 17, 2021, IR on shelf life
and date of manufacture. ( SMITH, MICHAEL )
Telecon. Labeling via FAX/e-mail - 5th set of PI labeling comments. (
SMITH, MICHAEL )
Telecon. Labeling via FAX/e-mail - 3rd set of comments on the carton and
container labels. ( GOTTSCHALK, LAURA )
Telecon. Information Request - Identification of BLA-compliant lots and
Letter to HCP. ( NAIK, RAMACHANDRA )
Memo. Committee Memo/Statistical Clinical - Statistical memo for clinical
efficacy data ( HUANG, LEI )
Memo. Committee Memo/Statistical Clinical - Statistical review for safety
data. ( YANG, YE )
Memo. Compliance Check Acceptable - Compliance check is acceptable. (
DECIERO, DANIEL )
Telecon. Information Request - IR RE PMR's and PMC's that were listed in
amendment 51. ( SMITH, MICHAEL )
Telecon. Labeling via FAX/e-mail - 6th set of PI labeling comments. (
GOTTSCHALK, LAURA )
Telecon. Information Request - IR RE PMC Study Completion Date and
Final Report Submission date for PMC Study C4591014. ( SMITH, MICHAEL
)
Memo. Committee Memo/Labeling - Review Memo: Containers, Cartons,
Sticker, Stamp ( STEWART, DAPHNE )DescriptionCOVID-19 Vaccine, mRNA Product:
For active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 16 years of age and older. Short Summary:
FDA Recd Date Login ID
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
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5 Page
***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM
***FOR OFFICIAL USE ONLY*** Exclude Inspection Related
Order: FDA/Appl, Then Date Ascending
L 125742/0STN:
BioNTech Manufacturing GmbH #2229 Applicant:
20-AUG-2021
20-AUG-2021
20-AUG-2021
20-AUG-2021
20-AUG-2021
20-AUG-2021
20-AUG-2021
20-AUG-2021
21-AUG-2021
21-AUG-2021
21-AUG-2021
21-AUG-2021
21-AUG-2021
21-AUG-2021
21-AUG-2021
22-AUG-2021
22-AUG-2021
22-AUG-2021
22-AUG-2021
23-AUG-2021
23-AUG-2021
23-AUG-2021
23-AUG-2021
23-AUG-2021Date
Memo. Other - CONFIDENTIAL - DO NOT POST TO THE WEB CBER
Laboratory Quality Product Testing Plan ( ANDERSON, MARIE )
Memo. Review - Pharmacovigilance Plan Review; Addendum Memorandum
( WELSH, KERRY )
Memo. Test Results - In-support Test
Results ( KONG, HYESUK )
Memo. Test Results - Test memo for (
WANG, HSIAOLING )
Telecon. Labeling via FAX/e-mail - 7th set of PI comments and shell table. (
GOTTSCHALK, LAURA )
Telecon. Information Request / Advice - Lot Numbers for the COVID Launch
Lots ( NAIK, RAMACHANDRA )
Telecon. Information Request - CBER comments regarding label for
identification of BLA lots and
Dear HCP Letter
( NAIK, RAMACHANDRA )
Telecon. Labeling via FAX/e-mail - Comment regarding vial label to include
the name of the diluent on vial labels. ( GOTTSCHALK, LAURA )
Memo. Committee Memo/CMC - CMC Product Review Memo ( WANG,
XIAO )
Memo. Committee Memo/CMC - DBSQC Analytical Review Memo (
YITBAREK, EMNET )
Telecon. Information Request - IR RE request to resubmit all PMR's and
PMC's and a commitment to conduct them in the timeframe noted in an
amendment to the BLA. Also, revised study completion date for study
C4591007. ( SMITH, MICHAEL )
Telecon. Labeling via FAX/e-mail - 8th set of PI labeling comments (
GOTTSCHALK, LAURA )
Telecon. Labeling via FAX/e-mail - The Applicant was notified that the
Carton and Container labels submitted in Amendment 63 dated August 19,
2021, are considered the Final Draft Labels for approval. ( GOTTSCHALK,
LAURA )
Telecon. Information Request - CBER comments regarding label for
identification of BLA lots and Dear HCP Letter. ( NAIK, RAMACHANDRA )
Telecon. Advice - The Applicant was notified that there are no additional
comments on the Dear HCP letter submitted in Amendment 73 submitted
August 21, 2021. ( NAIK, RAMACHANDRA )
Memo. Committee Memo/Postmarketing Safety Epidemiological - OBE Real
World Evidence Memo ( LU, YUN )
Memo. Committee Memo/Review - DMPQ Review Memo - Recommend
approval ( JONES, KATHLEEN )
Memo. Other - Employee/Officer List Memo ( GOTTSCHALK, LAURA )
Telecon. Labeling via FAX/e-mail - The Applicant was notified that the
Package Insert submitted in Amendment 74 dated August 21, 2021, is
considered the Final Draft Label for approval ( GOTTSCHALK, LAURA )
Letter. Approval - BLA Approval Letter ( SMITH, MICHAEL )
Memo. Committee Memo/SBRA - SBRA - Summary Basis for Regulatory
Action ( NAIK, RAMACHANDRA )
Memo. Committee Memo/Toxicology - Committee Memo/Toxicology ( AL-
HUMADI, NABIL )
Memo. Other - OCOD Transmittal Memo for web posting ( SMITH,
MICHAEL )
Memo. Review - OBE Sentinel Sufficiency Assessment ( OBIDI, JOYCE )DescriptionCOVID-19 Vaccine, mRNA Product:
For active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 16 years of age and older. Short Summary:
FDA Recd Date Login ID
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
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Y
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YElec Post
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(b) (4)
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6Page
***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM
***FOR OFFICIAL USE ONLY*** Exclude Inspection Related
Order: FDA/Appl, Then Date Ascending
L 125742/0STN:
BioNTech Manufacturing GmbH #2229 Applicant:
30-AUG-2021
30-AUG-2021
01-SEP-2021
02-SEP-2021
13-SEP-2021
13-SEP-2021
30-SEP-2021
08-NOV-2021
06-MAY-2021
18-MAY-2021
19-MAY-2021
19-MAY-2021
24-MAY-2021
07-JUN-2021
16-JUN-2021
17-JUN-2021
02-JUL-2021
02-JUL-2021
09-JUL-2021
15-JUL-2021
16-JUL-2021
19-JUL-2021
20-JUL-2021Date
Telecon. Other - Amendment 125742.0.41 was reviewed in the DBSQC
memo dated 08/20/2021. Pfizer's responses were acceptable. ( WANG,
HSIAOLING )
Telecon. Other - Amendment 125742.0.60 was reviewed in the Andover 483
response memo. Pfizer's responses were acceptable. ( JONES, KATHLEEN )
Memo. Committee Memo/Labeling - RPM Labeling Review Memo (
GOTTSCHALK, LAURA )
Memo. Committee Memo/Clinical Review - Committee Memo/Clinical
Review. Ann Schwartz and Lucia Lee contributed to this review memo. (
WOLLERSHEIM, SUSAN )
Memo. Committee Memo/Review / Benefit-Risk assessment - Benefit-Risk
assessment review memo; Patrick Funk, Ph.D., and Osman N. Yogurtcu, Ph.D.,
also contributed to the review memo. ( YANG, HONG )
Memo. Committee Memo/Review - Documentation review memo. ( SMITH,
MICHAEL )
Memo. Revised Post Lockdown / Committee Memo/Toxicology - Revised
Post Lockdown/ Committee Memo/Toxicology/23-Aug-2021 ( AL-HUMADI,
NABIL )
Memo. Revised Post Lockdown / Committee Memo/SBRA - Table 2 header
and value for water in the table were changed. ( NAIK, RAMACHANDRA )
________________________________________________________________
Original Application. For active immunization to prevent COVID-19 disease
caused by SARS-CoV-2 in individuals 16 years of age and older.
Amendment # 1. Second and final rolling piece to start the review clock.
Amendment # 2. Request for Proprietary Name Review
Amendment # 3. Response to May 18, 2021, clinical IR RE three dataset
questions.
Amendment # 4. Response to DMPQ¿s May 20, 2021, IR RE four facilities
questions and a request for a t-con on 5/25/21 or 5/26/21 to discuss production
schedules and the shutdown activities planned for the Puurs, Belgium site.
Amendment # 5. COVID-19 case strain sequencing data.
Amendment # 6. Response to June 8, 2021, clinical IR on three clinical
questions regarding datasets and the PI.
Amendment # 7. Response to June 9, 2021, clinical IR requesting dates for
PREA deferred studies.
Amendment # 8. Response to June 29, 2021, clinical IR RE latest date of
randomization for participants included in the reactogenicity subset for Study
C4591001.
Amendment # 9. Response to June 25, 2021, clinical IR regarding IR
regarding the document titled ¿bnt162-01-interim3-report-body¿
Amendment # 10. Response to DBSQC¿s June 25, 2021, IR regarding the lot
release protocol (LRP) template and samples & reagents.
Amendment # 11. Response to DVP¿s July 13, 2021, IR regarding exception
or alternative to the requirement that products in multiple-dose vials include a
preservative.
Amendment # 12. Response to July 6, 2021, clinical IR regarding IR
regarding the document titled ¿c4591001-interim-mth6-report-body.pdf.¿
Amendment # 13. The applicant waives their rights to the mid- and late-cycle
review meetings for BLA 125742.
Amendment # 14. DescriptionCOVID-19 Vaccine, mRNA Product:
For active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 16 years of age and older. Short Summary:
06-MAY-2021
18-MAY-2021
19-MAY-2021
19-MAY-2021
24-MAY-2021
07-JUN-2021
16-JUN-2021
17-JUN-2021
02-JUL-2021
02-JUL-2021
09-JUL-2021
15-JUL-2021
16-JUL-2021
19-JUL-2021
20-JUL-2021FDA Recd Date Login ID
1067058
1086158
1087747
1088844
1094917
1119355
1137474
1139420
1168170
1168177
1183932
1199647
1201833
1204967
1207929Y
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***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM
***FOR OFFICIAL USE ONLY*** Exclude Inspection Related
Order: FDA/Appl, Then Date Ascending
L 125742/0STN:
BioNTech Manufacturing GmbH #2229 Applicant:
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10-AUG-2021Date
Amendment # 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.
Amendment # 16. Response to July 9, 2021 IR RE the validation of the RNA
Integrity by capillary gel electrophoresis method.
Amendment # 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.
Amendment # 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.
Amendment # 19. Response to July 2, 2021 DVP IR regarding 18 question on
product related issues and categorical exclusion for an environmental
assessment.
Amendment # 22. Response to July 27, 2021 third Clinical IR RE vaccine
effectiveness.
Amendment # 24. Response to July 26, 2021 DMPQ IR regarding
manufacturing and equipment.
Amendment # 25. Response to the observations contained in the FDA form
483 that was issued for the pre-approval inspection of the Pfizer Andover
facility.
Amendment # 26. Response to July 29, 2021 clinical IR regarding safety
analysis for two age groups.
Amendment # 27. Response to 7/28/2021 first set of labeling comments
regarding the PI.
Amendment # 28. Response to comment 5b of July 22, 2021 clinical-
statistical IR.
Amendment # 29. Follow-up response (remaining supporting documents to
response 10) to July 26, 2021 DMPQ IR regarding manufacturing and
equipment.
Amendment # 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.
Amendment # 31. Response to DVP and OBE Questions regarding the
Validation Report VR-MVR-10077.
Amendment # 32. Response to clinical and stats IR¿s fromJuly 22nd and
August 4th regarding shell tables and two additional clinical/stats questions
regarding July 26, 2021, submission and SAS program.
Amendment # 33. Responses to DVP¿s six CMC-related questions from
August 3, 2021.
Amendment # 34. Responses to August 4, 2021, IR RE two questions
regarding the potency assay for determination of by
.
Amendment # 35. Response to DBSQC and Xiao Wang's August 2, 2021,
questions regarding validation of assay methods and lot release.
Amendment # 36. Response to four questions regarding the diluent dated
August 5, 2021.
Amendment # 37. Response to July 22nd Clinical and stats IR regarding shell
tables to include safety and efficacy data from study C4591001.
Amendment # 38. Revised PI labeling in response to August 5, 2021, second
round of labeling comments.
Amendment # 39. Response to Xiao Wang¿s August 6, 2021, questions
regarding two drug product (DP) documents. DescriptionCOVID-19 Vaccine, mRNA Product:
For active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 16 years of age and older. Short Summary:
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10-AUG-2021FDA Recd Date Login ID
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1221258
1227088
1227383
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1236249
1236634
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***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM
***FOR OFFICIAL USE ONLY*** Exclude Inspection Related
Order: FDA/Appl, Then Date Ascending
L 125742/0STN:
BioNTech Manufacturing GmbH #2229 Applicant:
11-AUG-2021
11-AUG-2021
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19-AUG-2021Date
Amendment # 40. Response to August 4, 2021, F/U IR RE the LRP that was
submitted to BLA 125742/0.14 on July 20, 2021.
Amendment # 41. Response to one testing related question from DBSQC on
August 10, 2021.
Amendment # 42. Response to August 10, 2021, second OBE IR regarding
safety-related postmarketing studies.
Amendment # 43. Responses to DMPQ¿s August 5, 2021 11 facilities
questions.
Amendment # 44. This amendment was skipped by the Applicant.
Amendment # 45. Response to August 9. 2021, clinical IR RE sequencing
data.
Amendment # 46. Response to August 9, 2021 IR RE Carton and Container
labeling comments.
Amendment # 47. Response to DMPQ¿s August 11, 2021, diluent IR and
amended response to Theresa Finn¿s August 5, 2021, IR regarding diluent.
Amendment # 48. Response to DBSQC¿s August 6, 2021, three questions RE
measurement of using
procedures.
Amendment # 49. Response to 3rd set of PI labeling comments that were sent
on August 13, 2021.
Amendment # 50. Response to DBSQC¿s August 13, 2021, IR RE LRP and
testing.
Amendment # 51. Response to August 13, 2021, IR RE Safety-related
Postmarketing Requirement/Postmarketing Commitment studies.
Amendment # 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).
Amendment # 53. Response to August 16, 2021 IR RE Carton and Container
labeling comments.
Amendment # 54. Response to follow-up to August 13, 2021, IR
and August 16, 2021, teleconference on this subject containing a commitment
to implement method on .
Amendment # 55. Response to Xiao Wang¿s August 16, 2021, IR to please
submit the same CMC stability information that was submitted to EUA
27034.260 to your BLA STN 125742 .0.
Amendment # 56. Response to DMPQ¿s August 16, 2021, IR to
.
Amendment # 57. Response to DMPQ¿s 7 facility questions dated August 13,
2021.
Amendment # 58. Response to August 17, 2021, 4th set of PI labeling
comments.
Amendment # 59. Response to August 17, 2021, follow up IR RE PMR &
PMC's commitments that were received in amendment 51 dated August 16,
2021.
Amendment # 60. Updated response to FDA form 483 for the Andover site
based off of teleconference with CBER on August 17, 2021.
Amendment # 61. Responses to DVP¿s August 17, 2021, two questions
regarding shelf life and date of manufacture.
Amendment # 62. Responses to DVP¿s August 17, 2021, two questions
regarding the drug substance.
Amendment # 63. Responses to the third set of comments and questions on
the carton and container labels.
Amendment # 64. Response to August 18, 2021, IR RE Identification of
BLA-compliant lots and Letter to HCP.
Amendment # 65. Responses to DBSQC¿s August 18, 2021, IR. DescriptionCOVID-19 Vaccine, mRNA Product:
For active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 16 years of age and older. Short Summary:
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19-AUG-2021FDA Recd Date Login ID
1271302
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1278583
1284081
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9 Page
***THIS REPORT MAY CONTAIN CONFIDENTIAL INFORMATION***License Action Recommendation Documents for Submissions and FDA Communication December 20, 2021 8:32 AM
***FOR OFFICIAL USE ONLY*** Exclude Inspection Related
Order: FDA/Appl, Then Date Ascending
L 125742/0STN:
BioNTech Manufacturing GmbH #2229 Applicant:
19-AUG-2021
19-AUG-2021
20-AUG-2021
20-AUG-2021
20-AUG-2021
20-AUG-2021
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07-JUN-2023
07-JUN-2023Date
Amendment # 66. Response to August 18, 2021, 5th set of PI labeling
comments.
Amendment # 67. Response August 19, 2021, IR RE PMR¿s and PMC¿s that
were submitted in amendment 51.
Amendment # 68. Response to August 19, 2021, 6th set of PI labeling
comments.
Amendment # 69. Additional Response to August 19, 2021, IR RE PMR¿s
and PMC¿s that were submitted in amendment 51.
Amendment # 70. Letter of authorization for a new U.S. agent. This
amendment was not in response to an information request.
Amendment # 71. Response to August 20, 2021, 7th set of PI comments and
shell table.
Amendment # 72. Response to August 20, 2021, clinical IR regarding the
shell table.
Amendment # 73. Response to August 20, 2021, CBER comments regarding
label for identification of BLA lots and Dear HCP Letter
Amendment # 74. Response to August 21, 2021, 8th set of comments on the
PI.
Amendment # 75. Response to August 21, 2021, IR RE PMR¿s and PMC¿s
and final study protocol date for study C4591007
Amendment # 76. Response to August 21, 2021, IR RE regarding
identification of BLA lots/Dear HCP Letter.
Amendment # 77. Final PI (when compared to the PI received in STN
125.0.74 it was the same EXCEPT Pfizer¿s version number at the very end of
the PI was changed from LAB-1448-.9 to LAB-1448-1.0).
Amendment # 78. Final PI which has been revised to include the license
number
Amendment # 20. Response to July 13, 2021 OBE IR to add myocarditis and
pericarditis to the PVP.
Amendment # 21. Response to July 16, 2021 DBSQC IR regarding
test methods.
Amendment # 23. Response to July 26, 2021 clinical IR regarding the
disposition of participants in safety populations who experienced pregnancy.DescriptionCOVID-19 Vaccine, mRNA Product:
For active immunization to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 16 years of age and older. Short Summary:
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30-JUL-2021FDA Recd Date Login ID
1338872
1339769
1341754
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1344590
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1346819
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