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FILING MEETING SUMMARY
Application number: BLA STN 125742/45
Product name: COVID-19 Vaccine, mRNA (COMIRNATY)
Proposed Indication: Active immunization to prevent coronavirus disease
19 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older
Applicant: BioNTech Manufacturing GmbH
Meeting date & time: January 31, 2022; 12:00 - 1:00 PM EST
Committee Chair: Ramachandra Naik, Ph.D.
Meeting Recorders: CAPT Michael Smith, Ph.D. and Laura Gottschalk, Ph.D.
Background:COMIRNATY (COVID-19 Vaccine, mRNA) was originally approved on August 23, 2021,for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16years of age and older. The current application, received on December 16, 2021, is an efficacy supplement from BioNTech Manufacturing GmbH (in partnership with Pfizer, Inc.) for COMIRNATY to extend the indication to adolescents 12 through 15 years of age.
The purpose of this meeting was to discuss 1) the completeness of the sBLA
submission and, 2) whether it is acceptable to be filed.
Table 1: Review Committee and Discipline Filing Decision Summary
Discipline/Organization Name
Attended
meeting
Fileable
RTF
Deficiencies
Identified
Regulatory Project Managers CAPT Michael Smith, PhD
Laura Gottschalk, PhD9
99
Chair Ramachandra Naik, PhD 99
Division Director – Clinical
Scientific Advisor – ClinicalDoran Fink, MD, PhDRebecca Reindel, MD9
9
Division Director – Regulatory
Scientific Advisor – Re gulator yLoris McVittie, PhDKirk Prutzman, PhD9
9
Office Director (actin g) Peter Marks, MD, PhD
Clinical Reviewer Susan Wollersheim, MD 99
CMC Reviewer Xiao Wan g, PhD 99
OCBQ/APLB Reviewer CAPT Oluchi Elekwachi, PharmD,
MPH9Ramachandra
Naik -SDigitally signed by Ramachandra Naik -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2001232361,
cn=Ramachandra Naik -S
Date: 2022.02.09 14:16:40 -05'00'
FDA-CBER-2022-5812-0500315
STN 125742/45 Filing Meeting dated: January 31, 2022
Filing Meeting Summary 2Discipline/Organization Name
Attended
meeting
Fileable
RTF
Deficiencies
Identified
OCBQ/BIMO Reviewers Kanaeko Ravenell
Char-Dell Edwards9
99
Statistical Reviewer of clinical
and non-clinical dataYe Yang, PhD 99
Postmarketing Safety Epidemiological/Pharmacovigilance ReviewerDeborah Thompson, MD, MSPH 9
9
CDISC Consult Brenda Baldwin, PhD 99
Other Attendees:Meghna Alimchandani, Maria Allende, Dennis Cato, Anissa Cheung, Nicolette Devore, Karen Farizo, Theresa Finn, Helen Gemignani, Maureen Hess, Brynn Hollingsworth, Lei Huang, Hector Izurieta, Lucia Lee, Shiowjen Lee, Robin Levis, Tsai-Lien Lin, Meghan MaguireThon, Carrie Mampilly, Narayan Nair, Manette Niu, Cassandra Overking, Keith
Peden, David Rouse, John Scott, Nikunj Sharma, Lisa Stockbridge, Elizabeth Sutkowski, Qun Wang, and Hong Yang
Review Timetable (PDUFA Milestones are in blue)
Review Milestone Target Due Date
Submitted: 16-DEC-2021Received: 16-DEC-2021Committee Assignment: 30-DEC-2021First Committee Meeting: 06-JAN-2022Filing reviews complete: 25-JAN-2022Confirm BIMO (GCP) Inspection Sites 30-JAN-2022Filing Meeting: 31-JAN-2022Filing Action: 14-FEB-2022Deficiencies Identified: 28-FEB-2022Primary Draft Reviews & Reviewer Reports Due(4 days prior to Mid-Cycle meeting): 31-MAR-2022Mid-Cycle Meeting (Internal): 06-APR-2022Determine if Advisory Committee Meeting is Necessary: 06-APR-2022PeRC Briefing materials due: xx-APR-2022Notify Safety Working Group (SWG) 18-APR-2022PeRC Meeting: xx-APR-2022Labeling Comments to Applicant: 18-MAY-2022Final draft primary reviews with supervisory Concurrence (upload not required): 18-MAY-2022
FDA-CBER-2022-5812-0500316
STN 125742/45 Filing Meeting dated: January 31, 2022
Filing Meeting Summary 3Notify OCOD of pending approval: 18-MAY-2022
Notify Applicant of PMC/PMR: 18-MAY-2022
Final reviews & addenda signed & uploaded: 12-JUN-2022
PDUFA ADD: 17-JUN-2022
Table 2: Scheduled Meetings
PDUFA Meetings:
xFirst Committee Meeting: January 6, 2022 (by email)
xFiling Meeting: January 31, 2022, 12:00PM – 1:00PM
xInternal Mid-Cycle: April 6, 2022, 1:00PM-2:30PM
Monthly Committee Meetings (to be scheduled):
xFebruary 23, 2022
xApril 18, 2022
xMay 19, 2022
Labeling Meetings:
To occur after the Mid-Cycle Meeting, TBD
UPDATES FROM REVIEW DISCIPLINES:
1. Chair (Ram Naik):
xThe Chair provided a brief overview of the submission including review milestone dates.
xDiscipline reviewers are not required to complete filing checklists for this supplement. Reviewers should st ill perform their due diligence to
ensure that the application is complete for the purposes of filing.
xThis application does not trigger PREA. However, it will need to go to PeRC as it includes the pediatric assessment for children 12 through 15 years of age as described in PMR #1 of the August 23, 2021 approval letter for the original COMIRNATY BLA. The PeRC meeting will be scheduled soon.
2. Regulatory Project Managers (Mike Smith and Laura Gottschalk):
x
The RPMs summarized the IRs and Amendments to the BLA to date (please
see details at end of document).
xThe sBLA is fileable.
xTo ensure the regulatory items were covered in the submission, the RPM Checklist was completed and will be uploaded to the file.
3. Clinical (Susan Wollersheim):
xThe sBLA is fileable and the clinical re viewer agrees with the Priority Review
designation.
4. CMC (Xiao Wang):
xThe sBLA is fileable.
FDA-CBER-2022-5812-0500317
STN 125742/45 Filing Meeting dated: January 31, 2022
Filing Meeting Summary 45. Statistics (Ye Yang):
xThe sBLA is fileable.
6. Epidemiology/Pharmacovigilance (Deborah Thompson):
xThe sBLA is fileable.
7. BIMO (Kanaeko Ravenell and Char-Dell Edwards):
xThe sBLA is fileable.
xPreliminarily investigator sites have been selected for inspection
assignments and will be sent to the clinical team for concurrence soon.
8. APLB (Oluchi Elekwachi):
xThe sBLA is fileable.
9. CDISC (Brenda Baldwin):
xThe sBLA is fileable.
REGULATORY CONCLUSIONS / DEFICIENCIES:
1. Does the application, on its face, appear to be suitable for filing or is the
application unsuitable for fili ng and require an RTF letter?
The application appears to be suitable for filing.
2. If fileable, list any substantive deficiencies or issues that have significant
impact on the ability to complete the review or approve the application :
No substantive deficiencies or issues were identified.
3. If RTF, list any substantive deficiencies or issues that would make this
application unsuitable for filing:
N/A
FILING MEETING DISCUSSION, IF FILED:4. Indicate any comments on the status of the proprietary name review (PNR).
N/A
5. Indicate whether the product sh/would be subject to lot release, surveillance,
or exempt from lot release. Verify sample availability.N/A
6. Confirm review schedule for the applic ation. If priority review, include
justification from clinical reviewer filing review checklist. [Standard Review, Priority Review, or Expedited Review]The submission is a 6-month Priority Review sBLA with a PDUFA Action Due Date (ADD) of June 17, 2022.
7. Indicate the decision regarding the need for an Advisory Committee.
FDA-CBER-2022-5812-0500318
STN 125742/45 Filing Meeting dated: January 31, 2022
Filing Meeting Summary 5This application does not need to go to VRBPAC - Confirmed by the DVRPA
management at the Filing Meeting.
8. Indicate whether the submission triggers PREA. If yes, a PeRC meeting is
needed. Verify whether the applicant has an initial pediatric study plan (iPSP)
in place.The submission does not trigger PREA. However, a PeRC meeting is needed as the supplement includes the pediatric assessment for adolescents 12 through 15 years of age from study C4591001 as described in PMR #1 of the August 23, 2021 approval letter for the original COMIRNATY BLA.
9. Indicate whether the submission contains a proposed REMS. If yes, or if a
REMS may be needed as a condition of approval, schedule an internal REMS
meeting between the Produc t Office and OBE/DE.
The submission does not contain a REMS.
10.Is a comprehensive and readily located list of all clinical sites included or
referenced in the application?A comprehensive and readily located list of all clinical sites is included in the application.
11. Is a comprehensive and readily located list of all manufacturing facilities
included or referenced in the application?
N/A. There is no change to the product information and the manufacturing facilities.
12.Indicate any updates since the First Committee Meeting on pre-license
inspection, pre-approval inspection, or BIMO sites requiring inspections (Is the establishment(s) ready for inspection?)None.
13.If the application is affected by the Application Integrity Policy (AIP), has the
division made a recommendation regard ing whether an exception to the AIP
should be granted to permit review based on medical necessity or public
health significance?The application is not affected by the AIP.
14.Is the product an Original Biological Product or a New Molecular Entity (NME)
for an NDA? N/A
FOR APPLICATIONS IN THE PDUFA PROGRAM (NME NDAs/Original BLAs), IF FILED15.Confirm that any late submission components were submitted within 30 days.
List any late submission components that arrived after 30 days. N/A
FDA-CBER-2022-5812-0500319
STN 125742/45 Filing Meeting dated: January 31, 2022
Filing Meeting Summary 616.Was the application othe rwise complete upon submission, including those
applications where there were no agreements regarding late submission
components?The application was complete upon submission.
ADMINISTRATIVE DETAILS, IF FILED:17.Review the Milestone Schedule and indicate if there are any issues with the
schedule. Note: This is a confirmation to capture any changes made since the First Committee Meeting. No changes have occurred in the Milestone Schedule since the First Committee Meeting. Please see Review Timetable above.
INFORMATION REQUESTS:1. 01/19/2022: Three questions regarding datasets.
2. 01/25/2022: Request for an updated FDA form 356h and an Environmental
Assessment or claim of Categorical Exclusion.
AMENDMENTS:
1. STN 125742/45.1 (January 28, 2022) – Response to January 25, 2022 request
regarding submitting (1) updated Form 356h to include information regarding all establishments and manufacturing facilit ies, and (2) an Environmental Assessment
or Claim of Categorical Exclusion.
FDA-CBER-2022-5812-0500320