Document text
www.fda.gov_________________________________________________________________________________________________________________
DATE: June 10, 2022
FROM: Kanaeko R. Ravenell, MS
Bioresearch Monitoring Branch (BMB)
Division of Inspections and Surveillance (DIS)Office of Compliance and Biologics Quality (OCBQ)
THROUGH: Dennis Cato, Chief, BMB
THROUGH: Carrie M. Mamp illy, MPH, Director, DIS
TO: Ramachandra Naik, PhD, Committee Chair
Susan Wollersheim, MD, Clinical Reviewer
Laura Gottschalk, PhD, RPM Michael Smith, PhD, RPM
SUBJECT: Bioresearch Monitoring Final Discipline Review
SPONSOR: BioNTech Manufacturing GmbH
PRODUCT: COVID-19 mRNA vaccine (nucleoside modified) COMIRNATY
sBLA: STN 125742/45
FINAL SUMMARY STATEMENT:
Bioresearch Monitoring (BIMO) inspections were issued for three US clinical investigators who
participated in the conduct of protocol C4591001. Th e inspections did not reveal substantiative
issues that impact the data submitted in this supplemental Biologics License Application
(sBLA). BACKGROUND:
Three US clinical study sites for protocol C4591001 were identified for BIMO inspections. The
sBLA review committee concurred with the proposed sites. The sites were selected based
upon sponsor-reported adverse event s, protocol deviations, tota l number of subjects enrolled,
and previous BIMO inspection histories. The inspections were conducted in accordance with FDA’s Compliance Program (CP) 7348.811, Inspec tion Program for Clinical Investigators.
Information submitted in the sBLA was compar ed to source documents at each inspected site.
The inspection assignment also included spec ific questions concerning the clinical study.
PROTOCOL:
Protocol C4591001: A Phase 1/2/3, Placebo-Controll ed, Randomized, Observer-Blind,
Dose-Finding Study to Evaluate the Safety, To lerability, Immunogeni city, and Efficacy of
SARS-COV-2 RNA Vaccine Candidates Agai nst COVID-19 in Healthy Individuals
This supplement and the included data only encompass the phase 2/3 portion of the protocol for vaccine BNT162b2 that is indica ted for adolescents 12 through 15 years of
Dennis Cato -SDigitally signed by Dennis Cato -S
Date: 2022.06.10 11:55:14 -04'00'
Carrie M. Mampilly -SDigitally signed by Carrie M.
Mampilly -S
Date: 2022.06.10 12:22:08 -04'00'
FDA-CBER-2022-5812-0500490
BLA STN 125742/45, BioNTech.,COMIRNATY Page 2 of 3 pages
age. Approximately 2260 subjects were randomized so that an equal number of
participants received the vaccine and the placebo. At Visits 1 and 2, participants were
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days apart. Follow-up visits were conducted at one and 6 months. Participants that were originally assigned to the placebo group, who become eligible for receipt of BNT162b2,
were given the opportunity to receive the vaccine at the 6-month visit.
BIMO INSPECTIONS SUMMARY:
No significant BIMO inspectional findings were noted. The below table summarizes site
information and outcomes from the BIMO inspections:
Site ID Firm Name Location FDA Form
483 Issued Final
Classification*
1039
Gretchen Crook, M.D.
Austin, TX
No NAI
1140
Stephen Thomas, M.D.
Syracuse, NY
No
NAI
1156
Hector Rodriguez, M.D.
Miami, FL
No
NAI
*No Action Indicated (NAI)
SPONSOR MONITO RING ISSUES:
No significant sponsor or m onitoring issues were identified during the above inspections.
FINANCIAL DISCLOSURE:
The Clinical Investigator Complia nce Program directs the FDA inve stigator to ask the clinical
investigator if and when he/she disclosed informati on about his/her financial interests to the
sponsor and/or interests of any sub-investigat ors, spouse(s), and depende nt children, as well
as if and when the information was updated. The information submitted to the sBLA was
verified for each of the inspected clinical study sites. ADMINISTRATIVE FOLLOW-UP
Should you have any questions or comments about t he contents of this memo or any aspect of
Bioresearch Monitoring, please c ontact me at (240) 402-8423.
_______________________
Kanaeko R. Ravenell, MS
Consumer Safety Officer
Kanaeko R.
Ravenell -SDigitally signed by Kanaeko R. Ravenell -S Date: 2022.06.10 16:14:31 -04'00'
FDA-CBER-2022-5812-0500491
BLA STN 125742/45, BioNTech.,COMIRNATY Page 3 of 3 pages
DISTRIBUTION
Electronic Copies:
CBER Connect BLA STN 125 742/45
Ramachandra Naik Susan Wollersheim Laura Gottschalk Michael Smith Carrie Mampilly Dennis Cato ChronFile [email protected]
FDA-CBER-2022-5812-0500492