FDA U.S. FOOD & DRUG
ADMINISTRATION
DATE:
August 13, 2021
FROM:
Haecin Chun, 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 Mampilly, MPH, Director DIS THROUGH: Mary A. Malarkey, Director OCBQ
TO:
Ramachandra Naik, PhD, Chair Susan Wollersheim, MD, Clinical Reviewer
CAPT Ann Schwartz, MD, Clinical Reviewer
CAPT Michael Smith, PhD, RPM Laura Gottschalk, PhD, RPM
SUBJECT: Bioresearch Monitoring (BIMO) Discipline Review Memo
SPONSOR: BioNTech Manufacturing GmbH
PRODUCT: COVID-19 Vaccine, mRNA (COMIRNATY) BLA: ST 125742/0
FINAL SUMMARY STATEMENT
BIMO inspection assignments were issued for a total of nine (9) clinical study sites that participated in the conduct of Study Protocol C4591001. Three (3) of these inspection assignments focused on clinical study sites that enrolled the pediatric population and six (6) of the study sites enrolled the adult population. The inspections did not reveal findings that impact the Biologics License Application (BLA).
BACKGROUND
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency (PHE) involving to a novel coronavirus named SARS-CoV-2 that causes Coronavirus Disease 2019 (COVID-19). On March 27, 2020, the Secretary of HHS issued a Notice of Emergency Use Authorization (EUA)
Declaration pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act or the Act).
www.fda.gov

BLA ST 125742/0 BioNTech/Pfizer COVID-19 Vaccine, mRNA (COMIRNATY)
Page 2 of 4
In response to the PHE, BIMO reviewers proactively performed a review of the sponsor's investigational new drug application (IND 19736) and issued the necessary BIMO inspections to review the study conduct of Protocol C4591001, "A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-COV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals."
Protocol C4591001 was a multi-center study conducted at a total of 153 clinical sites: 131 study sites in the United States and 22 sites outside of the United States. Due to the COVID-19 pandemic travel restrictions, only the domestic sites were considered for an on-site BIMO inspection. Initially, six (6) study sites were inspected, before FDA issued the original Emergency Use Authorization for individuals 16 years of age and older. Subsequently, three
(3) additional sites were inspected before FDA authorized use of the vaccine in those 12 and older. All of the study sites were selected based on subiect enrollment, previous inspectional history, and other information submitted in IND 19736.
The inspections were conducted in accordance with FDA's Compliance Program 7348.811, Inspection Program for Clinical Investigators, focusing primarily on the study conduct, human subject protection and compliance with related FDA regulations. The data integrity and verification portion of the BIMO inspections were limited because the study was ongoing, and the data required for verification and comparison were not vet available to the IND. The table below summarizes the domestic study site information and the outcome of each BIMO inspection:
Site ID
1007
1009
1044
1056
1109
1118
1125
1133
1149
Site Location
Cincinnati Children's Hospital Medical Center
Cincinnati Center for Clinical Research
Cincinnati, OH
J. Lewis Research Inc./ Foothill Family Clinic
South, Salt Lake City, UT
Virginia Research Center, LLC.
Midlothian, VA
Indago Research and Health Center, Inc.
Hialeah, FL
Deland Clinical Research Unit
DeLand, FL
Meridian Clinical Research, LLC.
Binghamton, NY
Meridian Clinical Research, LLC
Norfolk, NE
Research Centers of America
Hollywood, FL
Collaborative Neuroscience Research, LLC at two locations: Long Beach & Garden
Grove, CA
Form FDA
483 Issued
No
No
No
No
No
No
No
No
Final
Classification
No Action Indicated
(NAI)
NAI
NAI
NAI
NAI
NAI
NAI
NAI
No
NAI

BLA ST 125742/0 BioNTech/Pfizer COVID-19 Vaccine, mRNA (COMIRNATY)
Page 3 of 4
SIGNIFICANT INSPECTIONAL FINDINGS
No significant inspectional findings were noted.
SPONSOR/MONITORING ISSUES
No significant sponsor or monitoring issues were noted at the sites that were inspected.
FINANCIAL DISCLOSURE
The Clinical Investigator Compliance Program directs the FDA investigator to ask the clinical investigator if and when he/she disclosed information about his/her financial interests to the sponsor and/or interests of any sub-investigators, spouses) and dependent children, and if and when the information was updated. The information submitted to the BLA was verified for each of the inspected clinical sites.
ADMINISTRATIVE FOLLOW-UP
Should you have any questions or comments about the contents of this memo or any aspect of Bioresearch Monitoring, please contact me at 240-402-8038.
Haecin Chun
Consumer Safety Officer