Document text
www.fda.gov
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: STN 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 E mergency Use Authorization (EUA)
Declaration pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act or the Act).
BLA STN 125742/0 BioNTech/Pfizer COVID -19 Vaccine , mRNA (COMIRNATY) Page 2 of 4
In response to the PHE, BIMO review ers 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 C459100 1 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 subject enrollment, previous inspectional
history , and other info rmation submitted in IND 19736.
The inspections were conducted in accordance with FDA’s Compliance Program 7348.811, Inspection Program for Clinical Investigators , focus ing primarily on the study conduct, human
subject protection and compliance with related FDA regulations . The data integrity and
verification portion of the BIMO inspection s were limited because the study was ongoing, and
the data required for verification and comparison were not yet available to the IND. The table below summarizes the domestic study site information and the outcome of each BIMO
inspection:
S
ite ID Site Location Form FDA
483 Issued Final
Classification
1007 Cincinnati Children’s Hospital Med ical Center
Cincinnati Center for Clinical Research
Cincinnati, OH No No Action Indicated
(NAI)
1009 J. Lewis Research Inc. / Foothill Family Clinic
South, Salt Lake City, UT No NAI
1044 Virginia Research Center, LLC.
Midlothian, V A No NAI
1056 Indago Research and Health Center , Inc.
Hialeah, FL No NAI
1109 Deland Clinical Research Unit
DeLand, FL No NAI
1118 Meridian Clinical Research, LLC.
Binghamton, NY No NAI
1125 Meridian Clinical Research, LLC
Norfolk, NE No NAI
1133 Research Centers of America
Hollywood, F L No NAI
1149 Collaborative Neuroscience Research, LLC
at two locations: Long Beach & Garden
Grove, CA No NAI
BLA STN 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, spouse(s) 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