Document text
CONCURRENCE PAGE
This page must be uploaded through CBER Connect. Do NOT send this page to the
applicant . Do NOT post this page to the Biological Approvals website.
Application #: STN: BL 125742.0
Communication Name: Filing Notification Communication ID: LTR -BLAFILE -02
Instructions for entering communication into the appropriate regulatory system:
Letter Type: Filing Notification (FL) ; No Deficiencies Identified (NDI)
Drafted by: M. Smith : 5/18/2021, 5/24/2021
Review History/concurrence:
R. Naik: 7/7/2021
M. Smith: 7/15/2021
L. Gottschalk: 7/12/2021
K. Prutzman: 7/7/2021
E. Sutkowski: 7/13/2021
D. Dickerson: 7/7/2021
S. Wollershiem: 7/7/21
A. Schwartz: 7/12/21
D. Thompson: 7/12/2021 H. Chun: 7/7/2021
X. Wang: 7/7/2021 A. Cheung: 7/12/2021 N. Al- humadi: 7/12/2021
M. Anderson: 7/8/2021 L. McVittie : 7/13/2021
D. Dickerson: 7/15/2021
cc: CBER Electronic Repository
END OF CONCURRENCE PAGE
The letter begins on the next page.
FDA-CBER-2021-5683-1150181
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 2099 3
www.fda.gov
Our STN: BL 125742/0 FILING NOTIFICATION
BioNTech Manufacturing GmbH
Attention: Elisa Harkins July 15, 2021
Pfizer Inc.
500 Arcola Road
Collegeville, PA 19426 Dear Ms. Harkins :
Please refer to your Biologics License Application (BLA) submitted and received on
May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for
COVID- 19 mRNA Vaccine .
We also refer to your amendments submitted and received on May 19, 2021 and
June 7, 2021.
We have completed our filing review and have determined that your application is
sufficiently complete to permit a substantive review . Under 21 CFR 601.2(a), we have
filed your application today . The review classification for this application is Priority , the
review action due date is January 16, 2022. This acknowledgment of filing does not
mean that we have issued a license, nor does it represent any evaluation of the
adequacy of the data submitt ed.
However, we plan to act early on this application under an expedited review, provided that no significant application deficiencies or unexpected shifts in work priorities or team staffing prevent an early action.
This application is also subject to the provisions of “the Program” under the Prescription Drug User Fee Act (PDUFA) . Refer to https://www.fda.gov/industry/prescription -dr
ug-
user-fee-amendments/pdufa-vi-fiscal- years -2018- 2022.
We are reviewing your application according to the processes described in the guidance for industry and review staff Good Review Management Principles and Practices for
New Drug Applications and Biologics License Applications at
https://www.fda.gov/regulatory -i
nformation/search- fda-guidance- documents/good-
review -management -principles -and-practices -new-drug- applications -and-biologics -
license . Therefore, we have established internal review timelines as described in the
guidance, which includes the timeframes for FDA internal milestone meetings (e.g., filing, planning, mid- cycle, team and wrap- up meetings). We plan to hold our internal
mid-cycle review meeting on August 31, 2021. Please be aware that the timelines
described in the guidance are flexible and subject to change based on workload and
FDA-CBER-2021-5683-1150182
Page 2 – STN 125742/0 – Elisa Harkins
other potential review issues (e.g., submission of amendments). We will inform you of
any necessary information requests or status updates following the milestone meetings or at other times, as needed, during the process. If major deficiencies are not identified during the review, we plan to communicate proposed labeling and, if necessary, any postmarketing requirement /commitment requests by December 17, 2021.
This date conforms to the 21
st Century Review timeline for your application. If our
review continues on an expedited timeline, we may communicate revised dates for
labeling and postmarketing requirement/commitment requests.
At this time, we are not planning a discussion of this application at an Advisory Committee meeting.
At this time, we h ave not identified any potential review issues. Our filing review is only
a preliminary review, and deficiencies may be identified during substantive review of
your application. Following a review of the application, we shall advise you in writing of
any action we have taken and request additional information if needed.
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and
effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.
We acknowledge you have addressed PREA for this application.
If you have any questions, please contact the Regulatory Project Manager s,
CAPT Mike Smith, Ph .D. (emai l: [email protected] ) and
Laura Gottschalk , Ph.D. (email: [email protected] ), at 301- 796 -2640.
Sincerely,
Loris D. McVittie, Ph.D.
Deputy Director - Regulatory
Division of Vaccines and Related Products Applications
Office of Vaccines
Research and Review Center for Biologics
Evaluation and Research
FDA-CBER-2021-5683-1150183