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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
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Our Reference: IND 19736 AGREED INITIAL
PEDIATRIC STUDY PLAN-AGREEMENT
April 23, 2021
BioNTech SE/Pfizer, Inc.
Attention: Neda Aghajani Memar235 East 42nd Street, 219/9/69New York, NY 10017
Dear Ms. Aghajani Memar:Please refer to your Investigational New Drug Application (IND) submitted under section
505(i) of the Federal Food, Drug, and Cosmetic Act for “Human Coronavirus mRNA
Vaccines (SARS-CoV-2 Spike Protein; BNT162a1 (uRNA; variant RBL 063.3);
BNT162b1 (modRNA; variant RBP020.3); BNT162b2 (modRNA; variant RBP020.2);
BNT162c2 (saRNA; variant RBS004.2)) in Lipid Nanoparticles (ALC -0315, ALC-0159,
DSPC and Cholesterol).”
We also refer to your amendment submitted and received on April 2 , 2021, containing
your final Agreed Initial Pediatric Study Plan (iPSP) as request ed in the March 24, 2021
correspondence from the Agency.We have completed our review of your Agreed iPSP and agree with your planned
pediatric study and your plan to request a deferral of the pedi atric assessment for the
pediatric population 0 to ޒ16 years of age.
This agreement does not necessarily imply agreement with other contents of the
document in its entirety.
Please be advised that this agreement with your Agreed iPSP, and acknowledgment of
your intention to request a deferral as stated above, does not constitute the “granting” of
such a deferral. This can only occur at such time if/when this investigational product is
licensed. A copy of your Agreed iPSP must be included in Module 1 of your Biologics
License Application.
In the event that it becomes necessary to make any changes to t his “Agreed iPSP”
before submission of your Biologics License Application, please contact the Regulatory
Project Manager to discuss the appropriate mechanisms for submi tting this to FDA and
for instructions on identifying your submission in order to ensu re timely review. FDA
must agree to any amendments to an Agreed iPSP.
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FDA-CBER-2021-5683-0013857
Page 2 – IND 19736 – Ms. Neda Aghajani Memar
If you have any questions, please contact the Regulatory Projec t Manager,
Ramachandra Naik, Ph.D., by email at [email protected] .
Sincerely,
Doran L. Fink, M.D., Ph.D.
Deputy Director – ClinicalDivision of Vaccines and Related Products ApplicationsOffice of Vaccines Research and ReviewCenter for Biologics Evaluation and ResearchDoran Fink -SDigitally signed by Doran Fink -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Doran Fink -S, 0.9.2342.19200300.100.1.1=0013724088 Date: 2021.04.23 07:58:47 -04'00'
090177e196dcd801\Final\Final On: 23-Apr-2021 13:46 (GMT)
FDA-CBER-2021-5683-0013858