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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Our Reference: IND 19736 GRANT FAST TRACK DESIGNATION
July 7, 2020
BioNTech RNA Pharmaceuticals GmbH
Attention: Ms. Elisa HarkinsPfizer, Inc.500 Arcola RoadCollegeville, PA 19426
Dear Ms. Harkins:Please refer to your Investigatio nal New Drug Application (IND) submitted under section
505(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) for “ Human Coronavirus
mRNA Vaccines (SARS-CoV-2 Spike Protein; BNT162a1 (uRNA; varian t RBL063.3);
BNT162b1 (modRNA; variant RBP020. 3); BNT162b2 (modRNA; variant RBP020.2);
and BNT162c2 (saRNA; variant RBS0 04.2)) in Lipid Nanoparticles ( ALC-0315, ALC-
0159, DSPC and Cholesterol).”
We also refer to your request for fast track designation submit ted and received on
May 15, 2020, and amendment 18, submitted and received on June 18, 2020, under
section 506(b) of the FDCA. We hav e reviewed your request and hav e determined that
Human Coronavirus mRNA Vaccines [ SARS-CoV-2 Spike Protein; BNT16 2b1
(modRNA; variant RBP020.3) and BNT 162b2 (modRNA; variant RBP020.2)] in Lipid
Nanoparticles (ALC-0315, ALC-0159 , DSPC and Cholesterol) for act ive immunization to
prevent COVID-19 disease caused by SARS-CoV-2 in adults 18 year s of age and older
meet the criteria for fast tra ck designation. Therefore, we are granting your request for
fast track designation. Please note that if the drug development program does not continue to meet the criteria fo r fast track designation, we ma y rescind the designation.
For further information regarding fast track drug development p rograms, please refer to
the guidance for industry Expedited Programs for Serious Conditions – Drugs and
Biologics at http://www.fda.gov/downloads/Drugs /GuidanceComplianceRegulatory
Information/Guidances/UCM358301.pdf .
We remind you that under secti on 561A(f)(2) of the FDCA, you ar e required to make
your expanded access policy for Human Coronavirus mRNA Vaccines [SARS-CoV-2
Spike Protein; BNT162b1 (modRNA ; variant RBP020.3) and BNT162b2 (m odRNA;
variant RBP020.2)] in Lipid Nano particles (ALC-0315, ALC-0159, D SPC and
Cholesterol) publicly available within 15 days of the signature date of this letter. For
further information regarding how to make your expanded access policy publicly
available, you may visit our e xpanded access webpage on FDA.gov at
https://www.fda.gov/NewsEvents/ PublicHealthFocus/Expanded
AccessCompassionateUse/ucm429687.htm .
FDA-CBER-2021-5683-0013855
Page 2 – IND 19736 – Ms. Elisa Harkins
If you have any questions, please contact the Regulatory Project Manager,
Ramachandra Naik, PhD, at [email protected] or 301-796-2640.
Sincerely,
Doran L. Fink, MD, PhD
Deputy Director - ClinicalDivision of Vaccines and Re lated Products Applications
Office 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: 2020.07.07 08:23:22 -04'00'
FDA-CBER-2021-5683-0013856