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FORM FDA 1571 (0 /1 )35(9,286 (',7,21 2%62/(7( Page 1 of 12. For Originals, is the product a
combination product (21 CFR 3.2(e))?Next Page Export Data Import Data Reset Form
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
INVESTIGATIONAL NEW DRUG APPLICATION (IND)
(Title 21, Code of Federal Regulations (CFR) Part 312)
5. Name of Drug (Include all available names: Trade, Generic, Chemical, or Code)
8. Phase of Clinical Investigation to be conducted
11. This submission contains the following (Select all that apply)
13. Select the following only if applicable. (Justification statement must be submitted with application for any items selected below.
Refer to the cited CFR section for further information.) 9. List numbers of all Investigational New Drug Applications (21 CFR Part 312), New Drug Applications (21 CFR Part 314) , Drug Master Files (21
CFR Part 314.420) , and Biologics License Applications (21 CFR Part 601) referred to in this application.
10. IND submission should be consecutively numbered. The initial IND should be numbered “Serial number: 0000.”
The next submission (e.g., amendment, report, or correspondence) should be numbered “Serial Number: 0001.”
Subsequent submissions should be numbered consecutively in the order in which they are submitted.. 1. Name of Sponsor
4. Telephone Number (Include country code if
applicable and area code)
6A. IND Number (If previously assigned)
6B. Select One:2. Date of Submission (mm/dd/yyyy) NOTE: No drug/biologic may be shipped or
clinical investigation begun until an IND for that investigation is in effect (21 CFR 312.40)
PSC Publishing Services (301) 443-6740 EFPhase 1
Initial Investigational New Drug Application (IND)
Request For Reactivation Or ReinstatementDevelopment Safety Update Report (DSUR)
New Protocol
Human Factors
Protocol
Expanded Access Use, 21 CFR 312.300
Individual Patient, Non-Emergency 21 CFR 312.310
Individual Patient, Emergency
21 CFR 312.310(d) Intermediate Size Patient Population, 21 CFR 312.315
Treatment IND or Protocol,
21 CFR 312.320 Emergency Research Exception From Informed Consent Requirements, 21 CFR 312.23 (f)
Charge Request, 21 CFR 312.8 Chemistry/Microbiology Meeting Initial Written Report
Change in Protocol Pharmacology/Toxicology Proprietary Name Review Follow-up to a Written
Report New Investigator Clinical/Safety Special Protocol Assessment Statistics PMR/PMC
Protocol
Clinical Pharmacology Formal Dispute Resolution Response to Clinical Hold
Annual ReportResponse To FDA Request For Information General Correspondence Phase 2 Phase 3 Other (Specify):
Other (Specify): Form Approved: OMB No. 0910-0014
Expiration Date: 0DUFK , 20
See PRA Statement on page 3.
Serial Number
Protocol Amendment Information Amendment Request for IND Safety Report
For FDA Use Only
CBER/DCC Receipt Stamp DDR Receipt Stamp Division Assignment
IND Number Assigned 7A. (Proposed) Indication for Use
7B. SNOMED CT Indication Disease Term (Use continuation page for each additional indication and respective coded disease term) Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this indication?If yes, provide the Orphan Designation number for this indication: YesCommercial
YesNo Research
No Continuation
Page for #7 3. Sponsor Address
Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.) CityCountryState/Province/Region
ZIP or Postal Code
Continuation
Page for #5
Yes No Combination Product
Type (See instructions) Request for Designation (RFD) Number BioNTech SE 01/15/2021
An der Goldgrube 12
Mainz Rhineland-Palatinate
Germany 55131215-280-5503
COVID-19 Vaccine (BNT162, PF-07302048) 019736
✔
Prophylactic immunization against COVID-19 in adults
16 years of age✔
✔
✔
01 84
✔ Summary Monthly Safety Report (SMSR)
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6HF 1. Form FDA 1571 (21 CFR 312.23(a)(1))
7. Chemistry, manufacturing, and control data
(21 CFR 312.23(a)(7))
Environmental assessment or claim for exclusion
(21 CFR 312.23(a)(7)(iv)(e))
8. Pharmacology and toxicology data (21 CFR 312.23(a)(8))
9. Previous human experience (21 CFR 312.23(a)(9))
10. Additional information (21 CFR 312.23(a)(10))
11. Biosimilar User Fee Cover Sheet (Form FDA 3792)
12. Clinical Trials Certification of Compliance (Form FDA 3674) 2. Table of Contents (21 CFR 312.23(a)(2))
3. Introductory statement (21 CFR 312.23(a)(3))
4. General Investigational plan (21 CFR 312.23(a)(3))
5. Investigator’s brochure (21 CFR 312.23(a)(5))
6. Protocol (21 CFR 312.23(a)(6))
a. Study protocol (21 CFR 312.23(a)(6))
b. Investigator data (21 CFR 312.23(a)(6)(iii)(b)) or
completed Form FDA 1572
c. Facilities data (21 CFR 312.23(a)(6)(iii)(b)) or completed
Form FDA 1572 d. Institutional Review Board data (21 CFR 312.23(a)(6)(iii)
(b)) or completed Form FDA 1572 14. Contents of Application – This application contains the following items (Select all that apply)
15. Is any part of the clinical study to be conducted by a contract research organization?
16. Name and Title of the person responsible for monitoring the conduct and progress of the clinical investigations
17. Name and Title of the person responsible for review and evaluation of information relevant to the safety of the drug
18. Name of Sponsor or Sponsor’s Authorized Representative
19. Telephone Number (Include country code if applicable and area code)
24. Name of Countersigner If Yes, will any sponsor obligations be transferred to the contract research organization?
If Yes, provide a statement containing the name and address of the contract research organization,
identification of the clinical study, and a listing of the obligations transferred (use continuation page) . Yes
YesNo No
20. Facsimile (FAX) Number (Include country code if applicable and area code)
21. Address
25. Address of Countersigner 22. Email Address
26. Email Address 23. Date of Sponsor’s Signature (mm/dd/yyyy)
Address 1 (Street address, P.O. box, company name c/o)
Address 1 (Street address, P.O. box, company name c/o) Address 2 (Apartment, suite, unit, building, floor, etc.)
Address 2 (Apartment, suite, unit, building, floor, etc.) City
CityCountry
CountryState/Province/Region
State/Province/Region ZIP or Postal Code
ZIP or Postal Code 6. Protocol (Continued)
27. Signature of Sponsor or Sponsor’s Authorized Representative 28. Signature of Countersigner
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Özlem Türeci, MD, Chief Medical Officer, BioNTech SE
Özlem Türeci, MD, Chief Medical Officer, BioNTech SE
Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines
215-280-5503 (845) 474-3500
500 Arcola Road
Collegeville PA
United States of America 19426elisa [email protected]
01/15/2021
United States of America
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The burden time for this collection of information is estimated to average 100 hours per
response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to the address to the right:
“An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB number.” Department of Health and Human Services Food and Drug Administration Office of Operations Paperwork Reduction Act (PRA) Staff [email protected]
Please do NOT send your completed form
to this PRA Staff email address.
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