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Food and Drug Administration
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(Title 21, Code of Federal Regulations, Parts 314 & 601)
3. Telephone Number (Include country code if applicable and area code)
9. Established Name (e.g., proper name, USP/USAN name)
10. Proprietary Name (Trade Name) (If any)
11. Chemical/Biochemical/Blood Product Name (If any)
17. If an NDA, identify the type
19. If a 351(k), identify the biological reference product that is the basis for the submission.
20. If an ANDA, or 505(b)(2), identify the listed drug product that is/are the basis for the submission. 12. Dosage Form
15A. Proposed Indication for Use
15B. 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: 5. Applicant Address
6. Authorized U.S. Agent (Required for non-U.S. applicants)
7. NDA, ANDA, or BLA Application Number2. Name of Applicant
16. Application Type
(Select one) 13. Strengths
18. If a BLA, identify the type14. Route of Administration 4. Facsimile (FAX) Number (Include country
code if applicable and area code)
8. Supplement Number (If applicable) 1. Date of Submission (mm/dd/yyyy)
PSC Publishing Services (301) 443-6740 EFYes
Yes No
No
505(b)(1)
P1 P2 P3 P4 Section viii - MOU Statement of no relevant patents 351(a) 505(b)(2) 351(k) New Drug Application (NDA) Biologics License Application (BLA)
Abbreviated New Drug Application (ANDA)
Name of Biologic:
Name of Drug:
Indicate Patent Certification:Holder of Licensed Application:
Application Number of Relied Upon Product:
)250 )'$K 35(9,286 (',7,216 2%62/(7( 3DJH RIForm Approved: OMB No. 0910-0338
Expiration Date: March 31, 2020 See PRA Statement on page 3.
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$33/,&$7,21 ,1)250$7,21Address 1 (Street address, P.O. box, company name c/o)
Address 1 (Street address, P.O. box, company name c/o) Authorized U.S. Agent Name Email Address
Telephone Number (Include area code)
FAX Number (Include area code)
Email Address
U.S. Agent DUNS U.S. License Number if previously issued Applicant DUNS Address 2 (Apartment, suite, unit, building, floor, etc.)
Address 2 (Apartment, suite, unit, building, floor, etc.) City
City Country
ZIP Code State/Province/Region
State ZIP or Postal Code 05/18/2021
BioNTech Manufacturing GmbH
+49 (0) 6131 9084-7593 +49 (0) 6131 9084-390
An der Goldgrube 12
Mainz N/A
Germany 55131 [email protected]
117645848
Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines
500 Arcola Road
Collegeville PA
19426215-280-5503
845-474-3500
[email protected]
125742
[COVID-19 mRNA Vaccine (nucleoside modified)]
COMIRNATY
COVID-19 Vaccine (BNT162, PF-07302048)
Liquid 30 mcg Intramuscular
Active immunization to prevent COVID-19 caused by
SARS-CoV-2 in individuals 16 years of age ✔
✔
COVID-19; SARS-CoV-2; Disease caused by severe acute respiratory syndrome coronavirus 2; SARS-CoV-2 vaccination; COVID-19 vaccination
✔
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FDA-CBER-2021-5683-1078315
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5. Nonclinical pharmacology and toxicology section
(e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2) 25. Does the submission contain:
Only Pediatric data?
Yes No N/A Is the site ready
for inspection?
If No, when will site be
ready? (mm/dd/yyyy)
)250 )'$K 35(9,286 (',7,216 2%62/(7( 3DJH RI29. Cross References (List related BLAs, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, MAFs, and DMFs referenced in the current applic ation.) 28. Establishment Information (Full establishment information should be provided in the body of the application.)
Establishment Name
Address 1 (Street address, P.O. box, company name c/o) Registration (FEI) Number
MF Number Establishment DUNS Number Address 2 (Apartment, suite, unit, building, floor, etc.)
City Country State/Province/Region
ZIP or Postal Code 27. Reasons for Submission 24. For Originals and all Supplements, is the product a
combination product (21 CFR 3.2(e))?
Yes YesYes
Prescription Product (Rx) No No No
Over-The-Counter Product (OTC) 23. If a supplement, identify
the appropriate category. 22. Submission
Sub-Type CBE Presubmission Amendment Prior Approval (PA)
CBE-30 Initial Submission Resubmission
26. Proposed Marketing Status (Select one) Combination Product
Type (See instructions) Request for Designation (RFD) Number
Human factors information?
Is the establishment new to the application? What is the status of the establishment?
Yes No Active Inactive Withdrawn Pending
Manufacturing Steps and/or Type of TestingName of Contact for the Establishment Telephone Number (Include area code)
FAX Number (Include area code)
Email Address Establishment Contact Information at the site/facility
30. This application contains the following items (Select all that apply)
8. Clinical data section (e.g., 21 CFR 314.50(d)(5); 21 CFR 601.2)
Item 30 continued on page 3 6. Human pharmacokinetics and bioavailability section
(e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2) 1. Index
7. Clinical microbiology section (e.g., 21 CFR 314.50(d)(4))4. Chemistry Section A. Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
B. Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA’s request)
C. Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2) Draft Labeling Final Printed Labeling 2. Labeling (Select one) : 3. Summary (21 CFR 314.50 (c)) 21. Submission (See
instructions)Original
Product Correspondence
Request for Proprietary Name ReviewREMS Supplement Postmarketing Requirements or Commitments Periodic Safety Report
Other (Specify): Labeling Supplement CMC Supplement Efficacy Supplement Annual Report ✔
✔
✔
✔ ✔ ✔
Rolling Submission Sequence 0002 for STN/BL 125742 - FINAL ROLL
Pharmacia and Upjohn Company LLC (Pfizer)
7000 Portage Road
Kalamazoo MI
USA 490011810189
618054084
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FDA-CBER-2021-5683-1078316
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I agree to update this application with new safety information about the product that may reasonably affect the statement of co ntraindications,
warnings, precautions, or adverse reactions in the draft labeling. I agree to submit safety update reports as provided for by regulation or as
requested by FDA. If this application is approved, I agree to comply with all applicable laws and regulations that apply to approved applications, including, but not limited to, the following:
1. Good manufacturing practice regulations in 21 CFR Parts 210, 211 or applicable regulations, Parts 606, and/or 820. 2. Biological establishment standards in 21 CFR Part 600. 3. Labeling regulations in 21 CFR Parts 201, 606, 610, 660, and/or 809. 4. In the case of a prescription drug or biological product, prescription drug advertising regulations in 21 CFR Part 202. 5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71, 314.72, 314.97, 314.99, and 601.12. 6. Regulations on Reports in 21 CFR 314.80, 314.81, 600.80, and 600.81. 7. Local, state, and Federal environmental impact laws.
If this application applies to a drug product that FDA has proposed for scheduling under the Controlled Substances Act, I agree not to market
the product until the Drug Enforcement Administration makes a final scheduling decision.
The data and information in this submission have been reviewed and, to the best of my knowledge, are certified to be true and a ccurate.
:DUQLQJ A willfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
)250 )'$K 35(9,286 (',7,216 2%62/(7( 3DJH RI30. This application contains the following items (Continued; select all that apply)
10. Statistical section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2)
12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2)
18. User Fee Cover Sheet (PDUFA Form FDA 3397, GDUFA Form
FDA 3794, BsUFA Form FDA 3792, or MDUFA Form FDA 3601) 14. A patent certification with respect to any patent that claims the
drug/biologic (21 U.S.C. 355 (b)(2) or (j)(2)(A))
16. Debarment certification (FD&C Act 306 (k)(1)) 9. Safety update report (e.g., 21 CFR 314.50(d)(5)(vi)(b);
21 CFR 601.2)
11. Case report tabulations (e.g., 21 CFR 314.50(f)(1);
21 CFR 601.2)
17. Field copy certification (21 CFR 314.50 (l)(3))
19. Financial Disclosure Information (21 CFR Part 54) 13. Patent information on any patent that claims the drug/
biologic (21 U.S.C. 355(b) or (c))
15. Establishment description (21 CFR Part 600, if applicable)
20. Other (Specify):
31. Typed Name and Title of Applicant’s Responsible Official
33. Telephone Number (Include country
code if applicable and area code)
37. Signature of Applicant’s Responsible Official or
Other Authorized Official 36. Address of Applicant’s Responsible Official
38. Countersignature of Authorized U.S. Agent32. Date (mm/dd/yyyy)
34. FAX Number (Include country code if
applicable and area code) 35. Email Address
Department of Health and Human Services
Food and Drug Administration Office of Operations Paperwork Reduction Act (PRA) Staff [email protected]
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72 7+,6 35$67$)) (0$,/$''5(66Address 1 (Street address, P.O. box, company name c/o)
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ZIP or Postal Code
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“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.” The burden time for this collection of information is estimated to average 24 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: ✔
Elisa Harkins, Global Regulatory Lead, Global Regulatory Affairs - Vaccines, Pfizer Inc. 05/18/2021
215-280-5503 845-474-3500 [email protected]
500 Arcola Road
Collegeville PA
United States of America 19426
Elisa Harkins TullDigitally signed by Elisa Harkins Tull DN: o=Pfizer Inc, cn=Elisa Harkins Tull Reason: I attest to the accuracy and integrity of this document Date: 2021 05 18 13:18:39 -04'00'
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