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DEPARTMENT OF HEAL TH AND HUMAN SERVICES Form Approved: 0MB No. 0910-0001
Food and Drug Administration Expiration Date: March 31, 2024
See PRA Statement on last page.
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL 1.Date Submitted
LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE 10/27/2021
2.Application Information X Single product Multiple products For multiple products, submit completed form and
Application Type: BLAspecimen of advertising/promotional materials to one
application of choice, and attach separate sheet
Application Number: 125742 Iaddressing items 3-5 for remainder of products. Refer
to No. 3 on instruction sheet.
NOTE: Form FDA 2253 is required by law. Reports are required for approved NDAs, ANDAs (21 CFR 314.81 ), and BLAs (601.12(f)(4))
3.Proprietary Name 4.Established Name
COMIRNATY[COVID-19 mRNA Vaccine (nucleoside modified)]
Product Code No.:
5.Package Insert Date and ID Number 6.Manufacturer Name
(Latest final printed labeling)
08/21 LAB-1448-1.0License No. (Biologics):
7. Advertisement / Promotional Labeling Materials
a.Please check only one: Professional X Consumer
Material Type Dissemination/
(use FDA codes) Publication Material ID Code Material Description
Date
b. C. d. e.
www-website 10/27/2021 PP-CVV-USA-04 78 Comimaty.com Consumer Mix and Match Booster Pop-up Delete
Row
To delete a row, click the "Delete Row" button for that row (or press the enter key
if you've tabbed into the button). You cannot delete the last remaining row. I Add New Row
f.Comments
PP-CVV-USA-0478 is an updated version of PP-CVV-USA-0430 filed 09/28/2021.
'
8.Applicant's (or Agent's) Return Address 9.Responsible Official's (or Agent's)
Address 1 (Street address, P. 0. box, company name c/o) a.Telephone Number (Include area code)
An der Goldgrube 12 (484)865-5035
Address 2 (Apartment, suite, unit, building, floor, etc.)b.FAX Number (Include area code)
(845)474-3500
City State/Province/Region
Mainz NIA c.Email Address
Country ZIP or Postal Code [email protected]
Germany 55131 I
FORM FDA 2253 (04/21) PREVIOUS EDITION IS OBSOLETE Page 1 of 2 PSC Publishng SCtVices (30 I) 443-6740 EF
FDA-CBER-2021-5683-0950597
Digitally signed by
DN o=Pfizer Inc cn
Reason I am signing on behalf of Donna Boyce
Date 2021.10.27 10 53 7 0800'
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0950598