Document text
August XX, 2021
RE: Pfizer-BioNTech COVID-19 Vaccine Now FDA Approved as
COMIRNATY® IMPORTANT PRODUCT INFORMATION
Specified Pfizer-BioNTech COVID-19 Vaccine Lots authorized for Emergency Use comply with the approved specifications in Biologics Licensing Application (BLA)
Dear Healthcare Professional,
Pfizer, Inc. would like to provide you with updated and very important information related to the Pfizer-BioNTech
COVID-19 Vaccine (now FDA approved as COMIRNATY®).
The Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®) was licensed for use on August XX, 2021. Generally,
when a product is licensed, the product’s brand name, in this case, COMIRNATY®, is used from that point on. Several lots of the vaccine are in circulation that were approved for Emergency Use Authorization and labeled as
“Pfizer-BioNTech COVID-19 Vaccine”. These lots comply with the specifications required in the recently approved Biologics License Application and are therefore considered “BLA approved” lots for administration to individuals 16 years of age and older.
The lots that are BLA-approved for administration may be found at
cvdvaccine-us.com/resources
Please note, it is imperative that you not discard any available EUA lots.
You should continue to maintain and use them up to the date of expiry.
Please see the COMIRNATY® full prescribing information for indication and
usage, dosing and administration, and important safety information. The information can be found by scanning the QR code.
For questions related to this notification please contact Pfizer Customer
Service at 1-800-666-7248.
Sincerely,
WHAT?
If you plan on redistributing the Pfizer-BioNTech COVID-19 Vaccine, you must include at least one copy of this letter in each of the smaller, portable packaging containers being used for transport. WHY? Once the Pfizer-BioNTech COVID-19 Vaccine arrives at its final destination, the QR code may be used to look up the lot number on the carton to determine if the product is BLA-approved.HOW? To create additional copies of this letter to include in smaller transport containers, you may:• Make a copies) of this letter using
a copy machine
• Make printouts by visiting
cvdvaccine-us.com/resources
If you plan to redistribute the Pfizer-BioNTech COVID-19 Vaccine, please read on…
Manufactured for
BioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, GermanyMarketing Authorization Holder
Manufactured by
Pfizer Inc.New York, NY 11017
US License No. 2229
090177e197da1c78\Approved\Approved On: 19-Aug-2021 13:46 (GMT)
FDA-CBER-2021-5683-0951263