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Pfizer-BioNTech Vaccine Gets Approval & Expiration Extension

Pfizer-BioNTech Vaccine Gets Approval & Expiration Extension

The Pfizer-BioNTech vaccine has been granted official Food and Drug Administration (FDA) approval! The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. Although the full approval is only for individuals 16 years of age and older, Comirnaty can still be given to individuals 12 through 15 under the existing EUA. The Comirnaty vaccine is still contracted under the federal government and will not be distributed commercially at this time. Providers are expected to continue following the CDC Provider Agreement terms set forth at the time of enrollment with PDPH.

In addition to the FDA’s full approval, an amendment to the EUA for the Comirnaty vaccine has been made to extend the expiration dates from 6 to 9 months.

Cartons and vials of Pfizer-BioNTech’s Comirnaty vaccine may remain in use for 3 months beyond the printed date as long as authorized storage conditions (-90°C to -60°C or -130°F to -76°F) have been maintained. Frozen vials stored at -25°C to -15°C and refrigerated vials stored at 2°C to 8°C are NOT eligible for extension.

See the below chart for guidance:

Printed Expiry Date Updated Expiry Date
August 2021 November 2021
September 2021 December 2021
October 2021 January 2022
November 2021 February 2022
December 2021 March 2022
January 2022 April 2022
February 2022 May 2022

The extended expiration date is effective immediately for all currently available batches that have not yet expired. Please note: Expiration dates extension does NOT apply to vials dated July 2021 and earlier

Currently available vaccine will not have an updated NCD. Please refer to the
current EUA Fact Sheet for information by clicking the button below. And additional information on Comirnaty’s storage and handling may be found at: Administration Overview for Pfizer-BioNTech COVID-19 Vaccine.

If you have questions about the extended expiration or the storage requirements of Comirnaty vaccine, please contact us at vaccines@phila.gov.

Thank you working to keep Philadelphia safe and healthy. Together we can stop COVID-19!