Use the Most Recent COVID-19 Vaccine EUA

Dear COVID-19 Vaccine Providers,

Please make sure your site is using the most up to date Emergency Use Authorization (EUA) for COVID-19 vaccine. Check the FDA website weekly for updates for each COVID-19 vaccine brand. The bullets below list the most recent information on the EUAs for each COVID-19 vaccine brand.

Pfizer-BioNTech (Comirnaty) | FDA page (last update 9/22)

• August 23, 2021 – The FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.
• Continues to be available under EUA, including for individuals 12 years of age and older, for the administration of a third dose in certain immunocompromised people, and for a single booster dose in people:
  • 65 and older
  • 18 through 64 at high risk of severe COVID-19; and
  • 18 through 64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

Moderna | FDA page (last update 9/27)

• December 18, 2020 – The U.S. Food and Drug Administration issued an EUA for Moderna.
• June 25, 2021 – Tue FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.
• August 12, 2021 – The FDA amended the Moderna COVID-19 Vaccine EUA to allow for an additional dose to be given to certain immunocompromised individuals.
• The EUA allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

Janssen COVID-19 Vaccine | FDA page (last update 8/27)

• February 27, 2021 – The U.S. Food and Drug Administration issued an EUA for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
• April 23, 2021 – The FDA amended the EUA to include information about a very rare and serious type of blood clot in people who receive the vaccine.
• The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

Thank you for keeping Philadelphia safe and healthy. If you have any questions, please email vaccines@phila.gov.

COVID-19 Vaccine Reporting Requirements

• If you are a flat file reporter, your excel spreadsheet should be uploaded to via your SFTP account daily.
• HL7 reporters should ensure that vaccination data is being captured within your Electronic Health Record (EHR) system.
• Please do not violate HIPAA regulations by sending patient and/or administration data via email to PDPH and/or the Philavax@phila.gov inbox.
• Providers that are not actively reporting doses administered to the IIS will not be able to place future orders for COVID-19 vaccines.
• If you are have having trouble uploading your data via your SFTP account or require additional assistance, please email vaccines@phila.gov.

• Providers should be reporting to Vaccine Finder daily including weekends and holidays.
• Provider should report to Vaccine Finder even if they have zero inventory.
• Providers that are not actively reporting doses on-hand to Vaccine Finder will not be able to place future orders for COVID-19 vaccines.
• If you are having trouble with your Vaccine Finder account, please email covidproviders@phila.gov.

Pfizer Vaccine Boosters Now Approved!

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Fill Out Our Vaccine Provider Capacity Survey!

Temporary Change to Vaccine Ordering Deadline

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:

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!