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Use the Most Recent COVID-19 Vaccine EUA

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.