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July 8, 2022 – Comirnaty® (COVID-19 vaccine, mRNA – Pfizer and BioNTech) is now FDA approved for use in adolescents who are 12-15 years old. This age group was previously eligible to receive Comirnaty under emergency use authorization (EUA).
- Under its newly expanded indication, the vaccine is approved to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals 12 years of age and older.
- Recommended dosing for ages 12-15 is a two-dose primary vaccination series, with a third dose recommended for individuals with certain types of immunocompromise. The age group is also eligible under EUA to receive a booster dose at least five months after completing a primary vaccination series. If a patient has certain types of immunocompromise, a second booster dose may also be appropriate.
- Comirnaty has been in use in the United States under EUA since December 2020, and first received FDA approval in August 2021.