Pfizer and BioNTech Receive Expanded US Emergency Use Authorization for an Additional COVID-19 Vaccine Booster

FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.

Pfizer and BioNTech announced on March 29, 2022 that FDA has expanded the Emergency Use Authorization (EUA) of their COVID-19 vaccine to include a second booster dose in adults aged 50 years and older. The second booster dose would apply to those who have already received a first booster dose of any authorized COVID-19 vaccine.

Additionally, FDA has authorized a second booster dose for individuals aged 12 years and older who are immunocompromised and have already received a first booster dose of any authorized COVID-19 vaccine. The second booster should be administered at least four months after the first booster dose.

The Pfizer-BioNTech COVID-19 vaccine was previously authorized as a single booster dose in individuals aged 12 and older after the completion of the companies’ primary vaccination series. The authorization of the second booster dose aims to further protect the most vulnerable individuals and extend and strengthen the levels of protection against COVID-19 in anticipation for potential future waves.

The vaccine is based on BioNTech’s proprietary messenger RNA technology, and BioNTech is the Marketing Authorization Holder in the United States, the European Union, United Kingdom, and Canada. BioNTech and Pfizer are jointly the holders of EUAs or equivalents in the US and other countries.

Source: Pfizer