BRIEF—FDA authorizes Comirnaty booster jabs for certain populations

23 September 2021

As widely expected following the recommendation last week of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), the US Food and Drug Administration yesterday formerly amended the emergency use authorization (EUA) for Comirnaty, the Pfizer-BioNTech COVID-19 vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:

individuals 65 years of age and older;
individuals 18 through 64 years of age at high risk of severe COVID-19; and
individuals 18 through 64 years of age 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.

The authorization applies only to the Pfizer-BioNTech COVID-19 vaccine.