BRIEF—FDA backs COVID-19 vaccine booster for 12+ year olds

The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 12 years of age and older.

The booster dose is the same dosage strength (30µg) as the dose approved in the primary series.

A booster dose of the Pfizer-BioNTech COVID-19 vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 16 years of age and older.

The vaccine is also authorized for eligible individuals 18 and older who have completed primary vaccination with a different authorized COVID-19 vaccine.