The FDA has granted Emergency Use Authorization (EUA) to Pfizer and BioNTech’s bivalent COVID-19 vaccine as a single booster dose at least two months following a primary vaccination of three doses of the monovalent Pfizer and BioNTech COVID-19 vaccine in children from six months through four years of age.

The EUA decision was supported by positive data from 60 children that showed immune response to both the original SARS-CoV-2 virus strain and the Omicron BA.4/BA.5 strains.

The authorization was also supported by the FDA’s previous analyses of the vaccine’s efficacy for primary vaccination as well as immune response data in adults older than 55 years old.