FDA authorizes bivalent COVID-19 vaccines as boosters for younger groups

Editor's Note

On October 12, the Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of the Moderna and Pfizer-BioNTech COVID-19 vaccines, Bivalent, to authorize their use as a single booster dose in younger groups, Health Purchasing News October 12 reports.

The Moderna vaccine is now authorized for administration for children 6 years old and up, at least 2 months following the administration of a primary or booster vaccination. The Pfizer-BioNTech vaccine is authorized for administration for children 5 years and up, at least 2 months following a primary or booster vaccination. Following this recent authorization, the monovalent Pfizer-BioNTech COVID-19 vaccine is no longer approved as a booster dose for younger age groups.

The FDA used previous immune responses and safety data from clinical studies when authorizing each bivalent vaccine for younger age groups. They evaluated data collected from studies of adults given the bivalent COVID-19 vaccine and studies of children given monovalent vaccines.

View the official FDA release here.