FDA authorizes Pfizer bivalent COVID booster for kids 6 months through age 4


Center for Infectious Disease Research and Policy.

By Lisa Schnirring.

The Food and Drug Administration (FDA) announced yesterday that it authorized the emergency use of Pfizer-BioNTech’s bivalent (two-strain) booster in children ages 6 months through 4 years who have had their primary Pfizer vaccine series, which is three doses.

In amending the emergency use authorization (EUA), the FDA said the booster can be given at least 2 months after children have completed the three-dose series of the single-strain vaccine.

In a press release, Peter Marks, MD, PhD, who directs the FDA’s Center for Biologics Evaluation and Research, said, “Currently available data show that vaccination remains the best defense against severe disease, hospitalization, and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine.”

In the release, the FDA detailed the vaccine effectiveness and safety data that supported the EUA.