FDA Authorizes Bivalent COVID-19 Boosters for Children Ages Five and Older

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FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

FDA announced on Oct. 12, 2022 that it would be amending its emergency use authorizations for the Moderna and Pfizer-BioNTech bivalent booster to permit their use in children as young as five years old. While the Pfizer vaccine is authorized for use in children as young as five, the Moderna vaccine is only permitted for children ages six and older.

According to an agency press release, FDA based its decision on immune response and safety data from a clinical study in adults whom received a bivalent COVID-19 vaccine, containing both the original strain and the BA.1 omicron variant. (FDA considers BA.1 as relevant and supportive of vaccines containing components of the BA.4 and BA.5 variants.) The bivalent boosters contain a protein in common between BA.4 and BA.5 to add protection against the omicron variant.

“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” said Peter Marks, director, Center for Biologics Evaluation and Research, FDA, in an agency press release. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”


In addition to this authorization, the amendment now restricts the use of the monovalent boosters in children aged 6 to 11 years old. Both vaccines remain authorized as a primary series for individuals six months and older.

Source: FDA