The FDA has given authorization to both the Moderna and the Pfizer-BioNTech COVID-19 vaccine, bivalent to authorize their use as a booster dose in younger age groups. The 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, after receiving a recommendation from the Centers for Disease Control and Prevention (CDC), will be available immediately for children 5–11 years of age.

“As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,” said Albert Bourla, chairman and CEO, Pfizer. “Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.”

These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The mRNA encodes the “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.

“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, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the FDA. “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.”

The Moderna COVID-19 vaccine, bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 vaccine, bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.

With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 vaccine continue to be authorized for primary series administration in individuals six months of age and older.

A Phase I/II/III pediatric study is currently underway to evaluate different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups.