On October 12, 2022, the FDA revised the Emergency Use Authorizations of the Moderna COVID-19 Vaccine, Bivalent, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to authorize their usage as a single booster dose at least 2 months following completion of primary or booster vaccination in younger age groups.

The bivalent vaccines contain the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant. The Moderna COVID-19 Vaccine, Bivalent, is now authorized for use as a single booster dose in individuals aged 6 years and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals aged 5 years and older. Due to this authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use as a booster dose for individuals aged 5 to 11 years.

The authorization of the Moderna COVID-19 Vaccine, Bivalent, was based on a previous analysis of immune response and safety data from a clinical study in adults aged 18 years and older who received a booster dose of Moderna's investigational bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1. Booster effectiveness was also established using data from studies assessing individuals aged 6 to 17 years who received a single booster dose of the monovalent Moderna COVID-19 Vaccine. The safety of the booster dose of the monovalent Moderna COVID-19 Vaccine was evaluated in approximately 2,600 pediatric participants aged 6 to 17 years.

The authorization of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, in children aged 5 to 11 years was based on safety and immunogenicity data from the 30-mcg Omicron BA.1–adapted bivalent vaccine, nonclinical and manufacturing data from the companies' 10-mcg Omicron BA.4/BA.5–adapted bivalent vaccine, and preclinical data from the 30-mcg Omicron BA.4/BA.5–adapted bivalent vaccine. Effectiveness of the booster dose was also supported by data evaluating the booster dose of the monovalent Pfizer-BioNTech COVID-19 Vaccine in children aged 5 to 11 years.

The safety of each bivalent vaccine was consistent with the monovalent vaccines because these vaccines are manufactured utilizing the same process.

"Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death," stated Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research. "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."

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