The Food and Drug Administration (FDA) has revised the Emergency Use Authorizations (EUAs) of the bivalent formulations of the Moderna and Pfizer-BioNTech COVID-19 Vaccines to include use 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 6 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use as a single booster dose in individuals 5 years of age and older. With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use as a booster dose for individuals 5 to 11 years of age.
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 18 years of age 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 based on data from studies evaluating individuals 6 to 17 years of age 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 2600 pediatric participants 6 to 17 years old.
The authorization of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent in children 5 to 11 years of age was based on safety and immunogenicity data from the 30µg Omicron BA.1-adapted bivalent vaccine, nonclinical and manufacturing data from the companies’ 10µg Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the 30µg 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 5 to 11 years old.
The safety of each bivalent vaccine was consistent with that seen with the monovalent vaccines because these vaccines are manufactured using the same process.
“Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” said Peter Marks, MD, PhD, Director, 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.”
- Coronavirus (COVID-19) update: FDA authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for use as a booster dose in younger age groups. News release. US Food and Drug Administration. Accessed October 12, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines
- Pfizer and BioNTech receive US FDA Emergency Use Authorization for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in children 5 through 11 years of age. News release. October 12, 2022. https://www.businesswire.com/news/home/20221011006028/en/Pfizer-and-BioNTech-Receive-U.S.-FDA-Emergency-Use-Authorization-for-Omicron-BA.4BA.5-Adapted-Bivalent-COVID-19-Vaccine-Booster-in-Children-5-Through-11-Years-of-Age
- Moderna receives FDA authorization for emergency use of Omicron-targeting bivalent COVID-19 booster vaccine for children and adolescents 6 to 17 years of age. News release. October 12, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-FDA-Authorization-for-Emergency-Use-of-Omicron-Targeting-Bivalent-COVID-19-Booster-Vaccine-for-Children-and-Adolescents-6-to-17-Years-of-Age/default.aspx