Pfizer and BioNTech have submitted an application to the Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the 3-dose primary series for children 6 months through 4 years of age.
Due to the high level of respiratory illnesses currently circulating in children under 5 years of age, the updated COVID-19 vaccine may help prevent severe illness and hospitalization. If authorized, children 6 months through 4 years of age would receive a 3-dose primary series that includes the initial two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg dose of the Omicron BA.4/BA.5-adapted bivalent vaccine.
The bivalent vaccine contains 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 bivalent vaccine is currently authorized for use as a booster dose only in adults and children 5 years of age and older.
According to recent study findings, the updated bivalent booster elicited a greater increase in neutralizing antibody titers than the original COVID-19 vaccine against newer Omicron sublineages, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1.
Pfizer and BioNTech submit application to US FDA for Emergency Use Authorization of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children under 5 years. News release. Pfizer and BioNTech. Accessed December 5, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-application-us-fda-emergency-1.