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.
This article originally appeared on MPR
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.