Pfizer-BioNTech and Moderna Seek EUAs for Pediatric Omicron-Adapted COVID-19 Shots
Pfizer and BioNTech have completed an Emergency Use Authorization (EUA) submission for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children between the ages of five and 11.
The bivalent vaccine is currently authorized for individuals 12 years and older.
The companies supported their EUA application with safety and immunogenicity data on their bivalent Omicron BA.1-adapted vaccine, nonclinical and manufacturing data on their bivalent Omicron BA.4/BA.5-adapted vaccine and preclinical data on their Omicron BA.4/BA.5-adapted vaccine, the companies said.
Moderna has also submitted EUA requests to the FDA to authorize its Omicron-targeting bivalent COVID-19 vaccine in the pediatric population between 12 and 17 years of age and in children between the ages and six and 11. Moderna also plans to file an emergency use application for children aged six months to under six years. That application is expected to be completed later this year.
Moderna’s bivalent vaccine is currently authorized for individuals 18 years and older.
September 27, 2022