KALAMAZOO, Mich. (Michigan News Source) – Pharmaceutical giant Pfizer, along with its partner BioNTech, is asking the Food and Drug Administration (FDA) to authorize its omicron-targeting COVID-19 booster for school-age children, the companies announced Monday.
A news release states Pfizer-BioNTech submitted an application for emergency use authorization of its BA.4/BA.5-adapted bivalent vaccine for children 5 to 11 years-of-age. If approved, children would receive a smaller dose than is normally administered to adults or teens.
The new booster was tested on mice, but studies in people are not complete.
The companies said they planned to submit a similar application to the European Medicines Agency “in the coming days.”
Moderna’s omicron-targeting bivalent booster also was authorized by the FDA at the end of August for Americans 18 and older. It is unclear when the company plans to submit an EUA for younger age groups.