Pfizer : FDA Grants Emergency Use Of Omicron Bivalent COVID-19 Vaccine Booster In Children

(RTTNews) - The U.S. Food and Drug Administration granted Emergency Use Authorization for a 10-micro gram booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age, Pfizer Inc. (PFE) and BioNTech SE (BNTX) said in a statement on Wednesday.

The companies noted that they will supply the original and bivalent vaccines under their existing supply agreement with the U.S. government. Booster vaccinations for individuals 5 through 11 years of age are anticipated to start subject to and after the CDC endorses a potential recommendation.

Pfizer and BioNTech will begin shipping bivalent doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government's commitment to free access to COVID-19 vaccines.

Pfizer and BioNTech have submitted an application to the European Medicines Agency (EMA) requesting a variation of the companies' marketing authorization in the European Union to include a 10-micro gram booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in this age group. Similar applications are planned for submission with regulatory authorities around the world in the coming weeks.

According to the companies, a phase 1/2/3 pediatric study is currently underway to evaluate different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups.