Pfizer/BioNTech Seeks US FDA Approval for New COVID-19 Boosters for Children


Pfizer and its German partner BioNTech are asking the US Food and Drug Administration (FDA) to approve the new COVID-19 booster vaccine shots targeting the Omicron variant for school-age children. Pfizer and BioNTech submitted an application for emergency use authorization of their BA.4 and BA.5 focused bivalent vaccines for children between 5 to 11 years old at a 10-microgram dose.

According to the reports, the bivalent booster vaccine of Pfizer and BioNTech is currently authorized by the US FDA at 15 micrograms for children aged over 12 years, at least two months after any past COVID-19 shots. The companies planned to submit similar vaccine applications to the European Medicines Regulatory Agency in the coming days.

The US FDA also authorized the bivalent booster vaccine of Moderna at the end of August 2022 for people above 18 years in the United States. It is still unclear when the company is planning to submit an emergency use authorization for children.

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The bivalent booster vaccines of both Pfizer and Moderna combine the original COVID-19 vaccine that targeted the spike protein on the surface of the COVID-19 virus, with a reformulation that mainly targets the mutated spike protein found on the different versions of the Omicron COVID-19 variant.