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Pfizer: to submit emergency use application to FDA

( - Pfizer and BioNTech will submit to the US FDA an emergency use application for the bivalent booster vaccine Omicron BA.
4/BA.5 booster vaccine suitable for children aged 5 to 11 years.

This application is for a 10 µg booster dose of Omicron BA.4/BA.5 bivalent vaccine adapted to COVID-19.

An application to extend the marketing authorisation for Omicron BA.4/BA.5-adapted bivalent vaccine to children aged 5-11 years will be submitted to the European Medicines Agency (EMA) in the coming days.

The companies have also initiated a Phase 1/2/3 study NCT05543616 (C4591048) to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens of COVID-19 bivalent vaccine adapted to Omicron BA.4/BA.5 in children aged 6 months to 11 years.

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