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Pfizer: submits vaccine booster to EMA with BioNtech

(CercleFinance.com) - Pfizer and BioNTech today announced that they have submitted an application to the European Medicines Agency (EMA) for a 10 µg booster dose of the bivalent vaccine Omicron BA.
4/BA.5 booster dose adapted to COVID-19 for children aged 5 to 11 years.

This application for a variation to the marketing authorisation (MA) is supported, amongst other things, by safety and immunogenicity data on the companies' adapted bivalent vaccine Omicron BA.1.

The companies have also submitted an Emergency Use Application (EUA) to the US Food and Drug Administration (FDA) for a booster dose of the COVID-19 bivalent vaccine adapted to Omicron BA.4/BA.5 for children aged 5 to 11 years.

In addition, the companies have also begun a study to evaluate the safety, tolerability and immunogenicity of different doses and administration schedules of COVID-19 bivalent vaccine adapted to Omicron BA.4/BA.5 in children aged 6 months to 11 years.


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