Pfizer: files for approval of Covid vaccine
(CercleFinance.com) - Pfizer and BioNTech today announced that they have submitted an application to the US FDA for emergency use authorization (EUA) of their bivalent COVID-19 vaccine adapted to Omicron BA.
4/BA.5 as the third dose of 3 µg in the primary three-dose series for children aged 6 months to 4 years.
If approved, children in this age group will receive a primary series consisting of two 3 µg doses of the original Pfizer-BioNTech COVID-19 vaccine, followed by a third 3 µg dose of the adapted bivalent Omicron BA.4/BA.5 vaccine.
An application to extend the marketing authorisation of Pfizer and BioNTech's COVID-19-adapted Omicron BA.4/BA.5 bivalent vaccine in the EU to include children aged 6 months to 4 years is under discussion with the European Medicines Agency (EMA).
The bivalent COVID-19 adapted vaccine Omicron BA.4/BA.5 is currently licensed as a booster dose for children aged 5 years and older in the US and the EU.
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