CHMP Recommends Marketing Authorisation Extension for the COVID-19 Vaccine Product Spikevax Bivalent Original/Omicron BA.4-5 for Use as Booster Vaccination for Children Aged 6 to 11 Years
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended extending the indication for the COVID-19 vaccine product Spikevax bivalent Original/Omicron BA.4-5. The vaccine, which has been adapted to the Omicron variants BA.4-5, is to be authorised for use as a booster vaccine for children aged 6 to 11 years. The vaccine was previously authorised as a booster vaccine for individuals aged 12 and older. The European Commission followed the recommendation and granted a marketing authorisation on 26 May 2023.