On 15 December 2022, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued an opinion in favour of marketing authorisation for the COVID-19 vaccine Spikevax from Moderna in a 50 µg dose as booster vaccine for children aged 6 to 11 years. The bivalent, Omicron subvariant BA.1-adapted Spikevax vaccine with Wuhan mRNA and Omicron BA.1 mRNA also received an authorisation recommendation as a booster vaccination for children from 6 years of age. The EU Commission granted the marketing authorisations on 16 December 2022.
The COVID-19 vaccine Spikevax (50 µg) contains messenger RNA (mRNA) with the blueprint of the spike protein of the original variant (Wuhan) of SARS-CoV-2. It was previously authorised at this dose for primary vaccination in individuals aged 6 to 11 years and as a booster vaccination from 12 years of age. This vaccine has now also been authorised as a booster vaccination for children aged 6 to 11 years.
Spikevax Bivalent Original/Omicron BA.1 contains 50 μg of mRNA, both the mRNA with the spike protein blueprint of the original variant (Wuhan) of SARS-CoV-2 and the mRNA with the spike protein blueprint of the Omicron subvariant BA.1. It was previously authorised as a booster vaccination from 12 years of age. This vaccine has now been authorised as a booster vaccination for children 6 years of age and older.
Updated: 20.12.2022
