The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended issuing a marketing authorisation variation for the Spikevax (Moderna) vaccine adapted to the Omicron XBB.1.5 variant. The vaccine is intended for use in adults and children aged six months and up. The European Commission followed the recommendation and granted the authorisation of Spikevax XBB.1.5.
In making its decision to recommend authorisation, the CHMP considered all available data on Spikevax and the other adapted Spikevax vaccine products. The Committee also assessed laboratory data indicating that the adapted vaccine is able to trigger an adequate immune response against XBB.1.5.
Omicron XBB.1.5 is closely related to other currently circulating Omicron subvariants. The vaccine is therefore expected to help maintain optimal protection against COVID-19.
Updated: 15.09.2023
