EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant.

The vaccine — known as Spikevax XBB.1.5 — is to be used for preventing COVID-19 in adults and children from 6 months of age.

In line with previous recommendations by EMA and the European Centre for Disease Prevention and Control (ECDC), adults and children from 5 years of age who require vaccination should have a single dose, irrespective of their COVID-19 vaccination history. Children from 6 months to 4 years of age may have one or two doses depending on whether they have completed a primary vaccination course or have had COVID-19.

In its decision to recommend the authorisation, the CHMP considered all the available data on Spikevax and its other adapted vaccines. In addition, the committee assessed laboratory data showing that the adapted vaccine is able to trigger an adequate immune response against XBB.1.5.
The CHMP also considered data from a study in which adults were given Spikevax XBB.1.5 as a booster. The study showed that the vaccine produced an immune response against the Omicron XBB.1.5 subvariant, as measured by a rise in the level of antibodies against this strain. The vaccine also produced an immune response against a number of other strains of the virus that causes COVID-19, including the currently circulating Omicron XBB.1.16 subvariant. 

EMA will now send the CHMP’s recommendation to the European Commission for an EU-wide legally binding decision.