Europe Recommends COVID-19 Vaccine Targeting Omicron XBB.1.5

The European Medicines Agency (EMA) today announced its Human Medicines Committee (CHMP) has recommended authorizing an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant.

In its decision to recommend the authorization on September 14, 2023, the CHMP considered all the available data on Spikevax and its other adapted vaccines.

Known as Spikevax XBB.1.5, this vaccine prevents COVID-19 in adults and children from six months of age.

In line with previous recommendations by EMA and the European Centre for Disease Prevention and Control, 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.

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 antibodies against this strain.

The vaccine also produced an immune response against several other strains of the betacornavirus that causes COVID-19, including the currently circulating Omicron XBB.1.16 subvariant.

The EMA has sent the CHMP’s recommendation to the European Commission for an EU-wide legally binding decision.

SpikeVax has recently been approved in Canada and the United States.