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

The vaccine – known as Comirnaty Omicron 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 three 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 Comirnaty and its other adapted vaccines, including data on safety, efficacy and immunogenicity (how well they trigger immune responses). In addition, the Committee assessed new laboratory data showing a strong response of the adapted vaccine against XBB.1.5 and related strains of the virus that causes COVID-19.

More data on emerging variants are expected and the Committee will assess these data when they are available.