Europe – Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5

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…