EMA’s human medicines committee (CHMP) has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus.

The vaccine, known as Nuvaxovid XBB.1.5, is to be used for preventing COVID-19 in adults and children from 12 years of age.

In line with previous recommendations by EMA and the European Centre for Disease Prevention and Control (ECDC), adults and adolescents from 12 years of age who require vaccination should have a single dose, irrespective of their COVID-19 vaccination history.

In its decision to recommend the authorisation, the CHMP assessed laboratory data showing that the adapted vaccine is able to trigger an adequate immune response against XBB.1.5. The Committee also considered data from a study in previously vaccinated adults showing that when Nuvaxovid was adapted to target another related strain, Omicron BA.5, it was able to trigger a strong immune response against this strain. Based on these data, the Committee concluded that Nuvaxovid XBB.1.5 is expected to trigger an adequate immune response against XBB.1.5.

The safety profile of Nuvaxovid XBB.1.5 is expected to be similar to that of the originally authorised Nuvaxovid. This was also supported by clinical data available with the version of the vaccine targeting Omicron BA.5. The most common side effects with Nuvaxovid XBB.1.5 are pain and tenderness at the injection site, tiredness, headache, muscle pain and feeling generally unwell.

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