On 31 October, 2023, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended issuing a marketing authorisation variation for the Nuvaxovid vaccine (NVX-CoV2373, Novavax CZ AS) adapted to the Omicron XBB.1.5 variant. The vaccine is intended for use in adults and children aged from 12 years of age. The European Commission followed the recommendation and granted the authorisation of Nuvaxovid XBB.1.5 on the same day.
In its decision to recommend authorisation, the CHMP assessed laboratory data showing that the modified vaccine can trigger an adequate immune response to XBB.1.5. The Committee also considered data from a study of previously vaccinated adults showing that when Nuvaxovid was adapted to another related SARS-CoV-2 strain, Omicron BA.5, it triggered a strong immune response against that strain. Based on this data, the Committee concluded that Nuvaxovid XBB.1.5 is expected to elicit an adequate immune response against XBB.1.5.
According to the CHMP, the safety profile of Nuvaxovid XBB.1.5 is likely to be comparable to that of the originally authorised Nuvaxovid. This was also confirmed by the clinical data available for the version of the vaccine targeting Omicron BA.5. The most common side effects of Nuvaxovid XBB.1.5 are pain and tenderness at the injection site, fatigue, headache, muscle pain, and general malaise.
Updated: 01.11.2023
