Novavax’s Nuvaxovid XBB.1.5 dispersion receives approval in Europe

Novavax announced the European Commission has granted approval for Nuvaxovid XBB.1.5 dispersion for injection COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. This decision follows positive opinion for approval from the Committee for Medicinal Products for Human Use of the European Medicines Agency. Novavax is working closely with EU member states that have requested doses through the advance purchase agreement to confirm timing of dose delivery on a country-by-country basis. Approval was based on non-clinical data showing that Novavax’s updated COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax’s vaccine induced neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax’s vaccine can stimulate both arms of the immune system and may induce a broad response against circulating variants. Novavax’s vaccine is authorized for use in the U.S. and is currently under review in other markets.