Novavax’s updated COVID-19 vaccine now authorized in Canada

Novavax announced that Health Canada has granted expanded authorization for Nuvaxovid XBB.1.5 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. The Public Health Agency of Canada’s National Advisory Committee on Immunization recommended XBB COVID-19 vaccines that target more recent, immune-evasive variants of the virus. The expanded authorization was based on non-clinical data showing that Novavax’s 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 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 currently circulating variants. In clinical trials, the most common adverse reactions associated with the vaccine included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise. Novavax’s updated COVID-19 vaccine is also authorized in the U.S., the European Union and by the WHO, and is under review in other markets.