Enhanced Protein-based COVID-19 Vaccine Approved for Europe
Novavax, Inc. today announced the European Commission has approved the Nuvaxovid™ XBB.1.5 COVID-19 vaccine for individuals aged 12 and older.
This decision follows a positive opinion on approval from the European Medicines Agency's Committee for Medicinal Products for Human Use.
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.
Novavax's vaccine is authorized for use in the U.S.
"Today's approval of the only updated protein-based non-mRNA COVID-19 vaccine in the EU is an important milestone as the need for vaccination continues," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on October 31, 2023.
"Novavax is working closely with national authorities to have our updated vaccine delivered and available in Europe in the coming weeks."
Nuvaxovid™ XBB.1.5 (recombinant, adjuvanted) (NVX-CoV2601) 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 (T-cell) responses against EG.5.1 and XBB.1.16.6.
These data indicate that Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against circulating variants.1,2
In clinical trials, the most common adverse reactions to Novavax's prototype COVID-19 vaccine (NVX-CoV2373) were headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.