NVX-CoV2601 is an updated iteration of Novavax's initial COVID-19 vaccine NVX-CoV2373 and is tailored specifically to target the Omicron XBB.1.5 subvariant
NVX-CoV2601 is an updated version of Novavax's initial COVID-19 vaccine NVX-CoV2373. (Credit: Novavax)
Novavax has secured the European Commission (EC)’s approval for Nuvaxovid XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older.
The EC’s decision comes after the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) towards the vaccine’s approval.
Novavax president and CEO John Jacobs said: “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.
“Novavax is working closely with national authorities to have our updated vaccine delivered and available in Europe in the coming weeks.”
NVX-CoV2601 represents an updated iteration of Novavax’s initial COVID-19 vaccine NVX-CoV2373 and is specifically tailored to target the Omicron XBB.1.5 subvariant.
The updated vaccine is protein-based and created by replicating the surface spike protein of SARS-CoV-2, the virus responsible for COVID-19.
By leveraging Novavax’s recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen, priming the immune system to recognise the virus. Additionally, Novavax’s Matrix-M adjuvant is said to amplify and diversify the immune response.
Its EC approval was driven by non-clinical data which showcased its effectiveness in generating functional immune responses against the XBB.1.5, XBB.1.16, and XBB.2.3 variants.
Additionally, supplementary non-clinical data illustrated that Novavax’s vaccine prompted neutralising antibody responses to newly emerging subvariants. These include 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.
The findings suggest that the vaccine has the capacity to activate both branches of the immune system and may foster a comprehensive response to the prevailing variants, said the company.
According to Novavax, the vaccine is available in a convenient ready-to-use liquid formulation and can be stored at temperatures ranging from 2° to 8°C, enabling its integration into existing vaccine supplies and cold chain distribution channels.