Novavax’s Updated COVID-19 Vaccine is Granted EUL by WHO

This week, Novavax announced its updated COVID-19 protein-based vaccine, NVX-CoV2601 (Nuvaxovid), has been granted an EUL by the WHO for immunization against COVID-19 in individuals aged 12 years and older. This listing now clears the way for this vaccine to be an option for all 194 member states of the WHO.

“The WHO Emergency Use Listing of our updated protein-based non-mRNA COVID-19 vaccine enables expedited regulatory approvals for its 194 member states and UN procurement agencies, such as UNICEF, thereby supporting equitable access to our vaccine around the world… Rural or hard-to-reach areas can benefit from our vaccine's ease of transport and storage profile,” Novavax CEO John C. Jacobs, said in a statement.

The vaccine can be stored at 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying delivery, decreasing the carbon footprint and reducing wastage. It has demonstrated efficacy against multiple variants including XBB15. This decision follows authorization in the US and approval in the European Union.

The EUL was based on non-clinical data showing that Novavax's COVID-19 vaccine induced functional immune responses against XBB15, XBB116, and XBB23 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to subvariants BA286, EG51, FL151 and XBB1166 as well as CD4+ polyfunctional cellular (T-cell) responses against EG51 and XBB1166. According to Novavax, these data indicate their vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.

This vaccine does not use the m-RNA platform, but the company’s patented saponin-based Matrix-M adjuvant.

“Our vaccine is a protein based vaccine; it's really unique in that it uses the entire full length spike protein. It takes that spike protein and arranges it as a three-dimensional shape, which puts it in a very similar shape to the natural wild type SARS-CoV-2,” explained Seth Toback, MD, senior vice president, Medical Affairs, Novavax. "So when we make antibodies towards that vaccine, the antibodies are more accurately reflecting the wild type virus and gives us a neutralization response. We then take that fully-spiked protein and we add it to our novel adjuvant, which is called matrix M…it enhances both the cellular and humoral arms of the immune system.

Contagion spoke to Toback recently at IDWeek and he discussed recent data being reported as well as some of the novel characteristics of this vaccine.

Reference

Novavax's Updated Protein-based COVID-19 Vaccine Now an Option for All 194 Member States of the World Health Organization. Novavax press release. November 28, 2023. Accessed December 2, 2023. https://ir.novavax.com/press-releases/2023-11-28-Novavaxs-Updated-Protein-based-COVID-19-Vaccine-Now-an-Option-for-All-194-Member-States-of-the-World-Health-Organization