WHO Authorise Emergency Use of Novavax Protein-based COVID-19 Vaccine

Novavax Inc have announced that Nuvaxovid XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunisation to prevent COVID-19 in individuals aged 12 and older. The EUL assists WHO member states in assessing vaccines with the aim of expediting availability and enables the WHO's 194 member states to expedite regulatory approvals to import and administer the vaccine.

"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," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Rural or hard-to-reach areas can benefit from our vaccine's ease of transport and storage profile. As part of a diversified vaccine portfolio, our vaccine can play an important role in helping to protect people around the globe against the latest variants."

Novavax's 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.

The EUL 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 neutralising 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 (T-cell) 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 Novavax's prototype COVID-19 vaccine (NVX-CoV2373) 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 authorised in the U.S. and the European Union, and is under review in other markets.