The EUL for NVX-CoV2601 was granted based on non-clinical evidence which demonstrated that the vaccine produced functional immune responses against the XBB.1.5, XBB.1.16, and XBB.2.3 variants

Nuvaxovid

A product image of Nuvaxovid. (Credit: Novavax)

Novavax has secured emergency use listing (EUL) from the World Health Organization (WHO) for its updated protein-based Covid-19 Vaccine, Nuvaxovid XBB.1.5 Covid-19 Vaccine (NVX-CoV2601).

WHO has granted the emergency use of the updated Covid shot for active immunisation to prevent Covid-19 in individuals aged 12 years and more.

NVX-CoV2601, which was approved in the US last month, is a new version of the company’s prototype Covid-19 vaccine, NVX-CoV2373. It is designed to target the Omicron XBB.1.5 subvariant.

The EUL will enable WHO’s 194 member states to expedite regulatory permissions to import and administer the Covid-19 vaccine.

It will also help the member states to evaluate vaccines with the goal of accelerating availability.

NVX-CoV2601 is said to have a 12-month shelf life and can be stored at 2-8° Celsius, which makes distribution easier and reduces waste and carbon footprint.

Novavax president and CEO John Jacobs said: “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. 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.”

The EUL was granted based on non-clinical evidence which demonstrated that the vaccine produced functional immune responses against the XBB.1.5, XBB.1.16, and XBB.2.3 variants.

Further non-clinical findings showed that Novavax’s vaccine [ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6 in addition to neutralising antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6.

These findings suggest that NVX-CoV2601 can stimulate both immune systems and may trigger a widespread defense against currently circulating variants, the American biotechnology company said.

The updated Covid-19 vaccine is also approved in the European Union and is being evaluated in additional markets.