192 WHO Members Can Access Updated Protein-based COVID-19 Vaccine

Novavax, Inc. today 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 immunization to prevent COVID-19 in individuals aged 12 and older.

The EUL enables the WHO's 194 member states to expedite regulatory approvals to import and administer the Nuvaxovid™ XBB.1.5 COVID-19 Vaccine.

Novavax's vaccines are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. Novavax's other COVID-19 brands include CovoVax™ and NVX-CoV2373.

"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, in a press release on November 28, 2023.

"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 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 neutralizing 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 that Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.5,6

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 authorized in the U.S. and the European Union and is under review in other markets. As of November 2023, the NVX-CoV2373 vaccine had been delivered globally in about 40 markets.