U.K. Authorized Updated Protein-based COVID-19 Vaccine

Novavax, Inc. today announced that the United Kingdom's (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 in individuals aged 12 and older.

Recent data indicate Novavax's vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants.

"Today's MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on January 24, 2024.

"We are in ongoing conversations with additional U.K. partners to identify potential opportunities to offer our protein-based non-mRNA COVID-19 vaccine to all eligible individuals who want one."

"We believe this is critical to supporting long-term, broad uptake of a seasonal COVID-19 vaccine in the U.K."

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.

If people are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/.

The U.K. authorization was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses for 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 JN.1, 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.

In 2023, the U.S. Food and Drug Administration amended its authorization for Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 and older, to include the 2023-2024 formula. 

Novavax COVID-19 vaccine brands include Nuvaxovid, NVX-CoV2601, CovoVax, NVX-CoV2373, and TAK-019, Trademark filing #90813423.