U.K. Authorized Updated Protein-based COVID-19 Vaccine Precision Vaccinations News – Precision Vaccinations

(Precision Vaccinations News)

Novavax, Inc. today announced that the United Kingdom's (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorizationfor 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 peopleare concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found athttps://coronavirus-yellowcard.mhra.gov.uk/.

The U.K. authorization wasbased on non-clinical datashowing 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 the2023-2024 formula.

Novavax COVID-19 vaccine brands includeNuvaxovid,NVX-CoV2601, CovoVax, NVX-CoV2373, andTAK-019,Trademark filing#90813423.

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U.K. Authorized Updated Protein-based COVID-19 Vaccine Precision Vaccinations News - Precision Vaccinations