EC approves Novavax Covid-19 vaccine for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals aged 12 & older

Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, announced the European Commission has granted approval for Nuvaxovid XBB.1.5 dispersion for injection Covid-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals aged 12 and older. This decision follows positive opinion for approval from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

"Today's approval of the only updated protein-based non-mRNA Covid-19 vaccine in the EU is an important milestone as the need for vaccination continues," said John C. Jacobs, President and chief executive officer, Novavax. "Novavax is working closely with national authorities to have our updated vaccine delivered and available in Europe in the coming weeks."

Novavax is working closely with EU member states that have requested doses through the advance purchase agreement to confirm timing of dose delivery on a country-by-country basis.

Approval was based on non-clinical data showing that Novavax's updated 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 newly emerging 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 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 vaccine is authorized for use in the US and is currently under review in other markets.

Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (Covid-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax Covid-19 Vaccine, Adjuvanted.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

NVX-CoV2601 is an updated version of Novavax's prototype Covid-19 vaccine (NVX-CoV2373) formulated to target the Omicron XBB.1.5 subvariant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes Covid. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.

When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.

Novavax, Inc. promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Maryland, US, offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response.

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