Health Canada grants expanded authorization to Novavax's Covid-19 vaccine, Nuvaxovid XBB.1.5 Vaccine

Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, announced that Health Canada has granted expanded authorization for Nuvaxovid XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals aged 12 and older. The Public Health Agency of Canada's National Advisory Committee on Immunization recommended XBB Covid-19 vaccines that target more recent, immune-evasive variants of the virus.

"Today's expanded authorization will support the Canadian government's strong commitment to provide its citizens with effective options, such as our protein-based non-mRNA vaccine, in the campaign against currently circulating Covid-19 variants," said John C. Jacobs, president and chief executive officer, Novavax. "We look forward to helping to protect Canadians in time for the upcoming holiday season and, pending vaccine batch release, have doses in market for access across the country."

The expanded authorization 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 Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently 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 updated Covid-19 vaccine is also authorized in the US, the European Union and by the WHO, and is under review in other markets.

The trade name Nuvaxovid has not been approved by the US Food and Drug Administration.

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-19. 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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