Novavax Inc (NVAX)

[JoeForkeyBolo]

NEWS: Novavax's Updated COVID-19 Vaccine Now Authorized in Canada

https://ir.novavax.com/press-releases/2023-12-05-Novavaxs-Updated-COVID-19-Vaccine-Now-Authorized-in-Canada

December 5, 2023

• Novavax's updated protein-based non-mRNA COVID-19 vaccine will be available in Canada for individuals aged 12 and older in the coming days

GAITHERSBURG, Md., Dec. 5, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today 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.1

"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.2,3

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., the European Union and by the WHO, and is under review in other markets.