Health Canada has granted expanded authorisation for Novavax’s updated Covid-19 vaccine, Nuvaxovid XBB.1.5 (recombinant protein, adjuvanted) [NVX-CoV2601].
The vaccine is indicated for the active immunisation of those aged 12 years and above for Covid-19 prevention.
The company plans to make the adapted protein-based, non-mRNA vaccine available in the country soon.
The move comes after the National Advisory Committee on Immunization of the Public Health Agency of Canada recommended the use of XBB Covid-19 vaccines that target new, immune-evasive viral variants.
Health Canada’s latest authorisation is based on non-clinical findings where Novavax’s vaccine elicited functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants of the SARS-CoV-2 virus.
Further data showed that the vaccine stimulated neutralising antibody responses to BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 subvariants, apart from CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6 variants.
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The company noted that these results demonstrated the vaccine’s potential to stimulate both arms of the immune system and elicit wide-ranging responses against newly emerged variants.
Headache, nausea, pain in muscles and joints, tenderness and pain at the injection site, malaise and fatigue are the most frequently reported adverse reactions linked to the prototype Covid-19 vaccine (NVX-CoV2373) in clinical trials.
The updated Covid-19 vaccine of Novavax is also authorised for use in the US and European Union.
Last month, the World Health Organisation granted emergency use listing for the company’s updated form of the Covid-19 vaccine.
Novavax president and CEO John Jacobs stated: “The expanded authorisation 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.
“We look forward to helping to protect Canadians in time for the upcoming holiday season and, pending vaccine batch release, have doses in the market for access across the country.”