Health Canada has granted authorization for Novavax Inc’s COVID-19 Vaccine “Nuvaxovid” (Recombinant protein, Adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older, the company reported. The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorized for use in Canada. The vaccine was also submitted for FDA emergency use authorization in the United States on January 31, 2022.
The Health Canada decision was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the US and Mexico and was published in the New England Journal of Medicine (NEJM); and a UK trial with almost 15,000 adult participants, which was also published in NEJM.
In both trials, NVX-CoV2373 demonstrated efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
“We are proud that Canada is part of the growing list of regions to authorize Nuvaxovid and that Canadians will have a protein-based COVID-19 vaccine option,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the Canadian government and the National Research Council of Canada for their ongoing partnership and commitment to helping combat the evolving pandemic.”
Novavax and the Government of Canada signed an advance purchase agreement for 52 million doses of Novavax’ COVID-19 vaccine, with the option for up to an additional 24 million doses, in January 2021 and established a memorandum of understanding to produce NVX-CoV2373 at the National Research Council of Canada’s (NRC) Biologics Manufacturing Centre in Montréal in February 2021. Novavax and the NRC have been working closely to establish the production of NVX-CoV2373 at the Biologics Manufacturing Centre. Good Manufacturing Practice (GMP) production is expected to begin later this year.
The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA.
Authorization of Nuvaxovid™ in Canada
Health Canada has granted authorization for registration of Nuvaxovid™ COVID-19 Vaccine (Recombinant protein, Adjuvanted) to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.