Novavax COVID vaccine gets nod in Canada

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 U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 adult participants in the U.K. 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. 

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.