Health Canada approves Novavax Inc's (NASDAQ:NVAX) Nuvaxovid COVID-19 Vaccine in individuals 18 years of age and older.
- The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine authorized for use 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 a trial with almost 15,000 adult participants in the U.K.
- NVX-CoV2373 demonstrated efficacy and a reassuring safety and tolerability profile in both trials.
- Related: Novavax's COVID-19 Vaccine Shows 80% Effectiveness In Adolescent Study.
- Novavax will continue to collect and analyze real-world data, including monitoring safety and evaluating variants, as the vaccine is distributed.
- Novavax and the Government of Canada signed an advance purchase agreement for 52 million doses of Novavax's COVID-19 vaccine, with the option for up to an additional 24 million doses, in January 2021.
- Price Action: NVAX shares are down 3.70% at $83.35 during the market session on the last check Thursday.
