Novavax Receives the Health Canada Marketing Authorization for Nuvaxovid (NVX-CoV2373) to Treat COVID-19
Shots:
- Health Canada has granted authorization to Nuvaxovid COVID-19 vaccine, administered as a two-dose regimen of 5mcg/ dose, 21 days apart for COVID-19 in patients aged ≥18yrs.
- The approval was based on the 2 P-III (PREVENT-19) trial in ~30,000 patients aged ≥18yrs. across US & Mexico & another trial in 15,000 patients in the UK. The studies showed an efficacy, safety & tolerability profile, SAEs were low in no. & balanced b/w vaccine & PBO, 90% effective to prevent symptomatic COVID-19 & 100% at sev. disease
- The company will collect & analyze real-world data including safety & evaluation of variants. NVX-CoV2373 is 1st protein-based vaccine & a ready-to-use liquid formulation in a vial containing 10 doses
Ref: PR Newswire | Image: Wikipedia
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