Novavax's COVID-19 Vaccine Scores Conditional Approval In Europe

The European Commission has granted conditional marketing authorization to Novavax Inc's NVAX Nuvaxovid COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years of age & older. 

• The authorization follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation today to authorize the vaccine.
• The decision is based on the totality of preclinical, manufacturing, and clinical trial data, including two pivotal Phase 3 trials. 
• Related: Novavax To Possibly Kickstart COVID-19 Vaccine Delivery To EU In Q1 2022: Source
• NVX-CoV2373 demonstrated high efficacy in both trials and an acceptable safety and tolerability profile. 
• Novavax and the EC announced an advance purchase agreement for up to 200 million Novavax's COVID-19 vaccine doses in August 2021. 
• Initial doses are expected to arrive in Europe in January. 
• The Company expects to submit its complete chemistry, manufacturing, and controls data package to the FDA by year-end.
• Price Action: NVAX shares are trading lower by 5.24% at $205.93 during the market session on the last check Monday.