Benzinga | Dec 20, 2021 02:43PM EST

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

The European Commission has granted conditional marketing authorization to Novavax Inc's (NASDAQ: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.