What happened
Shares of Novavax (NVAX 2.06%) were soaring 28.4% higher this week as of the market close on Thursday, according to data from S&P Global Market Intelligence. Much of this big gain came after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended granting expanded conditional marketing authorization for Novavax's COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), in adolescents ages 12 through 17.
So what
Novavax already secured authorization for Nuvaxovid in the European Union (EU) for immunizing adults ages 18 and older in December 2021. CHMP's recommendation that the vaccine be authorized for adolescents seems likely to pave the way for the company's sales to increase.
The authorization process in Europe is different than the one followed in the U.S. The CHMP recommendation will be given to the European Commission's Standing Committee on Medicinal Products for Human Use. Unless this committee raises objections, the European Commission should move forward with authorization.
If authorized, Nuvaxovid will become the first protein-based COVID-19 vaccine available to adolescents in the EU. Novavax previously received Emergency Use Authorization (EUA) for its vaccine in protecting adolescents from COVID-19 in India.
This week's move was welcome news for the vaccine stock. Shares of Novavax had plunged more than 70% year to date prior to the nice gain in recent days.
Now what
Novavax also filed on Thursday for expanding the label for Nuvaxovid to include adolescents ages 12 to 17 in Canada. The company still awaits an important decision by the U.S. Food and Drug Administration for EUA of its vaccine in adults pending a review of its manufacturing processes.
