What happened
Shares of Novavax (NVAX 13.92%) climbed 28.4% this week as of Thursday’s market close, according to data from S&P Global Market Intelligence. Much of this significant gain came after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting extended conditional marketing authorization for Novavax’s COVID-19 vaccine. , Nuvaxovid (NVX-CoV2373), in adolescents aged 12 to 17 years.
So what
Novavax has already obtained authorization of Nuvaxovid in the European Union (EU) for vaccination of adults aged 18 years and over in December 2021. The CHMP recommendation to authorize the vaccine for adolescents seems likely to open the way to increase the company’s sales.
The authorization process in Europe is different from that followed in the United States. The CHMP recommendation will be given to the Standing Committee for Medicinal Products for Human Use of the European Commission. Unless this committee raises objections, the European Commission should go ahead with the authorization.
If approved, Nuvaxovid will become the first protein-based COVID-19 vaccine available for adolescents in the EU. Novavax has previously received an Emergency Use Authorization (EUA) for its vaccine in the protection of adolescents against COVID-19 in India.
This week’s decision was good news for the vaccine stock. Shares of Novavax had plunged more than 70% since the start of the year before the nice gain in recent days.
Now what
Novavax also filed on Thursday to expand the label of Nuvaxovid to include teens 12 to 17 in Canada. The company is still awaiting a major decision from the US Food and Drug Administration for the EUA of its adult vaccine pending a review of its manufacturing processes.
