Novavax shares jumped 10% in premarket trading on Monday after the European Medicines Agency approved the company's long-awaited Covid vaccine for treating adults.
The European Commission's formal clearance is still pending, although it is often a rubber-stamp process.
Nuvaxovid will be the brand name for the company's NVX-CoV2373 vaccine.
Novavax has a deal to supply up to 200 million doses of their vaccine to the European Union. Novavax's Covid shots will be manufactured by the Serum Institute of India, the Indian business that supplies a substantial portion of AstraZeneca's Covid vaccination supply. It will be augmented subsequently by production from additional locations in Novavax's global supply chain, according to the business.
On Friday, the World Health Organization approved Novavax's Covid vaccine. With this approval, it will be able to export doses to the Covax program, allowing it to provide a new vaccination to low-income countries.
Novavax's protein-based vaccine has been found in clinical studies to be more than 90% effective against a range of coronavirus types. According to a major newswire, the business hopes to start commercial production of a vaccine targeted to the highly transmissible Omicron coronavirus strain in January.
In Indonesia and the Philippines, Novavax's injection has been approved for emergency use, and the company has applied for similar licenses in the United Kingdom, the United Arab Emirates, Australia, New Zealand, India, Canada, Singapore, and Japan. These permissions should be made easier thanks to WHO and EU approvals.
Novavax plans to petition for approval in the United States with the Food and Drug Administration by the end of this month.
The company has been behind schedule in delivering its Covid vaccine to market, owing to production issues that have now been resolved.