By Dhirendra Tripathi
Investing.com – Novavax stock (NASDAQ:NVAX) climbed 10% in Monday’s premarket trade as the company’s much-delayed Covid vaccine secured the European medicines regulator’s approval for treating adults.
Formal approval from the European Commission is still outstanding but is generally a rubber-stamp process.
The company will market its NVX-CoV2373 vaccine as Nuvaxovid.
Novavax has a contract to supply the EU with up to 200 million doses of its vaccine. The Serum Institute of India, the Indian company behind a large part of AstraZeneca's (NASDAQ:AZN) Covid-vaccine supplies, will also be making Novavax’s Covid shots. It will later be supplemented with production from other sites in Novavax's global supply chain, the U.S. company said.
Novavax’s Covid vaccine secured the World Health Organization’s nod on Friday. That approval allows it to ship doses to the Covax program, providing another vaccine to low-income countries.
The protein-based vaccine developed by Novavax has been shown in trials to be more than 90% effective against a variety of coronavirus variants. The company plans to begin commercial manufacturing of a vaccine tailored to the highly transmissible Omicron coronavirus variant in January, according to Reuters.
Novavax's shot has received authorization for emergency use in Indonesia and the Philippines, and the company has filed for similar approvals in U.K., U.A.E., Australia, New Zealand, India, Canada, Singapore and Japan. The WHO and the EU approvals should make those clearances easier.
Novavax expects to file with the U.S. Food and Drug Administration for approval in the U.S. by the end of this month.
The company has been late in bringing its Covid vaccine to market, held back by manufacturing challenges, which have since been addressed.