Investing.com – Novavax stock (NASDAQ:NVAX) was looking to extend its previous session’s gains Tuesday after its Covid-19 vaccine secured its first approval for emergency use in any country.
The stock climbed more than 5% in premarket trading after closing almost 16% higher Monday on the news that Indonesia had allowed Novavax’s NVX-CoV2373 for emergency use.
CEO Stanley Erck told Reuters it expects regulators in India, the Philippines and elsewhere to decide on the approval within weeks.
The development is a big boost to Novavax’s plans, which have been held back by manufacturing challenges. Those issues delayed the approvals to the vaccine in the U.S. and Europe, pegging it behind the likes of Pfizer (NYSE:PFE)-BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) which have already delivered billions of doses.
The problems led Novavax's stock to shed more than half of its value in the last two months. It has now recouped around one-third of those losses.
Erck said Novavax has resolved all of its manufacturing challenges and does not expect regulators to have any further concerns about its production processes.
India’s Serum Institute will make the vaccine and market it in Indonesia under the brand name Covovax.
In a separate press release, Novavax said it has filed for vaccine authorization with the Canadian regulator and completed submission for final review to the European Medicines Agency. It also expects to make a full submission for approval to the U.S. Food and Drug Administration in "several weeks", according to Erck.