Novavax Inc and partner Serum Institute of India said on Monday they received emergency use authorisation for their Covid-19 vaccine in Indonesia, making it the first approval anywhere in the world for Novavax.
The shot will be sold under the brand name Covovax.
Novavax has so far applied for EUA in various countries, including Canada, the UK, Australia, India and to the European Medicines Agency.
The company, along with Japanese partner Takeda Pharmaceutical Co, said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.
Novavax has delayed filing for US approval to the end of this year, and Politico reported last month that the company has faced production and quality problems.
The Novavax shot is a protein-based vaccine, and was shown to be more than 90% effective, including against a variety of concerning variants of the coronavirus in a large, late-stage US-based clinical trial.