NovavaxInc received the first emergency use authorization (EUA) from Indonesia for its COVID-19 vaccine on Monday, and expects regulators in India, the Philippines and other countries to make a decision on the vaccine within weeks, stated the company’s chief executive.

For Indonesia, the vaccine will be manufactured by the Serum Institute of India (SII), and will be sold under the company′s brand name, Covovax. Novavax′s regulatory filing is also being reviewed by the World Health Organization (WHO) and the company expects the review to be resolved in the coming weeks, said Chief Executive Stanley Erck. Erck also stated that the company has resolved all manufacturing challenges and added that the company is “in dialogue with the U.S. FDA and ... we expect a full submission within the next several weeks.” Novavax had delayed filing for U.S. regulatory approval… (Reuters, November 2, 2021)