2 min read.Updated: 02 Nov 2021, 05:55 AM ISTCarl O'Donnell,Dania Nadeem, Reuters
The Novavax shot 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 trial
Listen to this article
Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within "weeks," its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia.
Novavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.
For Indonesia, the shot will be manufactured by the world's largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company's brand name, Covovax. Novavax said initial shipments into Indonesia are expected to begin imminently.
The World Health Organization (WHO) is also reviewing Novavax's regulatory filing and the U.S. drugmaker expects that review to be resolved in the coming weeks, Chief Executive Stanley Erck told Reuters in a phone interview on Monday.
A green light from the WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries. Novavax and SII have together committed to provide more than 1.1 billion doses to COVAX, which is co-led by the WHO.
“I think we'll get some doses to COVAX this year," Erck said. "But I think (Novavax is) going to really start being able to ship large quantity to COVAX in the first quarter" of 2022.
Erck said Novavax has resolved all of its manufacturing challenges and does not expect regulators to have any further concerns about its production processes.
He said Novavax is “in dialogue with the U.S. FDA and ... we expect a full submission within the next several weeks."