Novavax CEO Stanley Erk said initial shipments to Indonesia are expected to begin soon. (file)
Washington:
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, its first emergency response from Indonesia since the shot on Monday. Usage authorization (EUA) received.
Novavax shares rose nearly 13 percent after the company also said it 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 will be sold under the Indian company’s brand name, Kovovax.
Novavax said initial shipments to Indonesia are expected to begin soon.
The World Health Organization (WHO) is also reviewing Novavax’s regulatory filing and the US drugmaker expects the 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 for the COVAX program that supplies shots to low-income countries.
Together, Novavax and SII have committed to providing over 1.1 billion doses to COVAX, which is co-led by WHO.
“I think we’ll give COVAX a few doses this year,” Erk said. “But I think[Novavax is]really going to be able to ship COVAX in large quantities in the first quarter of 2022”.
Erk said Novavax has resolved all of its manufacturing challenges and doesn’t expect regulators to have any further concerns about its production processes. He added that Novavax is “in talks with the US FDA and … we expect to have a full submission within the next several weeks.”
Novavax had delayed filing for US approval, and Politico reported last month that the company faced production and quality problems. SII is authorized to manufacture the Novavax vaccine and the US company said it would apply for regulatory authorization for other facilities like its plant in the Czech Republic in the coming weeks.
Indonesia expects to receive 20 million doses of the protein-based vaccine this year, according to the government. Penny Lukito, head of Indonesia’s National Agency for Drug and Food Control, did not immediately respond to a Reuters request for comment.
Novavax has so far applied for EUA in various countries including the UK, Australia, India and the Philippines.
For Novavax to clear the shot for regulatory submission and potentially use, “it will be months, not weeks, to review it,” Erck said.
The company, along with Japanese partner Takeda Pharmaceutical Co, said on Friday that it is preparing to seek regulatory approval for a rollout in Japan early next year.
The Novavax shot was shown to be more than 90 percent effective in a large, late-stage US-based trial involving a variety of related variants of the coronavirus.
(Except for the title, this story has not been edited by NDTV staff and is published from a syndicated feed.)
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