Nov 1 (Reuters) – Novavax Inc (NVAX.O) expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within “weeks,” its CEO told Reuters, after the shot was fired on Monday. received first emergency use authorization (EUA) from Indonesia.
Novavax shares rose about 13% after the company also said it filed an emergency application for the vaccine with Canada and the European Medicines Agency.
For Indonesia, the injection will be manufactured by the world’s largest vaccine manufacturer, Serum Institute of India (SII), and sold under the Indian company’s brand name, Covovax. Novavax said the first shipments to Indonesia are expected to begin shortly.
The World Health Organization (WHO) is also reviewing Novavax’s registration, and the US drugmaker expects that review to be resolved in the coming weeks, Chief Executive Stanley Erck told Reuters in a telephone interview on Monday.
A green light from the WHO would clear the way for Novavax to begin sending doses to the COVAX program that supplies shots to low-income countries. Novavax and SII have jointly committed to provide more than 1.1 billion doses of COVAX, which is co-led by the WHO.
“I think we’re going to get some doses to COVAX this year,” Erck said. “But I think (Novavax will) be able to ship really large quantities to COVAX in the first quarter of 2022.”
Erck said Novavax has solved all of its manufacturing challenges and does not expect regulators to worry about its manufacturing processes any more.
He said Novavax is “in dialogue with the US FDA and … we expect a full filing within the next few weeks.”
Novavax had delayed its application for US approval, and Politico reported last month that the company was dealing with manufacturing and quality issues.
SII has been authorized to make the Novavax vaccine, and the US company said it will apply for licenses for other facilities, such as its plant in the Czech Republic, in the coming weeks.
According to the government, Indonesia will receive 20 million doses of the protein-based vaccine this year.
Penny Lukito, head of Indonesia’s National Agency for Drugs and Food Control, did not immediately respond to a request from Reuters for comment.
Novavax has so far applied for EUA in several countries, including the UK, Australia, India and the Philippines.
“It will be weeks, not months, before they review Novavax’s regulatory submissions and potentially release the opportunity for use,” Erck said.
The company, along with Japanese partner Takeda Pharmaceutical Co (4502.T), said Friday it was preparing to receive regulatory approval for a rollout in Japan early next year. read more
The Novavax injection was found to be more than 90% effective, including against some of the worrying strains of the coronavirus in a large, late-stage US-based trial.
Reporting by Dania Nadeem in Bengaluru and Carl O’Donnell in New York; additional reporting by Leroy Leo in Bengaluru and Stanley Widianto in Jakarta; Editing by Maju Samuel and Bill Berkrot
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