Novavax COVID-19 vaccine first approved. CEO says he expects more in the coming weeks

Novavax Inc. hopes India, Philippines and other regulators will make a COVID-19 vaccine decision within “a few weeks” after Monday’s Shot receives the first Emergency Use Authorization (EUA) from Indonesia. I told Reuters that I was doing it. ..

Novavax shares rose about 13% after the company announced that it had filed an emergency vaccine application with Canada and the European Medicines Agency.

In the case of Indonesia, Shot is manufactured by the Serum Institute (SII) of India, the world’s largest vaccine maker, and sold under the Indian company brand name Covovax. Novavax said the first shipment to Indonesia is expected to begin shortly.

The World Health Organization (WHO) is also considering filing with Novabax regulators, and U.S. pharmaceutical companies expect the review to be resolved in the coming weeks, Stanley Elk said. He told Reuters in a telephone interview on Monday.

The green light from WHO prepares Novavax to begin shipping doses to the COVAX program, which supplies shots to low-income countries. Novavax and SII have jointly promised to deliver more than 1.1 billion doses to WHO-led COVAX.

“I think we’ll get some COVAX this year,” Erck said. “But I think [Novavax is] It will be available for mass shipment to COVAX in the first quarter of 2022. “

Erck said Novavax has resolved all manufacturing challenges and expects regulators to have no further concerns about the manufacturing process.

He said Novavax is “in dialogue with the US FDA … and expects a full submission in the coming weeks.”

Novavax has postponed the US approval application, and Politico reported last month that the company is facing production and quality issues.

SII has been licensed to produce the Novavax vaccine, and US companies have announced that they will apply for regulatory approval for other facilities, such as factories in the Czech Republic, in the coming weeks.

According to the government, Indonesia plans to receive 20 million protein-based vaccines this year.

Indonesian National Agency of Drug and Food Supervision Commissioner Penny Rukito did not immediately respond to Reuters’ request for comment.

Novavax has applied for EUA in a variety of countries, including the United Kingdom, Australia, India and the Philippines.

“They will be reviewing for weeks instead of months,” Erck said, confirming Novavax’s regulatory submissions and potentially clearing shots for use. ..

The company, along with its Japanese partner Takeda Pharmaceutical Company, said it is preparing to seek regulatory approval for its rollout in Japan early next year.

Novavax Shot has been shown to be more than 90% effective, including against a variety of related variants of the coronavirus, in a large US-based late-stage study.

Karl O’Donnell and Dania Nadim



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