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Novavax again delays seeking US approval for COVID-19 vaccine

Novavax again delays seeking US approval for COVID-19 vaccine

FILE PHOTO: Vials labelled "COVID-19 Coronavirus Vaccine" and syringe are seen in front of displayed Novavax logo in this illustration taken, February 9, 2021. REUTERS/Dado Ruvic/Illustration

Novavax on Thursday (Aug 5) again delayed its timeline for seeking US authorisation for its two-dose COVID-19 vaccine, and the company now expects to file for its emergency use in the fourth quarter of 2021.

It had previously said it would seek emergency use authorisation (EUA) from the US Food and Drug Administration in the third quarter.

Novavax shares dropped 8.5 per cent in after-hours trading.

"It's a matter of getting validation work done" to demonstrate consistency in the vaccine's manufacturing process to the FDA, said Chief Executive Officer Stanley Erck, adding that other countries' regulators have been more aggressive in moving Novavax's vaccine through the authorisation process.

Despite promising clinical data, the Maryland-based company has lagged rival vaccine makers such as Pfizer and Johnson & Johnson. It has repeatedly delayed regulatory filings and the timeline for ramping up production as it struggled to access raw materials and equipment needed to produce the vaccine.

The company said it has filed for regulatory authorization of NVX-CoV2373 in India, Indonesia and the Philippines and expects to file for the World Health Organization's emergency listing for its shot this month, a prerequisite for exports to numerous countries participating in the COVAX international vaccine sharing program.

Erck told Reuters the company is on track to submit a regulatory filing in the United Kingdom in September followed within weeks by submissions in Australia and Canada.

He expects Novavax to emerge as a major distributor of vaccines to lower and middle-income countries in 2021.

Separately, Novavax said a single booster shot of its vaccine given six months after an initial two-dose regimen, elicited a 4.6-fold increase in antibodies.

According to Erck, the company will file a separate application with the FDA once its EUA submission is processed.

The company said it remained on track to produce 100 million doses per month in the current quarter and 150 million doses by the fourth quarter.

"We appear to have got past (certain) supply issues and are now being able to produce at scale," Erck said.

Novavax reported a net loss of US$352 million, or US$4.75 per share, for the second quarter of 2021, far higher than its net loss of US$18 million for the same period in 2020. It's second quarter revenue was US$298 million.

Analysts had expected higher revenue and a lower loss per share, according to data from Refinitiv. Novavax attributed the greater loss to drug development costs.

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Source: Reuters/jt

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