Novavax again delays seeking U.S. approval for COVID-19 vaccine
Aug 5 (Reuters) - Novavax Inc on Thursday again delayed its timeline for seeking authorization for its two-dose vaccine in the United states, and the company now expects to file for emergency use authorization in the fourth quarter of 2021.
It had previously said it would seek authorization from the U.S. Food and Drug Administration (FDA) in the third quarter of 2021.
"It's a matter of getting validation work done" to demonstrate consistency in its vaccine 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 authorization process.
Despite promising clinical data, the Maryland-based company has lagged rival vaccine makers such as Pfizer Inc and Johnson & Johnson. It has repeatedly delayed its regulatory filings and timeline for ramping up production as it struggled to access raw materials and equipment needed to make its vaccine.
The company said it has filed for regulatory authorization of NVX-CoV2373 in India, Indonesia and the Philippines and expects to file for World Health Organization's emergency listing for its vaccine this month, which is a prerequisite for exports to numerous countries participating in the COVAX Facility.
Erck told Reuters the company is on track to submit 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 emergency use authorization submission is processed.
The company said it remained on track to produce 100 million doses per month by the third 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.
(Reporting by Mrinalika Roy in Bengaluru and Carl O'Donnell in New York; Editing by Lisa Shumaker)
