Aug 5 - Novavax Inc has again delayed its timeline for seeking authorization for its emergency uses in the United States for two dose vaccine. The company expects to file for emergency use authorization in the fourth quarter of 2021.
It previously said it would seek authorization from the U.S. Food and Drug Administration in the third quarter of 2021.
It's a matter of validation work done to demonstrate consistency in the vaccine manufacturing process at 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-CoV 2373 in India, Indonesia and the Philippines and expects to file the emergency listing for its vaccine this month for the WHO, which is prerequisite for exports to numerous countries participating in COVAX Facility.
Erck told Reuters the company was on track to submit regulatory filing in Australia in September, followed within weeks by filings in the United Kingdom (in london) and Canada.
He expects Novavax to emerge in 2021 as a major distributor of vaccines to low and middle-income countries.
Separately, Novavax said a single 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 approval is processed.
The company said it was 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 past supply issues and we are now able to produce at scale, Erck said.