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Aug. 5 (Reuters) – Novavax Inc on Thursday again delayed its authorization application schedule for its two-dose vaccine in the United States, and the company now plans to file an emergency use authorization application at the fourth quarter 2021.
He had previously announced that he would seek clearance from the United States Food and Drug Administration (FDA) in the third quarter of 2021.
“It’s about getting validation work done” to demonstrate the consistency of its vaccine manufacturing process at the FDA, said managing director Stanley Erck, adding that regulators in other countries have been more aggressive in doing so. pass the Novavax vaccine through the authorization process.
Despite promising clinical data, the Maryland-based company lags behind rival vaccine makers such as Pfizer Inc and Johnson & Johnson. It has repeatedly delayed its regulatory filings and schedule to ramp up production as it struggled to access the raw materials and equipment needed to make its vaccine.
The company said it has filed for regulatory approval for NVX-CoV2373 in India, Indonesia and the Philippines and expects to file the World Health Organization’s emergency list this month for its vaccine, which is a prerequisite for exports to many countries participating in the COVAX facility. .
Erck told Reuters the company was on track to submit a regulatory dossier to the UK in September, followed in a few weeks by submissions in Australia and Canada.
He expects Novavax to become a major vaccine distributor in low- and middle-income countries in 2021.
Separately, Novavax said that a single booster of its vaccine, given six months after an initial two-dose regimen, caused 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 application is processed.
The company said it remains on track to produce 100 million doses per month by the third quarter and 150 million doses by the fourth quarter.
“We seem to have overcome (some) supply issues and are now able to produce on a large scale,” Erck said.
(Reporting by Mrinalika Roy in Bangalore and Carl O’Donnell in New York; Editing by Lisa Shumaker)
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