Novavax Delays in Applying for U.S. Regulatory Approval for Covid-19 Vaccine

Novavax Inc. has said it will delay the emergency clearance request in the United States for its Covid-19 vaccine until the fourth quarter as it works to complete the manufacturing portion of its request.

“The manufacturing part has been the most important job we have to do,” Stanley Erck, CEO of Novavax, said in an interview on Thursday. “I’m hoping for October for the FDA, but we don’t have a chosen date.”

He said Novavax planned to seek approval from UK regulators in September and would follow shortly thereafter in Canada and Australia.

The Novavax vaccine can be stored at normal refrigerator temperatures, thus avoiding the need for freezers required for certain other Covid-19 vaccines. If cleared by regulators, the shot could provide a much-needed boost to global efforts to vaccinate people against the coronavirus, which has revealed growing disparities between developed and developing countries.

Novavax, of Gaithersburg, Md., Said Thursday it has filed for regulatory approval in India, Indonesia and the Philippines. He also said he plans to file the World Health Organization’s emergency list this month, which is a prerequisite for exporting vaccines through the agency’s Covax facility to provide vaccines to the poorest countries.