Novavax delays COVID vax EUA submission

Aug. 6, 2021

Novavax announced in its S.E.C. filing that it will delay the submission of its COVID-19 vaccine to the U.S. FDA for emergency use authorization until its fourth quarter.

The Gaithersburg, Maryland-based drugmaker, which has a $1.75 billion federal contract to develop and produce a coronavirus vaccine, is a few months behind its prior estimate in seeking regulatory approval in the U.S. for its NVX-CoV2373 candidate. In yesterday's S.E.C. filing, Novavax said: “The U.S. government has recently instructed the company to prioritize alignment with the U.S. Food and Drug Administration on the company’s analytic methods before conducting additional U.S. manufacturing and further indicated that the U.S. government will not fund additional U.S. manufacturing until such agreement has been made.”

Four people familiar with Novavax’s operation told the NY Times that the company has been unable to demonstrate that its production process meets FDA standards.

However, according to the drugmaker, it remains on track to reach manufacturing capacity of 100 million doses per month by October and 150 million doses per month by the end of the year.

Novavax has filed for regulatory approval in India, Indonesia and the Philippines and plans to submit for emergency use listing at the World Health Organization this month.