Although Novavax (NSDQ:NVAX) disclosed the news in a July 31 SEC filing, investors apparently didn’t react to the development until today. In mid-day trading, the stock dipped 20% to $188.18. The company’s stock had surged earlier in the week.
In the SEC filing, Novavax said the U.S. government told the company to align its analytic methods with the FDA before planning additional domestic manufacturing. Furthermore, the government told Novavax that it would withhold funding for additional manufacturing until the company had done so.
The company had landed a $1.75 billion contract as part of the U.S. government’s Operation Warp Speed program to produce a COVID-19 vaccine. The U.S. agreed to purchase 110 million doses of the vaccine after it receives emergency use authorization.
Similar to Moderna, the COVID-19 vaccine will be Novax’s first commercial product.
The New York Times report suggests that Novavax has struggled to convince the FDA that it can manufacture its vaccine candidate according to FDA standards.
The company is partnering with vaccine manufacturer Serum Institute of India Pvt. Ltd. The two have jointly filed for emergency use authorization for its vaccine in India, Indonesia and the Philippines.
Novavax has said it intends to file for EUA in the U.S. in the fourth quarter of 2021.
The company has stressed that it still intends to manufacture 100 million doses per month by the end of the third quarter, with that sum increasing to 150 million by the end of 2021.
Filed Under: clinical trials, Drug Discovery, Infectious Disease