The U.S. said it will not continue to fund the production of Novavax's COVID-19 vaccine until the biotech can prove to the FDA that it meets the agency's manufacturing standards, according to Novavax's quarterly filing with the Securities and Exchange Commission.
The federal government awarded Novavax two deals for its COVID-19 vaccine candidate. Operation Warp Speed pledged $1.74 billion for 100 million doses, and the Department of Defense pledged $60 million for 10 million doses.
Novavax has faced continuous manufacturing hurdles throughout its vaccine candidate's development process. An anonymous HHS official told The New York Times the government wanted the company to strengthen its testing and quality control operations before it continues to fund production.
"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," Novavax said in its Aug. 5 SEC filing.