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WASHINGTON — Maryland firm Novavax, which won a $1.75 billion federal contract to develop and manufacture a coronavirus vaccine, said Thursday that the federal government will not fund further production of the vaccine until the company resolves concerns about the work of federal regulators.
of the firm statement came quarterly filing with the Securities and Exchange Commission. The Trump administration has agreed to purchase 110 million doses of the vaccine from Novavax as part of its emergency vaccine development program.
Although the company reported in June Saying that the vaccine is 90 percent effective against symptomatic Covid-19 cases and 100 percent effective against severe diseases, Novavax has struggled for months to mass-produce its product. Distribution of the vaccine has not been allowed in the United States, and federal officials said it was unclear when or if it would.
Four people familiar with the operation of Novavax said the company has so far been unable to prove that its manufacturing process meets Food and Drug Administration standards. They spoke on the condition of anonymity to discuss sensitive contractual issues.
Novavax said in its SEC filing on Thursday: “The US government has recently instructed the company to prioritize alignment with the US Food and Drug Administration on the company’s analytical methods before it undertakes additional US production, and also stated that the US government will not provide additional funding. U.S. production until such an agreement is made.”
An official with the Department of Health and Human Services, which oversees Novavax’s federal contract, said the government wanted the company to strengthen its testing and quality control operation. The official spoke on condition of anonymity to discuss confidential negotiations with the firm.
Novavax said in a statement that the federal government continues to fund other studies that are underway, including clinical trials. “We do not expect any impact on our funding arrangement with the US government to support the overall development and production of our 110 million doses of vaccine candidates,” the firm said.
The company’s manufacturing problems come on top of manufacturing failures at a federally funded vaccine factory in Baltimore operated by Emergent BioSolutions.
Federal regulators halted production at this facility for more than three months this year until the firm resolved quality control issues, including the failure to prevent contamination that ruined tens of millions of doses. The facility used to produce vaccines from Johnson & Johnson’s and AstraZeneca, but now only produces doses for Johnson & Johnson.
Chris Hamby contributing reporting.
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