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WASHINGTON – Novavax, the Maryland company that won a $ 1.75 billion federal contract to develop and produce a vaccine against the coronavirus, said on Thursday that the federal government would not fund additional production of its vaccine until the company will not have resolved the concerns of federal regulators about its work.
The company’s disclosure came in a quarterly filing with the Securities and Exchange Commission. The Trump administration has agreed to purchase 110 million doses of vaccine from Novavax as part of its crash vaccine development program.
Although the company reported in June that its vaccine was 90% effective against symptomatic cases of Covid-19 and 100% effective against serious illness, Novavax struggled for months to mass manufacture its product. His vaccine has not been cleared for distribution in the United States, and federal officials said it was not clear when or if it would be.
Four people familiar with Novavax’s operations said the company has so far been unable to demonstrate that its production process meets Food and Drug Administration standards. They spoke on condition of anonymity to discuss sensitive contractual issues.
In its SEC filing on Thursday, Novavax said, “The US government recently asked the company to prioritize alignment with the US Food and Drug Administration on analytical methods for l company before proceeding with additional manufacturing in the United States and further indicated that the United States government would not fund further manufacturing in the United States until such an agreement is reached.
An official from 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 operations. The official spoke on condition of anonymity to discuss confidential negotiations with the company.
Novavax said in a statement that the federal government continues to fund other ongoing work, including clinical trials. “We do not anticipate any impact on our funding agreement with the US government to support the overall development and production of 110 million doses of our vaccine candidate,” the company said.
The company’s manufacturing problems add to production failures at a federally funded vaccine manufacturing plant in Baltimore operated by Emergent BioSolutions.
Federal regulators halted production at this plant for more than three months this year until the company addressed quality control issues, including the failure to prevent contamination that has bankrupted tens of millions of people. doses. The factory had produced the vaccines for Johnson & Johnson and AstraZeneca but now manufactures doses only for Johnson & Johnson.
Chris Hamby contributed reports.
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