Novavax says U.S. paused federal funding to make more of its yet-to-be-approved vaccine.

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Novavax, the Maryland agency that received a $1.75 billion federal contract to develop and produce a coronavirus vaccine, mentioned on Thursday that the federal authorities wouldn’t fund additional manufacturing of its vaccine till the corporate resolves considerations of federal regulators about its work.

The disclosure got here in a quarterly submitting with the Securities and Change Fee. The Trump administration agreed to purchase 110 million doses of vaccine from Novavax as a part of its crash vaccine growth program.

Though the corporate reported in June that its vaccine had an efficacy of 90 p.c in opposition to symptomatic Covid-19 instances, and 100 p.c in opposition to extreme illness, Novavax has struggled for months to mass manufacture its product. Its vaccine has not been approved for distribution in the US, and federal officers mentioned it’s unclear when or if it will likely be.

4 folks conversant in Novavax’s operation mentioned the corporate had been unable to date to exhibit that its manufacturing course of met Meals and Drug Administration requirements. They spoke on the situation of anonymity to debate delicate contracting points.

An official for the Division of Well being and Human Companies, which oversees Novavax’s federal contract, mentioned the federal government needed the corporate to strengthen its testing and high quality management operation. The official spoke on the situation of anonymity to debate confidential negotiations with the agency.

Novavax mentioned in an announcement that the federal authorities continued to fund different work it had underway, together with medical trials. “We don’t count on any impression on our funding association with the U.S. authorities to assist general growth and manufacturing of 110 million doses of our vaccine candidate,” the agency mentioned.

Sheryl Homosexual Stolberg and Chris Hamby contributed reporting.

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