WASHINGTON — Novavax, the Maryland agency that gained a $1.75 billion federal contract to develop and produce a coronavirus vaccine, stated 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 agency’s disclosure got here in a quarterly submitting with the Securities and Trade Fee. The Trump administration agreed to purchase 110 million doses of vaccine from Novavax as a part of its crash vaccine improvement program.
Though the corporate reported in June that its vaccine had an efficacy of 90 % in opposition to symptomatic Covid-19 circumstances, and 100% in opposition to extreme illness, Novavax has struggled for months to mass manufacture its product. Its vaccine has not been licensed for distribution in the USA, and federal officers stated it’s unclear when or if it is going to be.
4 individuals accustomed to Novavax’s operation stated the corporate had been unable to this point to show that its manufacturing course of met Meals and Drug Administration requirements. They spoke on the situation of anonymity to debate delicate contracting points.
In its S.E.C. submitting on Thursday, Novavax stated: “The U.S. authorities has lately instructed the corporate to prioritize alignment with the U.S. Meals and Drug Administration on the corporate’s analytic strategies earlier than conducting further U.S. manufacturing and additional indicated that the U.S. authorities won’t fund further U.S. manufacturing till such settlement has been made.”
An official for the Division of Well being and Human Companies, which oversees Novavax’s federal contract, stated 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 stated 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 affect on our funding association with the U.S. authorities to help general improvement and manufacturing of 110 million doses of our vaccine candidate,” the agency stated.
The corporate’s manufacturing issues come on prime of manufacturing failures at a federally funded vaccine-making manufacturing unit in Baltimore operated by Emergent BioSolutions.
Federal regulators halted manufacturing at that plant for greater than three months this 12 months till the agency resolved high quality management issues, together with failure to stop contamination that ruined tens of tens of millions of doses. The plant had produced Johnson & Johnson’s and AstraZeneca’s vaccines however now manufactures doses just for Johnson & Johnson.
Chris Hamby contributed reporting.