WASHINGTON — Novavax, the Maryland agency that received 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 came in a quarterly filing 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 towards symptomatic Covid-19 circumstances, and 100 p.c towards 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 stated it’s unclear when or if will probably be.
4 folks accustomed to Novavax’s operation stated the corporate had been unable to date 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 extra U.S. manufacturing and additional indicated that the U.S. authorities won’t fund extra 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 a press release that the federal authorities continued to fund different work it had underway, together with scientific trials. “We don’t count on any affect 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 stated.
The corporate’s manufacturing issues come on high of manufacturing failures at a federally funded vaccine-making manufacturing facility 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.