Politics|Novavax Says U.S. Will Pause Funding for Production of Its Vaccine
The Maryland company, which has a $1.75 cardinal national declaration to make and nutrient a coronavirus vaccine, said it needed to code the concerns of national regulators.
Aug. 5, 2021
WASHINGTON — Novavax, the Maryland steadfast that won a $1.75 cardinal national declaration to make and nutrient a coronavirus vaccine, said connected Thursday that the national authorities would not money further accumulation of its vaccine until the institution resolves concerns of national regulators astir its work.
The firm’s disclosure came successful a quarterly filing with the Securities and Exchange Commission. The Trump medication agreed to bargain 110 cardinal doses of vaccine from Novavax arsenic portion of its clang vaccine improvement program.
Although the institution reported successful June that its vaccine had an efficacy of 90 percent against symptomatic Covid-19 cases, and 100 percent against terrible disease, Novavax has struggled for months to wide manufacture its product. Its vaccine has not been authorized for organisation successful the United States, and national officials said it is unclear erstwhile oregon if it volition be.
Four radical acquainted with Novavax’s cognition said the institution had been incapable truthful acold to show that its accumulation process met Food and Drug Administration standards. They spoke connected the information of anonymity to sermon delicate contracting issues.
In its S.E.C. filing connected Thursday, Novavax said: “The U.S. authorities has precocious instructed the institution to prioritize alignment with the U.S. Food and Drug Administration connected the company’s analytic methods earlier conducting further U.S. manufacturing and further indicated that the U.S. authorities volition not money further U.S. manufacturing until specified statement has been made.”
An authoritative for the Department of Health and Human Services, which oversees Novavax’s national contract, said the authorities wanted the institution to fortify its investigating and prime power operation. The authoritative spoke connected the information of anonymity to sermon confidential negotiations with the firm.
Novavax said successful a connection that the national authorities continued to money different enactment it had underway, including objective trials. “We bash not expect immoderate interaction connected our backing statement with the U.S. authorities to enactment wide improvement and accumulation of 110 cardinal doses of our vaccine candidate,” the steadfast said.
The company’s manufacturing problems travel connected apical of accumulation failures astatine a federally funded vaccine-making mill successful Baltimore operated by Emergent BioSolutions.
Federal regulators halted accumulation astatine that works for much than 3 months this twelvemonth until the steadfast resolved prime power problems, including nonaccomplishment to forestall contamination that ruined tens of millions of doses. The works had produced Johnson & Johnson’s and AstraZeneca’s vaccines but present manufactures doses lone for Johnson & Johnson.
Chris Hamby contributed reporting.