The biotechnology company Inovio's planned Phase 2/3 coronavirus vaccine trial has been put on a partial hold, the company announced on Monday.
The announcement notes that the US Food and Drug Administration notified the company that it has additional questions about the company's planned Phase 2/3 trial of the vaccine candidate INO-4800, including questions about the device to be used as part of delivering the vaccine in the trials.
Until the FDA's questions have been "satisfactorily addressed," the Phase 2/3 trial is on partial clinical hold, according to the company announcement.
"The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed," the announcement says.
"This partial clinical hold is not due to the occurrence of any adverse events related to INOVIO's ongoing expanded Phase 1 study of INO-4800, the conduct of which may continue and is not impacted by the FDA's notification," the announcement says. "In addition, this partial clinical hold does not impact the advancement of INOVIO's other product candidates in development."
Some context: Inovio’s Covid-19 vaccine is being funded, in part, by the US Department of Defense, the Bill & Melinda Gates Foundation, and The Coalition for Epidemic Preparedness Innovations.
The company has not received funding from Operation Warp Speed, the Trump administration’s initiative to fast-track the development and delivery of a Covid-19 vaccine.