Inovio Pharmaceuticals Inc said on Monday a planned mid-to-late-stage trial of its experimental coronavirus vaccine candidate was put on partial clinical hold by the U.S. Food and Drug Administration, which sought additional information.
The U.S. drug developer said it was working to address the agency’s queries by October, including on the vaccine delivery device, after which the U.S. agency wold have 30 days to decide whether the trial should proceed.
The company said the pause was not due to any side effects in its early-stage study of the vaccine, which is continuing.
Shares of the company were halted after the news.
The company in June had reported encouraging results from an early-stage human trial of its experimental coronavirus vaccine. INO-4800.
Inovio’s development timeline is already lagging behind those of rivals such as Moderna Inc, Pfizer Inc and AstraZeneca , all of which have begun late-stage studies of their coronavirus vaccine candidates.