Inovio, a biotechnology company developing a vaccine for the coronavirus, has put its trial on a partial hold as it answers questions from the Food and Drug Administration.
The company announced Monday that the FDA notified Inovio that it had additional questions regarding the company’s phase two/three trial of vaccine candidate INO-4800, including questions about the device being used to deliver the vaccine in the trial.
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Until the administration’s questions “have been satisfactorily addressed,” the trial is on partial clinical hold.
“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 company said in the announcement.
The hold is not due to any adverse events related to the trials of the vaccine candidate, Inovio said, and phase one of the trial may continue and is not impacted by the FDA’s inquiry. The FDA’s questioning also does not impact any of Inovio’s other product candidates in development.
The biotech company and its partners are continuing to prepare for a planned phase two/three following the conclusion of the FDA’s partial clinical hold and subject to external funding to conduct the trial.
Inovio’s vaccine candidate is one of many in development. and four COVID-19 vaccines in the U.S. that have reached phase three trials.