FDA hitch for COVID-19 vaccine candidate INO-4800 Phase II/III trial

The US Food and Drug Administration says it has additional questions about the planned Phase II/III trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial.

News of the pause sent shares of the vaccine’s developer, US biotech firm Inovio Pharmaceuticals (Nasdaq: INO), plummeting 25% to $12.29 by mid-morning, as the FDA request pushes the firm even further behind other potential novel coronavirus vaccine developers, such as Moderna (Nasdaq: MRNA), Pfizer (NYSE: PFE) and AstraZeneca (LSE: AZN), which have begun Phase III studies of their candidates.

Until the FDA's questions have been satisfactorily addressed, Inovio’s Investigational New Drug Application (IND) for the Phase II/III trial is on partial clinical hold. The company says it 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.