September 28, 2020 -- The U.S. Food and Drug Administration (FDA) has halted Inovio's clinical trial of its COVID-19 vaccine candidate, INO-4800.
The FDA has revoked Inovio's investigational new drug (IND) application until the company answers additional questions about the planned phase II/III trial to investigate INO-4800 and the associated Cellectra 2000 delivery device.
Inovio said it is working to address the administration's questions and plans to respond in October. Once the answers are received, the FDA has up to 30 days to notify Inovio whether the trial can proceed as planned.
The IND revocation does not affect Inovio's ongoing phase I study of INO-4800 or other vaccine candidates in development. It was also not issued because of the occurrence of any adverse event related to the vaccine candidate, Inovio noted.