Inovio’s COVID-19 Vaccine Trial Placed on Partial Hold

The FDA has placed a partial clinical hold on Inovio Pharmaceuticals’ planned phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, calling for more information.

Inovio said the hold was not due to any adverse events related to its ongoing phase 1 trial of INO-4800, but that the agency had questions about the late-stage study and about the company’s Cellectra 2000 device that will be used to administer the vaccine.

“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 [us] of its decision as to whether the trial may proceed,” Inovio said, declining to give further details of the FDA’s concerns.

Interim results from Inovio’s phase 1 study of its vaccine candidate, which were announced in June, showed that it was safe and well-tolerated and generated immune responses in 94 percent of participants at week six following two doses. INO-4800 was also selected to participate in a non-human primate challenge study as part of the government’s Operation Warp Speed initiative (DID, July 1).

A late-stage trial of AstraZeneca’s vaccine candidate, AZD1222, is also on hold in the U.S. pending the outcome of an FDA investigation into an adverse event. The phase 3 trial was paused earlier this month (DID, Sept. 9). Despite the FDA’s concerns, other countries including the UK, Brazil and South Africa have allowed the study to resume. — James Miessler