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.
Interim results from the phase 1 trial showed that INO-4800 was safe and well-tolerated and induced immune responses in a majority of participants. The company said it plans to respond to the agency’ concerns in October, after which the FDA has up to 30 days to decide whether the trial can go ahead.