FDA puts partial hold on Inovio vax trial

Sept. 28, 2020

Inovio Pharmaceuticals announced that its Investigational New Drug Application for the Phase 2/3 trial of its COVID-19 vaccine is on partial clinical hold after the U.S. FDA raised questions about a delivery device used in the inoculation.

The trial for candidate INO-4800, a vaccine based on messenger RNA, is on hold while the Pennsylvania-based drugmaker answers additional questions from regulators about the Cellectra 2000 device used in the trial. The device uses brief electrical pulses to create small openings in cells that allow injected genetic material to enter more easily.

The company says hold is not due to an adverse event, nor will it impact the advancement of Inovio's other product candidates in development. 

Inovio plans to respond in October, after which the FDA will have 30 days to notify the drugmaker whether or not the trial can proceed.

Read the press release