Inovio says COVID-19 vaccine candidate safe, effective in mid-stage trial

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The trial, which enrolled about 400 participants aged 18 and above, helped the company confirm an appropriate dose for testing in a late-stage Phase 3 trial, Inovio said on Monday.

Inovio has lagged behind rivals in the race to develop a COVID-19 vaccine after the U.S. Food and Drug Administration (FDA) last year put the Phase 3 portion of its mid-to-late stage trial on hold for more information on the device used to deliver the vaccine candidate into skin cells.

Shots from Pfizer Inc (NYSE:PFE) and partner BioNTech SE (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) Inc received U.S. emergency use authorization as early as late last year, and Johnson & Johnson (NYSE:JNJ) earlier this year.

Inovio said it plans to use data from the mid-stage trial to answer pending regulatory questions about its delivery device before beginning the Phase 3 portion of the study, on partial hold, after FDA’s approval to proceed.

Last month, the company said the U.S. government pulled the funding for a late-stage study testing its vaccine candidate, citing increasing availability of authorized COVID-19 vaccines, and it would now conduct the trial largely outside the country.