Inovio’s COVID-19 Vaccine Poised for Phase 3 Trial, but FDA Partial Hold Remains

Inovio Pharmaceuticals has announced that its COVID-19 vaccine candidate, INO-4800, was shown to be safe and well-tolerated in a phase 2 clinical trial.

The company’s plan for a phase 3 trial is delayed due to a partial clinical hold by the FDA because of questions about the company’s proprietary intradermal DNA delivery device used to administer the vaccine.

Inovio said the results from the 400-person phase 2 study will help answer the agency’s questions and that the phase 3 trial will advance once the hold is lifted.