A small Pennsylvania biotech company is planning to start injecting healthy volunteers with a potential coronavirus vaccine this week, after having received regulatory clearance to start clinical testing.
Researchers plan to dose the first person on Monday. The experimental vaccine was developed by Inovio Pharmaceuticals, and the effort has received funding from the Bill and Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations.
Inovio's candidate, called INO-4800, is the second potential coronavirus vaccine to start human trials in the US. The Massachusetts biotech Moderna started its safety trial in mid-March.
Anthony Fauci, the longtime leader of the National Institutes of Health's infectious-disease unit, has repeatedly said it will take at least a year to know if any vaccine is safe and effective against the virus.
For Inovio's vaccine study, the company is enrolling up to 40 healthy adult participants in Philadelphia, at the University of Pennsylvania's medical school, and in Kansas City, Missouri, at the Center for Pharmaceutical Research.
Each volunteer will receive two doses of the vaccine, four weeks apart. Inovio said it expects quick enrollment in the study and safety results by late summer. If those results are positive, the company will start another study focused on assessing the vaccine's efficacy against the virus.
Given the unprecedented global demand, any vaccine that proves to be safe and effective will face a major challenge in manufacturing.
Inovio said it was scaling up its production capabilities and aiming to have 1 million doses available by the end of 2020, which could be used in additional clinical trials or for emergencies.
