A small Pennsylvania biotech company is planning to start injecting healthy volunteers with a potential coronavirus vaccine, after receiving regulatory clearance to start clinical testing.
Researchers plan to dose the first person Monday. The experimental vaccine was developed by Inovio Pharmaceuticals, with the effort receiving 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 dosing in mid-March for its own safety trial.
Anthony Fauci, the longtime leader of the National Institutes of Health’s infectious disease unit, has repeatedly stated it will take at least a year to know if any vaccine is safe and effective against the virus.
For the study of Inovio’s vaccine, the company is enrolling 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 expects quick enrollment in the study and safety results by late summer. If those results are positive, the company will quickly start another study focused on assessing the vaccine’s efficacy against the virus.
Given unprecedented global demand, any vaccine that proves to be safe and effective will face a major challenge in manufacturing.
Inovio stated it is now scaling up its production capabilities and is aiming to have 1 million doses available by the end of 2020. These doses could be used in additional clinical trials or emergency use, if required.
PULLED FROM business insider