Plymouth Meeting firm gets FDA green light to test COVID-19 vaccine

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Monday, April 6, 2020
Action News coverage of the coronavirus COVID-19 outbreak

PLYMOUTH MEETING, Pa. (WPVI) -- A Montgomery County company has an OK from the FDA to test its new vaccine against the coronavirus.

And the company has high hopes for success, based on its experience with another vaccine.

In the phase 1 study, the new vaccine, called INO-4800, will be tested in 40 healthy volunteers at the University of Pennsylvania and the Center for Pharmaceutical Research in Kansas City, Missouri.

Volunteers will receive 2 doses 4 weeks apart.

They'll be watched for side effects, as well as whether their bodies generate an immune response.

Inovio's vaccine doesn't use any of the virus itself, but is based on the DNA of the coronavirus.

CEO Dr. Joseph Kim says China's move in early January, uploading the genetic code of the virus, enabled vaccine developers to get a fast start on vaccine candidates.

Inovio built theirs on a platform used before, to develop vaccines for SARS and MERS.

Both of those are also coronaviruses, related to COVID-19.

Inovio's CEO hopes that experience will translate into success this one.

"We saw about 90 per cent of our volunteers generating very high levels of antibody responses to the spike protein of the MERS vaccine, uh, MERS virus - which was our target. so we believe we can achieve similar levels of immune responses using our COVID-19 vaccine," says Dr. Joseph Kim.

Data from the first phase of the study is expected to be available by summer.

At that time, phase 2 will begin with about 1500 volunteers to determine whether the level of immune response is sufficient to prevent infection with COVID-19.

The FDA does have one option called the "2 animal rule" to get a vaccine to patients faster.

If the vaccine is effective in creating an immune response in 2 animals, and safe in humans, the FDA can approve it.

Whether the FDA exercises that option remains to be seen.