FDA Places Hold On Montco Company's Coronavirus Vaccine

PLYMOUTH MEETING, PA — A Montgomery County biopharmaceutical company has run into a snag in the development of its coronavirus vaccine.

Plymouth Meeting-based Inovio Pharmaceuticals announced on Monday morning that the U.S. Food and Drug Administration had placed a clinical hold on the Phase 2 and 3 trials of their vaccine.

The hold is due to concerns the FDA has with the vaccine; specifically, the company says, with the "Cellectra" device which must be used to deliver the vaccine. Inovio plans on addressing the FDA questions in October.

The news caused a 39 percent dip in Inovio's stock on Monday, Business Insider reported. It's a notable development as the company seeks additional funds for the continued development and planned production of the vaccine.

Inovio said the FDA's questions were only about Phases 2 and 3 of their clinical trials, which the company was slated to move into this month, and not Phase 1, which can continue.

>>Montco Pharma Company's Coronavirus Vaccine Is Progressing

"Inovio and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding to conduct the trial," the company said in a statement.

Inovio drew international attention when they announced their DNA-based vaccine in early March, and stated they planned to have a million doses ready by the end of 2020.

They're not the only Montgomery County-based company on the world's shortlist for developing a COVID-19 vaccine candidate. Animal health company MBF Therapeutics, based in Ambler, is also working on one.

According to the New York Times coronavirus vaccine tracker, there are 15 vaccines in Phase 2, and nine currently in Phase 3, as of Tuesday afternoon.

This article originally appeared on the Plymouth-Whitemarsh Patch