Inovio vaccine trial on partial hold as FDA questions device used
The Cellectra 2000 device is under the spotlight, not the actual vaccine or its positive results, yet Inovio shares dropped 35% in early trade
London — Inovio Pharmaceuticals has put a partial hold on a phase 2-3 study of its Covid-19 vaccine after US regulators raised questions about a delivery device used in the inoculation.
The US vaccine maker is working to answer questions from the US Food and Drug Administration (FDA) about the Cellectra 2000 device used in the trial, Plymouth Meeting, Pennsylvania-based Inovio said in a statement on Monday. The hold is not due to any adverse events from the vaccine, Inovio said.
The company plans to respond in October, after which the FDA will have 30 days to notify Inovio whether the trial can proceed. Its shares fell 35% in early trading before US markets opened.
Cellectra 2000 is an electroporation device designed to improve the delivery of vaccine particles. Inovio’s inoculation is based on messenger RNA (mRNA), an approach similar to that used by rival Moderna, which instructs the body’s cells to produce proteins that spark a protective response.
Inovio said in June that it’s early stage study of 40 healthy volunteers found that 94% of trial participants demonstrated overall immune responses at week six after two doses of the vaccine.
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