By Joe Hoppe

British American Tobacco PLC said Wednesday that its Investigational New Drug application for a coronavirus vaccine has been approved by the U.S. Food and Drug Administration, allowig it to proceed to Phase 1 clinical trials in adult volunteers.

BAT--which produces cigarettes, electronic and vape products and other tobacco products--said its vaccine candidate will shortly enroll 180 healthy volunteers for a trial, with results expected in mid-2021. If positive, the results would allow for a Phase 2 study, subject to regulatory approval.

The candidate vaccine, developed by BAT's U.S. bio-technology arm Kentucky BioProcessing, uses fast-growing plant-based technology. The approach brings a number of possible advantages, including the rapid production of vaccine active ingredients in six weeks rather than several months, and has the potential to be stable at room temperature.

"Moving into human trials with both our Covid-19 and seasonal flu vaccine candidates is a significant milestone and reflects our considerable efforts to accelerate the development of our emerging biologicals portfolio," BAT's Director of Scientific Research David O'Reilly said.

Shares at 1551 GMT were up 6.5 pence, or 0.2%, at 2844.5 pence.

Write to Joe Hoppe at joseph.hoppe@wsj.com

(END) Dow Jones Newswires

December 16, 2020 11:07 ET (16:07 GMT)

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