British American Tobacco (BAT) said its potential COVID-19 vaccine has been shown to produce a positive immune response and is ready for human trials.
Kentucky BioProcessing (KBP), the subsidiary developing the vaccine, is now waiting the US Food (FDA) and Drug Administration authorization to move to the next stage of testing, Phase 1 human clinical trials, the company added.
BAT in April has announced that its US biotech unit was working on a potential vaccine for COVID-19 using proteins extracted from tobacco leaves.
“We have submitted our Pre-Investigative New Drug package to the US FDA who have acknowledged its submission whilst our correspondence with other government agencies around the world continues,” BAT said in a statement.
The tobacco major said it can start the clinical trials as early as late June, pending the authorization from regulators, including in the UK.
BAT added that it has earmarked funds to conduct the trials and invested in additional equipment to boost manufacturing capabilities.
The company has earlier promised that KBP, a division of BAT’s US unit Reynolds American, would develop the vaccine on a not-for-profit basis.
The vaccine uses a cloned portion of COVID-19’s genetic sequence to create an antigen that is then inserted into tobacco plants for reproduction.
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