The company seeks government support to launch Phase I of human trials
Claiming that they have got very promising results from pre-clinical trials on rabbits and mice of the coronavirus vaccine, “BNCOVID,” Bangladesh’s Globe Biotech Ltd on Monday said they wanted to bring it to the market by January next year if they are allowed to launch the first phase of human trials very soon.
The Bangladeshi pharmaceutical company said they have completed all the necessary preparations for making their vaccine initiative a success, but they said everything now depends on the government’s cooperation in completing the required process.
“We hope the government will stand beside us and assist us in every necessary area. If we all can make collective efforts, we hope, we’ll be able to start giving our vaccine to people across Bangladesh by January next,” Harunur Rashid, chairman of Globe Biotech, told a press conference at a city hotel.
He said pre-clinical trials suggest that their vaccine is as promising as the other leading Covid-19 vaccine candidates in the world. “If we can now make united efforts, we can export the vaccine to all over the world alongside meeting the local demand.”
Stating that the government has set aside Tk10,000 crore for the coronavirus vaccine, he said they will be able to earn over Tk50,000 by exporting the BNCOVID vaccine if only the government extends the necessary support to them.
Globe Biotech CEO Kakon Nag said their vaccine has already proved safe and effective in the pre-clinical trials on mice following an animal model and the results of the pre-clinical trial were published in the international platform, biorxive.org – an archive for unpublished pre-prints in life sciences.
“We’re now preparing the protocol for conducting a clinical trial of the vaccine together with Contract Research Organization [CRO],” he said.
Kakon hoped that CRO would soon apply to the Bangladesh Medical Research Council (BMRC) with the protocol for getting the approval for the clinical trial of the vaccine.
Once they get the BMRC’s approval, he said, CRO will apply to the Directorate General of Drug Administration (DGDA) for permission to carry out the clinical trial.
Mentioning that Bangladesh is now witnessing the second wave of coronavirus, Kakon said recent studies recommend that D614G variant is cent percent responsible for it.
“The BNCOVID vaccine developed with our own technology is the only and the first vaccine against the D614G variant,” he said.
“We’ve done whatever necessary to bring an effective and safe vaccine to the market, but the further steps and final success depend on the cooperation of the government and the people of the country,” he observed.
On July 2, Globe Biotech announced that they were developing a Covid-19 vaccine as they completed preliminary animal trials successfully.