Guaranteeing that they have promising outcomes from pre-clinical trials on rabbits and mice of the coronavirus vaccine styled ‘BNCOVID’ developed by it, Bangladesh’s Globe Biotech Ltd on Monday said they need to carry it to the market by January next in the event that they are permitted to dispatch the first phase of human trials very soon.
The Bangladeshi pharmaceutical company said they have finished all the fundamental arrangements for making their vaccine activity a triumph, however, they said all that presently relies upon the administration’s collaboration in finishing the necessary cycles.
“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 corona 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 Tk 10,000 crore for the corona vaccine, Harun said they will be able to earn over Tk 50,000 by exporting the BNCOVID vaccine if only the government extends the necessary support to them.
“Developing a vaccine is a daunting task. But our team worked hard and made an impossible job possible. We’ve built a cent percent foundation for the vaccine as we’re now at the stage of conducting phase-1 and phase-2 clinical trials,” he observed.
He urged the government and the regulatory body, including DGDA, to allow them to conduct the clinical trials of the vaccine as soon as possible. “We believe our vaccine will turn out to be one of the effective vaccines in the world and we’ll be able to save many lives. But we need government patronage to make it possible.”
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and the results of the pre-clinical trial were published in the international platform, biorxive.org — an archive for unpublished pre-prints in life sciences.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 Organisation (CRO),” he said.
Kakon hoped that CRO will 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.”
“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.
Kakon said now their only responsibility is to provide vaccine doses for the clinical trial as per the protocol.
Asked whether they have any plan to conduct the trial of the vaccine in any other country, he said they are now focusing on trials only in Bangladesh as their primary target is to provide the BANCOVID here. “If we want to export the vaccine, then we may need to conduct the trial in other countries.”
The Globe Biotech CEO said they want to complete the trial within a short time by appointing a bigger number of volunteers as many people are contacting them to work as volunteers.
About the possible price of the vaccine, he said it is now difficult to say the exact price of it since their product does not reach the final stage. “But we can say it will be relatively cheaper.”
Speaking at the programme, Prof Mamun Al Mahtab, chairman of the hematology department at Bangabandhu Sheikh Mujib Medical University (BSMMU), said he hopes the BANCOVID will be an effective vaccine. “BANCOVID has just completed the preclinical stage. Even then, this vaccine may finally become unsuccessful. But we appreciate this imitative of Globe Biotech.”
BSMMU deputy registrar Dr. Sheikh Abdullah Al Mamun thanked Globe Biotech for making efforts for devolving the vaccine. “But you’ve to still go a long way to succeed.”
On July 2, Asif Mahmud, in-charge of research and development of Globe Biotech Limited, announced at a press conference that they were developing a Covid-19 vaccine as they completed preliminary animal trials successfully.
Photo credit: Collected
News source: UNB