Globe Biotech gets nod to test Covid vaccine on 64 adults25 November 2021
Bangavax, Bangladesh's first homegrown COVID-19 vaccine, has received ethical clearance from the authorities for a human trial on up to 64 healthy adult participants.
The plan is to administer the vaccine, developed by Globe Biotech, to the participants at Bangabandhu Sheikh Mujib Medical University, said Dr Mamun Al Mahtab, who is heading the team for the trials.
Mahtab, working for Clinical Research Organisation Ltd which will conduct the trials on behalf of Globe Biotech, said the volume of Bangavax samples is similar to those developed by US firms Pfizer and Moderna.A BSMMU professor, Mahtab also said they are ready to begin the small Phase-1 trial immediately after getting the final approval.
Bangladesh Medical Research Council gave the ethical clearance on Tuesday after reviewing data submitted by the company on animal trials.
Globe Biotech had earlier sought approval after experiments on rabbits, but the authorities said the vaccine needed to be tested on monkeys or chimpanzees before human trials.
Dr Mohammad Mohiuddin, a senior manager at Globe Biotech, said they will apply to the Directorate General of Drug Administration for the final approval for human trial now.
He believes the DGDA review for approval will not take time because the directorate already approved the production of Bangavax for trial after visiting the company's plant last year.
Mohiuddin had earlier said that the vaccine yielded "good results" in trials on monkeys and the firm hopes it will be effective and safe for humans as well.
The vaccine can be stored at a temperature of 4 degrees Celsius for one month and of -20 degrees Celsius for up to six months.
Globe Biotech received a licence to produce the potential vaccine for trial in December 2020 and applied for ethical clearance to begin clinical trials in 2021.
One dose of the vaccine had created working antibodies during initial trials on animals, the company said.
It initially named the vaccine 'Bancovid', but later changed it to Bangavax.
Bangladesh's neighbour India is producing homegrown and foreign vaccines against Covid-19.
Bangladesh is purchasing vaccine doses from India and China. It is also receiving shots for free from COVAX, a global vaccine-sharing programme led by the World Health Organization.