Staff Reporter :
Globe Biotech Ltd (GBL), a local pharmaceutical company has received Directorate General of Drug Administration’s (DGDA) approval to conduct human trials of its single-dose Covid-19 vaccine ‘Bangavax’.
The organization has been waiting for long despite receiving approval from the Bangladesh Medical Research Council (BMRC) for human trials of the vaccine on November 23 last year.
Globe Biotech Senior Manager (quality and regulation) Dr Mohammad Mohiuddin said that the government agency had given the approval on Sunday.
“The drug administration has informed us regarding the approval and the next course of action will be taken through discussion,” he says. Prof Mamun Al Mahtab, the Chief Researcher of the Bangavax clinical trial, said that the organization has received the clearance for human trial in first stage, which is expected to start by September at Bangabandhu Sheikh Mujib Medical University (BSMMU).
“Local company Globe Biotech Ltd made coronavirus vaccine Bangavax’s human trial and it will be conducted on 60 volunteers divided into two groups at BSMMU,” the researcher told The New Nation.
He said that the volunteers aged 18-55 years will be placed in one group and those aged 55 and above in another group for the trial.
“They will be given two doses of the vaccine. The second dose will be given 21 days after the first dose. Volunteers will be monitored and kept them under observation for 24 hours after vaccination,” Prof Mahtab said.
He also said the trial is expected to be completed in a total of 35 days.
During the animal trial of the Bangavax vaccine on monkeys, they found that it had created sufficient anti-body and hundred per cent effective against all 11 coronavirus variants including the Delta one, GBL researchers said.
On January 17, Globe Biotech, the only Bangladeshi company trying to develop a Covid-19 vaccine, submitted a protocol to the BMRC for ethical approval to conduct Bangavax’s clinical trials.
On October 5 last year, the company announced that its first vaccine candidate had shown promise in pre-clinical trials on mice. Researchers initially named it “Bancovid” but later renamed it ‘Bangavax’.
Bangavax, along with two other vaccine candidates developed by Globe Biotech, were included in the World Health Organization’s draft landscape and tracker of Covid-19 vaccines in development worldwide, on October 17, 2021.
On 2 July 2020, Globe declared that it had developed a Covid-19 vaccine for the first time in Bangladesh.
