Bangavax gets DGDA nod for human trials
Local pharmaceutical company Globe Biotech Ltd has received approval from the Directorate General of Drug Administration (DGDA) to begin human trials of its mRNA Covid-19 vaccine "Bangavax".
Globe Biotech Senior Manager (quality and regulation) Dr Mohammad Mohiuddin said the government agency granted the approval on Sunday.
The human trial is expected to start by September at Bangabandhu Sheikh Mujib Medical University (BSMMU), Prof Mamun Al Mahtab, the chief researcher of the Bangavax clinical trial, told The Business Standard.
Keep updated, follow The Business Standard's Google news channel
"Human trial will be conducted on 60 volunteers divided into two groups," he said.
Volunteers aged 18-55 years will be placed in one group and those aged 55 and above in another group for the trial, he added.
"They will be given two doses of the vaccine. The second dose will be given 21 days after the first dose. Volunteers will be kept under observation for 24 hours after vaccination," Prof Mahtab said.
He also said the trial is expected to be completed in 35 days.
The results will be reviewed after the first phase of the trial. Then there will be a second stage trial. The researchers could not say when this vaccine can be administered to people on a large scale.
Earlier in November 2021, the organisation received approval from the Bangladesh Medical Research Council (BMRC) for human trials of the vaccine.
On 2 July 2020, Globe declared that it had developed a Covid-19 vaccine.
