Bangladesh’s Globe Biotech has received the approval from the Directorate General of Drug Administration (DGDA) to launch a clinical trial on humans for the home-grown Bangavax Covid-19 vaccine.
Ayub Hossain, a director at the DGDA, said they notified the company about the approval on Sunday, reports bdnews24.com.
Initially it has been decided that 60 volunteers will receive the vaccine during the Phase 1 trial at Bangabandhu Sheikh Mujib Medical University hospital.
In November 2021, the company submitted a ‘positive’ vaccine trial report of monkeys to the Bangladesh Medical Research Council and got ethical clearance to begin clinical trials on humans. Globe is the only Bangladeshi company that is trying to develop a Covid-19 vaccine.
The trial of Bangavax will be overseen by Clinical Research Organisation Limited.
Professor Dr Mamun Al Mahtab, who is leading the research team at the organisation, said more people will have easy access to vaccines once Bagavax gets the final approval.
“Now the production of vaccines will begin after import of raw materials. During the trial, 60 people will be divided into two age groups. One group will consist of people aged 18-55 and another will be of people above 55 years old. Everyone is getting two doses in the first phase,” Dr Mamun said. “If the vaccine is proved safe in Phase 1, we'll move on to Phase 2.”
Globe Biotech, a sister concern of Globe Pharma Group of Companies, said they had started work to produce Covid-19 vaccines in July 2021.
At first, they had applied for the BMRC’s approval, claiming that a trial of the vaccine on rabbits has been successful. However, the research council instructed them to conduct a trial on monkeys and submit a report based on that.
Globe Biotech submitted a report of clinical trials on 56 monkeys.