Covid-19: Globe Biotech finally gets nod to start human trials of Bangavax
The trial will be conducted on 60 individuals at the BSMMU
The local pharmaceutical company Globe Biotech Limited on Sunday finally received approval from the Directorate General of Drug Administration (DGDA) to conduct human trials of Bangavax, a single-dose Covid-19 vaccine.
The company’s Quality and Regulatory Department Senior Manager Mohammad Mohiuddin confirmed the development on Sunday, reports Bangla Tribune.
The Bangladesh Medical Research Council (BMRC) on November 23, 2021 approved the human trials of Bangavax vaccine.
Now, with the approval from the DGDA, Globe Biotech will start the human trials as soon as possible.
According to Globe Biotech, the trial will be conducted on 60 individuals at the Bangabandhu Sheikh Mujib Medical University (BSMMU).
Dr Mamun Al Mahtab, professor of hepatology at BSMMU, is the principal investigator of this trial.
The research protocol is approved for the period of one year from the date of approval by DGDA, according to the DGDA letter sent to Dr Mamun conveying the decision.
Bangladesh now joins the elite group of nine countries in the world with mRNA vaccine capability next to the US, Canada, Japan, India, China, South Korea, Thailand, and Vietnam.
Globe Biotech Limited has claimed that Bangavax is 100% effective for fighting 11 variants of Covid-19, including the Delta variant.
On January 17 last year, Globe Biotech, the only Bangladeshi company trying to develop a Covid-19 vaccine, submitted an application to the Bangladesh Medical Research Council (BMRC) for approval to conduct Bangavax's clinical trials.
Globe Biotech received a license to produce their potential vaccine for trial on December 28, 2020.
The BMRC, which oversees all such trials, got back to them in June last year with certain conditions that had to be met before the clinical trials could go ahead.
The key condition was that Globe Biotech would have to run trials on monkeys or chimpanzees first.
One of the bottlenecks the company identified at the time was that the country did not have a third-party clinical research organization (CRO) that could conduct such tests on animals.