Bangavax gets approval for human trial

  |  Wednesday, November 24th, 2021 |  10:38 am
       

Bangladesh Medical Research Council (BMRC) has approved in principle Globe Biotech Limited’s Covid-19 vaccine ‘Bangavax’ for human trial.

“BMRC has given the approval in principle for administering Covid-19 vaccine of Bangavax and we’ll submit an application to the Bangladesh Directorate General of Drug Administration (DGDA), seeking its permission for the clinical trial. The administration of its jabs will start once the final approval is given,” said Dr Mohamamd Mohiuddin, senior manager of BMRC’s Quality and Regulatory Department.

BMRC Director Dr Ruhul Amin signed the letter of approval issued on Tuesday.

Globe Biotech Limited has claimed that Bangavax is 100% effective for fighting 11 variants of Covid-19, including the Delta variant.

On January 17, Globe Biotech, the only Bangladeshi company trying to develop a Covid-19 vaccine, submitted an application to the BMRC for approval to conduct Bangavax’s clinical trials.

On June 16, the BMRC decided to approve Globe Biotech’s Covid-19 vaccine, Bangavax, for human trials.

Globe Biotech received a licence to produce their potential vaccine for trial on December 28 last year.

The BMRC, which oversees all such trials, got back to them in June 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.

UR/