BMRC yet to permit Globe Biotech for human trials

An official protocol was submitted to Bangladesh Medical Research Council (BMRC) by the company for ethical approval to conduct the clinical trial of its vaccine – Bangavax – on January 17.

It’s been more than a month but the BMRC haven’t approved the company to start conducting the human trials stating that such procedures take time. However, officials at the council claimed that necessary steps have been taken to complete the procedure promptly.

Despite all the delays Globe Biotech is hoping to complete at least two trial phases of their vaccine and make them available around late June this year.

Globe Biotech Chairman Md Harunur Rashid said that the firm’s primary objective is to start vaccine production early this year but due to several factors it could not be executed.

 “But now we are on the right track. As far as we have been informed the [BMRC] review committee has given the clearance that we needed and it will be announced soon,” he said. 

 “We are hoping to start trials within March and after that’s done, we want to go for production after June,” the Globe Biotech executive added.

The BMRC National Research Ethics Committee Chairman, National Professor Dr Shahla Khatun, said it wouldn’t be wise to divulge information related to an ongoing process.

Referring to the procedure she said that after taking a decision necessary proclamation will be made soon.

Referring to the issue, Cabinet Secretary Khandker Anwarul Islam said that the Globe Biotech issue was discussed at a weekly virtual meeting.

“Globe Biotech needs to conduct its trials. After conducting them as per WHO’s protocol, we will see what can be done,” he added.

Globe Biotech was allowed by the Directorate General of Drug Administration (DGDA) to manufacture the homegrown vaccine for clinical trials on last December.