Globe Biotech applies for approval to run clinical trial of COVID vaccine

Bangladeshi drugmaker Globe Biotech has applied for approval to begin clinical trials of its COVID-19 vaccine candidate 'Bangavax'.

Professor Mamun Al Mahtab, who is leading a team of 57 researchers for the trial, submitted the application and relevant papers – around 10,000 pages - to Bangladesh Medical Research Council or BMRC on Sunday. An assistant director there received the application.

The team seeks to conduct the first and second phases of the trial at a unit of a government hospital. The name of the hospital will be disclosed after the approval.  

The researchers aim to experiment the vaccine on more than 100 people in the trial, said Prof Mahtab.

“We have decided the number of participants after checking data from Pfizer and Moderna who had the same number of trial participants,” he said.

Clinical Research Organisation Ltd will run the trial on behalf of Globe, he said.

After checking details of the Globe vaccine, CRO concluded that it is eligible for a clinical trial. “Hence, we prepared the protocol for clinical trial," said Prof Mahtab.

The National Research Ethics Committee of the BMRC will examine the application and forward it to the Directorate General of Drug Administration or DGDA after approval.

The National Clinical Advisory Committee of the DGDA will then evaluate the application.

"The clinical trial can be kicked off once the DGDA approves it. We're prepared to start the work within seven days from getting the approval," said Prof Mahtab.

Bangladeshi nationals, who will have tested negative for COVID-19 with no comorbidities and aged over 18 years, are eligible for the vaccine trial, he said.

Globe Pharmaceutical Chairman Md Harunur Rashid, Globe Biotech CEO Kakan Nag, icddr,b Director Tahmina Shirin and others were also present.

Globe received a licence to produce the potential vaccine for trial on Dec 28 last year.

It is the only Bangladeshi firm in the race to develop an effective and safe coronavirus vaccine, seen as the only way out of the pandemic that has claimed at least 2 million lives and infected more than 94 million globally.

The vaccine was initially called Bancovid, but was later renamed Bangavax in December.

The experimental COVID-19 vaccine features on the World Health Organisation’s list of draft landscape of candidate vaccines.

The drugmaker shared their effort to produce COVID-19 vaccine in a press briefing on Jul 3 last year and later on Oct 10, said the vaccine ‘has proved its efficacy and safety’ when applied on mice.

Initially, Globe Biotech had signed an MoU with the icddr,b for running a clinical trial which was later cancelled due to the lack of interest on icddr,b’s part, said Globe Pharmaceuticals Chairman Rashid.