Bangladesh approves homegrown COVID vaccine Bangavax for human trial

Bangladesh Medical Research Council, or BMRC, has given ethical clearance to the Bangavax COVID-19 vaccine of Globe Biotech for a small Phase-1 clinical trial on humans.

Developed by the local pharmaceutical company, Bangavax is set to become the first experimental vaccine to be used on humans in Bangladesh. 

The clinical trial of the vaccine will be conducted at Bangabandhu Sheikh Mujib Medical University once the Directorate General of Drug Administration approves it for human use, according to Dr Md Mohiuddin, a senior manager at Globe Biotech.

"We will seek permission from the DGDA to administer the vaccine to humans. After the (DGDA) review committee approves it, we will be able to conduct the clinical trial,” he said on Tuesday.

The pharmaceutical company is expecting to get the nod from DGDA soon as the authorities have already inspected Globe's factory before issuing a licence to produce the vaccine, according to Mohiuddin.

The trial of Bangavax will be overseen by Clinical Research Organisation Limited.

Prof Mamun Al Mahtab, who is leading a team of researchers for the trial, said the vaccine will be tested on 64 adults with no underlying health issues.

"The sample size is the same as that of the Pfizer and Moderna vaccine. The trial will be held in a universally recognised hospital. With the permission of the authorities, we can start the trial immediately because we have made the necessary preparations,” Prof Mamun said.

"Our plan is to administer the vaccine at BSMMU."

Globe Biotech applied for approval for a human trial on Nov 1, saying the vaccine yielded "good results” in trials on monkeys.

Mohiuddin said all the documents properly and hopes to begin the human trial in November if they get the clearance.

The vaccine can be stored at a temperature of 4 degrees Celsius for one month and of -20 degrees Celsius for up to six months.

Globe Biotech received a licence to produce the potential vaccine for trial in December 2020 and applied for ethical clearance to begin clinical trials in 2021.

One dose of the vaccine had created working antibodies during initial trials on animals, the company said.