Globe Biotech submits clinical trial protocol to BMRC

Globe Biotech Limited, the only Bangladeshi company that has developed a Covid-19 vaccine, has submitted a protocol to Bangladesh Medical Research Council (BMRC) for ethical approval to conduct the clinical trial of their vaccine Bangavax.

The CRO Bangladesh, a contract research organization (CRO), on behalf of the company submitted the protocol around 12:30pm on Sunday, Dr Asif Mahmud, in-charge of the Molecular and Cell Biology unit and assistant manager of Globe Biotech Limited, told the Dhaka Tribune.

"Although we came to BMRC around 11am, it took one hour and a half to submit the protocol," he said.

"Principal investigator of the clinical trial Prof Mamun Al Mahtab informed us that we would be able to start the human trial within seven to 10 days after the protocol approval. 

"It is a milestone for us that a human trial of any local vaccine is going to be conducted in Bangladesh," he added.

Also Read - Globe Biotech gets permission to manufacture Covid-19 vaccine for trial

Earlier on December 28 last year, the Directorate General of Drug Administration (DGDA) gave permission to Globe Biotech to manufacture Bangavax for clinical trials.

On December 1, Globe Biotech announced that they would part ways with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) for conducting human trials of their vaccine.

Globe Biotech cancelled the memorandum of understanding (MoU) as they observed less progress in icddr,b's approach to conducting the human trials.

On July 2, claiming success in preliminary animal modelling trials for Covid-19 vaccine, Globe Biotech claimed to be the first company from Bangladesh to have a Covid-19 vaccine under development.

They received the result after conducting the preliminary trial on five rabbits from June 10 to June 28, Dr Asif said at a press conference.