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Dhaka Tribune

Globe Biotech yet to get BMRC nod for human trials

A decision regarding this to be made soon, say officials

Update : 22 Feb 2021, 09:58 PM

Globe Biotech Limited, the only Bangladeshi company that is trying to develop a Covid-19 vaccine in the country, is yet to get ethical permission for conducting human trials.

The company had submitted a protocol to the Bangladesh Medical Research Council (BMRC) for ethical approval to conduct the clinical trial of its vaccine – Bangavax – on January 17. 

Although more than a month has since passed, the BMRC is yet to give approval for human trials for the homegrown vaccine on the explanation that such procedures take time.

However, officials at the council claimed that they were trying to finish everything within the shortest possible time.

High officials of Globe Biotech have said that despite all the delays, they were hopeful of completing at least two trial phases of their vaccine and launch it after June this year.

Talking to Dhaka Tribune, Globe Biotech Chairman Md Harunur Rashid said that the firm’s primary target, to get vaccine production started early this year, could not be attained due to several factors.

“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. 

Also Read - Covid-19: Daily test positivity rate rises above 3% again in Bangladesh

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

The BMRC National Research Ethics Committee Chairman, National Professor Dr Shahla Khatun, said it would be “unwise” to disclose information related to an ongoing process.

Dr Shahla Khatun also pointed out that the BMRC would only provide “ethical permission” for human trials. “It is the government which will finally decide whether or not Globe Biotech will be allowed to conduct trials,” she said.

“A decision regarding the issue will be announced soon,” she added.  

Meanwhile, Cabinet Secretary Khandker Anwarul Islam, after a weekly virtual meeting of the Cabinet Division on Monday, said that the Globe Biotech issue was discussed at the meeting.

Also Read - News Analysis: Vaccine management so far so good

“Globe Biotech is yet to conduct its trials. If it is allowed to do so, in line with WHO protocol, we will see what can be done,” he added.

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

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

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

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

It obtained the result after conducting preliminary trials on five rabbits from June 10 to June 28, said Dr Asif Mahmud, assistant manager and in-charge, Research and Development, Globe Biotech Limited at a press conference.

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