Bangavax first buzzed with hope, then fizzled
PBC News: Globe Biotech, a Bangladeshi company, applied for permission to begin clinical trials of its COVID-19 vaccine candidate ‘Bangavax’ in January. But, over three months later, it has yet to receive the approval of the Bangladesh Medical Research Council.
As trials have yet to begin, it means the effectiveness of the domestically produced vaccine is still unknown, reports bdnews24.com.
Globe Biotech applied for approval to begin testing on humans, known as a clinical trial, on Jan 17.
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According to the rules, applications are first screened by the BMRC’s National Research Ethics Committee. If the BMRC gives its ethical consent, it goes to the Directorate General of Drug Administration. There it will wait for the consideration and approval of the National Clinical Trial Advisory Committee.
The relevant government agencies have yet to issue any clear statement on why there has been no progress on approving trials in the three and a half months since the application was submitted.
“The matter is fully overseen by our chairman,” BMRC Director Dr Md Ruhul Amin told bndews24.com when asked.
“I don’t have much to say on this matter.”
When asked for the latest update on the approval process for Bangavax, BMRC Chairman Dr Syed Modasser Ali said: “I shall not make a comment to the media, or anywhere about this.”
Globe Biotech says it submitted its vaccine for ethical clearance for phase-1 and phase-2 clinical trial protocols to BMRC through an institution named Clinical Research Organisation Ltd on Jan 17.After reviewing the protocols, the committee wrote to Globe Biotech on Feb 9 with observations on several issues. Then, on Feb 17, Globe Biotech submitted a set of protocols corrected in accordance with the BMRC’s demands alongside some additional information and data.
One dose of the vaccine had created working antibodies during trials on animals, Dr Mohammad Mohiuddin, the quality and regulatory operations manager at Globe Biotech, told bdnews24.com. He believes the clinical trial will yield similar results.
The vaccine can be preserved for one month at 4 degrees Celsius and six months at -20 degrees Celsius, Dr Mohiuddin said. As it is created synthetically, the vaccine is also virus-free and 100% halal, he said.
The whole vaccine process is at a standstill because the company is yet to receive ethical clearance from the BMRC.
