Globe seeks permission for human trials
The location of the trials would be Farabi General Hospital in the capital’s Dhanmondi
Clinical Research Organisation Ltd sought approval of the Bangladesh Medical Research Council (BMRC) yesterday for human trials of BANGAVAX, a Covid-19 vaccine developed by Globe Biotech.
As a third party, it would conduct the first and second phases of the trial. Alongside an application for approval, the research organisation submitted a protocol of the clinical trial.
A team of 57 researchers, led by Prof Mamun Al Mahtab Shwapnil, plans on beginning the trial 10 days after receiving permission to do so.
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"We plan to deploy more than a hundred volunteers for the trial," Shwapnil said.
The three co-investigators of the team are Sheikh Mohammad Fazle Akbar, Prof Tahmina Shirin and Prof Sitesh Chandra Bachar.
The location of the trials would be Farabi General Hospital in the capital's Dhanmondi.
Results of the Globe vaccine's animal trials were published on the Bio-Archive on 29 September last year.
The company, on 5 October, 2020 claimed that vaccine trials on rabbits and mice had shown "very promising results."
That same month, the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) announced that it had signed a memorandum of understanding with Globe Biotech to begin the phase 1 human trial.
Globe Biotech, on 1 December, 2020 cancelled its agreement with icddr,b, alleging that the latter had shown little interest in conducting the trial.
According to Globe Biotech, BANGAVAX vaccine secured the approval of the Directorate General of Drug Administration to manufacture the Covid-19 vaccine for clinical trials.
