Globe Biotech Limited, a Bangladeshi biotech firm, is going to submit its protocol to the Bangladesh Medical Research Council (BMRC) for the clinical trial of its Covid-19 vaccine Bangavax on Sunday.
Dr Asif Mahmud, in-charge of Globe Biotech research and development, told The Business Standard, "The BMRC approval is usually given within one to two weeks of submission. If approved, we hope to be able to start the trial within this month."
He said, "Our protocol mentions how many people will take part in Phase-I and II trials of the vaccine. The protocol will be submitted through our CRO. However, the name of the CRO, or what the protocol contains, cannot be revealed now."
On 28 December, Globe Biotech got approval from the Directorate General of Drug Administration (DGDA) to produce Covid-19 vaccine candidate Bangavax to carry out clinical trials.
The results of animal trials were published on the Bio-Archive on 29 September last year. In the same month, Globe also announced plans to launch human trials after completing Phase-II animal trials.
The company on 5 October claimed it had "very promising results" in the vaccine trials on rabbits and mice. The vaccine was then named BANCOVID.
That month, the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) announced that it would hold a human trial of BANCOVID and signed a memorandum of understanding with Globe Biotech on 14 October to conduct the phase-I trial.
But Globe on 1 December cancelled its agreement with the icddr,b, alleging that the latter was not showing enough interest in conducting the trials of the vaccine candidate.
Earlier on 2 July last year, Globe declared it had developed a Covid-19 vaccine.