Globe Biotech gets BMRC nod for human trials
Local pharmaceutical company Globe Biotech Ltd has received Bangladesh Medical Research Council (BMRC) approval to begin human trials of its single-dose Covid-19 vaccine "Bangavax."
"The BMRC has given us ethical permission to conduct human trials of Bangavax," confirmed Globe Biotech Senior Manager (quality and regulation) Dr Mohammad Mohiuddin to The Business Standard on Tuesday night.
"However, to start the trials we need permission from the Directorate General of Drug Administration (DGDA)."
Meanwhile, when contacted, DGDA Deputy Director Md Salahuddin, said, "We are yet to receive any official letter from the BMRC. It may take a couple of days to reach us.
"A decision in this regard will be taken following a review of the approval."
Globe, on 1 November, submitted a report on the results of the trial on monkeys to BMRC as per guidelines.
On 22 June, BMRC sent a letter to Globe Biotech asking it to conduct a trial on monkeys or chimpanzees before a clinical trial.
On 28 December, 2020, the vaccine developer got approval from the DGDA to produce the coronavirus jab to carry out clinical trials.
The results of animal trials were published on the Bio-Archive on 29 September the same 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.
Researchers had initially named it Bancovid but later renamed it as Bangavax.
That month, the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) announced that it would hold a human trial of the locally produced vaccine and signed an MoU 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.
