Clinical trials: Globe Biotech gets approval to produce Bangavax

Bangladeshi firm Globe Biotech Ltd has secured approval from the Directorate General of Drug Administration (DGDA) to produce Covid-19 vaccine candidate "Bangavax" to carry out clinical trials.

Dr Asif Mahmud, in-charge of research and development at Globe Biotech, disclosed this to The Business Standard on Wednesday, adding, "The DGDA gave us the approval on 28 December."

"We will apply to the Bangladesh Medical Research Council (BMRC) within the next week for its permission to conduct clinical trials. If BMRC approves, we will launch the trials by this month," he said.

However, the DGDA could not be reached for comment on the matter till the filing of this report.

The results of the Globe vaccine's animal trials were published on the Bio-Archive on 29 September last year. The same month, Globe also announced plans to launch human trials after completing its phase 2 animal trial.

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 1 trial.

The Globe Biotech Ltd on 1 December cancelled its agreement with the icddr,b alleging that the latter was not showing enough interest in conducting the trials of Globe's vaccine candidate.

Addressing the delay on launching the clinical trial, Dr Asif Mahmud said, "It takes time to launch a new initiative, so we faced delays too. The icddr,b wasted two months of our time."

"However, as the DGDA gave us permission to produce the vaccine and the Institute of Epidemiology Disease Control and Research's (IEDCR) is presently reviewing the matter, we are optimistic that the process will now move forward at a faster rate," he continued.

When asked for details about the trial, Dr Mahmud said, "We have a protocol regarding who will participate in the trial as subjects, the number of volunteers and whether anyone from the Globe Biotech will act as a subject."

"We will release this protocol after securing approval from the BMRC," he added.

"Our expert committee has officials from IEDCR, Bangabandhu Sheikh Mujib Medical University Hospital and also from abroad. These experts have conducted field visits and scrutinised the related documents," he continued.

Meanwhile, IEDCR's Principal Scientific Officer Dr ASM Alamgir told The Business Standard that Globe Biotech has not yet submitted its protocol.

"The World Health Organisation (WHO) has included Globe's DNA plasmid vaccine on its pre-clinical evaluation list," he added.

According to WHO data, 18 Covid-19 vaccines are currently undergoing phase 3 trials in different countries. On 2 July last year, Globe Biotech Limited declared it had developed a Covid-19 vaccine.