Bangladesh's lone coronavirus vaccine candidate Globe Biotech on Wednesday assigned icddr,b as a contract research organisation (CRO) to start human trials of the homegrown immunisation in the country.
To advance the trial process of BANCOVID, the local pharmaceutical group signed a memorandum of understanding with the icddr,b at its Tejgaon headquarters in the afternoon.
Chairman of Globe Biotech MD Harunur Rashid and icddr,b executive director Dr Tahmeed Ahmed signed the contract on behalf of the respective organizations.
The signing will allow the icddr,b to seek ethical approval from the state-run Bangladesh Medical Research Council for launching clinical trials in the country.
With that achievement, Globe Biotech overcame the last stage for seeking ethical approval from the BMRC to conduct human modelling experiments.
When contacted, manager (quality and regulatory operations) of Globe Biotech Limited Dr Mohammad Mohiuddin said the centre will also seek permission from the Director General of Drug Administration to start the human trials after getting approval from the BMRC.
"With this development, we finished our tasks. Now the icddr,b will inject the vaccine into human bodies," he added.
He said they found in the sequence that the virus went through a genetic mutation in the position of its 614 number protein, which was converted into G614 from D614.
Because of the transition, the virus became more infectious and deadly and many global studies blamed the G614 variant for the recent spread of the pandemic, he said.
"Those who started developing vaccines in the early pandemic period did not consider the variant but we did it. So, we are very confident that our vaccine will work as it is scientifically proven," he said.
Mr Mohiuddin said they have brought the mutated deadly spike protein of the virus into their vaccine target sequence to prevent infections from spreading.
A person at the company said it has planned to organise a press briefing on November 5 to share the outcomes and possible date to launch the clinical trials before it markets the medicine commercially.
In the three phases of human modelling trials, safety and efficacy of the vaccine on human bodies will be examined before getting the final approval for its commercial use.
