Local drug firm Globe Biotech Limited (GBL) has finally got the much-expected approval from the Directorate General of Drug Administration (DGDA) to start human trial of its homegrown Covid-19 vaccine 'Bangavax'.
Confirming the development, sources at the DGDA said the drug regulatory body gave the go-ahead to initiate phase-1 clinical trial of the single-dose mRNA vaccine on Sunday.
When contacted, principal investigator of the trial Mamun al-Mahtab Swapnil said they planned to start the human trial in September after completing the necessary formalities that include development of the coronavirus antidote for the trial to be administered to the volunteers.
"It (the trial) will be started on 60 volunteers divided into two groups at Bangabandhu Sheikh Mujib Medical University (BSMMU)," he said.
Sharing the trial planning, he said volunteers aged between 18 and 55 years will be placed in one group and those aged above 55 years in another group for the trial.
"Two doses of the vaccine will be administered in the phase-1. The second dose will be given 21 days after the first shot. Volunteers will be kept under observation for 24 hours after vaccination at the BSMMU," Prof Mahtab added.
He also said the trial is expected to be completed in a total of 35 days.
The principal investigator said Bangladesh will be the 9th country of the world after USA, China, India, South Korea, Japan, Canada, Vietnam and Thailand that developed the mRNA vaccine, which has immense potentials to use the technology beyond the Covid-19 like cancer therapy.
GBL senior manager (quality and regulatory operations) Dr Mohammad Mohiuddin said they had already started the process of bringing raw materials to develop the vaccine for the trial.
He said they had long been waiting for green signal of the DGDA. Because of the delay, the vaccine raw materials got expired on few occasions.
"That's why we had decided to import the materials once the approval is issued. After receiving the approval, the process of bringing raw materials has started," he added.
GBL, in October 2020, announced that its mRNA vaccine showed promise in animal trial on mice. Based on the successful trial, the local drug firm approached the BMRC early last year for ethical clearance before the human trial.
But after months of silence, the BMRC approved clinical trial of Bangavax on a condition that the vaccine producer required to conduct an animal trial on monkeys or chimpanzees before starting any human trial.
Then GBL restarted the animal trial on monkeys in August last year and got satisfactory response from the trial. And the promising results were submitted to the BMRC in early November, 2021.
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