Health desk- 13 September 2020: With the success of two-phase animal trials in the pre-clinical stage and plans to start human trials after necessary permissions are granted, Bangladeshi drug firm, Globe Biotech, came up with good news of vaccine in the desperate times of COVID-19.
Explaining the company's plan, Mr. Mohiuddin, manager (quality and regulatory operations) Globe Biotech Limited, said they have planned to complete the clinical trial by December as it will take 28 days for finishing each trial."We're hopeful about releasing the vaccine commercially from January next year," he said.
After being able to produce expected amount of antibodies with the vaccine in trial animals in two phases of the pre-clinical stage, Globe Biotech will officially seek ethical approval from Bangladesh Medical Research Council (BMRC) to start the first phase of human trial for the vaccine through CRO (contract research organization) of the only local pharmaceutical company by later next week.
"Our third party (CRO) will hopefully apply for ethical approval later this week. If we get it quickly, we've planned to start the first phase of clinical trial either from late September or early October," he said.
Clinical trial is done basically in three phases. In the first phase, the dose is applied on a small group of volunteers to test the safety of the drug. To evaluate its safety and effectiveness, phase two is done on a larger group of volunteers than the phase one.
And finally, the phase three is done to evaluate the side effects of each drug and which drug suits more people of different age and gender, according to the healthcare professionals.
As each of the phase will require considerate amount of time, the officials of Globe Biotech are hopeful that they can bring the vaccine for the common market within January.
To ensure the quality of the vaccine, after receiving the approval for human trial it will also seek assistance from the drug regulator, Directorate General of Drug Administration.