Local drugs maker Globe Biotech on Sunday applied to the Bangladesh Medical Research Council for approval to conduct clinical trials of its COVID-19 vaccine named BANGAVAX, said the firm’s head of research and development Asif Mahmud.
CRO Bangladesh Ltd will conduct the phase-1 trial of the vaccine on about 100 volunteers, if approved, he told New Age.
The volunteers will include employees of Globe and healthcare providers from Farabi Hospital in the capital’s Dhanmondi area, according to the application.
Mamun Al Mahtab, principal investigator of the planned trials and professor of haematology at Bangabandhu Sheikh Mujib Medical University, told New Age that Globe Biotech had proposed the phase-1 and phase-2 trials together.
‘It’ll take about a year to have the results from the trials of the two phases,’ he said, adding that the phase -3 trial would include more volunteers and take additional time.
BMRC director Mahmood Uz Jahan said that they would analyse the proposal at the earliest and approve it if found sound due to the urgency of the issue.
Globe Biotech is the only Bangladeshi pharmaceutical company to have joined the race for developing a COVID-19 vaccine.
The private sector company received approval from the Directorate General of Drug Administration on December 28 for producing the vaccine for clinical trials.
The government has granted the approval amid confusion and uncertainty over obtaining the Oxford-AstraZeneca vaccine manufactured by the Serum Institute of India.
Globe has three vaccine candidates that are on the World Health Organisation list of draft landscape of COVID-19 candidate vaccines.
On July 2, 2020, Globe Biotech announced that it was developing a COVID-19 vaccine after successfully completing the preliminary trials on animals.
On October 5, 2020, the company said that it had received ‘very promising’ results from the pre-clinical trials of the vaccine on rabbits and mice.
According to the US Centres for Disease Control and Prevention, the development of new vaccines is required to go through six stages.
They include exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing, and quality control.
Clinical development is a three-phase process, it said.
In phase 1, small groups of people receive the trial vaccine.
In phase 2, the clinical study is expanded and the vaccine is administered to people who have characteristics such as age and physical health similar to those for whom the new vaccine is intended.
In phase 3, the vaccine is given to thousands of people and tested for efficacy and safety.
Many vaccines go through phase 4, in which the vaccine is approved and licensed.
According to the WHO list, Globe Biotech’s three vaccine candidates — DNA plasmid vaccine, Adenovirus Type 5 Vector, and D614G variant LNP-encapsulated mRNA — have been received for pre-clinical evaluation.
Currently there are 63 COVID-19 vaccines in the clinical development stage and 172 in the pre-clinical development stage around the world, according to the WHO list updated in the first week of January.
The three Globe candidates are on the list of those vaccines that are passing through pre-clinical development stages.
The government on January 11announced that Bangladesh would start its mass COVID-19 vaccination from early February as 50 lakh doses of the Oxford-AstraZeneca vaccine are expected to arrive from the Serum Institute of India by the end of January.
Bangladesh has so far tallied around 5.3 lakh COVID-19 cases with 7,800 deaths from the disease since its first three cases were detected on March 8, 2020.
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