Local pharmaceutical company Globe Biotech Limited hopes to receive approval from the Bangladesh Medical Research Council (BMRC) to begin human trials of itsBangavax, a single-dose Covid-19 vaccine, in the first week of September.
The company expects to complete trials on 56 monkeys and submit a report to the BMRC by the end of August, Globe Biotech Senior Manager (Quality and Regulation) Dr Mohammad Mohiuddin told Dhaka Tribune on Thursday.
“After [completing monkey trials], we will seek permission for human trials. If granted, we will conduct clinical trials on humans for two and a half months,” he said.
“Once the BMRC endorses the human trial report, we’re capable of producing the Covid-19 vaccine in 7-10 days,” the official added.
In July last year, Globe Biotech announced that it was developing a Covid-19 vaccine and became the only vaccine candidate developed by a Bangladeshi company, so far.
On December 28, 2020, the Directorate General of Drug Administration (DGDA) gave permission to Globe Biotech Limited to manufacture its Covid-19 vaccine for clinical trials. The pharmaceutical company approached the DGDA on January 15 this year, seeking permission for clinical trials.
In June this year, the BMRC, which oversees such trials, said certain conditions needed to be met before it would grant permission for human trials.
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The main condition imposed by the BMRC was to complete trials on monkeys or chimpanzees first.
Earlier, the company conducted trials on rats six months ago.
Dr Mohiuddin said they had received assistance from the government and got approval from the DGDA, but the BMRC had not been cooperative.
Globe Biotech claims animal trials are not necessary before testing Bangavax on humans as it is an mRNA vaccine. The mRNA vaccines contain the genetic code to create a protein that triggers an immune system response, while traditional vaccines use modified viruses to trigger the same response.
“The vaccine is a single dose and does not have any side effects. We have conducted trials on monkeys and attained a 95% success rate. The success rate will only vary by about 2%, hopefully, in human trials,” he said.
He claimed the vaccine would be effective for 11 variants of Covid-19, including the Delta variant.
Human Trial Process
If Bangavax gets a go-ahead from the BMRC, Globe Biotech will conduct human trials through a third-party clinical research organization (CRO).
Dr Mohiuddin said the clinical trial would be a four-phase process.
During Phase I, small groups of 20-100 healthy volunteers would receive the vaccine to assess its safety, confirm it generates an immune response, and determine the right dosage.
In Phase II, the clinical study would be expanded to over 100 volunteers. Among them, a portion would receive the vaccine while others would receive placebos.
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The volunteers will be monitored for side effects and to further assess the vaccine’s ability to generate an immune response.
In Phase III, the vaccine would be given to over a thousand people.
In phase IV, researchers will analyse long-term data on the vaccine’s benefits and side effects.
When contacted, BMRC Chairman Dr Syed Modasser Ali declined to comment on the Bangavax trial and the approval process.
