After months of uncertainty, Globe Biotech Limited (GBL) restarted preclinical or animal trials of its homegrown Covid vaccine, Bangavax, in a breakthrough.
This time, it is being trialed on monkeys to meet the condition set by Bangladesh Medical Research Council (BMRC), the authority that gives approval for clinical or human trials of any antidote here.
The company, GBL, earlier in October last year, had announced that its mRNA vaccine showed promise in animal trials on mice. Based on the successful trials, company officials said, the local drug firm had approached the BMRC for ethical clearance before the human trials.
But the council approved clinical trials of Bangavax under the condition that "before starting any human trial, the vaccine producer requires to conduct an animal trial on monkeys or chimpanzees.
"We started animal trials of Bangavax on monkeys on August 1st in line with BMRC's condition," senior manager (quality and regulatory operations) of Globe Biotech Limited Dr Mohammad Mohiuddin said.
Citing revised plan of the GBL, he said the pre-clinical trials are expected to be completed within next month and the company planned to conduct human trials from November.
Responding to a question, he said they tried to conduct trials on monkeys overseas. India asked them to move ahead with the G2G (government to government) mechanism but did not get expected response from the department concerned even after repeated approach.
He said Bangavax is a new-generation mRNA vaccine like the Pfizer and Moderna ones. Developed countries say monkey trials of mRNA-type vaccines are not necessary but BMRC makes it mandatory.
"So, we are forced to conduct the monkey trials after getting permission from the forest department maintaining international standards," he added.
Talking to the FE, BMRC director Prof Dr Ruhul Amin said they would provide all kinds of corporation to the Bangavax authority once the monkey trials are done.
"I know conducting animal trials again will take time, but we have nothing to do. This is a major requirement that needs to be fulfilled," he added.
The lone coronavirus-vaccine candidate of the country sought ethical approval from the BMRC for human trials of the antidotes on January 17 last.
The BMRC on February 09 asked for some documents and the company delivered those on February 17. After four months of silence, the BMRC in June last gave the conditional approval.
Expressing dissatisfaction over the dilemmas, healthcare experts feared that Bangavax might face the same fate as the rapid-test kit developed by Gonoshasthaya Kendra.
"I don't understand why the BMRC did not notify the GBL about the money factor when the vaccine developer first approached them. Why is it delayed needs to be cleared," BMA secretary-general Dr Md. Ehteshamul Huq Choudhury said.