Globe Biotech Limited (GBL) submitted results of pre-clinical trials of its homegrown Covid-19 vaccine - Bangavax - on monkeys to the Bangladesh Medical Research Council (BMRC) on Monday.
With the submission, the country's lone coronavirus vaccine manufacturer met the final pre-condition of the BMRC - the authority that gives approval for clinical or human trials of any antidote, before launching human trial of its antidote here.
At the same time, the local drug maker also submitted responses to more than 50 quarries, as required by the BMRC on June 22.
Confirming the development, GBL senior manager (quality and regulatory operations) Dr Mohammad Mohiuddin said they officially submitted outcomes of the pre-clinical trials of its Covid-19 vaccine to the council, and sought ethical approval for starting its clinical trial on human.
"We got very good responses from the trials, and the vaccine helped develop antibody in the inoculated monkeys to fight out 11 variants of the coronavirus, including Delta one."
He said they also responded to many quarries of the BMRC for the third time on the day regarding the pre-clinical trial.
"So, we've met all the requirements of the BMRC. Now we're ready to start the human trial of our vaccine. Once the council gives the approval, we will be able to start the human trial. We hope the council will not take too much time now."
The local drug maker started the animal trial on monkeys from August to meet the BMRC's conditions.
Dr Mohiuddin noted that the monkeys - on which the vaccine doses were administered - responded well, and the shots were found safe for the animal.
He said they administered doses of Bangavax to the monkeys that helped develop effective antibody among those. Later, eleven variants of the virus were pushed in to the animals to see whether the animals were infected with the viral disease or not.
"No monkey is infected with the virus. It means the antibody helps neutralise the virus in a few days. But the virus badly infects those which were not inoculated," he added.
When contacted, BMRC director Prof. Dr. Md. Ruhul Amin said they received results of the Globe's pre-clinical trial, which is also called phase-zero trial.
Now the BMRC will crosscheck whether the procedure of the trial was right or not. "If it is okay, we will issue the ethical clearance. If it is not, we will ask Globe to correct it."
When asked how much time the BMRC will need to give response, he said they cannot say anything about the time at this moment, as they need to scrutinise it.
"So, I cannot say the exact time now. But one thing I can say that we are dealing the matter with due importance," he added.
The GBL, in October last year, announced that its mRNA vaccine showed promise in animal trials on mice. Based on the successful trials, the local drug firm approached the BMRC for giving ethical clearance before human trial.
But the BMRC approved clinical trials of Bangavax under the condition that before starting human trial, the vaccine producer would conduct an animal trial on monkeys or chimpanzees.
Seeking anonymity, an official of the Directorate General of Drug Administration (DGDA) said the GBL has to submit their results to them.
"Once the BMRC issues ethical approval, we will give green signal to the company," he added.
The DGDA is the monitoring authority of vaccine human trial process here.
