The Financial Express

Pre-clinical trials of Bangavax show success

| Updated: October 15, 2021 20:16:43

Pre-clinical trials of Bangavax show success

Globe Biotech Limited has got a positive response from the ongoing pre-clinical trials of its home-grown Covid-19 shot Bangavax on monkeys, officials claimed.

The local drug-maker started animal trials last August to meet the matrix of the Bangladesh Medical Research Council (BMRC) that endorses any clinical or human trials of any antidote here.

"We've got a very good response… as their vaccine helps develop antibody among the inoculated monkeys to fight out 11 coronavirus forms, including the Delta variant," said Globe Biotech senior manager (quality and regulatory operations).

Dr Mohammad Mohiuddin said the vaccinated monkeys responded well as the shots were found safe for them.

They also did a 'virus challenge study' with analysing sequence of the mutants and matched it with their vaccine and found the antidote very effective against them, according to him.

Globe Biotech administered Bangavax to the monkeys that helped develop effective antibody among them.

Later, all the 11 variants were pushed in to the animals to see whether they caught the viral disease.

"Alhamdulillah [the Almighty be praised], no monkey is down with the virus, meaning that the antibody helps neutralise the pathogen in a few days."

"But the virus badly infects those who were not inoculated," Mr Mohiuddin added.

The firm will finish the study in a few weeks and then share the findings with the BMRC and the Directorate General of Drug Administration (DGDA) before their human trials.

Mamun al-Mahtab Swapnil, principal investigator of the trial, said many vaccines were applied directly to humans or animals and humans at a time after rats.

As a result, progress in those vaccines has been quite rapid. But in this case, it is being late only because of many phases of trials, he said.

"The responses… from the trails are very encouraging. We'll probably come up with good results next month," said Mr Swapnil, also a professor at Bangabandhu Sheikh Mujib Medical University.

When asked, BMRC director Prof Dr Md Ruhul Amin said they have already given the all-clear, suggesting that the DGDA try the vaccine on monkeys or chimpanzees.

"We've done our part. The ball is in the DGDA's court now. We'll submit the results of the trial to the DGDA for the next course of action," he told the FE.

Last October, Globe announced that its mRNA vaccine showed promise in trials on mice. Based on the successful trials, it approached the BMRC for ethical clearance before human trials.

But the BMRC approved clinical trials of Bangavax under the condition that "before starting any human trial, the vaccine producer requires to conduct a trial on monkeys or chimpanzees.

Seeking anonymity, a drug administration official said Globe Biotech should submit their results to them.

"We'll scrutinise the trials. If everything is fine, we intend to give them the green light," he added.

Meanwhile, healthcare experts expressed dissatisfaction with the developments centring the Bangavax issue.

Bangladesh Medical Association secretary general Dr Md Ehteshamul Huq Choudhury said Globe Biotech came up with the announcement of developing vaccine last year, but unfortunately the agencies concerned did not pay much heed to it, rather killing time.

"I don't know why they (the agencies) are doing so. I hope the agencies would cooperate WITH the vaccine developer this time and allow its human trials asap if everything of the animal trial is okay."

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