Bangavax, a homegrown vaccine, first buzzed with hope, then fizzled

Globe Biotech, a Bangladeshi company, applied for permission to begin clinical trials of its COVID-19 vaccine candidate ‘Bangavax’ in January. But, over three months later, it has yet to receive the approval of the Bangladesh Medical Research Council.

As trials have yet to begin, it means the effectiveness of the domestically produced vaccine is still unknown.

Globe Biotech applied for approval to begin testing on humans, known as a clinical trial, on Jan 17.

According to the rules, applications are first screened by the BMRC’s National Research Ethics Committee. If the BMRC gives its ethical consent, it goes to the Directorate General of Drug Administration. There it will wait for the consideration and approval of the National Clinical Trial Advisory Committee.

The relevant government agencies have yet to issue any clear statement on why there has been no progress on approving trials in the three and a half months since the application was submitted.

“The matter is fully overseen by our chairman,” BMRC Director Dr Md Ruhul Amin told bndews24.com when asked.

“I don’t have much to say on this matter.”

When asked for the latest update on the approval process for Bangavax, BMRC Chairman Dr Syed Modasser Ali said: “I shall not make a comment to the media, or anywhere about this.”

Globe Biotech says it submitted its vaccine for ethical clearance for phase-1 and phase-2 clinical trial protocols to BMRC through an institution named Clinical Research Organisation Ltd on Jan 17.

After reviewing the protocols, the committee wrote to Globe Biotech on Feb 9 with observations on several issues. Then, on Feb 17, Globe Biotech submitted a set of protocols corrected in accordance with the BMRC’s demands alongside some additional information and data.

One dose of the vaccine had created working antibodies during trials on animals, Dr Mohammad Mohiuddin, the quality and regulatory operations manager at Globe Biotech, told bdnews24.com. He believes the clinical trial will yield similar results.

The vaccine can be preserved for one month at 4 degrees Celsius and six months at -20 degrees Celsius, Dr Mohiuddin said. As it is created synthetically, the vaccine is also virus-free and 100% halal, he said.

The whole vaccine process is at a standstill because the company is yet to receive ethical clearance from the BMRC.

“If we get their permission, we will submit these protocols to the Directorate General of Drug Administration. Only when we’ve received their approval can we begin testing the vaccine on humans.

"At first, only a handful of human subjects will be tested to check whether the vaccine is safe and viable. Once it is proven to be effective and safe, we can move on to tests on a larger scale.”

“We received permission to produce doses of the vaccine for clinical trials last December. But we still need ethical clearance and permission from the drug administration. Once we have that we can produce the vaccines and test them on humans.”

On Jul 2, 2020, Globe Biotech, a unit of Globe Pharmaceuticals, said they would begin work on the vaccine on Mar 8 and hoped to have the vaccine on the market within six to seven months.

It also said the vaccine was ‘successful’ when tested on rabbits and the company was hopeful it would be similarly effective on humans.

At a press conference in October 2020, Globe announced that the vaccine ‘has proved its efficacy and safety’ when applied on mice.

In October, three vaccines from Globe were added to the World Health Organization’s list of COVID-19 candidate vaccines. Mohammad Mohiuddin told bdnews24.com at the time that, among the three vaccines, the D614G variant mRNA vaccine had completed pre-clinical trials.

The vaccine was initially called Bancovid, but was later renamed Bangavax in December.

Globe received a licence to produce the potential vaccine for trial on Dec 28 last year and applied for ethical clearance to begin clinical trials on Jan 17.