No response to Bangavax

Over four months have passed with no response from a government body to a local pharmaceutical company's application to conduct clinical trials for a home-grown Covid-19 vaccine.

Vaccine developer Globe Biotech Ltd sent a letter to the Bangladesh Medical Research Council (BMRC) on January 17 this year to get ethical permission to conduct human trials.

Officials of the local drug company said they were yet to get any response from the regulatory body in this regard, adding that if they had already been allowed to conduct the trials, they would have been close to vaccine production by this time.

Bangladesh has been facing uncertainty in running the mass inoculation campaign against Covid-19 due to a dearth in vaccine supply.

"We do not know why there is such a delay. The BMRC sought some documents from us on February 9 and we complied with it by February 17. But after that there is no update," Dr Mohammad Mohiuddin, head of Globe Biotech's quality and regulatory operations, told The Daily Star recently.

He said their nominated Clinical Research Organisation (CRO) is ready to start trials within a week of getting the green signal.

Mohiuddin also said the single-dose vaccine they developed, Bangavax, would be cheaper than other vaccines in the market.

Contacted, BMRC Chairman Dr Syed Modasser Ali said, "Till now, there is no progress. I cannot say more."

A BMRC ethical committee member, requesting not to be named, told The Daily Star that Bangavax is not up to the mark and before the Phase III trial, the drug company has more work to do.

During the clinical development of vaccines, small groups of people are given the trial vaccine in Phase I, is then expanded to give people with similar characteristics to the vaccine target group in Phase II, and thousands of people are given the vaccine in Phase III to test for efficacy and safety, according to the US Centres for Disease Control and Prevention (CDC) website.

The BMRC's website states drugs tested in Bangladesh require clinical trials to be carried out from Phase I to Phase III. It adds, "Generally permission to carry out these trials are given in stages, considering the data found in earlier Phase(s)."

Prof Kamrul Hassan Khan, former vice-chancellor at Bangabandhu Sheikh Mujib Medical University, said a decision on the ethical permission to hold clinical trials should be given immediately in an emergency situation.

"I don't know whether there are any other issues behind this process. But whatever it is, no decision for the last four months is unacceptable," he said.

"People are dying and there is a crisis of vaccines, so if the vaccine [candidate] meets the standard then it should be given ethical permission immediately."

BANGAVAX DEVELOPMENT TIMELINE

On October 5 last year, the company announced that its first vaccine candidate had shown promise in pre-clinical trials on mice. Researchers initially named it Bancovid but later renamed it as Bangavax.

Bangavax, along with two other vaccine candidates developed by Globe Biotech, were included in the World Health Organisation's draft landscape and tracker of Covid-19 vaccines in development worldwide, on October 17.

The company received permission from the Directorate General of Drug Administration to manufacture the necessary doses needed in a clinical trial on January 6.

The company had initially signed an agreement with icddr,b to hold the clinical trials. That agreement was later cancelled with CRO subsequently getting the contract.

Earlier this month, Globe Biotech's CEO Kakon Nag and others published a study on Bangavax in Vaccine, an open access peer-reviewed medical journal in the US.