When does Bangavax get cleared for clinical trials?

Almost five months into applying for ethical approval to conduct the clinical trial on humans, Globe Biotech Limited, the only Bangladeshi candidate in the global vaccine race, has yet to get a clearance for Bangavax. 

BMRC Chairman Dr Syed Modasser Ali declined to give any update on the trial, saying that he was not authorized to disclose any information related to vaccines or clinical trials of any vaccine. 

“I can’t make any comment about the trial. We are looking into the issues related to it. But I’m not authorized to share any information about it,” he said on Thursday.

Modasser Ali claimed that the BMRC was waiting for the Health Ministry’s decision on disclosing updates about the trials. 

For his part, Globe Biotech Chairman Dr Harunur Rashid hopes to get positive news about the clinical trial of Bangavax next week.

“I can’t give any information at this moment as it is confidential and we are not authorized to disclose anything. However, I am hoping that we will get positive news about the clinical trial next week,” he said.     

In July last year, the vaccine producer announced that it was developing a Covid-19 vaccine, making it the only vaccine candidate developed by a Bangladeshi company.

On December 28, 2020, the Directorate General of Drug Administration (DGDA) gave permission to Globe Biotech Limited to manufacture its Covid-19 vaccine for clinical trials.

The pharmaceutical company approached the DGDA on January 15 this year seeking permission for the clinical trials.

According to the US Centres for Disease Control and Prevention (CDC), clinical development is a three-phase process. 

During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccines are given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.

Virologist Prof Nazrul Islam said he could not vouch for any specific company, but if Bangladesh succeeded in producing Covid-19 vaccines, it would be a blessing in many ways. 

“Any country which has the capacity to produce vaccines locally will be ahead of countries relying on other nations for importing vaccines to fight the global pandemic,” said Nazrul Islam, a member of the National Technical Advisory Committee on Covid-19.

There are numerous benefits of locally produced vaccines: accessibility, availability and easier storage facility and cost-effectiveness, he said.

“As the trial will be run on locals, researchers will be able to gather specific data,” he concluded. 

‘Easy to store’

Bangavax can be stored at 2-8 degrees Celsius for one month and at minus 20 degrees Celsius for six months. 

“Since cold chain [a temperature-controlled supply chain] capacity is going to be an issue to store vaccine vials in the right temperatures, locally produced vaccines can largely resolve this issue,” Dr Asif Mahmud, in-charge of the research and development department at Globe Biotech Limited, said earlier this year. 

On December 1, 2020, the vaccine manufacturer announced that it would part ways with International Centre for Diarrhoeal Disease Research, Bangladesh on conducting vaccine trials. 

On July 2 last year, claiming success in preliminary animal modelling trials for the Covid-19 vaccine, Globe Biotech claimed to be the first company from Bangladesh to have a Covid-19 vaccine under development.