Bangavax Covid shots: BMRC moves to resume process for clinical trials
Bangladesh Medical Research Council has sought documents of the homegrown Bangavax Covid-19 vaccine to further proceed towards allowing its clinical trial.
The BMRC is also considering whether to allow two more vaccines -- one each from China and India -- for the trials.
"We did not give approval to anyone. The process of approval remained stalled for a while but we resumed it. We sought some documents from them to fulfil the conditions of the BMRC," Dr Ruhul Amin, director of the council, told The Daily Star.
The director also said the three companies will get approval for clinical trial only after they meet BMRC conditions.
When asked whether the BMRC sent any letter to those companies, Ruhul said the letters will be sent by Sunday.
Vaccine developer Globe Biotech Ltd, the developer of Bangavax, sent a letter to the BMRC on January 17 this year to get ethical permission to conduct human trials.
Chinese state-owned pharmaceutical company Institute of Medical Biology and Chinese Academy of Medical Sciences (IMBCAMS) and Indian state-owned Bharat Biotech applied to Bangladesh last year for third-phase trials.
Chinese IMBCAMS appointed local pharmaceutical company One Pharma as its local agent. One Pharma sent a letter to the health secretary on December 23.
IMBCAMS and icddr,b signed an agreement on December 20. The icddr,b applied to BMRC to carry out the clinical trials.During the clinical development of vaccines, small groups of people are given the trial vaccine in Phase I. In Phase II, it is expanded to a larger group of people with similar characteristics to the vaccine target group, and thousands of people are given the vaccine in Phase III to test for efficacy and safety, according to the US Centers for Disease Control and Prevention 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)."
On October 5 last year, Globe Biotech 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 a company named CRO subsequently getting the contract.
Last month, Globe Biotech's CEO Kakon Nag and other researcherspublished a study on Bangavax in Vaccine, an open access peer-reviewed medical journal in the US.