DGDA approves Bangavax for clinical trial in 1st phase
Directorate General of Drug Administration (DGDA) has approved Globe Biotech Limited's Covid-19 vaccine Bangavax to begin clinical trials in the first phase.
The DGDA deputy director Salahuddin confirmed the matter to UNB on Sunday.
The trial will take place at Bangabandhu Sheikh Mujib Medical University Hospital (BSMMU).
Mamun Al Mahtab, professor of hepatology at BSMMU, is the principal investigator of this trial.
The research protocol is approved for the period of one year from the date of approval by DGDA, according to the DGDA letter sent to Mamun conveying the decision.
Bangladesh now joins the elite group of nine countries in the world with mRNA vaccine capability next to USA, Canada, Japan, India, China, South Korea, Thailand and Vietnam.
Globe Biotech Limited has claimed that Bangavax is 100 per cent effective for fighting 11 variants of Covid-19, including the Delta variant.
On 17 January last year, Globe Biotech, the only Bangladeshi company trying to develop a Covid-19 vaccine, submitted an application to the Bangladesh Medical Research Council (BMRC) for approval to conduct Bangavax's clinical trials.
On 23 November, the BMRC approved in principle Bangavax for human trials.
Globe Biotech received a license to produce their potential vaccine for trial on 28 December 2020.
The BMRC, which oversees all such trials, got back to them in June last year with certain conditions that had to be met before the clinical trials could go ahead.
The key condition was that Globe Biotech would have to run trials on monkeys or chimpanzees first.
One of the bottlenecks the company identified at the time was that the country did not have a third-party clinical research organization (CRO) that could conduct such tests on animals.