Publish: 23 Nov 2021, 08:17 pm
Bangladesh Medical Research Council (BMRC) has given the local pharmaceutical
company Globe Biotech Limited ethical approval to commence human trials of
Bangavax, a single-dose Covid-19 vaccine.
On Tuesday, BMRC director Prof Md Ruhul Amin and Globe Biotech senior manager (Quality and Regulation) Dr Md Mohiuddin verified the news.
The Globe Biotech will now apply to the Directorate General of Drug Administration (DGDA) in a few days to perform the experiment, according to Dr Md Mohiuddin of the Dhaka Tribune.
Dr. Ruhul stated that Globe Biotech is now able to perform Phase I of the trial while adhering to the BMRC's guidelines.
Previously, the vaccine developers had responded to all of the BMRC's questions and observations in order to receive approval for human trials.
Globe Biotech revealed in July of last year that it was working on a Covid-19 vaccine.
The DGDA granted the pharmaceutical business license to manufacture its Covid-19 vaccine for clinical trials on December 28, 2020.
On January 15, this year, the pharmaceutical company applied to the DGDA for approval to conduct clinical studies.
The company conducted rat testing in February of this year.
Earlier, Dr Mohiuddin said: “Bangavax is a single dose vaccine without any side effects. We have conducted trials on monkeys and obtained a 95% success rate. The success rate will only vary by about 2%, hopefully, in human trials.”
Human trials process
The human trials will be conducted in four-phase process through a third-party clinical research organization (CRO).
In Phase I, the vaccine would be given to small groups of 20-100 healthy volunteers to assess its safety, confirm that it produces an immunological response, and identify the proper dosage.
The clinical trial will be expanded to over 100 volunteers in Phase II. A subset of them will be given the vaccination, while the others will be given placebos.
Side effects will be evaluated, and the vaccine's ability to elicit an immunological response will be assessed further.
The vaccine will be given to over a thousand people in Phase III.
Researchers will examine long-term data on the vaccine's advantages and negative effects in Phase IV.
The vaccination, according to Dr. Mohiuddin, will be effective against 11 Covid-19 variations, including the Delta version.