Bangvax gets approval for human trial on condition
Published : Thursday, 17 June, 2021 at 12:00 AM Count : 402
After a long wait finally Bangladesh Medical Research Council (BMRC) has decided to approve human trail to Globe Biotech's Covid-19 vaccine Bangvax on condition.
The National Research Ethics Committee of BMRC came up with the disclosure in a virtual meeting on Wednesday.
The companies will be informed about this in a letter on Sunday.
'The Daily Observer' published two special news items about 'Bangavax' on May 25 titled 'A vaccine unborn'
and on June 15 titled 'Globe Biotech writes to Prime Minister for human trial permission'.
However, the committee suggested that there may be some errors in the protocol paper provided by Globe Biotech. After the correction, formal approval will be given for the human trial of 'Bangavax'.
Prof Dr Ruhul Amin, Director of BMRC, said, "It could not be said that permission has been given directly. However, conditions have been given. We will allow after correcting their mistakes. If the conditions are met, approval will be given. Two more vaccines, one from China and another Indian, were also taken into consideration for approval." "The three organizations that have applied to BMRC have been given policy approval. However, some rules must be followed. The first stage clinical trial should be run on monkeys. Safety will be considered when applied to the human body. If they follow these rules, we will be able to give approval," he added.
However, on December 28, the Directorate General of Drug Administration (DGDA) allowed Globe Biotech to produce a vaccine for human trial but without the permission of BMRC.
Globe Biotech had submitted its vaccine for ethical clearance for phase-1 and phase-2 clinical trial protocols to BMRC through an institution named Clinical Research Organisation Ltd on January 17.
After reviewing the protocols, the committee wrote to Globe Biotech on February 9 with observations on several issues. Then, on February 17, Globe Biotech submitted a set of protocols corrected in accordance with the BMRC's demands alongside some additional information and data.