Globe Biotech Limited, the lone Bangladeshi pharmaceutical firm which developed Covid-19 vaccine ‘Bangavax’, submitted a protocol to Bangladesh Medical Research Council (BMRC) on Sunday seeking approval to conduct its clinical trial.
Dr Asif Mahmud, In-Charge of the Molecular and Cell Biology unit and Assistant Manager of Globe
Biotech Limited confirmed it.
He said, CRO Bangladesh, a private research institute, submitted the protocol on behalf of Globe Biotech Limited.
The National Research Ethics Committee of the BMRC will examine the protocol and forward it to the Directorate General of Drug Administration (DGDA) after giving initial approval. The National Clinical Advisory Committee of the DGDA will then evaluate the relevance.
Dr. Asif Mahmud said, “After getting approval, we would be able to start the human trial within 10 days, as Professor Mamun Al Mahtab, the Principal Investigator of the clinical trial, informed us.”
He said, “It is the first time that a local vaccine is going to be conducted human trial in Bangladesh. It is a milestone for the country.” Globe Pharmaceutical Chairman Md Harunur Rashid, Globe Biotech CEO Kakan Nag, icddr,b Director Tahmina Shirin and other officials were also present during submitting the protocol.
On December 28, the Directorate General of Drug Administration (DGDA) gave permission to Globe Biotech to produce Bangavax for clinical trials.
After getting the permission, Globe Biotech on December 1, announced that they would part ways with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) for conducting human trials of the Bangavax.
Later, the Globe Biotech cancelled the agreement observing the less progress in icddr,b’s approach to conduct the clinical trials. “We have cancelled the Memorandum of Understanding (MoU) due to the lack of interest on icddr,b’s part,” said Globe Pharmaceuticals Chairman Harunur Rashid.
Earlier, on July 2, in a press conference, Globe Biotech claimed success in preliminary trials on animal for Covid-19 vaccine as the first firm from Bangladesh to have a Covid-19 vaccine candidate initiative.
