Home-grown Vaccine: Globe Biotech wants to start human trials
The lone Bangladeshi coronavirus vaccine developer Globe Biotech Ltd said their coronavirus vaccine --named BANCOVID-- has shown high efficacy in pre-clinical trial on mice.
Officials of the Globe Biotech Ltd now wants to start clinical trial on human "as early as possible", and is seeking cooperation from the government regulatory bodies to accelerate the approval process.
"We have completed our basic task -- the development of the vaccine. Now we want to go for clinical trial on humans and we need approval from the regulatory bodies," Kakon Nag, CEO of the company, said during a press conference in Dhaka yesterday.
He claimed that they were confident their vaccine candidate would prove to be one of the advanced coronavirus vaccines.
"If things go smoothly, we hope to supply the vaccine in the market by next December-January," Nag claimed.
The pre-clinical trial results were pre-published in the international platform, biorxive.org -- an archive for unpublished pre-prints in life sciences.
The result, however, has not been published in any peer-reviewed journals yet.
Peer-review involves subjecting the author's scholarly work and research to the scrutiny of other experts in the same field to check its validity and evaluate its suitability for publication.
Peer-reviewed means the article is more likely to be scientifically valid and reach reasonable conclusions.
"We have submitted our findings to multiple journals. Those will take three to four months to be published. But we do not want to sit idle for that," Nag said.
Asked why BANCOVID was not in the draft Covid-19 candidate vaccines list of the World Health Organisation (WHO), Nag alleged, "We have submitted all necessary documents to them [WHO] [two months ago]. But they are delaying the process unnecessarily."
Asked about, Bardan Jung Rana, country representative of WHO said, "There is no delay. There are lots of people who have been applying. So I think they [officials at headquarters] will look on all the papers and things like that… These things are not with us; these things are at the headquarters.
"We will continue following especially [since] they have finished the preclinical [stage]," he added.
HOW MUCH POTENTIAL?
According to the Globe Biotech researchers, the BANCOIVID is a mRNA (messenger RNA) vaccine. This is a new type of vaccine for providing acquired immunity through an RNA containing vector, such as lipid nanoparticles.
Speaking at the occasion, experts also lauded the efforts of Globe Biotech Ltd, but said there was a long way to go.
"Just the pre-clinical stage of BANCOVID has ended. The issue whether the vaccine will be proved effective will come later. But we appreciate Globe Biotech Ltd for it," Prof Mamun Al Mahtab, chairman of hematology department at BSMMU, said at the event.
The researchers of the company said they have not fixed any contract research organisation (CRO) to start the first phase of human trials yet, but they hope to "sign a MoU soon".
The next level trials will be conducted in supervision of the CRO.
"The BNCOVID vaccine is developed with our own technology and is the only and the first vaccine against the D614G variant," Nag said.
On July 2, Globe Biotech announced that they were developing a Covid-19 vaccine.
According to the US Centre for Disease Control (US-CDC), the general stages of the development cycle of a vaccine are: exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing and quality control.
The final stage trial or Phase-III clinical trial means the vaccine is at its final stage of major trials in which the vaccine is given to thousands of people and tested for efficacy and safety.
"Globally, many vaccines have been failing even at the final stage of trials. And BANCOVID has just passed the first stage. It does not authenticate the vaccine is effective. We could be sure about the efficacy after the mass scale human trial," Muniruddin Ahmed, a professor of pharmacy at Dhaka University told The Daily Star yesterday.
"If a vaccine become successful in the long run, it will shake the entire world. We are optimistic, but we should not make any exaggeration; because drug is a very sophisticated thing," he added.