Globe Biotech’s CEO says the three-stage trials will take five months
Health and vaccine experts are surprised by Globe Biotech's claim that it can bring its Covid-19 vaccine to the market by December this year if it gets the government's help.
The Globe Biotech Ltd has neither applied to the Bangladesh Medical Research Council (BMRC) yet to conduct clinical trials of its vaccine candidate nor appointed any contract research organisation (CRO).
Yet, the local pharmaceutical company claims that it can roll out its potential Covid-19 vaccine on the market within 2-3 months if they get the necessary support.
At a press briefing on Monday, the company said they have successfully completed animal trials of its coronavirus vaccine named BNCOVID.
They hope that they will be able to go into production after human trials if the government provides support.
Prof Sayedur Rahman, chairman at the Bangladesh Pharmacological Society, told The Business Standard, "It would take 10 years on an average to bring a vaccine to the market before the Covid-19 pandemic hit. This is for the first time, the production time has been reduced to 18 to 24 months."
On 2 July, Globe Biotech first officially announced it had developed a Covid-19 vaccine. It would take five to six months to bring its vaccine to the market as per its claim.
"Do they have a magic wand? Will they make a vaccine by December just by the touch of it?" said Dr Muniruddin Ahmed, a professor at the Department of Clinical Pharmacy and Pharmacology of the University of Dhaka.
"It is October now. How will it be possible to complete three stage trials of the vaccine, data collection and analyses, plus peer review in an international journal only in two months? How can this claim be termed scientifically correct?" he added.
The clinical trial is very lengthy, critical and important as well, he added.
"We hope the Globe Biotech's initiative to develop a [novel] coronavirus vaccine sees success. But it is not possible to do so through exaggeration and unrealistic talks," he continued.
Harunur Rashid, chairman of Globe Pharmaceuticals Limited, at a press conference on Monday, said "We will be able to launch the vaccine between December and January. We are ready to prepare the doses. We have completed everything on our part. Now, we are waiting for the overall cooperation of the BMRC and the Directorate General of Drug Administration, particularly of the government."
Dr Kakon Nag, Globe Biotech's chief executive officer, said "We are now working to appoint a CRO and make a protocol for clinical trials of our vaccine. After the appointment of the CRO, we will apply to the BMRC for a permission to conduct clinical trials."
"When we go for the clinical trials depends on the government's decision. The three-stage trials will take five months," he pointed out.
When asked about how it is possible to bring the vaccine to the market if it takes five more months to complete the remaining job, Kakon Nag told The Business Standard, "If we get support from the government, like what the United States' Moderna has got from their government, our vaccine will hit the market in December or January."
"We have completed our job. We have developed the vaccine and done whatever is required from scientific safety to efficacy," he added.
Dr M Mushtaq Hussain, adviser to the Institute of Epidemiology, Disease Control, told The Business Standard that there is an opportunity to complete administrative work quickly. But it is necessary to wait for a specific time to see how the vaccine works in the human body. There is no shortcut."
According to the United States Centres for Disease Control and Prevention, 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.
Clinical development is a three-phase process. During phase I, small groups of people receive the trial vaccine. In phase II, the clinical study is expanded and the vaccine is given to people who have characteristics – such as age and physical health – similar to those for whom the new vaccine is intended. In phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
Medical Scientist Professor Liakot Ali told The Business Standard that each phase of the trials and other formalities must follow their rules and timing.
"There is no scope for showing-off or illogical claims here," he added.
Kakon Nag claimed that they have published the animal trial reports of their potential vaccine to the international platform, biorxive.org.
Regarding this, Dr M Mushtaq Hussain said peer-reviewed articles for publication in any scientific journal are authentic.
He said, "They are only one step ahead as they submitted the article. However, it has yet to be published in any scientific journal."
BMRC Director Dr Mahmood-uz-Jahan told The Business Standard that it was too early to comment on the potential vaccine developed by Globe Biotech since they had yet to receive the documents.
"We will give the approval after verifying the papers. We will maintain all the required procedures," said Dr Mahmood.