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Delay In Getting Review Report

Clinical trial of Globe vaccine gets stuck

Published : Friday, 27 November, 2020 at 12:00 AM  Count : 318

In spite of being fully prepared for clinical trial of the vaccine developed by Globe Biotech, the company is stuck due to the delay in getting the review report of the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) and approval of Bangladesh Medical Research Council (BMRC).  
To start the first phase of human trial for the much-talked about vaccine, the local pharmaceutical company, through its CRO (contract research organisation) icddr,b, will officially seek ethical approval of BMRC.
Officials of Globe Biotech, a pharmaceutical research firm, said it is the only company in the world to be listed with three vaccine candidates - DNA plasmid vaccine, Adenovirus Type 5 Vector and D614G variant      LNP-encapsulated mRNA.
Dr Mohammad Mohiuddin, manager (quality and regulatory operations) of Globe Biotech said, "We are fully prepared to go for human trial through icddr,b. We have reached an agreement with our CRO icddr,b for conducting the phase-1 human trial."  
He said they were expecting they would get the BMRC approval soon to conduct the trial.
"The protocol for the trial is yet to be developed. It will be developed by icddr,b and then submitted to the BMRC for permission. icddr,b will seek permission from the BMRC to conduct the trial," he added.
Dr Asif Mahmud, in-charge of research and development at Globe Biotech, said, "We are not getting expected response from icddr,b as we have shared our data and protocol with them about one and half months ago but they are yet respond. But by this time they could have completed half of the human trial."
"We are observing that most of the vaccine developing companies are getting help from their governments and they are trying to come to the market as soon as possible but in our case, it is absent from our CRO as well as from our government but our government should come forward to help develop the vaccine for their own interest," he added.
"Those who started developing vaccines in the early pandemic period did not consider The D614G variant, but we did. So, we are very confident that our vaccine will work, as it is scientifically proved."
Confirming the development, Asif Mahmud, said, "The D614G variant LNP-encapsulated mRNA vaccine- well-known as BANCOVID-is currently in the process of human trial."
However, earlier, Bangladeshi lone coronavirus vaccine candidate Globe Biotech has achieved another much-needed milestone, as a globally recognised journal has certified its 'BANCOVID' scientifically okay for human trial.
With the achievement, Globe Biotech overcame the last requirement in seeking ethical approval from BMRC for conducting the vaccine's human modelling experiment.
The New York-based Cold Spring Harbor Laboratory (CSHL)-operated bio archive or BioRxiv published the results of its pre-clinical trials on September 30.
It termed the Bangladeshi company's homegrown vaccine the first D614G variant mRNA-based vaccine candidate in the world that elicits neutralising antibody and balances cellular immune response.
Meanwhile, on October 15, Globe's vaccine was listed on the World Health Organisation's (WHO) draft landscape of Covid-19 vaccines candidates.
However, although there is still a long way to go before Globe Biotech's coronavirus vaccine BANCOVID enters the market as the human trials have not yet started. But, there are already orders for a large number of doses of this vaccine, said the officials of the pharmaceutical company.
Nepalese private company Anmol Health Care is one of the companies that has recently entered into an agreement with Globe Biotech for 2 million doses of BANCOVID.
However, on 2 July, Globe Biotech announced they were developing a Covid-19 vaccine as they had completed preliminary animal trials successfully.
On October 5, they said they had received 'very promising' results from the pre-clinical trials on rabbits and mice.
Officials of the company said that BANCOVID would hit the market in late December or early January next year if the government was fully supportive.









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