Bangladeshi drug firm Globe Biotech has entered the global race for developing COVID-19 vaccines.
Three COVID-19 vaccine candidates, developed by Globe Biotech, have been included in the World Health Organisation’s list of draft landscape of COVID-19 candidate vaccines.
Globe Biotech is the first ever Bangladeshi drug manufacturer to join the race for developing a COVID-19 vaccine.
According to the WHO list, Globe Biotech’s three vaccines – DNA plasmid vaccine, Adenovirus Type 5 Vector, and D614G variant LNP-encapsulated mRNA – have been received for the pre-clinical evaluation.
Globe Biotech in a release on Saturday pointed out that it was the only company in the world having three COVID-19 vaccine candidates in the WHO draft landscape.
On July 2, Globe Biotech announced that it was developing a COVID-19 vaccine after successfully completing preliminary animal trials.
On October 5, the company said that it had received ‘very promising’ results from the pre-clinical trials of the vaccine on rabbits and mice.
It sought government cooperation for human trial.
The company on October 14 reached an agreement with ICDDR,B for conducting human trial of one its COVID-19 vaccines named BANCOVID, said the drug firm’s in-charge of research and development Asif Mahmud.
ICDDR,B will now seek permission from the Bangladesh Medical Research Council before conducting the trial, officials said.
Asif said that they were expecting they would get the approval from the BMRCH soon to conduct the trial.
The protocol for the trial is yet to be developed, he said, adding that the protocol would be developed by the ICDDR,B and submit to the BMRC for the permission.
According to the Centers for Disease Control and Prevention of USA, development of new vaccines is required to go through six stages.
They include exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing and quality control.
Clinical development is a three-phase process, it said, during the phase I when 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.
Many vaccines undergo phase IV in which the vaccine is approved and licensed.
There are 42 candidate vaccines now in the clinical evaluation stage, according to the WHO list.
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