Bangladeshi company Globe Biotech will look for government endorsement to begin clinical trials of its Covid-19 vaccine this month, having just finished effective animal trials in the pre-clinical stage.
The company will look for endorsement through a contract research organization (CRO) to begin the first phase of human trials of the vaccine to examine whether the dose is safe and compelling for people.
The pharmaceutical company asserted they have gotten encouraging results from pre-clinical trials, at first done on rabbits and afterwards mice.
Asif Mahmud, in-charge of research and development of Globe Biotech limited, said, “If everything goes smooth and according to plan, we hope [all three phases of] the human trial will be completed by January.”
Contacted, Dr. Mahmood-Uz-Jahan, director of Bangladesh Medical Research Council (BMRC), said he could only comment once they got the application.
According to healthcare professionals, clinical or human modelling trial is done in three phases. In the first phase, the dose is given to a small group of people to test the drug’s safety. The phase-II trial is done in larger groups to further assess safety and effectiveness.
The phase-III trial is conducted to assess the side-effects of each drug and to see which one works better and enrols more people than the previous two phases, said, healthcare professionals.
Every day, a substantial number of people are volunteering to sign up for the trials, said Asif Mahmud.
He said human trials would begin after taking necessary measures as per international protocol.
A third-party CRO has also been finalized and Globe Biotech is now working with them to formulate the protocol and guidelines.
When asked about the name of the CRO, the officials said they would disclose the name soon after finalizing background work.
In a press conference on July 2, Globe Biotech announced that they were developing a Covid-19 vaccine.
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News source: The Daily Star