Bangladesh

Clinical Trial of Vaccine: Globe Biotech plans to start it this month

Bangladeshi company Globe Biotech will seek government approval to start clinical trials of its Covid-19 vaccine this month, having already completed successful animal trials in the pre-clinical stage.

The company will seek approval through a contract research organisation (CRO) to start the first phase of human trials of the vaccine to examine whether the dose is safe and effective for humans.

The pharmaceutical company claimed they have gotten encouraging results from pre-clinical trials, initially done on rabbits and then mice.

The pre-clinical trial results were pre-published in the internationalplatform, biorxive.org -- an archive for unpublished pre-prints in life sciences. and the company is likely to hold a press conference in this regard early next week, Asif Mahmud, in-charge of research and development of Globe Biotech limited, told The Daily Star yesterday.

"If everything goes smooth and according to plan, we hope [all three phases of] the human trial will be completed by January," Asif added.

Contacted, Dr Mahmood-Uz-Jahan, director ofBangladesh Medical Research Council (BMRC), said he could only comment once they got the application.

Prof Md Sayedur Rahman, chairman, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, an expert on research ethics, told The Daily Star that Globe Biotech has to apply to BMRC and its national research ethics committee will analyse the pre-clinical trial results, and then make a decision on whether or not it will give permission for human trials.

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 finalised 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 finalising background work.

In a press conference on July 2, Globe Biotech announced that they were developing a Covid-19 vaccine.

During that press conference they said they would need six to eight weeks to complete regulated animal trials, after which they would apply for permission to conduct human trials if the animal trials proved successful.

More than 200 studies across the globe were conducted for developing a Covid-19 vaccine. Half a dozen are in the final stages of human trials.

University of Oxford and British company AstraZeneca; US firm Moderna; a collaboration between American pharmaceutical company Pfizer and Germany's BioNTech; and China's CanSino Biological, SinoVac Biotech and SinoPharm are well advanced in the race.

Moderna became the first to publish the complete blueprints of its study following calls for greater transparency.

Russia's Gamaleya Institute has become the first to get the nod to produce its vaccine, although its final trials are still ongoing. 

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