After a two-phase of successful animal trials in the pre-clinical stage, Bangladeshi drug firm Globe Biotech is set to start clinical trials of the homegrown vaccine joining the global battle for finding the immunisation, officials say.
To start the first phase of human trial for the vaccine, the only local pharmaceutical company through its CRO (contract research organisation) will officially seek ethical approval from Bangladesh Medical Research Council (BMRC) by later next week.
Once the approval is given, the company will enter into the human clinical trial stage to examine whether the dose is safe and effective for humans.
The development came at a time when the government is desperately looking for vaccines to contain the new coronavirus that has spread across the country, killing at least 6,668 people so far.
"We have almost reached the doorstep of clinical trials. We've completed our preclinical animal trials successfully," manager (quality and regulatory operations) Globe Biotech Limited Dr Mohammad Mohiuddin said.
He said they will soon submit this report of the pre-clinical trials to the CRO, which will submit it to BMRC for ethical approval for human trial.
"Our third party (CRO) will hopefully apply for ethical approval later this week. If we get it quickly, we've planned to start the first phase of clinical trial either from late September or early October," he said.
Globe Biotech Ltd, a sister concern of Globe Pharmaceutical, did preliminary trials on rabbits and mouses and the results encouraged the biotech firm for further advancements, the company sources said.
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 of people compared to the phase-I to assess safety and its effectiveness.
The Phase-III trial, in fact, is conducted to assess the side effects of each drug and which drug works better but it enrols more people or patients, according to the healthcare professionals.
Explaining the company's plan, Mr Mohiuddin said they have planned to complete the clinical trial by December as it will take 28 days for finishing each trial."We're hopeful about releasing the vaccine commercially from January next year," he said.
Following receiving the ethical approval, it will also seek assistance from the drug regulator, Directorate General of Drug Administration, which will monitor whether the vaccine has enough quality.
For patent issue, the company is in the process to submit its report having it examined in an internationally recognised journal for publication.
When contacted, DGDA director Auyub Hossain said Globe Biotech has the permission to conduct such research.
"But initiatives like this will always be appreciated and supported by us, and we will provide all necessary assistance if they approach us about the vaccine issue," he added.
According to the global media, around 190 companies in the world are working on developing a vaccine, including Moderna and Pfizer of the USA, the University of Oxford in the UK, Sinovac Biotech in China, and Bharat Biotech India (BBIL) in India.
Of the vaccines, some nine are in the third phase stage.
