‘Clinical trials for Covid-19 vaccine on in city too’

On the occasion of World Clinical Trial Day, TOI spoke to Vijaya Bhakte, director and founder of Canvass Clinical Research Services Pvt Ltd in Nagpur. She said researchers attached to many companies were conducting clinical trials for Covid-19 vaccine and some of them were in Nagpur too. However, creating a vaccine and making it available for public was a time-taking process.
Q: How important are clinical trials for creating Covid-19 vaccine?
A: Vaccine is the only final remedy for Covid-19. In case of pandemic or viral infections, vaccines are best. Research for vaccine is a time-taking process. Phases of clinical trials are the most important parts of vaccine invention process. Researchers across the globe are conducting such clinical trials and they are also Covid warriors.
Q: Any clinical trials for Covid-19 vaccine going on in Nagpur?
A: Yes. In India, many hospitals – both government and some private— have collaborated with pharma companies and researchers for clinical trials. Some of them are going on in Nagpur too. Largely, pre-clinical trials for Covid-19 vaccines are going on in India. We can’t reveal the details as of now. But, there are several phases of trials and we are into second or third phase.
Q: Can you elaborate about these phases?
A: In first phase, we ensure safety of the vaccine. Second phase is vaccine efficacy. We interpret effectiveness of vaccine in reduction in disease. Third is proportion or arms of vaccine. In this phase, we decide how much milligram dose of the vaccine will work. Fourth phase is post-marketing surveillance. Most researches in the world are in second or third phase right now.
Q: In USA, a pharma company has claimed to be successful in clinical trials?
A: It is third phase of the trial and they have to submit their research for approval. Bringing vaccine is a time taking process. There are ethics committees, approving authorities, mass production ethics, pricing and many other factors to deal with. In India, we have to take Drugs Controller General’s approval.
Q: When can we expect the vaccine for Covid-19?
A: It is a continuous process. Sometimes it takes years. But as entire world needs Covid-19 vaccine on an urgent basis, all are completing clinical research on fast track. If everything goes well, vaccine will still take a year or two to reach markets. Till then, we have no option but to follow Covid distancing and improve immunity.
Q: You mean lockdown should continue?
A: No. After six weeks of lockdown, the clinical behaviour of coronavirus in Indian conditions is quite clear. Our mortality rate is very low and those having comorbidities are becoming victims of the virus. By taking due care, we can now get away with lockdown situation. Healthy youths should start working in a new normal situation.
Q: Do you think vaccine can come from India?
A: India has all potential to bring out a vaccine for Covid-19. Our population is our strength in clinical trials. Global clinical trials market size was estimated at USD 60 billion in 2019 and is anticipated to expand at CAGR (compound annual growth rate) of 12% from 2020 to 2025. We need young researchers to join this field.