Chennai: “The study is designed to evaluate the safety, reactogenicity, tolerability and immunogenicity of healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations,” said Dr Satyajit Mohapatra, professor, department of pharmacology in SRM Medical College and principal investigator of Covaxin study.
The college is one of the 12 institutions chosen by the Indian Council of Medical Research to conduct the trials for the vaccine developed by Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology.
Along with his colleague Dr Melvin George, who is the co-investigator of the study, Dr Satyajit was speaking at a webinar on “Covid-19 Vaccines- Looking for a silver lining” organised by Ministry of Information and Broadcasting, Press Information Bureau and Regional Outreach Bureau.
Speaking on the trials of the vaccine, he said, “In phase one, the criteria for selection of volunteers for the trails was: they should be in 18-55 years of age and in good health, and other specifications were for heart beat, blood pressure, temperature, medical history and negative for Covid.”
In the phase two criteria, volunteers in the age group of 12 to 65 with good health, specified heart rate, blood pressure, oral temperature, medical history and physical examination were selected.
The total sample size is 1,125 healthy volunteers, with 375 volunteers in the phase one study and 750 volunteers in phase two study.
Dr Melvin George said that the time taken is usually seven to 17 years, but for the Covid-19 pandemic, they have taken the accelerated path by merging some phases taking into account all safety regulations.
Dr Melvin said that by hastening the process, the approval timelines are shortened, animal testing requirements reduced, the manufacturing and scaling is advanced and there is proactive government facilitating. At the same time, enough care is being taken at each and every step to ensure that things don’t go wrong.
He said that some pharma giants are sharing technology with other smaller generic companies so that they could step up production of the vaccine to ensure that it reaches the people in shortest possible time once necessary approvals are given.
S Venkateswar, Director General, South Zone, delivered the welcome address. The discussion was moderated by Gurubabu Balaraman, Director, Press Information Bureau, Chennai.