The progress shown in the trials of Covaxin, the COVID-19 vaccine being developed by Bharat Biotech and Indian Council of Medical Research (ICMR) and National Institute of Virology, Pune, offered hope against the pandemic, said experts from the SRM Medical College and Research Centre during a webinar on Thursday.
Chennai:
The trial that is under way has a total sample size of 1,125 healthy volunteers, including 375 in the first phase and the remaining 750 in phase two.
Dr Satyajit Mohapatra, professor, Department of Pharmacology in SRM Medical College, who is the principal Investigator of the study at the research centre, said the criteria for selection of volunteers for phase one of the trial were that they should be in 18-55 age group and in good health, and should have parameters like normal heart beat, blood pressure, temperature, medical history, besides testing negative for coronavirus.
In phase two, volunteers in the age group of 12 to 65 with good health, specified heart rate, blood pressure, oral temperature, medical history and physical examination have been selected. Dr Mohapatra added that the study was designed to evaluate the safety, reactogenicity, tolerability and immunogenicity of volunteers who receive two doses of BBV152 formulations.
The co-investigator of the study Dr Melvin George, associate professor, Department of Clinical Pharmacology, SRM, said that an accelerated path was being pursued by merging some phases, taking into account all safety regulations to counter the pandemic.