Karnataka: Government-run Cheluvamba hospital, one of the oldest in the country and part of Mysuru Medical College and Research Institute (MMCRI), will soon commence Covaxin clinical trials among children and young adults in the age group two to 18 years. MMCRI’s human ethical committee has granted approval for the trial.
CP Nanjaraj, dean and director of the institute and Dr HB Shashidhar, member secretary of the ethical committee, said Cheluvamba hospital is one of five sites selected for the trial across the country. It’s the only hospital in the state selected for pediatric trials of the Covid-19 vaccine.
The Drugs Controller General of India had approved Bharat Biotech’s proposal to test the vaccine on those below 18 years on May 13. Dr Prashanth and Dr Pradeep have been named principal investigators.
“It will be phase 2 and 3 trials of the vaccine. It will be carried out in the hospital with all precautions. The entire trial will be monitored by a panel of experts,” said Dr Shashidhar.
The number of subjects for trials is yet to be determined. As per the plan, initially the trial will be conducted among children in the age group of 12 to 18 years. In the second session, the vaccine will be tried on children in the age group 6 to 12 years. Later the doses will be administered to children between 2 and 6 years of age. Cheluvamba hospital, launched in 1880, has been a part of several vaccine trials including DPT vaccine. The hospital is fully equipped to carry out the trials.
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