On Wednesday, the Subject Expert Committee (SEC) on COVID- 19 of the Central Drugs Standard Control Organisation (CDSCO) gave its approval to the Bharat Biotech’s COVID – 19 vaccine, Covaxin for phase II and III human clinical trials to evaluate the safety, reactogenicity, and immunogenicity for the age group of 2 to 18 years, according to an ANI report.
The trial will take place in a total of 525 subjects at different sites including AIIMS Delhi, AIIMS Patna, and Meditrina Institute of Medical Sciences, Nagpur.
Earlier the proposal was deliberated in the SEC meeting held on 24th February, and a revised clinical trial protocol was asked to submit by the firm. The Covaxin is developed indigenously by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
"After detailed deliberation, the committee recommended for the conduct of proposed phase II/III clinical trial of the whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source said.
At present, there is no vaccine available for children. According to experts, there is a high chance that the third wave of corona will hit India soon. The children between the age group of 2 to 18 years, will be at high risk and will be an easy target for the virus. If the trials get completed successfully and prove efficiency, then it will boost the country’s drive to eliminate the virus. Right now, the vaccine is only available for the age groups above 18 years of age across the country.