India : Biological E’s Covid vaccine gets permission to conduct trials on children aged 5-18
The Drug Controller General of India (DCGI) on Wednesday granted permission to Hyderabad-based Biological E Limited to conduct Phase 2 & 3 clinical trials for its anti-COVID shots called Corbevax on children between 5 and 18 years of age with certain conditions.
The phase 2 and 3 clinical trials have be conducted as per approved protocol titled ‘A Prospective, Randomised, Double-blind, Placebo controlled, Phase-2/3 Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax Vaccine in Children and Adolescents’.
The government had in June announced that it made an advance payment of Rs 1,500 crore to Biological E for the 30 crore vaccines. Meanwhile, the trials of Bharat Biotech’s Covaxin for phases 2 and 3 for children in the age group of 2 to 18 are underway, and its result is expected in September.
The trials will be conducted in 10 sites across the country. This would be the fourth vaccine to conduct trials on children in India after Bharat Biotech, Serum Institute and Zydus Cadila.