New Delhi: The Drugs Controller General of India (DCGI) has given nod to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trials of its ‘Made in India’ Covid-19 vaccine on children aged between 5 and 18 years with certain conditions. Serum Institute of India, Bharat Biotech and Zydus Cadila are already in the race to manufacture vaccines for the kids.

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’, said sources in the Ministry.

The trial will be conducted across 10 sites in the country. The DCGI’s permission was given based on the recommendations by the Subject Expert Committee (SEC) on COVID-19.

“Phase 3 trial work of Biological E going on. Stockpile being produced. We should wait for results, we hope it’ll be in next month or 2. They’ve made a broad commitment that they’ll supply a significant amount by year-end,” said  Dr VK Paul,Member-Health,Niti Aayog on Biological E for adult vaccines.

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