DCGI nod to phase 2, 3 trials of Biological E Corbevax in children
New Delhi: The Drugs Controller General of India (DCGI) on Wednesday granted permission 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, sources said.
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'', a source said.
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.
So far, indigenously developed Zydus Cadila's needle-free COVID-19 vaccine ZyCoV-D has received Emergency Use Authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.
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