India
pti-PTI
New Delhi, Sep 01: 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…