Phase 2/3 trials of Corbevax on 5-18 age group permitted
What's the story
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, Corbevax, on children aged between 5 and 18 years with certain conditions, sources said.
The phase two and three clinical trials will be conducted as per an approved protocol.
Details
The trial will be conducted across 10 sites in India
The approved protocol is 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.
EUA
Earlier, ZyCoV-D had received EUA for 12-18 group
So far, indigenously developed Zydus Cadila's needle-free COVID-19 vaccine ZyCoV-D has received Emergency Use Authorization from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.
Meanwhile, the data of phase 2/3 clinical trials of Bharat Biotech's COVAXIN in the age group 2 to 18 years is underway.
Trials
Corbevax is currently undergoing phase 2/3 clinical trials on adults
India's drug regulator in July had granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged two to seventeen years with certain conditions.
Biological E's anti-coronavirus shot, Corbevax, which is an RBD protein sub-unit vaccine, is currently undergoing phase 2/3 clinical trials on adults, sources had said earlier.
Information
Centre will receive 30 crore Corbevax doses by December
Biological E will supply 30 crore doses of Corbevax to the central government by December, as announced by the Union Health Ministry in June. The ministry finalized arrangements with the Hyderabad-based vaccine manufacturer to reserve 30 crore vaccine doses, an official statement had said.