Biological E gets DCGI nod for phase 2/3 trials of its Covid vaccine on 5-18 year age group

The prospective, randomized, double-blind, placebo controlled, phase-2/3 trials of 'Corbevax' will be conducted across 10 sites in the country

New Delhi: As per reports, the Drugs Controller General of India (DCGI) has 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.
The DCGI’s permission was given based on the recommendations by the Subject Expert Committee (SEC) on COVID-19.
The prospective, randomized, double-blind, placebo controlled, phase-2/3 trial will be conducted across 10 sites in the country.
Biological E’s anti-coronavirus shot, Corbevax, which is a RBD protein sub-unit vaccine is currently undergoing phase 2/3 clinical trials on adults.
The company will supply 30 crore doses of Corbevax to the central government by December, as announced by the Union Health Ministry in June. The ministry finalised arrangements with the Hyderabad-based vaccine manufacturer to reserve 30 crore vaccine doses, an official statement had said.
The Biological E COVID-19 vaccine candidate has been supported by Government of India from preclinical stage to phase 3 studies. The Department of Biotechnology has not only provided financial assistance in terms of grant-in-aid of over Rs 100 crore but has also partnered with Biological E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad.
DCGI has earlier granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.
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.
Meanwhile, the data of phase 2/3 clinical trials of Bharat Biotech’s Covaxin in the age group 2 to 18 years is underway.