DCGI gives nod for Biological E’s COVID-19 vaccine’s phase-II/III trials on kids aged between five and 18
The trial will be conducted across 10 sites in the country
The Drugs Controller General of India (DCGI) yesterday granted permission to Hyderabad-based Biological E to conduct phase-II/III clinical trials of its ‘Made in India’ COVID-19 vaccine on children aged between five and 18 years with certain conditions, sources said.
The phase-II and -III clinical trials have to be conducted as per approved protocol titled ‘A Prospective, Randomised, Double-blind, Placebo-controlled, Phase-II/III Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax Vaccine in Children and Adolescents,’ a source said.
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.
Meanwhile, the data of phase-II/III clinical trials of Bharat Biotech’s Covaxin in the age group two-to-18 years is underway.
India’s drug regulator in July granted permission to the Serum Institute of India (SII) for conducting phase-II/III trials of Covovax on children aged two-to-17 years with certain conditions.
Biological E’s anti-coronavirus shot, Corbevax, which is an RBD protein sub-unit vaccine, is currently undergoing phase-II/III clinical trials on adults, sources had said earlier.
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 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 the Government of India from the pre-clinical stage to the phase-III studies. The Department of Biotechnology (DBT) has not only provided financial assistance in terms of grant-in-aid of over Rs 100 crores, 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, a Health Ministry statement had stated.