Vaccination for children: DGCI approves phase 2/3 trials of Biological E's Covid vaccine on 5-to-18-year-olds

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.   

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The phase 2 and 3 clinical trials have been 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.   

Meanwhile, the data of phase 2/3 clinical trials of Bharat Biotech''s Covaxin in the age group 2 to 18 years is underway.   

India''s drug regulator in July 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.   

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, 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 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, a Health Ministry statement had stated. PTI PLB AAR