Biological E gets DCGI approval to conduct phase 2/3 trials on kids

On Wednesday, The Drug Controller General of India (DCGI) granted permission to Hyderabad-based Biological E Limited to conduct Phase 2 & 3 clinical trials for its anti-COVID shots called Corbevax on children between 5 and 18 years of age with certain conditions, sources told ANI.

The trial will be conducted in ten locations. The permission has been given to Biological E after the recommendation from the Subject Expert Committee. Meanwhile, Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D has already received emergency use authorisation (EUA) to inoculate children in the age group of 12-18. It is expected to be administered from the first week of October.

The trials of Bharat Biotech’s Covaxin COVID-19 vaccine for phases 2 & 3 for children are underway, and its result is expected in September. It is to be noted that the government has made an advance payment of Rs 1,500 crore to BGiological E for 30 crore vaccines.

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 Biological E COVID-19 vaccine candidate has been supported by the Government of India from the 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.

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