The Drug Controller General of India (DCGI) has granted permission to Hyderabad-based Biological E Limited to conduct Phase 2 and 3 clinical trials for its anti-Covid shots called Corbevax on children. The trial will be on children between 5 and 18 years of age with certain conditions.

The permission was given on Wednesday after the recommendation from the Subject Expert Committee. The trial will be conducted in ten locations across the country. The government has made an advance payment of Rs 1,500 crore to Biological E for the 30 crore vaccines.

The phase 2 and 3 clinical trials have be 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.

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.

Meanwhile, the trials of Bharat Biotech’s Covaxin Covid-19 vaccine for phases 2 and 3 for children are underway, and its result is expected in September.

The Zydus Cadila’s needle-free Covid-19 vaccine ZyCoV-D has already received emergency use authorization (EUA) to inoculate children in the age group of 12-18. It is expected to be administered from the first week of October.

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

Meanwhile, India reported 47,029 coronavirus cases and 509 deaths in the last 24 hours. With this the country’s overall caseload rose to 3.28 crore (3,28,57,937) and the death toll increased to 4.39 lakh (4,39,529).