Biological E gets DCGI nod to conduct phase 2/3 trials on children

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.

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 authorisation (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).