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

DCGI gave permission to Biological E 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 said

The Drug Controller General of India (DCGI) on Wednesday 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 Biological E for 30 crore vaccines.