DCGI grants Bharat Biotech permission to conduct vaccine trials on children above 12: Report

Covaxin, Bharat Biotech

Bharat Biotech's COVID-19 vaccine 'Covaxin' has been approved for conducting trials on children above the age of 12 years by the Drugs Controller General of India (DCGI) on January 3.

According to a report by NDTV, the vaccine was already administered to children above 12 years of age, in the last round and was held safe. The Hyderabad-based firm is conducting Phase III trials. Covaxin is yet to complete late-stage human clinical trials in India.

DCGI on January 3 granted restricted emergency use authorisation for the Serum Institute of India (SII)’s ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ vaccines against COVID-19, the disease caused by the novel coronavirus.

The report added that the government had said that the vaccination drive is meant only for use by adults. However, this latest development gives hope that, as per conditional to sufficient data, the use of Covaxin can be extended to children, as well.

However, Union Health Minister Dr Harsh Vardhan also clarified that the the emergency approval granted to Covaxin is different from the one given to Serum Insitute’s Covishield. All Covaxin recipients will be tracked and monitored as if they are in trial.