India approves Bharat Biotech’s Covid vaccine for phase 2/3 trials on children

• Chandrashekar Bhat
• 13 May, 2021

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By: Chandrashekar Bhat

INDIA’S drug regulator has granted permission for conducting phase 2 and phase 3 clinical trials of Bharat Biotech’s Covaxin Covid-19 vaccine for those aged 2-18 years, the health ministry said today (13).

The trials will be conducted on 525 healthy volunteers and the vaccine will be given by intramuscular route in two doses on day 0 and day 28.

“The Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of the subject expert committee and accorded permission to conduct the phase 2/3 clinical trials of Covaxin in the age group 2-18 years, to its manufacturer Bharat Biotech Ltd on May 12,” the ministry said.

As a rapid regulatory response, the proposal was deliberated by the subject expert committee on Covid-19 on Tuesday (11). It recommended the grant of permission subject to certain conditions.

Covaxin, which has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing Covid-19 vaccination drive.