New Delhi: The Drugs Controller General of India (DCGI) reportedly gave nod to clinical trial of Bharat Biotech’s Covaxin vaccine in phase 2 and 3 on the children falling under the age group of 2 to 18 years, the ministry of health and family welfare informed on Thursday.
“The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (Covid vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on May 12, 2021,” the ministry said.
Bharat Biotech will conduct trials on 525 healthy volunteers. “In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28,” it said.
The proposal was deliberated in the Subject Expert Committee (SEC) (Covid-19) on May 11, 2021 as a rapid regulatory response.
The Committee after detailed deliberation recommended for grant of permission to conduct the proposed phase 2 and phase 3 clinical trials to certain conditions.
‘Covaxin’ is one of the two Covid vaccines being indigenously manufactured in India at present and has been developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology.
On Tuesday, the firm informed that it has been supplying its Covid-19 vaccine directly to 18 states since May 1.