1. Home
  2. Nation
  3. DCGI approves phase II, III clinical trials of Covaxin on kids aged 2 to 18 years

DCGI approves phase II, III clinical trials of Covaxin on kids aged 2 to 18 years

By Saima Siddiqui 
Updated Date
DCGI approves phase II, III clinical trials of Covaxin on kids aged 2 to 18 years

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.

Also Read :- K'taka extends lockdown, Section 144 imposed in Bengaluru till June 21

“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.

Also Read :- 'Delta Plus' variant of Covid-19 resistant to vaccines in India: Scientists

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.

Further reading:
For the latest news and reviews, follow us on Facebook and Twitter ...
X