DCGI nod for Covaxin trials in 2-18 age group
NEW DELHI: India’s apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech’s Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
The trial will be conducted on 525 healthy volunteers. “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,” the ministry said.
Hyderabad-based Bharat Biotech had proposed to carry out the clinical trial in the age group of 2 to 18 years.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) on COVID-19 meeting held on May 11.
The Committee, after detailed deliberation, recommended for grant of permission to conduct proposed phase II/
HYDERABADBASED BHARAT BIOTECH HAD PROPOSED TO CARRY OUT THE CLINICAL TRIAL ON CHILDREN IN THE AGE GROUP OF 2 TO 18 YEARS
III clinical trial to certain conditions.
Covaxin is one of the two vaccines being 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.
Earlier the proposal was deliberated in the SEC meeting on February 24 and the firm was asked to submit a revised clinical trial protocol. 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.