DCGI approves phase II/III trials of Covaxin on children between 2 to 18 years
The Union Health Ministry said that the clinical trials will be conducted on 525 healthy volunteers from the age group
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 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/III clinical trial to certain conditions.
Earlier the proposal was deliberated in the SEC meeting on 24 February 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.
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In April, the Hyderabad company had got the nod from the Central Drugs and Standards Control Organisation (CDSCO) to conduct phase 3 clinical trials on its Covid vaccine candidate, which it is developing in association with Baylor College of Medicine, US