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 – Drugs Controller General of India – after careful examination, has accepted the recommendation of subject expert committee 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.