Chandigarh, May 13
National regulator Drugs Controller General of India (DCGI) has accepted the recommendation of the Subject Expert Committee (SEC) and accorded permission to conduct the phase-II/III clinical trials of Covaxin in the age group 2 to 18 years.
Covaxin manufacturer Bharat Biotech had proposed to carry out the trial, which will be conducted on 525 healthy volunteers.
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 by the SEC on May 11.
Discussions
Discussions
