DCGI approves phase 2, 3 clinical trials of Covaxin on children trials of Covaxin on children aged 2 to 18 years
In an important development, the Drugs Controller General of India (DCGI) on Thursday granted approval for the Phase 2 and 3 clinical trial of Bharat Biotech’s COVID-19 vaccine, Covaxin, in the age group of 2 to 18 years.
“The DCGI, after careful examination, has accepted the recommendation of Subject Expert Committee and accorded permission to conduct the Phase II/III clinical trial of Covaxin in the age group 2 to 18 years, to its manufacturer Bharat Biotech,” the government said in a press note”
“After detailed deliberation, the committee recommended for conduct of proposed Phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study,” a source was quoted as saying in a PTI report.
The vaccine will be given by intramuscular route in two doses on day 0 and day 28, in the trial.
This move comes in as India recorded 3,62,727 new COVID-19 cases, 3,52,181 discharges, and 4,120 deaths in the last 24 hours, as informed by Union Health Ministry.