COVID Vaccine: DCGI Approves Phase 2/3 Clinical Trial Of Covaxin In Age Group Of 2 To 18 Yrs

Hyderabad-based Bharat Biotech Ltd had proposed to carry out a Phase- 2/3 clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted on 525 healthy volunteers.

New Delhi: The Drugs Controller General of India (DCGI) has , after careful examination, accorded permission to conduct the Phase 2/3 clinical trial of Bharat Biotech's Covaxin in the age group 2 to 18 years.

This comes as a reassuring update while experts predict that the third wave of Coronavirus pandemic in India could most severely affect children.

"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 12.05.2021," the official statement read.

It further informed that Hyderabad-based Bharat Biotech Ltd had proposed to carry out a Phase- 2/3 clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted on 525 healthy volunteers.

The vaccine will be given by intramuscular route in two doses on day 0 and day 28, in the trial.

As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase II/III clinical trial to certain conditions.

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.

The fresh surge has taken the total caseload to 2,37,03,665, while total discharges are at 1,97,34,823 and the overall death toll has reached 2,58,317. Active cases are reported to be 37,10,525.