DCGI approves phase 2/3 clinical trails of Covaxin on children

Share this post on:

Phase 2 and 3 will be tested on 525 volunteers

New Delhi, 13 May: Clinical trials of the Covaxin to protect children against coronavirus formulated in collaboration with Bharat Biotech and Indian Council of Medical Research (ICMR) is now going to start as well.

After getting approval from the committee of experts, on Wednesday, the Drug Controller General of India (DCGI) has approved a trial for children between 02 years to 18 years.

Earlier, the Subject Expert Committee of the Central Drugs Standard Control Organization recommended its second and third stage trials.

The test will be conducted at 525 volunteers at various locations including AIIMS in Delhi, Patna and the Institute of Medical Sciences at Nagpur.

According to the Union Health Ministry, Bharat Biotech had sought permission for trials of phase two and three, for which 525 volunteers were prepared.

The vaccine will be investigated in two doses

On Tuesday, the Covid-19 Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO) discussed the application made by Bharat Biotech. It was requested to allow the second / third phase of the test to assess, among other things, the enhancement of safety and immunity of Covaxin vaccine in children from two to 18 years.