DCGI approves second / third phase test of covaxin on 2 to 18 year olds

New Delhi: The Drugs Controller General of India (DCGI), the country’s regulatory body on drugs, has accepted the recommendations of the Expert Committee (SEC) after careful scrutiny and for the second / third stage of covicin for people aged between two and 18 years.

The test is approved. The approval was granted on 12 May 2021 to cocaine manufacturer Bharat Biotech Limited.

M / s Bharat Biotech International Limited, Hyderabad (BBIL) had proposed second / third stage testing of covicin on people in the age group of two to 18 years. This test will be done on 525 healthy volunteers.

The vaccine will be given through the muscles (intramuscularly) during the test. Volunteers will be given two doses. The second dose will be given on the 28th day of the first dose.

In a swift implementation of this proposal, the proposal was sent to the Expert Committee on 11 May 2021. After detailed discussion, the committee had recommended to allow the proposed second / third stage test with certain conditions.