Covaxin trials on 90 Karnataka children done, efficacy results awaited

BENGALURU: Close on the heels of homegrown vaccine maker Zydus Cadila getting Emergency Use Authorization from the DCGI for its ZyCoV-D Covid-19 vaccine for children aged 12 years and above, the paediatric trials for Covaxin, being conducted in Karnataka on 90 children, has been completed. The final samples to check the efficacy through antibody titre tests has been collected and sent to the designated laboratory.

Mysuru’s Cheluvamba Hospital, attached to the Mysore Medical College and Research Institute (MMCRI), is one among the five medical institutions identified across India which had got the institutional ethics committee approvals for Covaxin’s clinical trials on children aged two years to 18 years. “Children who were administered Covaxin as part of the clinical trials are healthy, fit and fine. We have completed administering both doses of the vaccine and their blood samples have been sent to the identified lab in Delhi for efficacy results,” explained Dr Pradeep N, principal investigator and Associate Professor, Department of Paediatrics, MMCRI.

Children were divided into three groups - 2-6 years, 6-12 years and 12-18 years - and before administering the vaccine, a Covid IGg test was done on them to see if they meet the main prerequisites of not being infected with Covid, and also an RT-PCR test to rule out present infection. Interestingly, children aged 12-18 have shown only symptoms like mild fever and pain in the arm and nothing else.

Dr Pradeep explained that the children, who are mostly based in Mysuru, and also around 10 from Bengaluru, will be under observation for seven months from the day of the first dose of the vaccine being administered. “They have to get checked five times over the seven months. There is a schedule set for them. They will have to come to the hospital on Day 1, the 28th day, 56th day, 118th day and 210th day for follow-ups. There will also be a window of two days. We call them and remind them to come for follow-ups,” Dr Pradeep explained.

According to sources, the third samples have been collected from almost all the centres and doctors said that the DCGI will soon announce the efficacy results of the vaccines on children. The third samples were collected from Mysuru’s hospital three days ago and sent to Delhi for analysis.