500+ kids roped in for Covaxin trials in six hospitals

New Delhi: The recruitment of children for the Covaxin trials has been completed.

A source said 175 children each have been enrolled for age groups— 2-6, 6-12 and 12-18. “Most of the children have received the first dose of Covaxin – India’s indigenously developed Covid-19 vaccine – and are being closely monitored for complications, if any, as well as the immune response generated after the vaccine,” said Dr Sanjay Rai, in charge of the trials at AIIMS Delhi.

Apart from AIIMS Delhi, the trials on kids are being conducted at five other medical institutions across the country, including ESI in Delhi, AIIMS Patna, Mysuru Medical College and Research Institute, Prakhar hospital in Kanpur, Pranaam hospital in Hyderabad and Meditrinia Institute of Medical Sciences in Nagpur.

India has approved three vaccines — Covaxin, Covishield and Sputnik — for immunisation of adults aged 18 years and above. However, there are no vaccines approved for children at present. The US and the UK have approved Pfizer for use in children above 12 years.

Bharat Biotech, the company manufacturing Covaxin, was permitted by the drug regulatory body to conduct clinical trials of its vaccine on May 12, following which phase II/III trials were started at various centres, including AIIMS Delhi.

It started with the screening of teens between 12 and 18 years — the oldest of the targeted population— to rule out Covid-19 and presence of antibodies against the virus. Also, the parents of these kids were asked to sign a consent form for participation of their wards in the trials. Those who cleared the screening process were administered the vaccine. Same process was followed in kids aged between 2 and 6 and 6 and 12 years, a source said.

“Some of the participants had to be excluded when tests confirmed they already had antibodies against the virus, possibly due to exposure to the virus that went unnoticed,” said a senior doctor.

AIIMS had also conducted phase I, II and III trials of Covaxin in adults. The hospital doctors said they had received 4,000 requests for participation when the requirement was for only 100 adults. “This time, we didn’t advertise much for participation in the clinical trials, but there were enough requests from parents keen to get their children vaccinated as a part of the trial,” said one of the doctors.

The clinical trials are significant given the apprehension of an impending third wave of the pandemic in the country which, many experts said, might affect the children more. However, there is no evidence to support the claim.