Recruitment for clinical trial of Covaxin in 6-12 age group to start at AIIMS from June 15

PTI, Jun 14, 2021, 3:26 PM IST

New Delhi: The recruitment for the clinical trial of the country’s first indigenously-developed COVID-19 vaccine, Covaxin, among children in the age group of 6-12 years will begin at the AIIMS here from Tuesday.

This will be followed by the clinical trial of children in the age-group of 2-6 years.

The enrolment of children volunteers aged 12-18 years at the All India Institute of Medical Sciences (AIIMS) has been completed and they have been given the first dose of Covaxin.

“The recruitment process for the clinical trial of Covaxin among children in the age group of 6-12 years will begin from Tuesday,” Dr Sanjay Rai, Professor at the Centre for Community Medicine at the AIIMS, told PTI.

The Drugs Controller General of India (DCGI) had granted permission for conducting the phase 2/3 clinical trial of Bharat Biotech”s Covaxin among children aged two to 18 years on May 12.

The trial is to be conducted in three parts — 175 volunteers each in the groups aged 12-18, 6-12 and 2-6 years.

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

Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in the country”s ongoing COVID-19 vaccination drive.

The clinical trials will evaluate the safety, reactogenicity and immunogenicity of the vaccine in children.

The government recently cautioned that even though COVID-19 has not taken a serious shape among children till now, its impact can increase among them if there is a change in the virus behaviour or epidemiology dynamics and said preparations are being strengthened to deal with any such situation.

A national expert group has been formed to review COVID-19 cases in children and approach the pandemic in a renewed way to strengthen the country”s preparedness, NITI Aayog Member (Health) V K Paul had told a press conference.

The group has examined signs that were not available four-five months before, he had said.