Recruitment for Covaxin trial in 6-12 age group to start from June 15

Photo: Bloomberg

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.

Dear Reader,

Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel