Covaxin trials on children ages 6-12 from today: All you need to know

Bharat Biotech has said that scientific standards and commitment of Covaxin are transparent, and the company has so far published nine research studies on its safety and efficacy.

All India Institute of Medical Sciences (AIIMS) in Delhi will begin screening of children in the age group of 6 to 12 years for the clinical trials of Covaxin, the indigenously developed Covid-19 vaccine, from Tuesday. AIIMS Delhi has already completed the clinical trial for a single dose of Covaxin for children aged 12-18 age group. The recruitment of children for the trial of a single dose of Covaxin among those aged between 12-18 years started at the AIIMS in New Delhi on June 7 after India's drug regulator, Drugs Controller General of India (DCGI), granted permission for conducting the Phase 2 and 3 clinical trials of the vaccine.

Bharat Biotech said that the complete data of Phase I and Phase II trials of Covaxin along with the partial data for Phase III trials have been scrutinised by the regulatory authorities. (HT Photo)

All you need to know about Covaxin trials

Covaxin, which has been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India's ongoing Covid vaccination drive, which started from January 16 this year.

Bharat Biotech has said that scientific standards and commitment of Covaxin are transparent, and the company has so far published nine research studies on its safety and efficacy.

The vaccine for children aged 6-12 will be administered by the intramuscular route in two doses on day 0 and day 28. The trial will assess the safety, reactogenicity and immunogenicity of the Covid-19 vaccine in children, PTI reported.

Once the recruitment of children from 6-12 years is done, AIIMS Delhi will begin trials for children between 2 and 6 years. The trials are taking place at 525 centres.

The government last week 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 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 infections in children and approach the pandemic in a renewed way to strengthen the nation's preparedness, NITI Aayog member (health) VK Paul said.

The Covaxin trial on children has already started at AIIMS Patna. Participants would be given the vaccine after their screening report comes.

The trials have been flagged off in anticipation of a mutated variant of Covid-19, that could leave children vulnerable.

A plea has been moved in the Delhi High Court seeking a stay on phase II/III clinical trials of Covaxin on 2-18-year-olds. Conducting the trial on healthy children would amount to "homicide", the petition has claimed and has sought criminal prosecution of the persons involved in such trials.