Covaxin's phase 2,3 clinical trials in children to begin in next 10 days

New Delhi: Bharat Biotech produced COVID vaccine Covaxin will be subjected to clinical trials of phase two and three in the age of group from two to 18 in the next 10 to 12 days with the approval of the Drugs Controller General of India.

"Covaxin has been approved by the Drugs Controller General of India (DCGI) for Phase 2 and 2 clinical trials in the age group of two to 18 years. I have been told that trials will begin in the next 10-12 days." NITI Aayog's Member Health, Dr V.K. Paul said while addressing the Union Health Ministry press conference.

However, public interest litigation (PIL) has been moved in Delhi High Court seeking quashing of Centre's "notification" of May 13, which has accorded permission for conducting the phase two/three clinical trials of Covaxin in children between 2-18 years.

The petitioner Sanjeev Kumar also sought directions from respondents to place on record details of the 525 children who will be subjected to the trials of the whole-virion inactivated coronavirus vaccine, as per an ANI report.

"A person can offer to do anything only if he/she is capable of understanding the consequences of his/her act. In the present case, the subject matter of clinical trials being minors (even toddlers who - for the reason of their age only - are not capable of even speaking and understanding languages in a proper manner) cannot be supposed to volunteer for the aforesaid clinical testing," the petition read.

The petition is scheduled to be heard by the Bench of Justice DN Patel and Justice Jyoti Singh on Wednesday.

Bharat Biotech, the manufacturer of Covaxin received the DCGI approval to conduct clinical trials of Covaxin in children on May 11. The approval was decided following the Central Drugs Standard Control Organisation's subject expert committee's recommendation, under certain conditions.

The approval of clinical trials of vaccine efficacy among children came amid reports from the US and Canada allowing Pfizer-BioNTech for the 12-15 age groups and as new variants are also affecting children.

The clinical trials are expected to be conducted among over 500 participants at various hospitals across the country. AIIMS Director, Dr Randeep Guleria had said that the need of the hour is some quick data and risk-benefit analysis of the vaccine's use in children.

Earlier in the day, Congress leader Rahul Gandhi urged the government to put in place a vaccine protocol for children.

(with inputs from IANS)