Delhi HC declines to stay Covaxin clinical trial on children

New Delhi : The Delhi High Court on Wednesday sought the Centre's response on a plea seeking to set aside the permission granted by the Drugs Controller General of India to Bharat Biotech for conducting the Phase 2/3 clinical trial of its Covaxin Covid-19 vaccine on the 2-18 age group.

A bench of Chief Justice D.N. Patel and Justice Jyoti Singh refused to pass any interim order staying the permission granted as it issued notice to the DCGI, the Ministry of Women and Child Development and others.

The plea, filed by advocate Sanjeev Kumar, argued that the children, who would part of the trials should not be termed as volunteers, as they cannot understand the nature of consequences for participating in the trial post their consent. The plea insisted that enrolling healthy children for the trial would amount to homicide.

According to the plea, a person can offer to do anything only if he/she is capable of understanding the consequences of his/her act. It argued that 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.

In the petition, the petitioner has raised apprehensions that the children who would be part of the trial might suffer adverse health or mental effects due to the use of vaccine on them. The petitioner has sought criminal prosecution of the people involved in such trials or those who conduct the trial, in the event of death or "loss of peaceful and pleasant enjoyment of life" of any of the toddlers or minors who participates in the trial.

The petitioner also sought directions to the government authorities to furnish details of the 525 children who will be enrolled in the trial.

The court has posted the matter for further hearing on July 15.