Plea against Covaxin Phase 2/3 trial in children: Delhi HC notice to Centre, Bharat Biotech

The Delhi High Court on Wednesday issued a notice to the Centre in a plea seeking setting aside of the permission granted to Bharat Biotech for conducting phase II and III clinical trial of Covaxin on children in 2-18 group.

The division bench of Chief Justice D.N Patel and Justice Jyoti Singh, however, declined to issue any interim order in the case and listed the case for hearing on July 15. It also issued a notice to Bharat Biotech.

Covaxin, which has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, is being used on adults in India’s ongoing COVID-19 vaccination drive.

In the petition filed by advocate Sanjeev Kumar, it has been argued that subjects of the clinical trial being minors cannot be supposed to be “volunteers: for clinical testing.

“In order to become a subject matter of a clinical trial, consent of the volunteer is a prerequisite. The Volunteer is also required to enter into a contract with the Institute carrying the clinical trial on various issues…In this case, since the alleged volunteers belong to the age group between 2 to 18 years, it is crystal clear that no such contract could be signed by the alleged volunteers (who are all minors and hence not competent to contract),” Kumar has argued in the petition.

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The plea further states that parents or legal guardians of children are authorised to give consent for administration of a drug or for conducting any operation on the body of the child for the purposes of saving their life but the situation is different in conduct of the clinical trials.

“The trial under impugned order shall be conducted on the otherwise healthy toddlers and children who are not at all facing any risk of life, and, therefore, such an action shall clearly amount to causing homicide with knowledge of doing so which, in turn, happens to fall under the category of culpable offence,” it adds.

Kumar has also contended that it cannot be ruled out that parents or legal guardians could have extended their consent out of questionable enticements and monetary considerations.

The petition seeks details and contract of the 525 children who will be subjected to the clinical trial. It also seeks prosecution of the persons involved in such trials in event of the death of any child.