December 9, 2023

Delhi HC refuses to put stay on Phase 2-3 clinical trials of Covaxin for 2-18 age group

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The Delhi High Court on Wednesday refused to put an interim stay on Phase 2-3 clinical trials of Covaxin COVID-19 vaccine for the 2-18 age group.

The Court has issued a notice to the Centre, Central Drugs Standard Control Organizations, and others on the petition sought for quashing of nod given to Bharat Biotech for phase 2/3 clinical trial of Covaxin for the age group 2-18 years.

The bench of Justice DN Patel and Justice Jyoti Singh, on Tuesday, sought response from all the respondents and refused to put an interim stay on the trial as prayed by the petitioner.

A Public Interest Litigation (PIL) was moved to the court, which sought to quash the Central government’s notification, dated May 13, that accorded permission to conduct the Phase II/III clinical trial of Covaxin for 2-18 age group to its manufacturer, Bharat Biotec Ltd.

The petition had also sought direction from respondents to place on record the details of the 525 children who will be subjected to phase II/III clinical trial of the Whole Virion inactivated Coronavirus vaccine.

The petitioner, Sanjeev Kumar, also sought Court’s direction to the state to criminally prosecute the persons involved in such trials, and the persons having authorised conduct of such trials in the event of any death or loss of peaceful and pleasant enjoyment of the life of any toddler or minor children.

The petition stated that the order which requires the conduct of Phase II/III clinical trial of Covaxin by the Bharat Biotec Ltd.

on 525 healthy volunteers (very young children ranging from 2 years old to 18 years old) is “prima facie unlawful, arbitrary and against the settled principles of law and natural justice” because the term ‘Volunteer’ itself means ‘A person who freely offers to do something’.

It further states that 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, and hence cannot be supposed to ‘Volunteer’ for the aforesaid clinical testing,” read the plea.

The petitioner also stated that in case the contract for the alleged volunteers has been signed by their parents/legal guardians, even then the same is unlawful as the same is clearly not for the welfare of the said children.

“It is trite in law that nobody can enter into a contract, the execution of which could endanger the life of minors,” read the plea.

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