Plea in Delhi HC seeking stay on Phase II/III clinical trial of Covaxin in 2 to 18 age group



NEW DELHI: A Fresh application was moved in Delhi High Court on Thursday seeking to stay the operation of the order of Drugs Controller General of India (DCGI) for conducting phase II/III clinical trials of Whole Virion Inactivated Coronavirus Vaccine in the 2 to 18 years age group.

Recently the Delhi High Court has sought response from Centre, Central Drugs Standard Control Organisations, and others in a petition which sought quashing of nod given to Bharat Biotech for phase 2/3 clinical trial of Covaxin for the age group 2-18 years. The fresh application is moved by same petitioner Sanjeev Kumar in the same ongoing matter.

Fresh application seeks to stay the operation of the order of DCGI till disposal of the ongoing petition in the interest of justice.

The fresh application was listed for hearing on Thursday but got adjourned for Friday as the concern bench of Delhi HC didn’t assembled

The main petition had 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’. 

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