Plea Filed In Delhi High Court Seeking Stay On Phase II/III Clinical Trial Of Covaxin In 2 to 18 Age Group

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.

A Fresh application was moved in Delhi High Court on Thursday seeking to stay the phase II/III clinical trials of Whole Virion Inactivated Coronavirus Vaccine in the 2 to 18 years age group.

Earlier, the Delhi High Court had sought responses from the 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.

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

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 also wants the court to direct the state to 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’.

Earlier, DGCI had accepted the recommendation of the Subject Expert Committee (SEC) and given a nod to the Hyderabad-based Bharat Biotech to conduct Phase II/III clinical trial of Covid-19 vaccine Covaxin in the age group 2 to 18 years.

Covaxin maker Bharat Biotech had proposed to carry out a Phase-II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers.

Patna’s All India Institute of Medical Sciences (AIIMS) started the paediatric trials for  Covaxin on Wednesday.

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