The Delhi High Court on Wednesday refused to put an interim stay on Phase 2-3 clinical trials of Bharat Biotech's Covaxin for children in the age group of 2 to 18.
Issuing a notice to the Centre, Central Drugs Standard Control Organizations, and others on a petition for quashing the decision of clinical trials, the court sought their responses.
A bench of Justice DN Patel and Justice Jyoti Singh was hearing the Public Interest Litigation (PIL) moved to the court, which sought withdrawal of the Central government's notification, dated 13 May, that accorded permission to conduct the 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 2-3 clinical trial of the Whole Virion inactivated coronavirus vaccine.
The petitioner, Sanjeev Kumar, sought the 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 2-3 clinical trial of Covaxin 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.
Trial on children
The NITI Aayog said on Tuesday that the Phase 2-3 clinical trials of the Covid-19 vaccine Covaxin for the age group of 2 to 18 years will begin in the coming 10 to 12 days.
"I have been told that trials will begin in the next 10-12 days," Dr VK Paul said.
The drug has been approved by the Drugs Controller General of India (DCGI) for administration to everybody above the age of 18.
This is the first time in India that a Covid-19 vaccine will be tested on children.
The clinical trials involve two Covid-19 vaccine shots injected on day 0 and day 28.
The trials will take place at several sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
