The Delhi High Court on Wednesday issued notices to the Centre and Bharat Biotech on a petition challenging the permission granted to the company to conduct trials of its coronavirus vaccine, Covaxin, on children aged two to 18, Live Law reported.
The Drugs Controller General of India had on May 13 allowed the Hyderabad-based firm to conduct phase two and three clinical trials of the vaccine on children and teenagers. The company said that 525 healthy volunteers will be a part of the trials. The Centre on Tuesday announced that the trials will begin in 10-12 days.
The petitioner, Sanjeev Kumar, submitted before the court that the approval for the clinical trials was unlawful and arbitrary.
“A person can offer to do anything only if he/she is capable of understanding the consequences of his/her act,” he said. “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 proper manner) cannot be supposed to volunteer for the aforesaid clinical testing.”
The petitioner added:
“This Hon’ble [honourable] Court is requested to kindly adjudge as to whether the respondents have ensured the ‘Voluntariness of the young toddlers’ for allegedly volunteering as subject matter of the aforesaid clinical trial which involves very clear possibility of loss of life and/ or loss of peaceful and pleasant enjoyment of life to a toddler/ minor child.”— The petitioner (Source: Live Law)
Kumar told the court that volunteers were required to enter into a contract related to compensation and damages with the institute carrying out the trials. “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) as the same is in the teeth of Section (g), 10, 1 and 12 of the Indian Contract Act, 1872,” he added.
However, the court refused to impose an interim stay on the permission granted to Bharat Biotech to conduct the trials, PTI reported. It sought the Centre and Bharat Biotech’s response to the petition by July 15.
Covaxin, developed by Bharat Biotech and the Indian Council of Medical Research, had shown an overall efficacy of 78% against the coronavirus in adults, according to an interim analysis of its third phase of clinical trials in April. This was slightly lower than the 81% efficacy reported by the company in March.
Covaxin had been granted emergency use authorisation along with Serum Institute of India’s Covishield ahead of India’s countrywide vaccination programme that started on January 16.