The Delhi High Court, on Wednesday, issued notices on a petition questioning the phase-II and III trials of Covaxin on children aged 2-18 years. The Court, however, refused to stay the trials.

The PIL prayed for setting aside the May 13 order of the Drugs Controller General of India granting permission to Bharat Biotech for conducting the phase II/III clinical trial of its vaccine on the 2-18 age group.

Notices issued

The plea was heard by a Bench comprising Chief Justice DN Patel and Justice Jyoti Singh, who issued notices to the ministries of Health and Woman and Child Development, Central Drugs Standard Control Organisation (CDSCO) and Bharat Biotech, seeking their stand by July 15 on the petition. The petitioner contended that the trials will adversely affect the mental and physical health of the children volunteers.

“It is contended that such trials will adversely affect the physical and mental health of such children, and may even result in the loss of their lives. Therefore, such an order is prima facie unlawful, arbitrary and contrary to the principles of natural justice,” said the petitioner.

“This Hon’ble Court is requested to kindly adjudge as to whether the respondents have ensured the ‘voluntariness of the young toddlers’ for allegedly volunteering as the 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,” said the petition.

Interim order

The court declined to pass any interim order staying the permission. The trial will be conducted on 525 healthy volunteers and the vaccine will be given by intramuscular route in two doses at day 0 and day 28, according to the Health Ministry. Covaxin, which has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing vaccination drive.

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