Plea filed in Delhi HC seeking stay on phase 2/3 clinical trials of Covaxin on children

A vial of Covaxin vaccine | Photo: T. Narayan | Bloomberg

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New Delhi: A plea has been moved in the Delhi High Court seeking stay on the phase II/III clinical trials of Covaxin COVID-19 vaccine on the 2-18 age group.

The application was moved in a petition filed in May for setting aside the permission granted by the Drugs Controller General of India (DCGI) to Bharat Biotech for conducting trials of its vaccine on children.

The petitioner, Sanjeev Kumar, has claimed in his application that while the issue was pending before the high court with notices issued to the Centre and Bharat Biotech, the trials have commenced from June.

He has said, in his plea, that since the court did not grant stay when it heard the matter, the government was going ahead with the trials.

Kumar has contended that on July 15, the next date of hearing of the petition, the government and the company would say that the trials have commenced and thus, the plea challenging the permission granted by DCGI would become infructuous.

The trial will be conducted on 525 healthy volunteers and the vaccine will be given by intramuscular route in two doses at day 0 (the first day) 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 COVID-19 vaccination drive.

Kumar, in his main petition, has raised an apprehension that the children who would be part of the trial could suffer adverse health or mental effects due to the testing of the vaccine on them.

He has claimed that the children, who would be the test subjects, cannot be termed as volunteers as they are not capable of understanding the consequences of the trial for consenting to the same.

Conducting the trial on healthy children would amount to “homicide”, the petition has claimed and has sought criminal prosecution of the persons involved in such trials or those authorised to conduct the same, in the event of death or “loss of peaceful and pleasant enjoyment of life” of any of the toddlers or minors who are part of the trial.

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