A PIL to set aside the permission granted by the Drugs Controller General of India to Bharat Biotech for conducting the phase II/III clinical trial of its Covaxin COVID-19 vaccine on the 2-18 age group was heard on Wednesday by the Delhi High Court which sought the Centre's stand.
A bench of Chief Justice D N Patel and Justice Jyoti Singh issued notice 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 court declined to pass any interim order staying the permission, granted on May 12, for clinical trials as sought by the petitioner, Sanjeev Kumar, who is a lawyer.
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 COVID-19 vaccination drive.
Kumar, in his plea, 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.
