Delhi HC Refuses to Stay Covaxin Clinical Trial On Children; Issues Notice to Centre, DGCI

This came as a PIL to set aside the permission granted by the DCGI was heard by the Delhi High Court.

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New Delhi: Refusing to pass an interim order on permission granted by the Drugs Controller General of India (DCGI) to Bharat Biotech for conducting phase two and three clinical trial of covaxin on the 2-18 age group, the Delhi High Court on Wednesday issued a notice to the Centre and Bharat Biotech.

Seeking the stand of the Centre and Bharat Biotech by July 15 on the petition, a bench of Chief Justice DN Patel and Justice Jyoti Singh declined to pass any interim order staying the permission granted earlier on May 12 for clinical trials as sought by petitioner Sanjeev Kumar.

This came as a PIL to set aside the permission granted by the DCGI was heard by the Delhi High Court.

The vaccine will be given by intramuscular route in two doses at day 0 and day 28 in the trial to be conducted on 525 healthy volunteers.

Earlier on Tuesday, Niti Aayog Member (Health) Dr V.K. Paul had said covaxin has been approved by the DCGI for phase two and three clinical trials in the age group of 2 to 18 years, adding the trials will begin in the next 10 to 12 days.