Delhi HC Refuses to Stay Covaxin Clinical Trial on Children Aged 2-18; Issues Notice to DCGI, Centre

City Express News

The trial will be conducted on 525 healthy volunteers.

   New Delhi,May,19,2021:ADelhi court on Wednesday refused to pass an interim order on permission granted by the Drugs Controller General of India (DCGI) to Bharat Biotech for conducting the phase II/III clinical trial of its Covaxin COVID-19 vaccine on the 2-18 age group. A PIL to set aside the permission granted by DCGI was heard on Wednesday by the Delhi High Court which sought the Centre’s stand. A bench of Chief Justice DN Patel and Justice Jyoti Singh issued notice to the Centre and Bharat Biotech seeking their stand by July 15 on the petition.

The court declined to pass any interim order to stay the trial as sought by the petitioner, Sanjeev Kumar. The trial will be conducted on 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. 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.

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