DCGI has rejected SII’s application to test ZyCoV-D vaccine on children

Drugs Controller General of India (DCGI) has rejected SII’s application to test ZyCoV-D vaccine on children.

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The expert group responsible for assessing the merits of SII’s proposal has noted that the vaccine has not been approved in any country and the trial on adult population in India also began only in March.

The government panel has asked Serum Institute to complete trials of Covavax COVID-19 vaccine on adults first.

Apart from SII, India’s indigenously developed COVID-19 vaccine Covaxin, developed by Hyderabad-based Bharat Biotech, started trials for children in the first week of June.

India’s drug regulator had granted permission for conducting the Phase 2/3 clinical trial of Covaxin in the age group 2 to 18 years on 12 May.