DCGI nod to Serum Institute for phase 2, 3 human trials of Oxford vaccine

Phase 2 and 3 clinical trials of the Oxford vaccine candidate are on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa

The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of a Covid-19 vaccine candidate, developed by the University of Oxford, in the country.

Government officials told PTI that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee on Covid-19.

As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO)