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DCGI gives permission to Serum Institute of India to conduct phase 2 and 3 human clinical trial of Corona vaccine 

Updated: August 3, 2020 7:00 pm
Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) to conduct phase 2 and 3 human clinical trials of COVID-19 vaccine developed by Oxford University.

The approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr VG Somani late last night after a thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19.

The expert panel at the Central Drugs Standard Control Organisation (CDSCO) had on Friday recommended granting permission for phase 2 and 3 clinical trials of the vaccine – Covishield on healthy adults in India.

The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials.

Currently, phase 2 and 3 clinical trials of the Oxford vaccine are going on in the UK, phase 3 clinical trials in Brazil and phase 1 and 2 clinical trials in South Africa.

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