Wednesday , 23 September 2020
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DCGI gives permission to SII to conduct phase II and III human clinical trial of Oxford University vaccine

DCGI gives permission to SII to conduct phase II and III human clinical trial of Oxford University vaccine

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.