Coronavirus India Live Updates: Serum Institute Gets Nod To Resume Oxford COVID-19 Vaccine Trial In India


Covid vaccine: DCGI has allowed Serum Institute to restart its phase two and three clinical trials

New Delhi:

Coronavirus Latest Updates: Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial.

The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be “scrupulously” followed by Serum Institute of India (SII).

The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of “an unexplained illness” in a participant in the study.

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