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Serum Institute Gets DGCI Approval To Resume Clinical Trials Of Oxford-AstraZeneca's COVID-19 Vaccine In India
Serum Institute of India (Pic Via Twitter)
In a positive development, just days after the clinical trials of Oxford and AstraZeneca's COVID-19 vaccine candidate had been halted in the nation, the Drugs Controller General of India (DCGI) Dr VG Somani on Tuesday (15 September) gave permission to Pune based Serum Institute of India (SII) to resume trials, reports Times of India.
Serum Institute has partnered with AstraZeneca to produce around 1 billion doses of the Covid-19 vaccine.
The trials of the vaccine candidate had been suspended in India a few days ago after AstraZeneca paused its study following "an unexplained illness" in a study participant in UK.
The DCGI's nod for the resumption of trials comes as the UK government, following the clearance from Medicines Health Regulatory Authority, has also accorded approval to the AstraZeneca for resuming the trials.
The DCGI has revoked its previous order to suspend the recruitment of volunteers for phase two and three trials of the vaccine candidate. However, it should be noted that a few conditions have been put in place for the trials, which include extra care during screening, providing additional information in informed consent, and close monitoring for adverse events during the follow-up study et cetera.
Adar Poonawalla-led SII has also been asked to submit to the DCGI's office the details of medication used in accordance with the protocol for managing any adverse events.
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