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India's drug controller orders Serum Institute to resume COVID-19 vaccine trials

People's Daily Online

(Xinhua) 15:38, September 16, 2020

NEW DELHI, Sept. 16 (Xinhua) -- The Drugs Controller General of India (DCGI) has ordered the Serum Institute of India (SII) to resume its phase 2 and phase 3 clinical trials of the Oxford University's Covishield vaccine along with pharma major AstraZeneca, local media reported Wednesday.

The DCGI, VG Somani, in a letter to the SII on Tuesday said the institute's reply has been "carefully examined" as also the recommendations of the Data Safety Monitoring Board (DSMB) in India and Britain.

The drug controller last week put on hold the trials in the wake of AstraZeneca pausing the clinical trials in other countries because of "an unexplained illness" in a participant in the study.

Reports said the SII had submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequelae.

AstraZeneca has already resumed trials in Britain for the vaccine.

India is in the grip of ongoing COVID-19 pandemic and the cases are surging with each passing day. The country's COVID-19 tally surpassed the 5 million mark on Wednesday, with 90,123 new cases and 1,290 related deaths.

Globally India is the second worst-hit country due to the pandemic.

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