Serum Institute gets nod for resumption of Oxford vax trials

9/16/2020

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The Serum Institute of India has received approval from the Drugs Controller General of India (DCGI) to resume the clinical trial of the Oxford Covid-19 vaccine candidate, officials from the drug manufacturing company confirmed on Wednesday.

India is the manufacturing partner of the vaccine candidate named Covishield, developed jointly by the University of Oxford's Jenner Institute's and AstraZeneca. The Pune-based firm is looking after the trials at 17 trial sites across India.

The permission to resume comes three days after AstraZeneca announced that it has resumed trials in the UK. On September 9, the trials were halted after one of the participants in the UK reported a suspected severe adverse reaction when administered a booster dose of the vaccine candidate.

On September 10, the Serum Institute of India also paused its trials after the DCGI issued a show-cause notice to them asking for an explanation as to why the institute decided to go ahead with the clinical trial of Covid-19 vaccine candidate while doubts about patient safety are yet unclear.

The next day, the DCGI had further 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.

Source: IANS

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