SII Gets Nod To Resume Trials For Oxford COVID-19 Vaccine in India
SII has also been asked to monitor closely for any adverse reactions during the follow-up of the study.
The Drugs Controller General of India on Tuesday, 15 September, granted permission to the Serum Institute of India (SII) to resume clinical trials for the Oxford COVID-19 vaccine in the country. The trials had been put on hold last week due to an adverse reaction in one of the participants in the UK.
According to an Economic Times report, the DCGI has revoked its order to suspend all new recruitment for phase two and phase three trials for the vaccine candidate.
In addition, the company has been asked to carefully ensure caution during screening, provide additional information in informed consent and closely monitor for adverse events during the follow-up of the study.
SII is also required to submit the details of the medication being used, in accordance with the protocol for management of adverse events.
On Saturday, AstraZeneca and the University of Oxford announced that they would be resuming trials for their COVID-19 vaccine in the UK. This announcement came after the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials being conducted were safe.
(With inputs from The Economic Times)
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