Serum Institute of India to resume clinical trials of Oxford Covid-19 vaccine
The Drugs Controller General of India gave the green light for the resumption of Oxford University's vaccine candidate trials following its earlier suspension.
The Drugs Controller General of India (DCGI) has given the Serum Institute of India (SII) the permission to resume trials of the candidate vaccine developed by Oxford University and AstraZeneca after they had been earlier suspended as per an order from the DCGI.
Oxford vaccine trials to restart
The trials have been suspended in several countries after a volunteer suffered from serious side effects during participation in the trial in the UK. However, trials have recently been resumed in various locations including the UK, Brazil, South Africa, and finally now in India.
In light of this, the DCGI has set out some new conditions to be abided by to ensure extra caution is taken during trials that include: taking extra care during screening, providing additional information for consent, and close monitoring for adverse events during follow-up of the study which has to be strictly followed by the Serum Institute of India.
The SII is also required to provide the DCGI's office with details of medications used in accordance with the protocol in the event that adverse effects are identified.
The SII, which is working with AstraZeneca in the manufacturing of the Covid-19 vaccine candidate, submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK, and DSMB, India, on Tuesday to be granted the permission from DCGI to restart their trials.
Oxford University's vaccine is considered one of the most promising candidates currently being developed and, all going well, has shown great potential of being officially approved in the near future.
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