New Delhi: The Drugs Controller General of India (DCGI) has given a go-ahead to Serum Institute of India (SII) to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country. The drug regulator also revoked its earlier order that suspended new recruitment for phase two and three trials.
The DCGI has, however, advised taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be “scrupulously” followed by the SII. The institute has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for management of adverse events.
Notably, this come days after pharma giant AstraZeneca announced that it has resumed clinical trials of the vaccine in the UK after the Medicines Health Regulatory Authority’s (MHRA) confirmed that the trials were safe. SII had Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial.
India is the manufacturing partner of the COVID-19 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.
