Serum Institute gets DCGI nod to resume clinical trial of Oxford COVID-19 vaccine

A research scientist works inside a laboratory of India's Serum Institute, the world's largest maker of vaccines, which is working on vaccines against the coronavirus disease (COVID-19) in Pune. (Source: REUTERS)

The Drugs Controller General of India (DCGI) has now allowed Serum Institute of India (SII) to resume the previously paused clinical trial of the Oxford COVID-19 vaccine in the country, confirmed a senior Health Ministry official.

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In its communication, the DCGI has instructed the company to take extra care during screening, providing additional information in informed consent and close monitoring for adverse events during a follow-up of the study. The SII has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for the management of adverse events.

This past Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their vaccine candidate had resumed in the U.K. after the Medicines Health Regulatory Authority confirmed that the trials were safe. SII had earlier this week submitted the recommendations of the Data and Safety Monitoring Board (DSMB), U.K. and DSMB, India, and requested permission to restart enrolment in the clinical trial.

Meanwhile, according to a release issued by the Health Ministry on Wednesday, India logged the highest number of single day recoveries in the last 24 hours.

Also read: Oxford vaccine: DCGI directs Serum Institute of India to suspend recruitment for trials

“82,961 COVID patients were cured and discharged from home/facility isolation and hospitals in the last 24 hours and with this the total recovered cases stand at 39,42,360. In the last 24 hours, Maharashtra (19,423) contributed 23.41% of the new recoveries while the States of Andhra Pradesh (9628), Karnataka (7406), Uttar Pradesh (6680) and Tamil Nadu (5735) contributed 35.5% of the new recoveries. Nearly 59% of the new recoveries came from these five States. 27 States/UTs are reporting a recovery rate more than 70%. There are 9,95,933 active cases in the country currently,” the release said.

It added that Maharashtra, Karnataka, Andhra Pradesh, Uttar Pradesh, Tamil Nadu compose close to 60% of the active cases and 70% of the total active cases are found in the nine most affected States/UTs.