The phase-3 human clinical trial of the COVID-19 vaccine being developed by Oxford University, and manufactured by the Serum Institute of India- SII, will begin at the KEM hospital of BMC in Mumbai today.
Dean of KEM hospital Dr. Hemant Deshmukh said, earlier this month the Drugs Controller General of India (DCGI) directed the SII to suspend any new recruitment in the phase-II and III clinical trial of the vaccine till further orders after AstraZeneca paused the trials in other countries because of “an unexplained illness” in a participant in the study.
However, on September 15, the DCGI gave permission to the SII to resume clinical trial of the vaccine and the third phase of the trials began in Pune from 21st of this month and another crucial stage of trials will also begin in Mumbai.
After receiving the nod from the Ethics Committee, the Clinical trials will begin in the KEM hospital in Mumbai. More than 350 volunteers have registered their names for these trials. But the dose of the vaccine will be administered to only 100 volunteers who are found to be medically fit. RT- PCR tests will be conducted on them and other health parameters will be checked. They will be given three doses during the period of four months.
All the necessary provisions including two different type of insurance covers have been provided to the volunteers participating in these trials. There is a community insurance of Rs. 10 crore for 160 persons. Similarly, each volunteer will have the insurance of Rs 35 lakh for the medical treatment and they will be entitled to it if they experience any health problems during the trials.