The Brihanmumbai Municipal Corporation (BMC) has finished the second phase clinical trials of the Covid-19 vaccine candidate led by Oxford-AstraZeneca. BMC further plans to commence third phase clinical trials once the first batch of volunteers have finished 28 days post consuming the vaccine.
The vaccine candidate, termed as COVSHIELD, was administered on total count of 200 healthy volunteers in the second phase of the clinical trials. The report about the clinical trials, conducted by King Edward Memorial (KEM) and BYL Nair Hospitals will be presented to the data safety monitoring board, Central Drugs Standard Control Organization for further approval of stage three trials.
Suresh Kakani, BMC additional commissioner, said, “With the approval, we will be able to start the third phase of the trial once the first set of volunteers complete 28 days of the first vaccination. As per ICMR (Indian Council of Medical Research), the third trial can only be conducted on volunteers after a gap of 28 days.”
Eralier, on September 26, three volunteers were administered the vaccine in KEM hospital as a part of second trial, who completed 28 days on October 23.
Alongside, the BMC has also approached Serum Institute of India who has collaborated with AstraZeneca, for including more volunteers for second trial. Dr. Ramesh Bharmal, dean of BYL Nair Hospital, stated, “As we have achieved our target of 100 volunteers, we have asked SII if they want us to include more volunteers. So far, we haven’t received any response. However, we have kept additional volunteers on standby.”
Though Kakani says, “We can’t wait any further as we need to provide the third dosage to the first volunteers who have completed their 28 days of waiting period.”
In the second week of September, the clinical trials were halted by both the hospitals when an adverse reaction was invoked in a participant in UK. Further, the Drug Control General of India gave approval for the second and third phase trials.