Mumbai civic body to soon begin Phase-3 of Oxford-AstraZeneca Covid-19 vaccine trialUpdated: Oct 25, 2020, 01:02 IST
The Brihanmumbai Municipal Corporation (BMC) has completed the second phase of clinical trials of the Oxford-AstraZeneca Covid-19 vaccine. The civic body will soon start third-phase trials as the first batch of volunteers of the second phase completed 28 days since their first vaccination on Friday.
On September 26, the first dosage of the second phase of trial was given to three volunteers between 20 and 45 years old at KEM Hospital.
As many as 200 healthy volunteers participated in the second phase of the trial of the vaccine candidate, Covidshield. Both, King Edward Memorial (KEM) and BYL Nair hospitals, which are conducting the trials, will now submit their reports to the data safety monitoring board under the Central Drugs Standard Control Organisation (the national regulatory body for medicines made in India) to seek approval for the Phase-3 of the trial.
“With the approval, we will be able to start the third phase of the trial as the first set of volunteers completed 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,” said Suresh Kakani, additional commissioner, BMC.
Dr Hemant Deshmukh, dean of KEM Hospital, also confirmed that they are soon to start the third phase of the trial.
Pune-based Serum Institute of India (SII) has partnered with British-Swedish pharmaceutical giant AstraZeneca to manufacture the experimental Covid-19 vaccine, formulated at the University of Oxford.
Meanwhile, SII has suggested the civic body to include 50 more volunteers for the first phase of the trial, following which, both the hospitals have written to ICMR seeking approval.
“As we have achieved our target of 100 volunteers, we have asked ICMR if they want us to include more volunteers. So far, we haven’t received any response. However, we have kept additional volunteers on standby,” said Dr Ramesh Bharmal, dean of BYL Nair hospital.
However, Kakani said that BMC is unlikely to wait any further for ICMR’s response and will start the third-phase trial.
“We can’t wait any further as we need to provide the dosage in the third phase to the first set of volunteers who have completed their 28 days of waiting period,” he said.
In August, when ICMR selected the two Mumbai-based hospitals to run clinical trials for the vaccine, they were instructed to enrol 160 volunteers at each hospital. Later, the number of total volunteers was reduced to 100 each for the second phase of the trial.
As per ICMR, every volunteer is covered by a life insurance worth Rs1 crore in the event of death owing to any side-effect of the vaccine administered during the trial. They are also covered under a medical insurance of Rs50 lakh for the treatment of any possible adverse effect from the vaccination.
In the second week of September, both hospitals had to halt the trial after a participant developed an adverse reaction in the United Kingdom. Later, the Drugs Control General of India granted permission to run the second and third phases of the trial. However, both civic hospitals had to receive final approval from their ethics committees before starting with the screening of the volunteers.