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 after the first batch of volunteers complete 28 days since their first vaccination.
200 healthy volunteers participated in the second phase of the trial of the vaccine candidate named COVISHIELD. Both King Edward Memorial (KEM) and BYL Nair hospitals, that are conducting the trials, will now submit their reports to the data safety monitoring board, Central Drugs Standard Control Organization to seek approval for the stage III of the trial.
“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,” said Suresh Kakani, additional commissioner, BMC.
On September 26, the first dosage of the second phase of trial was given to three volunteers between ages 20 and 45 years at KEM hospital. On October 23, they completed 28 days of their first vaccination.
The 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, BMC has also written to SII if they want to include more volunteers for the second phase of the trial. “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,” said Dr Ramesh Bharmal, dean of BYL Nair hospital.
However, Kakani said that they wouldn’t wait further for a response from SII and start their third phase trial. “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,” 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 a total of 200 – or 100 each – for conducting the second phase of the trial.
As per ICMR, every volunteer is covered by life insurance worth Rs 1 crore in the event of death due to any side effect of the vaccine administered in the trial. Also, they get Rs 50 lakh medical insurance to cover the cost for 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 drug 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.
