The Brihanmumbai Municipal Corporation (BMC) has completed the second phase of clinical trials for the Oxford-AstraZeneca Covid-19 vaccine. The civic body will soon begin testing for the third phase after the first group of volunteers completes 28 days from their first vaccination.
200 healthy volunteers participated in the second phase of the trial of the vaccine candidate called COVISHIELD. 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, Central Drugs Standard Control Organization to seek approval for the stage III trial.
“With approval, we will be able to begin the third phase of the trial once the first group of volunteers completes 28 days after the first vaccination. According to the ICMR (Indian Council for Medical Research), the third trial can only be done with volunteers after an interval of 28 days, ”said Suresh Kakani, Additional Commissioner of BMC.
On September 26, the first dose of the second phase of the trial was administered to three volunteers between the ages of 20 and 45 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 the SII if they want to include more volunteers for the second phase of the trial. “As we have achieved our goal of 100 volunteers, we have asked the SII if they want us to include more volunteers. So far we have not received a response. However, we have kept more volunteers on hold, ”said Dr. Ramesh Bharmal, dean of BYL Nair Hospital.
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However, Kakani said they would no longer wait for a response from the IBS and would begin their third phase of testing. “We cannot wait any longer, as we need to provide the third dose to the first volunteers who have completed their 28-day waiting period,” he said.
In August, when ICMR selected the two Mumbai-based hospitals to conduct clinical trials of the vaccine, they were asked to enroll 160 volunteers at each hospital. Subsequently, the total number of volunteers was reduced to a total of 200, or 100 each, for the second phase of the trial.
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According to ICMR, each volunteer is covered by life insurance worth Rs 1 million in the event of death due to any side effects of the vaccine administered in the trial. In addition, they obtain Rs 50 lakh medical insurance to cover the cost of treating any possible adverse effects of vaccination.
In the second week of September, both hospitals had to stop the trial after one participant developed an adverse reaction in the UK. Later, the Indian drug control general granted permission to conduct the second and third phase of the trial. However, both civic hospitals had to receive final approval from their ethics committees before beginning the selection of volunteers.
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