The Lokmanya Tilak Municipal General Hospital (Sion) which has been selected to run the clinical trial on the first indigenous Covid-19 vaccine -- Covaxin, is still waiting to get an approval from the ethics committee of the hospital.
In the meantime, the hospital which will run the trial on 1,000 volunteers has received over 100 queries from people to participate in the trial.
In the last week of October, the Indian Council of Medical Research (ICMR) selected the hospital for a pan-India trial of the third phase of Covaxin -- the promising vaccine manufactured by Bharat Biotech.
The hospital, having sought 1,000 volunteers for testing the vaccine being developed by Hyderabad-based Bharat Biotech, will soon advertise in the newspapers for potential candidates. Sion Hospital will open only 5 per cent of the testing pool for its own staff and 20 per cent of volunteers will be those who have controlled comorbidities. The volunteers will be followed up for 12 months as per the rules of ICMR.
Dr Mohan Joshi, dean of the hospital, said they had submitted the proposal to the ethics committee of the hospital in the first week of November for final approval, but they are still awaiting for the green signal from the committee. “We have already received over 100 inquiries from people who are willingly wanting to participate in the trial. However we are waiting for the final nod from the committee to start the trial,” he said. Moreover the focus of the trial will be on testing the efficacy and the safety of the vaccine. “We will also study if it produces good anti-bodies and will study the diminishing pattern of antibodies,” Joshi added.
Meanwhile, the hospital has started a dedicated helpline number- 022-24073700/3703 where people can call for inquiries regarding the trial. “The details of the trail have been put up on a board at the entrance of the hospital with the helpline number. The process of approval has got delayed due to the festival season but we believe that within the next 2-3 days, we will get the nod from the committee," said Dr. NT Awad, head of the pulmonary medicine of the hospital.
Moreover, the hospital administration is also planning to dedicate an Outpatient Department (OPD) for the trial of COVAXIN. As informed by officers, the hospital is procuring a special refrigerator to store the serum of the trial.
"The third phase will have two stages. After 28 days of the first vaccination, the volunteers will be given the second vial," added Dr. Joshi.
As per the official website of Bharat Biotech, it is developed in BSL-3 (Biosafety Level 3) high containment facility. The vaccine received Drugs Controller General of India (DCGI) approval for Phase I and II Human Clinical Trials and the trials commenced across India from July, 2020.