Lokmanya Tilak Municipal General Hospital (LTMG), Sion and Sir Jamshedji Jeejeebhoy (JJ) Hospitals have received the approval of the ethics committee to start the Phase 3 clinical trial of the COVID-19 vaccine, Covaxin, being manufactured by Hyderabad-based biotech company Bharat Biotech.
Health officials said both the hospitals will run trial on 1,000 healthy volunteers and the trails will start by next week.
Dr Ranjit Mankeshwar, Dean, JJ Hospital, said that they are expecting at least 1,000 volunateers for the trial of Covaxin. “A special team of doctors, including ethics committee doctors, have been appointed to look into the trial. All the paperwork has been done. We are all set to start enrolling the volunteers soon,” he said.
Bharat Biotech plans to test more than 20,000 volunteers across 12-14 states for Covaxin. Meanwhile, the Sion hospital has started a dedicated helpline number - 022-24073700/3703 where people can call for inquiries regarding the trial.
Dr Mohan Joshi, dean of the hospital said they have received the green signal from the ethics committee and in next 2 to 3 days trial will be started.
“We have already received over 300 volunteers who are willingly wanting to participate in the vaccine 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.
With this, JJ will become the second hospital in Mumbai to test an Indian vaccine. KEM and Nair hospitals are currently testing the AstraZeneca vaccine (also known as Oxford vaccine), which will be manufactured by Pune-based Serum Institute of India.
Dr Shashank Joshi, member of the state task force on COVID-19, said currently four vaccine trials are going on in the state, including the two Covaxin trials.
“The Serum Institute is leading the race in terms of completing the trials and, hopefully, if they get permission, the vaccine can be given from December onwards,” he said.
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.
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