Sion, JJ hospitals in Mumbai get approval to start phase 3 of Covaxin clinical trials

The Lokmanya Tilak Municipal General Hospital (Sion hospital) and JJ Hospital have received approvals from their respective ethics committees to conduct third phase of clinical trials for Covaxin, the indigenous vaccine candidate for Covid-19 by Bharat Biotech. Both hospitals, which are conducting human trials for Oxford-AstraZeneca’s Covishield vaccine, will require around 2,000 volunteers for their trials of Covaxin. Of these, 20% will be people with co-morbidities and 5% will be medical health workers.

Civic-run Sion hospital, which received the nod on Thursday, is expected to start the trial within two-three days. “We have already got 300 volunteers, who want to participate in the trial, and we are currently running tests on them. Each will have to undergo Reverse Transcription Polymerase Chain Reaction (RT-PCR) and antibody tests to check if they are or have been infected with Covid-19,” said Dr Mohan Joshi, dean of Sion hospital.

The government-run JJ hospital will start their trial after a week, as they are yet to select volunteers. “We will start the selection process by next week. We will also start a dedicated helpline number where people can call to participate in the trial,” said Dr Ranjit Mankeshwar, dean of JJ Hospital.

People between the age group of 18 and 60 years will participate in the trials, with a second dose of the vaccine given to them 28 days after the first dose. The hospitals will follow up with the volunteers for a year.

As per Bharat Biotech’s official website, Covaxin is developed in BSL-3 (Bio-Safety Level 3) high containment facility. The vaccine received Drugs Controller General of India (DCGI) approval for Phase I and II human clinical trials, which commenced across India from July.

DEDICATED ZONE FOR TESTING AT MUMBAI AIRPORT

After the state made it mandatory for passengers from NCR, Rajasthan, Gujarat and Goa to have a negative RT-PCR test result before entering Maharashtra, Mumbai airport has created a dedicated zone for fliers to undergo the test upon arrival. Passengers, who have not undergone the test before boarding the flight, can take the test at Mumbai airport and they will be given the result in 8 hours, while they wait in the dedicated zone.

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