Mumbai’s Sion hospital awaits approval from its panel to start clinical trials of first indigenous Covid-19 vaccine

Mumbai’s Lokmanya Tilak Municipal General Hospital, also known as Sion hospital, is waiting for the final approval from its ethics committee to start the clinical trial of the first indigenous Covid-19 vaccine.

In the last week of October, the Indian Council of Medical Research (ICMR) had selected the Sion hospital for the pan-India trial of the third phase of Covaxin, manufactured by Hyderabad-based firm Bharat Biotech. A proposal for the trial was then placed before the hospital’s ethics committee in the first week of November for a final nod.

“We will start the trial once we receive the final green signal. We have already received more than 100 inquiries from interested participants,” said hospital dean Dr Mohan Joshi.

As many as 1,000 volunteers between 18 and 60 years of age will be part of the trial, of which 20% will comprise those with comorbidities while 5% of the participants will be medical health workers. As per ICMR rules, the hospital will follow-up with the volunteers for 12 months over their health.

Meanwhile, the hospital has also started a special outpatient department (OPD), OPD-28, to assist volunteers interested in the trial with regards to their queries. It has deployed its staffers, Tejas Tambe and Sushil Pendharkar, at the OPD building to answer the queries of the citizens.

“We have put up a board about the details of the trial at the entrance of the hospital with the helpline number. The process of approval has been delayed owing to the festive season, but we believe that within the next two-three days, we will get the nod from the committee,” said Dr NT Awad, head of the hospital’s pulmonary medicine.

For the trial, the hospital is also upgrading the infrastructure. Its officials said that 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 Bharat Biotech’s website, Covaxin is developed in BSL-3 (bio-safety level-3) high containment facility. The vaccine received the approval from the Drugs Controller General of India (DCGI) for Phases 1 and 2 of human clinical trials, following which the trials commenced across India from July.

Citizens interested in the vaccine trial can call on 022-24076381 and ask for the extensions 3700/3703 between 9am and 4pm for queries.

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