Trials for the indigenous vaccine candidate, 'Covaxin’, manufactured by Bharat Biotech will soon begin at the Lokmanya Tilak Municipal General (LTMG) Hospital, Sion. While the Indian Council of Medical Research (ICMR) has approved the trial, a final nod from the hospital ethics committee is awaited. Authorities have said it will be a Phase III clinical trial, with 1,000 participants, ranging in age from 18 to 60 years.
According to the official website of Bharat Biotech, the vaccine candidate has been developed in a BSL-3 (Bio-Safety Level 3) high-containment facility. The vaccine has received the approval of the Drugs Controller General of India (DCGI) for Phase I and II human clinical trials, which had commenced across India from July. “The trial will be conducted at 25 to 30 sites across 13 or 14 states and will provide two doses each of the vaccine and the placebo. About 2,000 subjects could be enrolled per hospital,” the website said.
Dr NT Awhad, head of the pulmonary medicine department, Sion Hospital, said there were several vaccines being used on a trial basis, to beat corona. Bharat Biotech has selected Sion Hospital for testing indigenous vaccines developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), using inactivated SARS-Cov-2, the virus that causes Covid-19.
“We have been selected for Phase III clinical trials of ‘Covaxin’. Currently, we are completing the paperwork and awaiting the approval of the ethics committee. We will be selecting 1,000 volunteers, of whom 20 per cent will have different comorbidities and five per cent will be medical Covid warriors. The trial will proceed in two phases. The second dose will be administered 28 days after the first,” he said.
Meanwhile, the KEM and BYL Nair Hospitals have now begun administering the second dose of the Oxford Covid-19 vaccine candidate to volunteers.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine, is also conducting Phases 2 and 3 of the human clinical trials of the candidate in India.