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The phase-3 clinical trials of India’s own COVID-19 vaccine candidate – Covaxin - will begin at Sir JJ Hospital in Mumbai. The medical facility is reportedly the second one in Maharashtra’s capital to start human trials of the vaccine candidate against the novel coronavirus after BMC-run Sion hospital.
Covaxin is being developed by the Hyderabad-based firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The ICMR completed paperwork with the hospital on November 25 and enrolment of suitable volunteers, following the norms, will start from November 27 onwards, reported Mumbai Mirror citing sources.
The hospital will also enroll frontline workers in the human clinical trial of Covaxin, said the report.
According to the dean of Sir JJ Hospital, Dr Ranjit Mankeshwar, it is expected to enroll at least 1,000 people for the trial of the coronavirus vaccine candidate.
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Each and every volunteer will be followed for 28 days for the trail, Dr TP Lahane, director of the Directorate of Medical Education and Research told the publication.
A special team of doctors, which includes ethics committee doctors, have been appointed to look into the trial, Dr Mankeshwar was quoted as saying. “All the paperwork has been done. We are set to start enrolling the volunteers soon,” said the dean.
At present, four COVID-19 vaccine trials are going on in Maharashtra, including the two Covaxin trials, said the report citing Dr Sashank Joshi, member of the state task force on COVID-19.
“The Serum Institute of India (SII) is leading the race in terms of completing the trials and, hopefully, if they get permission, the vaccine can be given from December onwards,” Dr Joshi said.
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Besides Maharashtra, the phase-3 clinical trials of Covaxin will begin at Sola civil hospital in Ahmedabad, Gujarat deputy Chief Minister Nitin Patel said on November 25. Talking to reporters, he said that the hospital received 500 doses of the vaccine candidate for the trial.
Patel, who also holds the Health portfolio, said doctors at the hospital would be trained for administering the shots by experts from Union Health Ministry.
(With inputs from PTI)
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