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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 this vaccine candidate against the novel coronavirus following BMC-run Sion hospital.
Covaxin has been developed by the Hyderabad-based company 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 appropriate volunteers, following the norms, will start from November 27 onwards, reported Mumbai Mirror citing sources.
The hospital will also enroll frontline employees in the 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 this coronavirus vaccine candidate.
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 book.
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 was done. We’re set to start enrolling the volunteers soon,” said the dean.
At the moment, four COVID-19 vaccine trials are happening 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 concerning finishing the trials and, ideally, should they get consent, the vaccine can be given from December onwards,” Dr Joshi said.
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. Speaking to reporters, he stated that the hospital received 500 doses of this vaccine candidate for the trial.
Patel, who also holds the Health portfolio, said doctors at the hospital could be trained for administering the shots by specialists from Union Health Ministry.
