Dr Hemant Deshmukh, dean of KEM Hospital, told Mumbai Mirror that the
Deshmukh said the hospital will now invite volunteers and select 160 healthy people between the ages of 20 and 50 who have not contracted Covid-19 for the trials. He added that the candidates will be from a variety of socio-economic backgrounds. “Those who have Covid-19 antibodies will not be eligible for the trials, which will begin in a week. We will not take very young or very old people. Simultaneous trials will be conducted in the United States and Brazil. We are waiting for a go-ahead from the state.”
He added, “Phase I human trials have been completed in the United Kingdom. The ones at KEM will be phase II and phase III trials, which will further test the immunogenicity [ability to provoke an immune response in the body] and safety of the vaccine.”
Suresh Kakani, additional municipal commissioner (health), said, “We will take consent from all volunteers. It is good that KEM Hospital has been chosen as one of the centres. Our credibility is good and we are prepared to execute the trials, following procedures communicated by ICMR.”
On August 3, India’s drug regulator, the Drugs Controller General of India (DCGI), had granted permission to SII to conduct phase II and phase III human clinical trials of Covidshield in India. “After a thorough evaluation, the DCGI has given approval to SII to perform phase-II, III clinical trial based on the recommendations of the Subject Expert Committee (SEC),” a senior government official had told ANI.
“As a rapid regulatory response, the proposal was deliberated in the SEC during a virtual meeting. After considering the data generated on the vaccine in phases I and II of the Oxford University trial, the committee recommended granting permission to conduct phase II and phase III clinical trials of Covidshield on healthy adult subjects in India,” the official said.
He added that each subject will be administered two doses of the potential vaccine, four weeks apart, after which its safety and immunogenicity will be assessed at predefined intervals. He said that after phase II of the trial, SII will have to submit safety data, evaluated by the Data Safety Monitoring Board, to the
SII had begun producing Covidshield in late July, and initial estimates suggested that at least one billion doses of the vaccine would be produced in India, which would make the country the world’s largest producer of the vaccine.
The results of the phase I and phase II trials, published on July 20 in the scientific journal The Lancet, indicated no early safety concerns and found that the vaccine candidate induced a strong immune response. It provoked a T cell (white blood cells that can attack cells infected with the coronavirus) response within 14 days of vaccination, and an antibody response within 28 days.