KEM, Nair hospitals of Mumbai get nod for phase 2-3 Oxford vaccine trials
The Indian Council for Medical Research (ICMR) granted approval to two civic-run hospitals in Mumbai — King Edward Memorial (KEM), Parel, and BYL Nair Hospitals, Mumbai Central — for phase 2 and 3 clinical trials of Oxford-AstraZeneca, a promising vaccine for the coronavirus disease (Covid-19). By August-end, the trial on 320 volunteers between the age group of 20 and 50 years will begin.
At present, Brihanmumbai Municipal Corporation (BMC) is looking for volunteers to participate in the trial.
A total of 10 medical institutes have been selected for the pan-India vaccine trial, of which two are from Mumbai. According to sources, BJ Medical College in Pune has also been selected for clinical trials.
The two Mumbai hospitals are waiting for a final nod from the state’s ethical committee to begin the trial.
“Each of the two hospitals will perform the trial on a group of 160 volunteers. These individuals have to be healthy, without any severe premedical ailments. They shouldn’t be on any immunosuppressants or undergoing other lifetime treatment,” said Suresh Kakani, additional commissioner, BMC.
All volunteers will be tested for Covid-19 through rapid antigen test (RAT). Also, they will be examined for Covid-19 antibodies to check if they were ever exposed to the infection in the past and recovered.
“The trial will include volunteers from all strata of society in various age groups. This will include people residing both in slums and non-slums,” said Dr Hemant Deshmukh, dean of KEM.
Pune-based Serum Institute of India (SII), which is the world’s largest manufacturer of vaccines in terms of volume, and British-Swedish pharmaceutical giant AstraZenecam have partnered to manufacture the experimental Covid-19 vaccine candidate formulated at the University of Oxford. The Oxford-AstraZeneca vaccine has been named as Covidshield in India. Phase 2 and 3 clinical trials of the Oxford vaccine candidate is on in the United Kingdom, Phase 3 in Brazil and Phase 1 and 2 in South Africa.
“Phase 1 of the trial was completed in July in UK, which has received a promising response. This will be the phase 2 and 3 trial of the vaccine. After the completion of phase 2 trial, reports will be submitted to the Data Safety Monitoring Board, then to the Central Drugs Standard Control Organization for stage 3 of the trial,” said Dr Deshmukh.
In the earlier trials, volunteers who were injected with two doses of the vaccine 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. The study was published in the science journal, Lancet.
“It is a proud moment for us as Mumbai is the only city where civic-run hospitals have been given permission to run the trial. In other cities, only government-run hospitals have been granted the opportunity,” said Kakani.