THE KING Edward Memorial (KEM) and BYL Nair Hospitals will submit a proposal to the ethics committee Monday seeking approval to participate in the phases 2 and 3 clinical trials of Oxford-AstraZeneca, a Covid-19 vaccine candidate.
The two civic-run hospitals, BMC additional municipal commissioner Suresh Kakani said, have already received approval from the Indian Council for Medical Research (ICMR) as possible sites from Mumbai for the vaccine trial.
Earlier this month, Pune-based Serum Institute of India (SII) got approval from the country’s regulatory authority to conduct late-stage human trials of the vaccine candidate. SII, the largest vaccine manufacturer in the world, has exclusive rights of marketing the vaccine candidate, called Covidshield in India.
Currently, the Oxford vaccine is a front-runner among all candidates and over 10 sites have been selected for its trials across India, of which two are from Mumbai. Each site will have 160 participants.
Apart from Oxford-AstraZeneca, India is also looking at two other vaccine candidates — Covaxin and ZyCov-D.
Senior BMC officials said they have started receiving inquiries from the general public willing to participate in the human trial. Hospital officials, however, said they will first look at recruiting eligible hospital staffers as participants before inviting the general public. The KEM and Nair hospitals plan to recruit 160 participants each.
“We still have to get approval from the ethics committee. KEM itself has 4,000 staffers. Only those who do not have past Covid-19 infection can be recruited. Based on ethics committee recommendations, the next phase of recruitment will begin,” dean Dr Hemant Deshmukh said.
An ethics committee comprises hospital officials, experts from outside the hospital and third-party representatives to monitor a human trial is conducted following ethical guidelines, from recording consent of participant to monitoring and reporting of adverse events. It also evaluates the scientific protocol a hospital will follow during the trial.
In July, researchers at the University of Oxford had announced that early trials showed the vaccine candidate had success in triggering an immune response against SARS-CoV-2 in the human body.
In Mumbai, participants in the 18-60 years age bracket, with no existing severe health condition or previous Covid-19 infection, will be chosen for the trials.
“Further criteria for eligibility will be shared by the ICMR,” said Dr RN Bharmal, dean in Nair hospital.
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