Two civic-run hospitals in Mumbai — King Edward Memorial Hospital Parel, and BYL Nair Hospitals, Mumbai Central — have received approval from the Indian Council for Medical Research to start phase II and phase III clinical trial of COVID-19 vaccine developed by the University of Oxford. At present, Brihanmumbai Municipal Corporation (BMC) is looking for volunteers to participate in the trial.
A total of 17 medical institutes were selected across the country for the trial of Oxford's COVID-19 vaccine, according to reports. The list includes AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.
How Oxford COVID-19 trial will work:
Each of the two hospitals in Mumbai to conduct trial on 160 volunteers. "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).
“The trial will include volunteers from all strata of society in various age groups," said Dr Hemant Deshmukh, dean of KEM.
Each participant will administer two doses in a gap of four weeks. First dose will be given on day one and second dose will be scheduled on day 29, according to the study design. Then, the drug maker will examine safety and immunogenicity at predefined interval, a senior official told PTI.
The COVID-19 vaccine has been developed by the University of Oxford and Astra Zeneca. British-Swedish firm Astra Zeneca partnered with Serum Institute of India to manufacture COVID-19 vaccine for India and low-and-middle income countries.
Oxford's COVID-19 vaccine has shown a positive result in its initial trial. According to a report published in the British medical journal, The Lancet, the COVID-19 vaccine produced a dual immune response in people aged 18 to 55.
“After the completion of phase II 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,” Dr Deshmukh told the Hindustan Times. Pune based vaccine maker earlier said that around 1,600 participants of more than 18 years would be enrolled in the study.
"According to the application, SII would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' in healthy Indian adults," PTI reported.
"I want to tell people, the talent of our scientists is like that of 'rishi munis' and they are working very hard in laboratories. Three vaccines are in various stages of testing. When scientists will give us the green signal, it will be produced on a mass scale and all preparations have been made for it," Prime Minister Narendra Modi said while addressing the nation on Independence Day.
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