India's apex drug regulatory body has granted approval to Serum Institute of India (SII) to conduct phase II and III human trial for the COVID-19 vaccine developed by the University of Oxford. The permission was given on Sunday after an evaluation based on the recommendations of the Subject Expert Committee on COVID-19, a health ministry official told.
"The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials," a senior official told the news agency PTI.
The officials said that the SII had submitted a revised proposal on Wednesday after the expert panel on Tuesday had asked it to revise its protocol for the phase II and III clinical trials.
The panel had recommended that the human trial sites for the study should be distributed across the country. Around 1,600 people will participate in the clinical trial. Volunteers must be above 18 years old to take part in the study. Serum Institute has selected 17 institutions to conduct the the advanced trials. These sites are 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.
"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the official told PTI.
"According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults," the official said, according to PTI.
The COVID-19 vaccine candidate has been developed by the Unversity of Oxford and British-Swedish firm AstraZeneca. At present, phase II and II clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase II clinical trial in Brazil and phase I and II clinical trials in South Africa. AstraZeneca has partnered with SII to develop COVID-19 vaccine for India and low-to-middle income countries.
All eyes are on Oxford's coronavirus vaccine as it has already shown promising results in the first phase of clinical human trial. The researchers said that they found their experimental COVID-19 vaccine produced a dual immune response in people aged 18 to 55. “We are seeing good immune response in almost everybody," said Dr Adrian Hill, director of the Jenner Institute at Oxford University. “What this vaccine does particularly well is trigger both arms of the immune system," he said.
Indian drugmaker Wockhardt Ltd will supply millions of doses of multiple COVID-19 vaccines to the UK, including the one being developed by AstraZeneca and Oxford University, it said. The company has reserved fill-and-finish capacity — the final manufacturing step of putting vaccines into vials or syringes and packaging them - as part of an agreement with the UK government, it said.
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