The trial, that will help determine the immunogenicity and safety of the vaccine candidate, will begin at Bharati Vidyapeeth Medical College and Hospital in Pune on healthy adults.
Coronavirus vaccine in India: As per the agreement signed by Pune-based Serum Institute of India (SII), the second phase of human clinical trials for Oxford’s Covishield will begin in India today. The trial, that will help determine the immunogenicity and safety of the vaccine candidate, will begin at Bharati Vidyapeeth Medical College and Hospital in Pune on healthy adults. Earlier this month, Serum Institute of India joined hands with pharma company AstraZeneca for manufacturing of Oxford’s COVID-19 vaccine candidate.
Citing Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs, SII, news agency PTI reported that the company has received all the necessary approvals from the Central Drugs Standard Control Organisation (CDSCO) and trials are set to take place from August 25. Singh said that the manufacturing of vaccines in India is in line with the company’s philosophy and India’s aim for an ‘AatmaNirbhar’ country and will provide Coronavirus vaccine for Indian people.
It is to note that the Drugs Controller General of India (DCGI) on August 3 had given a green signal to Serum Institute of India to conduct phase II and III human clinical trials of the Oxford COVID-19 vaccine candidate in the country. The decision was taken as a regulatory response owing to the increased number of Coronavirus cases in India. Further, the trials are expected to be conducted across 17 selected sites. The places that have been selected for Covishield trials include AIIMS Delhi, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, B J Medical College in Pune, Post Graduate Institute of Medical Education and Research in Chandigarh, Nehru Hospital in Gorakhpur, AIIMS-Jodhpur, Andhra Medical College in Visakhapatnam along with JSS Academy of Higher Education and Research in Mysore. More than 1,600 people above the age of 18 years will be a part of these trials.
The report highlighted that the initial results of the first two-phases of Covishield’s trials that were conducted in five sites in the UK has pointed towards an acceptable safety profile.