NEW DELHI: The Pune-based Serum Institute of India (SII) will start Phase 2 human clinical trial of an Oxford COVID-19 vaccine candidate in the country on Tuesday, August 25. At Bharati Vidyapeeth Medical College and Hospital, Pune, the observer blind, randomized controlled survey to determine the protection and immunogenicity of “Covishield” will begin.
Serum Institute of India has collaborated for the manufacturing of COVID-19 vaccine candidate developed by the University of Oxford with the British-Swedish pharmaceutical firm AstraZeneca.
Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs, SII, said that they have got approvals from Central Drugs Standard Control Organisation (CDSCO) and are set to begin the human clinical trial process at the Bharati Vidyapeeth Medical College and Hospital from August 25. He added that they are confident in line with the philosophy of their group, that they will deliver a world class COVID-19 vaccine for people living in India and make the country ‘Aatma-Nirbhar’.
As a rapid regulatory response, SII, on August 3, received a nod from the Drugs Controller General of India (DCGI) to conduct phase 2 and 3 human clinical trials of the Oxford COVID-19 vaccine candidate in the country. According to the SII, the tests will also be carried out in 17 selected sites, including 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. Around 1,600 people over 18 years of age are expected to participate in the trials.
As per sources, preliminary results of the first two-phases of vaccine trials conducted at five trial sites in the United Kingdom showed an acceptable safety profile and homologous boosting increased antibody responses.