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The Drugs Controller General of India (DCGI) has contributed nod to the Serum Institute of India (SII) for conducting phase 3 and 2 human clinical trials of a COVID-19 vaccine candidate, developed at the University of Oxford, in the country.
Government officials told PTI that the approval of conducting stage 2 and 3 clinical trials by the SII was awarded by DCGI Dr VG Somani late mnight about August 2 following a thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19.
As a quick regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on July 31, following a comprehensive deliberation and considering the data created by the vaccine candidate in stage 1 and 2 of the Oxford University trial, had advocated granting permission for stage 2 and 3 clinical trials of the potential vaccine,’Covishield’, on healthy adults at India, the officials stated.
“As per the study design, each topic will be administered two doses four weeks apart (initial dose on day one and second dose on day 29) after that the safety and immunogenicity will be assessed in predefined periods,” the official said.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is happening in the United Kingdom, stage 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
The officials stated that the SII had submitted a revised proposal on Wednesday after the expert panel on Tuesday, after deliberation over its program, had requested it to revise its own protocol for the stage 2 and 3 clinical trials apart from needing some extra details.
The panel also has recommended that the clinical trial sites that have been suggested for the study have been distributed across India.
According to this revised proposal, 1,600 people aged above 18 years will participate in the trials across 17 selected websites, 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 at Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.
“According to this program, it would conduct an observer-blind, randomised controlled study to ascertain the safety and immunogenicity of’Covishield’ on healthy Indian adults,” the official stated.
The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its initial application to the DCGI on July 25 looking for permission for running the stage 2 and 3 trials of the potential vaccine.
