A subject expert committee on COVID-19 on Friday recommended to the country's drug regulator that permission be granted to Serum Institute of India (SII) for conducting the second and third phases of human clinical trials of the Oxford vaccine candidate.
The recommendations of the committee at the Central Drugs Standard Control Organisation (CDSCO) have been sent to the Drugs Controller General of India (DCGI) for approval, highly-placed sources told PTI.
They said that the SII had submitted a revised proposal on Wednesday after the expert panel on Tuesday, following deliberations over its application, had asked it to revise its protocol for the trials besides seeking some additional information.
"An urgent meeting was held by the subject expert committee on COVID-19 on Friday to consider SII's application. Following deliberation, it has recommended that permission be granted for the phase 2 and 3 human clinical trials of the potential vaccine developed by the Oxford University – Covishield," an official source said.
According to the revised proposal, 1,600 people aged above 18 will participate in the trials across 17 selected sites including AIIMS Delhi, BJ Medical College, Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) 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 & Research in Mysuru.
"According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of Covishield in healthy Indian adults," the source said. The DCGI on Tuesday had asked SII to clearly define Phase 2 and Phase 3 part of the protocol and resubmit their application for the evaluation by the committee.
The panel has also recommended that the clinical trial sites which have been proposed for the study be distributed across pan India. SII which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first application to the DCGI on Friday seeking permission for conducting phase 2 and 3 trials of Covishield.
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Initial results of the first two-phase trials of the vaccine conducted in five trial sites in the UK showed it has an acceptable safety profile and homologous boosting increased antibody responses, the source said.
To introduce the vaccine, SII, the world's largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.