COVID-19 panel recommends DCGI to permit SII to conduct human trials of Oxford vaccine candidate
SII had submitted a revised proposal on Wednesday after the expert panel had asked it to revise its protocol for the trials besides seeking some additional information
A committee of subject experts on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) has recommended the Drugs Controller General of India (DCGI) to grant approval to Serum Institute of India (SII) for conducting the second and third phases of human clinical trials of the Oxford vaccine candidate, as per PTI reports.
“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 phase 2 and 3 human clinical trials of the potential vaccine developed by the Oxford University – Covishield,” informed sources.
SII had submitted a revised proposal on Wednesday after the expert panel had asked it to revise its protocol for the trials besides seeking some additional information.
Reportedly, the revised proposal states that 1,600 people aged above 18 will take part in the human clinical trials across 17 sites, which will include the likes of Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) Patna, AIIMS Delhi, Andhra Medical College in Visakhapatnam, AIIMS Jodhpur, BJ Medical College, Pune, Nehru Hospital in Gorakhpur, Post Graduate Institute of Medical Education and Research in Chandigarh, 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.
(Edits from EP News Bureau)
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