Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and three human clinical trials of the Oxford University developed COVID-19 vaccine candidate within the country
Government officials told PTI that the approval for conducting phase 2 and three clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a radical evaluation supported the recommendations of the topic Expert Committee (SEC) on COVID-19
“The firm has got to submit safety data, evaluated by the info Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials,” a senior official said
“As per the study design, each subject are going to be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the security and immunogenicity are going to be assessed at predefined intervals,” the official said
As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after an in depth deliberation and considering the info generated on the vaccine candidate in phase 1 and a couple of of the Oxford University trial, had recommended granting permission for phase 2 and three clinical trials of the potential vaccine, ‘Covishield’, on healthy adults in India,? the officials said.??
Currently, phase 2 and three clinical trials of the Oxford vaccine candidate goes on within the uk , phase 3 clinical test in Brazil and phase 1 and a couple of clinical trials in South Africa
The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July 28, following deliberation over its application, had asked it to revise its protocol for the phase 2 and three clinical trials besides seeking some additional information
The panel had also recommended that the clinical test sites which are proposed for the study be distributed across India
According to the revised proposal by the SII, 1,600 people aged above 18 years will participate within the trials across 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 upper Education and Research in Mysore
“According to the appliance , it might conduct an observer-blind, randomised controlled study to work out the security and immunogenicity of ‘Covishield’ on healthy Indian adults,” the official said
The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first application to the DCGI on July25 seeking permission for conducting the phase 2 and three trials of the potential vaccine.
Initial results of the primary two-phases of trials of the vaccine conducted in five trial sites within the UK showed that it’s a suitable safety profile and homologous boosting increased antibody response, sources had said.