Pune-based Serum Institute of India (SII) has been given a green light by the Drugs Controller General of India (DCGI) for conducting the Phase 2 and 3 human clinical trials of the Covid-19 vaccine candidate developed by Oxford University, news agency PTI has reported.
The news agency reported citing unnamed government officials as saying that the approval to SII was granted by Dr VG Somani late on Sunday after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid-19.
“The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to Phase 3 clinical trials,” a senior official was quoted as saying by PTI.
“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” the official said.
SII, the world’s largest vaccine maker, has signed an agreement to manufacture the potential vaccine developed by University of Oxford’s Jenner Institute in collaboration with British-Swedish company AstraZeneca.
Phase 2 and 3 clinical trials of the Oxford vaccine candidate is on in the United Kingdom, Phase 3 in Brazil and Phase 1 and 2 in South Africa.
The officials, according to PTI, said Serum Institute had submitted a revised proposal on Wednesday after the SEC on July 28 had asked it to revise its protocol for the Phase 2 and 3 clinical trials besides seeking some additional information.
The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India.
The expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, as a rapid regulatory response, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, ‘Covishield’, on healthy adults in India.
Serum Institute has said in its revised proposal that 1,600 people above 18 years of age will participate in the trials across 17 selected sites, including All India Institute of Medical Sciences (AIIMS) in Delhi, BJ 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 in Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.
“According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ on healthy Indian adults,” the official said.
