New Delhi: The Drugs Controller General of India (DCGI) has given nod to Serum Institute of India (SII) for conducting Phase 2 and 3 human clinical trials of the Oxford University developed COVID-19 vaccine candidate in India. Government officials said that the approval was granted by DCGI chief Dr VG Somani late Sunday evening. The decision to conduct the trials was taken 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. Then Serum Institute can proceed to phase 3 clinical trials,” a senior official said
“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). Then their safety and immunogenicity will be assessed at predefined intervals,” the DCGI official stated.
The expert panel at the Central Drugs Standard Control Organisation (CDSCO) had a detailed deliberation Friday on the human trials. It also considered the data generated on the vaccine candidate in Phase 1 and 2 of the Oxford University trial. The panenl then recommended permission for Phase 2 and 3 clinical trials of the potential vaccine, ‘Covishield’. The trials will be carried out on healthy adults in India, officials informed.
Currently, Phase 2 and 3 clinical trials of the Oxford University vaccine candidate is going on in the United Kingdom. Phase 3 clinical trial is on in Brazil and Phase 1 and 2 clinical trials in South Africa.
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The officials said that the SII had submitted a revised proposal Wednesday. This came after the SEC July 28, had asked SII 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
According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites. Some of the places where the trials will be conducted are AIIMS-Delhi,B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna and Post Graduate Institute of Medical Education and Research in Chandigarh.
“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.
SII has partnered with AstraZeneca, for manufacturing the Oxford University vaccine candidate for COVID-19. It had submitted its first application July 25 to the DCGI seeking permission for conducting the Phase 2 and 3 trials of the potential vaccine.
To introduce the vaccine, SII has signed an agreement to manufacture it developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company ‘AstraZeneca’.
