The Serum Institute of India and the Drugs Controller department has finally given a green signal to the Oxford vaccine candidate to conduct the Phase 2 and 3 clinical trials. The approval was granted by Dr VG Somani after thorough evaluation based on the recommendations of the subject expert committee.
The officials mentioned that as per the study design, each subject will be administered with two doses four weeks apart following the safety protocols and immunogenicity will be assessed at predefined intervals. It is also mandatory that the firm submits its safety data which will be evaluated by the Data Safety Monitoring board before moving to the 3rd phase of the clinical trials.
Based in Pune, SII is the world’s largest vaccine maker that has signed an agreement with Oxford University’s Jenner Institute in collaboration with British Swedish company AstraZeneca to manufacture the potential vaccine. The 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 expert panel at the Central Drugs Standard Control Organisation (CDSCO) recently mentioned that as a rapid regulatory response, it is recommended that they grant permission for phase 2 and 3 clinical trials of the potential vaccine, 'Covishield', on healthy adults in India.
In its revised proposal, Serum Institute has said 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.