The expert panel has asked Drug Controller of India (DCI) to permit the Serum Institute of India to conduct the second and the third phases of the human clinical trial of the Oxford vaccine.
Serum Institute of India which is located in Pune is the world’s largest vaccine manufacturer in terms of the number of doses produced and sold. The drug manufacturer has signed a deal with British-Swedish pharma company AstraZeneca to manufacture the Oxford vaccine against the coronavirus. It plans to manufacture the vaccine in mass quantity and sell it at a price pegged below Rs 1,000. However, SII has come under the scrutiny of an expert committee who suggested making a few revisions in the proposal of producing the vaccines in huge quantities including changes in the protocol of the trials and availing some additional information. SII has then submitted a revised proposal on Wednesday to get the permission.
According to a government official, “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”.
SII will now conduct human trials with 1,600 participants above the age of 18 from 17 selected sites comprising AIIMS Delhi, BJ Medical College, Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) 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 Higher Education & Research in Mysuru.
The official added, “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”.