New Delhi: The expert panel which was looking into Serum Institute of India’s proposal to conduct the second and the third phases of the human clinical trial of the Oxford vaccine candidate has asked the country’s drug controller to allow Serum Institute of India to proceed.Also Read - Jadavpur University to Hold Free Vaccination Camp for Students; Details to be Notified Soon
Pune’s Serum Institute of India is the world’s largest vaccine maker by the number of doses produced and sold. It has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca. Also Read - 'Chalo Bhai Vaccine Vaccine': Man Promotes Covid Vaccination at Bus Stop in Hilarious Way, Leaves Internet in Splits | Watch
It aims at mass-producing the vaccine, which will be priced below Rs 1,000. Also Read - Centre Files Plea Against Allowing 2nd Dose of Covishield After Gap of 4 Weeks
The initial proposal submitted by the Pune firm came under scrutiny and the expert committee suggested a few revisions.
The SII had submitted a revised proposal on Wednesday after the expert panel on Tuesday, following deliberations over its application, had asked it to revise its protocol for the trials besides seeking some additional information.
“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,” an official source said.
According to the revised proposal, 1,600 people aged above 18 will participate in the trials across 17 selected sites, including 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.
“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,” the source said.