A subject expert committee on Covid-19 on Friday recommended to the country’s drug regulator that the Serum Institute of India (SII) be granted the second and third stages of clinical trials on Oxford’s vaccine humans.
PTI quoted sources as saying that the recommendations of the committee, run under the Central Drugs Standard Control Organization (CDSCO), have been sent to the Drug Controller of India (DCGI) for approval.
He said SII submitted a revised proposal on Wednesday. Earlier on Tuesday, the committee of experts, after deliberating on the company’s application, asked him to change the protocol for testing and asked for some additional information from him.
An official source said, ‘The subject expert committee on Kovid-19 held an urgent meeting on Friday to consider SII’s application. After deliberation it has been recommended that the vaccine ‘Covishield’ developed by Oxford University be allowed for the second and third stages of clinical trials on humans. ‘
According to the revised proposal, the test would include 1,600 participants over the age of 18 years. These tests will be conducted at 17 selected locations including AIIMS-Delhi, BJ Medical College-Pune, RMRIMS-Patna, PGI-Chandigarh, AIIMS-Jodhpur, Nehru Hospital-Gorakhpur, Andhra Medical College-Visakhapatnam and JSS Academy of Higher Education and Research- Mysuru is included.
