Oxford’s COVID-19 vaccine trials in India! DCGI gives nod to Serum for Phase- II, III human clinical trials

CDSCO gave permissions for conducting Phase II and Phase III clinical trials of Covidshield in Indian adults.

The Drugs Controller General of India (DCGI) has given a go-ahead for conducting the advance stages of clinical trials of a potential COVID-19 vaccine, jointly developed by the Oxford University and AstraZeneca, in India. The nod has been given to Serum Institute of India (SII) that will conduct Phase II and Phase III of human clinical trials, news agency PTI reported citing government officials. Serum Institute of India is supporting Oxford-AstraZeneca in the development of the vaccine. The approval for these trials had come late night on Sunday as DCGI Dr V G Somani gave approvals after evaluating the recommendations of the Subject Expert Committee on COVID-19, the report said.

It is to note that the Central Drugs Standard Control Organisation (CDSCO) last week deliberated on generating some detailed data on Oxford’s vaccine candidate and gave permissions for conducting Phase II and Phase III clinical trials of Covidshield in Indian adults. The report highlighted that the firm conducting clinical trials of potential Coronavirus vaccine in India will have to submit the safety data to the CDSCO which will be first evaluated by the Data Safety Monitoring Board (DSMB), before Phase III clinical trials are initiated.

Further, the report said that study design is as such, that every subject who will be a part of this trial will be two doses (four weeks apart). The first dose will be given on day one and the second dose on day 29. The immunogenicity as well as safety of the vaccine will be assessed at predefined intervals. The panel, according to the report, has also suggested that clinical trials should be conducted across India. The revised proposal stated that as many as 1,600 people above the age of 18 years will come on board for the clinical trials in 17 select cities. The trials will be conducted at AIIMS Delhi, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, B J Medical College in Pune, Post Graduate Institute of Medical Education and Research in Chandigarh, Nehru Hospital in Gorakhpur, AIIMS-Jodhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore among others.

To be sure, SII joined hands with AstraZeneca, for manufacturing the Oxford vaccine candidate and had submitted an application to DCGI on July 25 for its permission on clinical trials. Meanwhile, the vaccine is in Phase III and Phase III trials in the United Kingdom; Phase III trials in Brazil and Phase I and Phase II trials in South Africa.