Oxford vaccine update: The first two-phase trials of Covishield COVID-19 vaccine conducted in the UK have shown that it has an acceptable safety profile and homologous boosting increased antibody responses.
Oxford vaccine update: Serum Institute of India (SII) was recommended on Friday by a committee of subject experts on COVID-19 to the country’s drug regulator so that it gets the permission to conduct the second and third phases of human clinical trials of the Oxford vaccine candidate, PTI reported.
The committee at the Central Drugs Standard Control Organisation (CDSCO) has sent its recommendations in this regard to the Drugs Controller General of India (DCGI) for approval, PTI quoted highly-placed sources as saying.
The source told PTI that SII’s application was considered in a meeting that was held by the subject expert committee on COVID-19 on Friday. After that the committee recommended that SII be granted the permission to conduct phase 2 and 3 human clinical trials of Covishield — the potential vaccine developed by Oxford University.
As per the report, the revised proposal states that 1,600 people aged above 18 will take part in the human clinical trials across 17 sites, which will include the likes of Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) Patna, AIIMS Delhi, Andhra Medical College in Visakhapatnam, AIIMS Jodhpur, BJ Medical College, Pune, Nehru Hospital in Gorakhpur, Post Graduate Institute of Medical Education and Research in Chandigarh, and JSS Academy of Higher Education & Research in Mysuru.
The source added that as per the application, an observer-blind, randomised controlled study will be conducted to determine the safety and immunogenicity of Covishield in healthy Indian adults.
The Serum Institute of India had been asked by the DCGI to clearly define Phase 2 and Phase 3 part of the protocol and resubmit their application to the committee for evaluation.
It was also recommended by the panel that the Covishield clinical trial sites be distributed across India, the report said.
SII has partnered with AstraZeneca to manufacture the Oxford vaccine candidate for COVID-19. In this regard, it had submitted its application to DCGI seeking permission for conducting phase 2 and 3 trials of Covishield.
The report added that the initial results of the first two-phase trials of Covishield COVID-19 vaccine conducted in the UK have shown that it has an acceptable safety profile and homologous boosting increased antibody responses.