Phase 2 and 3 clinical trials of the Oxford vaccine candidate are underway in the UK. (Representative)
New Delhi:
The Comptroller General of Drugs of India (DCGI) has nodded to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials on a COVID-19 vaccine candidate, developed by the University of Oxford, in the country.
Government officials told PTI that approval for the conduct of phase 2 and 3 clinical trials by the SII was granted by DCGI Dr VG Somani late Sunday evening after a thorough assessment based on the recommendations of the Expert Committee. on COVID-19.
As a quick regulatory response, the Central Drugs Standard Control Organization (CDSCO) expert group on Friday, after detailed deliberation and taking into account the data generated on the vaccine candidate during phases 1 and 2 of the trial Oxford University had recommended granting permission. for phase 2 and 3 clinical trials of the potential vaccine, “Covishield”, in healthy adults in India, officials said.
“The company must submit safety data, assessed by the Data Safety Monitoring Board (DSMB), to CDSCO before moving on to phase 3 clinical trials,” said a senior official.
“Depending on the study design, each subject will be administered two doses four weeks apart (first dose on day 1 and second dose on day 29), after which safety and immunogenicity will be assessed at predefined intervals.” , said the official.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate are underway in the UK, a phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
Officials said the SII submitted a revised proposal on Wednesday after Tuesday’s expert panel, after deliberating on its application, asked it to revise its protocol for phase 2 and 3 clinical trials in addition to looking for Additional Information.
The group also recommended that the clinical trial sites proposed for the study be spread across India.
According to the revised proposal, 1,600 people over the age of 18 will participate in the trials at 17 selected sites, including AIIMS Delhi, BJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in 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 and Research in Mysore.
“Depending on the app, it would conduct a randomized, randomized, observer-controlled study to determine the safety and immunogenicity of ‘Covishield’ in healthy Indian adults,” the official said.
The SII, which has partnered with AstraZeneca, to manufacture the Oxford vaccine candidate against COVID-19 had submitted its first application to DCGI on July 25 for approval to conduct the phase 2 and 3 trials of the potential vaccine.
