National health authorities have given permission to Serum Institute of India for conducting phase 2 and 3 human clinical trials of a Covid-19 vaccine candidate, developed by the University of Oxford.
Officials confirmed, with Indian news agency PTI, that Serum got the government nod late on Sunday night (Aug 2) after a thorough evaluation based on the recommendations of an expert body on Covid-19.
As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after detailed deliberations and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, ”Covishield”, on healthy adults in India, the officials said.
“The firm has to submit safety data, evaluated by the Data Safety Monitoring Board, to the CDSCO before proceeding to phase 3 clinical trials,” a senior official told PTI.
“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” the official said.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate are going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.