The Serum Institute of India (SII) is set to begin its phase-2 human clinical trials of the Oxford University-AstraZeneca Covid-19 vaccine candidate, Covishield, on Tuesday.
The observer-blind, randomised and controlled study to determine the safety and immunogenicity of ‘Covishield’ on healthy Indian adults will begin at Bharati Vidyapeeth Medical College and Hospital in Pune, sources said. Dr Prasad Kulkarni will be the principal investigator for SII and spearhead the process.
According to the Clinical Trials Registry of India, 17 sites (including PGIMER) have been selected to conduct the trials and around 1,600 adults above 18 are expected to be recruited across India.
SII, world’s largest vaccine manufacturer, has entered a partnership with British-Swedish pharma company AstraZeneca to produce the vaccine, which has been developed by the University of Oxford.
On August 3, India’s drugs controller gave approval to SII for conducting phase II and III clinical trials of the vaccine candidate in the country. The results of its phase I trial held in the UK had shown promise in generating an immune response against SARS-CoV-2.
“We have got all approvals from the Central Drugs Standard Control Organisation (CDSCO). We are sure that in line with the philosophy of our group, we are going to make available a world class Covid-19 vaccine for people of our country and make our country ‘AatmaNirbhar’,” said Prakash Kumar Singh, additional director, Government and Regulatory Affairs, SII. The trials will be conducted at 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.
Process of administering the vaccine
The vaccine will be administered as a two-dose schedule on days 1 and 29 as 0.5 ml dose intramuscularly. Placebo will be administered as a two-dose schedule on days 1 and 29 as 0.5 ml dose intramuscularly. The vaccine is made from a weakened version of a common cold adenovirus taken from chimps and genetically modified.
