New Delhi, 3 Aug (Prensa Latina) The Serum Institute of India will conduct phase two and three of human clinical trials of the Covid-19 vaccine candidate developed in the UK, it was announced today.
The Institute has been granted permission by India’s Comptroller General of Drugs to conduct the clinical trials in healthy adults of the potential Covishield vaccine, developed by Oxford University and the British-Swedish pharmaceutical company AstraZeneca.
According to the study design, each subject will be given two doses four weeks apart (the first dose on day one and the second on day 29), after which safety and immunogenicity will be assessed at predefined intervals.
Currently, phases Two and Three of the candidate Oxford vaccine are being conducted in the United Kingdom, Three in Brazil and One and Two in South Africa, All India Radio reported.
According to the proposal, 1,600 people over the age of 18 will participate in the trials at 17 selected sites in the country.
Initial results from the first two phases of the vaccine trials conducted at five sites in the United Kingdom showed that it has an acceptable safety profile and an equivalent antibody response booster.
India’s Serum Institute, the world’s largest vaccine producer by number of doses produced and sold, signed an agreement to manufacture the potential vaccine developed by Oxford University’s Jenner Institute in collaboration with AstraZeneca.