The Drugs Controller General of India gave its approval to the Serum Institute of India in Pune to conduct Phase II and III human clinical trials of Oxford University-Astra Zeneca Covid-19 vaccine, known as Covishield, being undertaken in India. Health Ministry officials said that the move is expected to ‘hasten the development of the Covid-19 vaccine.’ The approval was granted after taking into account the recommendations of a Subject Expert Committee on Covid-19 and a detailed evaluation of the vaccine candidate.
Earlier last week, the committee had deferred its approval and suggested eight changes to the initial proposal. These changes included a fair distribution of the clinical trials across cities in India, proper demarcation of Phase II and III, revision of the 41 per cent dropout rate to make it at par with other vaccine studies, and making cellular immunity a part of the immunogenicity assessment.
A revised proposal submitted by the SII, proposed that 1600 people above 18 years of age will participate in the trials across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences 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.
The institute said it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ on healthy Indian adults. In the proposed study design, it has been stated that each subject will be administered two doses four weeks apart, the first dose on day one and second dose on day 29, following which the safety and immunogenicity will be assessed at predefined intervals. Studies in the United Kingdom have so far shown that a single dose of the vaccine led to a four-fold increase in antibodies to the SARS-CoV-2 (Covid-19) spike protein in 95 per cent of participants one month following the vaccination. Additionally, a Tcell response that peaked by day 14 and remained for two months after injection was observed in all subjects.
AstraZeneca had forged deals with multiple countries to produce more than two billion doses of the investigational Covid-19 vaccine. The tie-up with SII is to manufacture about a billion doses for low and middle-income countries.