The Drugs Controller General of India (DCGI) recently granted the Serum Institute of India (SII), based in Pune, approval to conduct Phase II/III clinical trials of Covishield in India. The institute is recognized as the world’s largest vaccine maker and they are partnering with AstraZeneca, a Swedish-British pharmaceutical giant, to produce the Covid-19 vaccine for less affluent countries.
Covishield: The Oxford-AstraZeneca Covid-19 Vaccine Candidate
Covishield is the name given to the Oxford-AstraZeneca Covid-19 vaccine candidate, technically known as AZD1222 or ChAdOx 1 nCoV-19. This vaccine candidate has already been tested in Brazil, the UK, and South Africa, where two doses were administered to participants nearly a month apart. In the early trials, it initiated an immune response against the novel coronavirus, establishing it as one of the leading contenders for the Covid-19 vaccine globally.
The Path to Approval
The Subject Expert Committee (SEC) for Covid-19 related therapies of the Central Drugs Standard Control Organisation (CDSCO) advised that the SII should adopt a ‘pan India’ approach when choosing trial sites. The SEC suggested that the authorization to market Covishield should be given after considering clinical data from both the India and international trials.
The Upcoming Trials
SII is now gearing up to launch its larger phase II/III trials, getting ahead of other vaccine candidates like Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D which are still in their phase I/II trials. The exact start date for these trials is unclear. Before the trials can commence, the ethics committee must give its approval, which could take at least a week. If everything goes according to plan, the vaccine could be available by the end of 2020. The trials for Covishield will include approximately 1,600 participants at over 18 sites across India, including locations identified by the National Biopharma Mission and Grand Challenges India Programme.
Covid-19 Fatality Rate in India
India continues to improve its Case Fatality Rate (CFR-the number of deaths per positive case) and maintain its global position of having one of the lowest Covid-19 fatality rates. At present, the CFR stands at 2.11%.
Grand Challenges India Programme
The Grand Challenges India Programme is a collaborative initiative of the Department of Biotechnology (DBT) in India, its Biotechnology Industry Research Assistance Council (BIRAC), and the Bill and Melinda Gates Foundation. BIRAC, set up by the DBT, is a Public Sector Company. The primary objective of the programme is to launch joint projects that will catalyze innovative health and development research within India.
National Biopharma Mission
The National Biopharma Mission is a collaborative industry-academia initiative for speeding up the development of biopharmaceuticals in India. Launched in 2017 with a total budget of Rs. 1500 crore, this mission is 50% co-funded by a World Bank loan and is administered by the BIRAC.