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Serum Institute of India (SII) has filed an application with the Drugs Controller General of India (DCGI) to study a Covid-19 vaccine candidate, being developed by the UK’s University of Oxford, in Phase II and III clinical trials.
SII is planning an observer-blind, randomised controlled trial to assess the safety and immunogenicity of the vaccine candidate, named ‘Covishield’ in India.
A total of 1,600 participants aged more than 18 years will be enrolled in the trial, which is expected to begin next month.
Last week, data from the Phase I/II COV001 trial performed in the UK showed that the vaccine candidate was tolerated and generated strong immune responses in all evaluated participants.
The blinded, multi-centre, randomised controlled trial recruited 1,077 healthy adult volunteers aged 18 to 55 years. It compared a single dose of the Oxford vaccine against meningococcal conjugate vaccine, MenACWY.
According to the results, a single dose of the Covid-19 candidate led to a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of subjects one month following vaccination.
In addition, a T-cell response that peaked by day 14 and maintained two months after injection was observed in all participants.
Oxford University licensed the vaccine candidate to AstraZeneca, which recently agreed to a manufacturing deal with SII.
Commenting on the manufacturing agreement, SII CEO Adar Poonawalla said: “Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply one billion doses of the Covid-19 vaccine being developed by Oxford University.”
These vaccine doses will be for India and middle and low-income countries globally.
Currently, late-stage Phase II/III trials of the Oxford vaccine are ongoing in the UK, Brazil and South Africa. Studies are also set to launch in the US.