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July 27, 2020

SII seeks approval to trial Oxford Covid-19 vaccine in India

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 University of Oxford, in Phase II and III clinical trials.

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.

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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.

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