Panel recommends DCGI to grant Serum Institute approval for human trial


New Delhi: India’s apex clinical trial regulation body in a meeting revised proposal of Serum Institute of India to start human trials in India for the Covid-19 vaccine candidate developed by the University of Oxford.

According to the revised proposal, over 1,600 people will participate in the trials in 20 selected cities across India.

The Subject Expert Committee at Central Drugs Standard Control Organisation (CDSCO) has recommended to the top drug regulator to grant permission to Serum Institute of India (SII) to conduct phase two and three clinical trials in India on a potential COVID-19 vaccine.

The domestic pharma giant has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.

The pharmaceutical company will perform an observer-blind, randomised controlled study enrolling at least 1,600 participants to determine the safety and immunogenicity of ‘Covishield’.

Lancet medical journal report has stated that a vaccine candidate developed at the University of Oxford has shown encouraging results and it appears to be “safe, well-tolerated, and immunogenic”.

The company is expected to manufacture a billion doses for low- and middle-income countries by 2021.

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