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Oxford vaccine trials: Serum Institute to begin Phase 2 vaccine trials

Written by : TNM Staff

Phase II trials for the COVID-19 vaccine candidate, ADZ-1222, are expected to begin this week, according to reports. The COVID-19 vaccine candidate being manufactured in India by the Serum Institute of India (SII), has tied up with the British-Swedish pharmaceutical firm AstraZeneca to manufacture the vaccine candidate developed at the University of Oxford.

The pharma company has shortlisted 10 centres across India where the phase 2 and phase 3 trials will be carried out. The trial is expected to involve 1,600 volunteers, reported Economic Times. Two other vaccines produced locally, Covaxin and ZyCOV-D are in early stages of development.

Reports on the phase II and III trials poured in after an expert panel meeting between authorities with AstraZeneca representatives to devise a framework for vaccine distribution in India.

The Adar Poonawalla-owned Serum Institute of India has reportedly promised to produce over 100 million vaccines by ramping up production. At least 50% of the vaccine produced in India by SII will be reserved for use in India if approved, reported Times of India.

The volunteers for the vaccine candidate will be administered two doses of the vaccine and four weeks later the safety of the vaccine and its immunogenicity will be assessed. The volunteers are to be aged between 20 and 50 years old and should not have a history of contracting the COVID-19 disease in the last eight to nine months. The trial will not cover young children or older people, for the time being, reported Times of India. The trials will also be carried out in the USA and Brazil.

The data published by the University of Oxford from phase 1 and 3 trials carried out on 1,077 healthy adults showed that the vaccine-induced a strong immune response with antibodies and T cells that lasted for 56 days.

A senior government official told Economic Times that phase three trials will be carried out after the company provides the phase 2 trials data to the Data Safety Monitoring Board for assessment.

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