COVISHIELD vaccine: Serum Institute completes enrolment of Phase III trial in India

New Delhi, Nov 12: Serum Institute of India (SII), the world's largest vaccine manufacturer by volume, and Indian Council of Medical Research (ICMR), the apex body in India for biomedical research, has on Thursday announced completion of enrolment of phase 3 clinical trials for Covishield or Oxford covid vaccine in India.

Serum Institute and ICMR are conducting Phase 2/3 clinical trial of the Oxford covid vaccine at 15 different centres across the country. It has completed the enrolment of all 1600 participants on 31 Oct 2020.

ICMR has funded the clinical trial site fees while SII has funded other expenses for COVISHIELD.

COVISHIELD has been developed at the SII Pune laboratory with a master seed from Oxford University/Astra Zeneca. The vaccine made in UK is currently being tested in large efficacy trials in UK, Brazil, South Africa and USA. The promising results of the trials so far give confidence that COVISHIELD could be a realistic solution to the deadly pandemic.

COVISHIELD is by far the most advanced vaccine in human testing in India. Based on the Phase 2/3 trial results, SII with the help of ICMR will pursue the early availability of this product for India.

SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI.

ICMR and SII have further collaborated for clinical development of COVOVAX (Novavax) developed by Novavax, USA and upscaled by SII.

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The partnership is a stellar example of private-public institutes collaborating to mitigate the dire consequences of the pandemic outbreak.