COVISHIELD completed enrollment of phase III clinical trials under partnership of ICMR and Serum Institute

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On Nov. 11, 2020, the Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) announced completion of enrollment of phase 3 clinical trials for COVISHIELD in India. ICMR and SII had further collaborated for clinical development COVOVAX (Novavax) developed by Novavax in the U.S. and upscaled by SII.

ICMR  funded the clinical trial site fees while SII funded other expenses for COVISHIELD. SII and ICMR were conducting Phase 2/3 clinical trial of COVISHIELD at 15 different centres, across the country. It has completed the enrollment of all 1,600 participants on 31 Oct 2020. COVISHIELD had been developed at the SII Pune laboratory with a master seed from Oxford University/Astra Zeneca.

The vaccine made in UK was being tested in large efficacy trials in UK, Brazil, South Africa and USA. COVISHIELD was by far the most advanced vaccine in human testing in India. SII had already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI.

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Source: Serum Institute of India
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