COVID-19 Vaccine: SII, ICMR Complete Enrolment of Phase III Clinical Trials for COVISHIELD

New Delhi: 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, announced completion of enrolment of phase 3 clinical trials for COVISHIELD in India.

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

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

ICMR has funded the clinical trial site fees while SII has funded other expenses for COVISHIELD. At present, SII and ICMR are conducting Phase 2/3 clinical trial of COVISHIELD at 15 different centres, across the country. It has completed the enrolment of all 1600 participants on 31 Oct 2020.

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 result 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.

Further more, US-based Novavax has initiated its late phase trials in South Africa and in UK and will soon commence the same in the USA. SII has received the bulk vaccine and Matrix-M adjuvant from Novavax and will soon fill and finish them in vials. This vaccine formulated at SII (COVOVAX) will be tested in a Phase3 trial in India and an application for the same to regulatory authorities will be made soon by ICMR and SII.