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Wednesday, December 02, 2020

Covidshield completes enrolment of volunteers for phase III clinical trials

At present, SII and ICMR are conducting Phase 2/3 clinical trials of Covidshield at 15 different centres, across the country. It has completed the enrollment of all 1,600 participants on October 31.

Written by Anuradha Mascarenhas | Pune | Updated: November 12, 2020 11:10:45 am
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The Serum Institute of India (SII), which is developing the Covidshield vaccine, has completed the enrolment of volunteers for phase III clinical trials.

The trials are being conducted under the partnership of Serum Institute of India and Indian Council of Medical Research (ICMR), the apex body in India for biomedical research. The two have also collaborated for clinical development of Covovax (Novavax) developed by Novavax, USA and upscaled by SII.

“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. Furthermore, US-based Novavax has initiated its late phase trials in South Africa and in the 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 Phase 3 trial in India and an application for the same to regulatory authorities will be made soon by ICMR and SII,” an official statement issued Thursday said.

The ICMR is paying the fees for the clinical trial sites while SII is funding other expenses for developing Covishield. At present, SII and ICMR are conducting Phase 2/3 clinical trials of Covidshield at 15 different centres, across the country. It has completed the enrollment of all 1,600 participants on October 31.

The vaccine has been developed at the SII Pune laboratory with a master seed from Oxford University/AstraZeneca. The vaccine made in the UK is currently being tested in large efficacy trials in the 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., the statement reads.

Commenting on the association, Adar Poonawalla, CEO of Serum Institute of India, said, “ICMR has played a huge role in coming forward and strengthening India’s fight against COVID-19. The collaboration will further aid us in putting India at the forefront of developing an immunogenic and efficacious vaccine.”

Dr. Balram Bhargava, Director General of Indian Council of Medical Research (ICMR), said, “At present, India plays a prominent role in vaccine development and manufacturing globally. Buoyed by the latest technology and well-equipped facilities, SII has continually proven its research and manufacturing prowess.”

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