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Home / Science / Health /  Oxford Covid Vaccine: Serum Institute completes enrolment of Phase III trial in India

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, today announced completion of enrolment of phase 3 clinical trials for Covishield or Oxford covid vaccine in India. Covishield has been developed at the Serum Institute Pune laboratory with a master seed from Oxford University/Astra Zeneca.

At present, Serum Institute and ICMR are conducting Phase 2/3 clinical trial of the Oxford covid vaccine at 15 different centres across the country.

Serum Institute has completed the enrolment of all 1,600 participants on 31 October 2020, the vaccine-maker said.

ICMR has funded the clinical trial site fees while Serum Institute has funded other expenses for the vaccine.

The Oxford covid vaccine is currently being tested in large efficacy trials in the UK, Brazil, South Africa and the US. "The promising results of the trials so far give confidence that Covishield could be a realistic solution to the deadly pandemic," Serum Institute said.

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. The pandemic has presented a chance to foster structural reforms in building robust public healthcare infrastructure. The partnership further testifies the importance of private-public institutes coming together in scaling up the management and containing the spread of the virus."

Earlier this week, Pfizer said its COVID-19 vaccine was more than 90% effective based on interim trial results, significantly higher than the at least 50% efficacy regulators are looking for.

ICMR and Serum Institute have further collaborated for clinical development of another experimental covid vaccine COVOVAX (Novavax) developed by Novavax, USA and upscaled by Serum Institute.

"Covishield is by far the most advanced vaccine in human testing in India. Based on the Phase 2/3 trial results, Serum Institute 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," the Pune-based company said.

Furthermore, 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 Serum Institute (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," the Pune-based company said.

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. The partnership is our contribution to lending our expertise and support to bolster our fight against the global pandemic."

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