The Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, and the Indian Council of Medical Research (ICMR), India’s leading body for biomedical research, today announced the completion of trial enrollment Phase 3 clinical trials for Covishield or Oxford covid vaccine in India. Covishield has been developed in the Serum Institute Pune laboratory with a master seed from the University of Oxford / Astra Zeneca.
Currently, the Serum Institute and ICMR are conducting a phase 2/3 clinical trial of the Oxford covid vaccine at 15 different centers across the country.
The Serum Institute completed enrollment of all 1,600 participants on October 31, 2020, the vaccine manufacturer said.
ICMR has funded the clinical trial center fees, while the Serum Institute has funded other expenses for the vaccine.
The Oxford covid vaccine is currently being tested in large efficacy trials in the United Kingdom, Brazil, South Africa, and the United States. “The promising results of the trials so far give confidence that Covishield could be a realistic solution to the deadly pandemic,” said Serum Institute.
Adar Poonawalla, Executive Director of the Serum Institute of India, said: “ICMR has played a very important role in advancing and strengthening India’s fight against COVID-19. The collaboration will further help us put India at the forefront of developing an effective and immunogenic vaccine. The pandemic has provided an opportunity to promote structural reforms in the construction of a solid public health infrastructure. The association further testifies to the importance of public and private institutes coming together to expand management and contain 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 effectiveness of at least 50% sought by regulators.
ICMR and the Serum Institute have also collaborated for the clinical development of another experimental covid vaccine COVOVAX (Novavax) developed by Novavax, USA and improved by the Serum Institute.
“Covishield is by far the most advanced vaccine in human testing in India. Based on the results of the phase 2/3 trial, Serum Institute, with the help of ICMR, will seek early availability of this product for India. IBS has already manufactured 40 million doses of the vaccine, under DCGI’s manufacturing and storage-at-risk license, “the Pune-based company said.
In addition, US-based Novavax has started its late-phase trials in South Africa and the UK and will soon start the same in the US “IBS has received the bulk vaccine and the adjuvant Matrix- M from Novavax and will soon fill them and end up in vials. This vaccine formulated at Serum Institute (COVOVAX) will be tested in a phase 3 trial in India and the same will be requested for Regulatory authorities will be made soon by ICMR and IBS, “he said the Pune-based company.
Dr Balram Bhargava, Director General of the Indian Council for Medical Research (ICMR), said: “Today, India plays a leading role in global vaccine development and manufacturing. Driven by the latest technology and well-equipped facilities, SII has continually demonstrated its prowess in research and manufacturing. The association is our contribution to provide our experience and support to strengthen our fight against the global pandemic. “
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