November 13, 2020 3:16:09 am
AT Serum Institute of India (SII) – the world’s largest vaccine manufacturer by volume – as many as 40 million doses of the Covishield vaccine have already been manufactured. “Covishield is by far the most advanced vaccine in human testing in India,” an official statement released by the SII Thursday read. The promising results of the trials so far give confidence that Covishield could be a realistic solution to the deadly pandemic, the statement read.
The vaccine maker along with the Indian Council of Medical Research (ICMR) will pursue the early availability of the product in India. While 40 million doses of the vaccine have been manufactured, under the at-risk manufacturing and stockpiling licence from the Drug Controller General of India, the SII also announced the completion of the enrolment of phase 3 clinical trials for the Covishield vaccine in the country.
“SII has also collaborated for clinical development of Covavax with ICMR. 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 Phase 3 trial in India and an application for the same to regulatory authorities will be made soon by ICMR and SII,” the statement read.
ICMR has funded the clinical trial site fees while SII has funded other expenses. It has completed the enrolment of 1,600 participants at 15 different centres on October 31. Covishield 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.
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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.”
Dr Balram Bhargava, Director General of 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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