New Delhi, Nov 12: Serum Institute of India (SII) has completed enrolment of volunteers for phase 3 clinical trials of Covishield, a COVID-19 vaccine it licensed from the Oxford University-AstraZeneca. Further, it has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling licence from the Drug Controller General of India (DCGI).
SII and the Indian Council of Medical Research (ICMR), the apex body in India for biomedical research, has completed the enrolment of all 1,600 participants for the trial on October 31, said SII. At present SII is conducting Phase 2/3 clinical trials at 15 different centres, across the country. ICMR has funded the clinical trial site fees while SII has funded other expenses for Covishield. Further, ICMR and SII have collaborated for clinical development of COVOVAX (Novavax) developed by Novavax, USA and being upscaled by SII, said the company.
Covishield has been developed at the SII Pune laboratory with a master seed from Oxford University/Astra Zeneca. The vaccine made in the UK is currently being tested in large efficacy trials in 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 and is by far the most advanced vaccine in human testing in India,” said SII.
“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,” said Adar Poonawalla, CEO of SII. “At present, India plays a prominent role in vaccine development and manufacturing globally,” says Dr Balram Bhargava, Director General of ICMR.
US-based Novavax has initiated its late phase trials in South Africa and 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-three trial in India and an application for the same to regulatory authorities will be made soon by ICMR and SII.
Meanwhile, WHO is in discussions with the Russian institute that developed the Sputnik V candidate vaccine against COVID-19 over its potential application for emergency use listing, the UN agency said on Thursday.
Russia’s Sputnik V vaccine is 92% effective at protecting people from COVID-19 according to interim trial results, the country’s sovereign wealth fund said on Wednesday.
The WHO, in a statement said, “WHO has been in touch with the Gamaleya Research Institute of Epidemiology and Microbiology, who expressed interest in applying for WHO emergency use listing.”
“We look forward to receiving the data for their Sputnik V candidate vaccine. If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely,” it said.