Tuesday, July 23, 2024

ICMR, SII complete enrolment of phase-3 clinical trials for Covishield vaccine


New Delhi, November 12: The Pune-based Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) on Thursday announced the completion of enrolment of phase-3 clinical trials for potential COVID-19 vaccine Covishield in India.
The ICMR and SII have collaborated for the clinical development of Covovax developed by Novavax, US and upscaled by SII, a statement said.
“The partnership is a stellar example of private-public institutes collaborating to mitigate the dire consequences of the pandemic outbreak,” the ICMR said in the statement.
While the ICMR has funded the clinical trial site fees, SII has funded other expenses for Covishield.
At present, SII and ICMR are conducting phase 2/3 clinical trials of Covishield at 15 different centres across the country. It had completed the enrolment of all 1,600 participants on October 31.
“The promising results of the trials so far gives confidence that Covishield could be a realistic solution to the deadly pandemic. Covishield is by far the most advanced vaccine in human testing in India,” the ICMR said.
“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,” the apex health research body said.
Covishield has been developed at SII Pune laboratory with a master seed from Oxford University/AstraZeneca.
The vaccine made in the United Kingdom is currently being tested in large efficacy trials in the UK, Brazil, South Africa and the US, the statement said.
Novavax has initiated its late phase trials in South Africa and in the UK and will soon commence the same in the US.
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. An application for the same to regulatory authorities will be made soon by the ICMR and SII.
Commenting on the association, Adar Poonawalla, CEO of SII, world’s largest vaccine manufacturer by volume, 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,” he said.
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,” he said.
The partnership will see scientists of both the entities facilitate the advancement of regulatory approvals for Covishield and Covovax while ensuring strict adherence to all the requisite scientific, ethical and regulatory standards. (PTI)