COVID-19 vaccine update: SII, ICMR complete enrolment of phase-3 clinical trials of COVISHIELD

Serum Institute of India (SII) and the Indian Council of Medical Research (ICMR) on Thursday announced the completion of enrolment of phase 3 clinical trials for COVISHIELD, the coronavirus vaccine candidate which is jointly developed by the University of Oxford and British firm AstraZeneca.

"ICMR and SII have further collaborated for clinical development COVOVAX (Novavax) developed by Novavax, USA and upscaled by SII. The partnership is a stellar example of private-public institutes collaborating to mitigate the dire consequences of the pandemic outbreak," Serum Institute of India said in a statement.

At present, SII and ICMR are conducting Phase 2/3 clinical trial of COVISHIELD at 15 different centres, across the country. Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, and ICMR have further collaborated for clinical development of COVOVAX (Novavax) developed by Novavax, USA, and upscaled by 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. 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,” Adar Poonawalla, CEO of Serum Institute of India said.

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 the UK, Brazil, South Africa and the USA.

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.

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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