COVISHIELD completes Enrolment of Phase III clinical trials with partnership of ICMR and Serum Institute of India. The SII and the ICMR strategic association will progress India’s part in the global race for COVID-19 vaccines. ICMR is extending constant help to SII in steering and funding the enduring clinical trials of COVISHIELD around 15 centres in India
November 12, 2020 – Serum Institute of India (SII), the world’s largest vaccine manufacturer, and Indian Council of Medical Research (ICMR), the zenith body in India for biomedical research, declare accomplishment of enrolment of phase-III clinical trials for COVISHIELD in India. Further, ICMR and SII work together for clinical expansion of COVOVAX (Novavax) established by Novavax, USA and up scaled by SII. The partnership is an astral illustration of private-public institutes coming together to alleviate the terrible consequences of the pandemic outburst.
ICMR has sponsored the clinical trial site fees whereas SII has sponsored other costs for COVISHIELD. Currently, SII and ICMR are steering Phase 2/3 clinical trial of COVISHIELD at 15 centres, around the country. It has finished the employment of all 1600 participants on 31 Oct 2020. COVISHIELD has been established at the SII Pune laboratory with a master seed from Oxford University/Astra Zeneca. The vaccine produced in UK is presently being verified in huge efficacy trials in UK, Brazil, South Africa and USA. The hopeful outcomes of the trials till date give assurance that COVISHIELD could be an accurate answer to the lethal pandemic. COVISHIELD is the supreme advanced vaccine among human testing in India. Depending on the Phase 2/3 trials output, SII with the aid of ICMR will track the early accessibility of this invention for India. SII by now has produced 40 million doses of the vaccine, under the license at-risk manufacturing and stockpiling from DCGI.
Additionally, US-based Novavax has commenced its late phase trials in South Africa and in UK and will quickly begin the same in the USA. SII has got the mass vaccine and Matrix-M adjuvant from Novavax and will soon fill and finish them in vials. ICMR and SII will test this vaccine in a Phase 3 trial in India after requesting regulatory authorities.
Remarking on the connotation, Adar Poonawalla, CEO of Serum Institute of India, said, “ICMR has played a big role in advancing and solidifying India’s battle against COVID-19. The association will also help in placing India at the head of mounting an immunogenic and efficacious vaccine. The pandemic has presented a chance to promote structural reforms in constructing vigorous public healthcare infrastructure. Additionally, the association gives evidence of the importance of private-public institutes joining together in clambering up the administration and containing the feast of the virus.”
Dr. Balram Bhargava, Director General of Indian Council of Medical Research (ICMR), said, “Currently, India has a noticeable part in vaccine development and manufacturing internationally. Sustained by the modern technology and well-equipped amenities, SII has persistently proved its research and manufacturing expertise. The association is providing proficiency and support to strengthen fight against the universal pandemic.”
COVISHIELD Completes Enrolment of Phase III clinical trials – The association will see the scientists of both the entities facilitate the advancement of regulatory approvals for COVISHIELD and COVOVAX while confirming strict loyalty to all the requisite scientific, ethical and regulatory standards.
