Enrolment for Phase III clinical trials of COVISHIELD vaccine completed

The Serum Institute of India (SII) and the Indian Council of Medical Research (ICMR) on Thursday announced the completion of enrolment for Phase 3 clinical trials for coronavirus vaccine COVISHIELD in India.

The SII, the world's largest vaccine manufacturer by volume, and ICMR, the apex body in India for biomedical research, have further collaborated for the clinical development of COVOVAX (Novavax) developed by Novavax, USA and upscaled by SII.

The enrolment of all 1,600 participants was completed on October 31, 2020. COVISHIELD has been developed at the SII Pune laboratory with a master seed from Astra Zeneca.

The ICMR has funded the clinical trial site fees while the SII has funded other expenses for COVISHIELD. At present, the SII and the ICMR are conducting Phase 2/3 clinical trials of COVISHIELD at 15 different centres across the country.

The vaccine made in the UK is currently being tested in large efficacy trials in the UK, Brazil, South Africa, and the US. The promising results of the trials so far give confidence that COVISHIELD could be a realistic solution to the deadly pandemic.

The two bodies said that COVISHIELD is, by far, the most advanced vaccine in human testing in India. Based on the Phase 2/3 trials' results, the SII with the help of the ICMR will pursue the early availability of this product for India.

The SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from the Drugs Controller General of India.

Furthermore, US-based Novavax has initiated its late phase trials in South Africa and in the UK, and will soon commence the same in the US.

The 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 and an application for the same will soon be made to regulatory authorities by the ICMR and the SII.

Adar Poonawalla, CEO of Serum Institute of India, said: "The 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."

He added: "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 is playing a prominent role in the vaccine's development and manufacturing globally. Buoyed by the latest technology and well-equipped facilities, the 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."