ICMR-SII’s COVISHIELD completes enrollment of Phase 3 clinical trials

Also collaborating on Novavax’ COVOVAX, to apply for phase 3 trial approval soon

Pune based Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) have completed enrollment of phase 3 clinical trials for COVISHIELD in India.

ICMR has funded the clinical trial site fees while SII has funded other expenses for COVISHIELD.

At present, SII and ICMR are conducting Phase 2/3 clinical trial of COVISHIELD at 15 different centres, across the country and completed enrollment of all 1600 participants on October 31.

COVISHIELD has been developed at the SII Pune laboratory with a master seed from Oxford University/Astra Zeneca. The vaccine made in UK is currently being tested in large efficacy trials in UK, Brazil, South Africa and US.

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 reportedly manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI.

They have further collaborated for clinical development of COVOVAX (Novavax) developed by US-based Novavax and upscaled by SII. This vaccine is in late phase trials in South Africa and in 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 and an application for the same to regulatory authorities will be made soon by ICMR and SII.

Commenting on the importance of the collaboration, Adar Poonawalla, CEO, SII, 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.”

Dr Balram Bhargava, Director General, ICMR commented, “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.”