Serum Institute, ICMR complete enrolment in Phase III trials for COVID-19 vaccine

Serum Institute of India (SII) and ICMR on Thursday announced the completion of enrolment process of 1,600 participants in the phase-III clinical trials for COVID-19 vaccine Covishield in the country. SII and the Indian Council of Medical Research (ICMR) are collaborating on the clinical trials of the vaccine in the country. While ICMR has funded the clinical trial site fees, SII is taking care of other expenses for the Covishield.

Currently, SII and ICMR are conducting phase II/III clinical trial of the vaccine at 15 different centres across the country, SII said in a statement. The entities have completed the enrolment of all 1,600 participants on October 31, it added. "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," SII CEO Adar Poonawalla said.

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 added. ICMR Director General Balram Bhargava said the partnership is their contribution to lending expertise and support to bolster fight against the global pandemic. Based on the phase II/III trial results, SII with the help of ICMR will pursue the early availability of this product in the country.

SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling licence from Drugs Controller General of India. 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 US. The promising results of the trials so far give confidence that Covishield could be a realistic solution to the pandemic.