COVISHIELD completes enrollment of Phase III clinical trials

Covid-19 potential vaccine candidate COVISHIELD has completed the enrollment of Phase III clinical trials. This was announced by the Indian Council of Medical Research, ICMR and Serum Institute of India, SII.

 

ICMR is providing continuous support to SII in conducting and funding the ongoing clinical trials of COVISHIELD. They are conducting Phase 2 and 3 clinical trials of COVISHIELD at 15 different centres across the country. The enrollment of all 1600 participants was completed last month.

 

DG, ICMR Dr. Balram Bhargava said, India is playing a prominent role in vaccine development and manufacturing



globally.

 

CEO of SII Adar Poonawalla said, ICMR has played a huge role in strengthening India’s fight against COVID-19.

 

COVISHIELD has been developed at the SII Pune laboratory with a master seed from Oxford University and AstraZeneca. Based on the Phase 2 and 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.

 

ICMR and SII have further collaborated for clinical development of COVOVAX developed by Novavax of the USA.