Serum Institute of India (SII) and the Indian Council of Medical Research (ICMR) have announced that the enrolment process of phase 3 of its clinical trials for COVISHIELD has been completed as of 31 October. Covishield is being developed at the Serum Institute laboratory in Pune with a master seed from Oxford University/Astra Zeneca trial. It is also being tested in trials in the UK, Brazil, South Africa and the USA. SII partnering with ICMR are conducting Phase 2/3 clinical trial of COVISHIELD at 15 different centres, across the country.
Phase 3 of the COVISHIELD human trials will involve 1600 participants.
ICMR is the apex body for biomedical research in India and is funding the clinical trial site fees. Meanwhile, SII is funding all the other expenses for the trials.
SII has also manufactured 40 million doses of the vaccines, under the at-risk manufacturing and stockpiling license from DCGI.
"The promising results of the trials so far give confidence that Covishield could be a realistic solution to the deadly pandemic," Serum Institute said in a press release.
ICMR and SII have also collaborated to get the US-based Novavax's COVID-19 vaccine candidate to India. Called COVOVAX, the vaccine is currently being tested in South Africa and in the UK. Trials will soon begin in the US as well.
SII will be testing the vaccine in a Phase 3 trial in India as well. However, no exact date has been given.
Dr Balram Bhargava, Director General of ICMR said in a statement, “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."
He added, "The partnership is our contribution to lending our expertise and support to bolster our fight against the global pandemic.”
source https://www.firstpost.com/health/icmr-serum-institute-complete-enrollment-of-phase-3-clinical-trials-of-covid-19-vaccine-covishield-9007461.html
