Covishield’s phase-3 trials completed in India: ICMR
At present, SII and ICMR are conducting Phase 2 and 3 clinical trials of the vaccine candidate at 15 different centres, across the country
The enrollment of phase-3 clinical trials of the Covishield vaccine has been completed in India, the Serum Institute of India and the Indian Council of Medical Research (ICMR) have jointly announced. Covishield is being developed jointly by world’s largest vaccine manufacturer SII and British Pharmaceutical giant AstraZeneca.
According to the official statement released by the ICMR, the clinical trials of the COVID-19 vaccine candidate is facilitated in India jointly by the SII and the ICMR. While ICMR is funding the clinical trial site fees, SII has funded other expenses for Covishield.
At present, SII and ICMR are conducting Phase 2 and 3 clinical trials of the vaccine candidate at 15 different centres, across the country. It has completed the enrolment of all 1600 participants on October 31 this year, the statement said.
Commenting on the same, the CEO of SII, Adar Poonawalla, 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, he said further. 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.
As per the ICMR, the SII will pursue the early availability of the vaccine in India based on the results of the phase 2 and 3 clinical trials. SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI, the statement said.
Covishield has been developed at the SII Pune laboratory with a master seed from AstraZeneca. The vaccine made in the UK is currently being tested in large efficacy trials in the UK, Brazil, South Africa and the USA. In India, Covishield is by far the most advanced vaccine in human testing.
Apart from Covishield, the institutes have also partnered for clinical development Covovax (Novavax) developed by Novavax, USA and upscaled by SII. It has already initiated its late phase trials in South Africa and in the UK and will soon commence the same in the USA.
The vaccine candidate will soon enter the phase-3 trials in India and an application for the same to regulatory authorities will be made soon by ICMR and SII, the statement said.
Calling the partnership between the SII and ICMR ‘a contribution to lending their expertise to fight against the pandemic,’ ICMR’s Director-General, Dr Balram Bhargava said, “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.”
India is also working towards developing an indigenous vaccine against the COVID-19. The phase-3 trials of Covaxin, being developed jointly by Bharat Biotech and ICMR, have already started. Interestingly, the Vice Chancellor of the Aligarh Muslim University (AMU) has registered as the first volunteer.
Another vaccine candidate, ZyCov-D by Cadila is also in the race. The government has announced a vaccine to be available in late December this year or by early 2021.