Serum Institute of India (SII) and the Indian Council of Medical Research (ICMR) have completed enrolment of people for the advanced Phase III trials for COVISHIELD in India.
ICMR and SII have further collaborated for the clinical development of COVOVAX, developed by American company Novavax and upscaled by SII, a joint note from SII and ICMR said.
COVISHIELD is the AstraZeneca-Oxford University Covid-19 vaccine candidate. With ICMR being the Government’s apex bio-medical research body, its partnership with SII marks a public-private alliance to tackle the pandemic outbreak.
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, the note said. It completed the enrolment of all 1,600 participants on October 31.
The COVISHIELD vaccine developed 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 deadly pandemic, the note said.
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COVISHIELD is by far the most advanced vaccine in human testing in India, the note said. 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 manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling licence from the Indian regulator.
Novavax trials
Meanwhile, Novavax has initiated late phase trials in South Africa and UK and will soon commence the same in the US, as well.
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, the note said.
Adar Poonawalla, SII Chief Executive, said, “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.”
ICMR Director General Balram Bhargava said, “At present, India plays a prominent role in vaccine development and manufacturing globally…The partnership is our contribution to lending our expertise and support to bolster our fight against the global pandemic.”