The Pune-based Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) on Thursday announced the completion of enrolment of phase-3 clinical trials for potential Covid-19 vaccine “Covishield” in India.
The world’s largest vaccine manufacturer SII and Union Health Ministry’s research wing ICMR are currently conducting phase 2/3 clinical trials of Covishield at 15 different centres across the country. The drugmaker said in a statement that as many as 1,600 participants were enrolled on October 31.
“The strategic alliance between SII and the ICMR will advance India’s role in the global race to develop Covid-19 vaccines,” further said the statement.
The ICMR has funded the clinical trial site fees while Serum Institute has funded other expenses for the vaccine.
The SII said that the trials of the Oxford vaccine have shown promising results, which “so far give confidence that Covishield could be a realistic solution to the deadly pandemic”.
Among the vaccines being developed in India, Covishield is in the most advanced stage of human testing. Based on the phase 2/3 trial results, SII with the help of ICMR will pursue the early availability of this product for India, the company said, adding that it has already manufactured 40 million doses under the at-risk manufacturing and stockpiling license from DCGI.
Apart from Covishield, developed at the Pune laboratory with a master seed from Oxford University/AstraZeneca, ICMR and SII have also collaborated for clinical development of Covovax developed by US-based Novavax. The Oxford Covid vaccine 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,” Serum Institute said.
Adar Poonawalla, CEO of SII said the pandemic has presented a chance to foster structural reforms in building robust public healthcare infrastructure and 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.”