COVISHIELD Covid vaccine's enrolment for Phase III clinical trials done: Serum Institute

In a significant development, 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. While the ICMR has funded the clinical trial site fees, SII has funded other expenses for Covishield. At present, SII and ICMR are conducting phase two clinical trials of Covishield at 15 different centres across the country. It had completed the enrolment of all 1,600 participants on October 31. Covishield has been developed at SII Pune laboratory with a master seed from Oxford University/ AstraZeneca. 

"The partnership is a stellar example of private-public institutes collaborating to mitigate the dire consequences of the pandemic outbreak..The promising results of the trials so far gives confidence that Covishield could be a realistic solution to the deadly pandemic. Covishield is by far the most advanced vaccine in human testing in India," the ICMR said in the statement.

"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 license from DCGI," the apex health research body added. 

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Commenting on the association, Adar Poonawalla, CEO of SII, the world's largest vaccine manufacturer by volume, 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. 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.    

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India's COVID cases

India witnessed a single-day increase of 47,905 infections taking the country's COVID-19 case-load to 86,83,916, while the number of people who have recuperated from the disease have surged to 80,66,501, according to the Union Health Ministry data updated on Thursday. The coronavirus death toll climbed to 1,28,121 with 550 new fatalities. The number of active cases remained below 5 lakh for the second consecutive day. There are 4,89,294 active cases of coronavirus infection in the country. The national recovery rate is 92.89 percent, while COVID-19 case fatality rate stands at 1.48 percent.

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Earlier this week, Pfizer said its COVID vaccine was more than 90% effective based on interim trial results, significantly higher than the at least 50% efficacy regulators are looking for. Earlier, speaking to ANI, AIIMS Randeep Guleria emphasised on the need to keep the vaccine at a low temperature, stating that Pfizer's vaccine has a lot of potential.

"The challenge with the Pfizer vaccine is that it has to be kept at a very low temperature, -70 degree Centigrade. That for low and middle-income countries would be a big challenge to maintain the cold chain, because having a vaccine to be kept at low temperatures especially going to smaller towns, rural India is going to be a challenge. This vaccine has a lot of potential but we will need to see as other vaccines also come out. Very encouraging news in the vaccine research field for all vaccine candidates in phase-III trials," he said.

COVID-19: AIIMS Director Finds 'potential' In Pfizer's Vaccine; States Challenge For India