Published 15:09 IST, November 12th 2020

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

In a significant development, the Pune-based Serum Institute of India and ICMR on Thursday announced the completion of enrolment of phase-3 clinical trials

Reported by: Navashree Nandini
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In a significant development, Pune-based Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) on Thursday anunced completion of enrolment of phase-3 clinical trials for potential COVID-19 vaccine Covishield. While ICMR has funded clinical trial site fees, SII has funded or expenses for Covishield. At present, SII and ICMR are conducting phase two clinical trials of Covishield at 15 different centres across country. It h completed 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. 

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

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"Based on phase 2/3 trial results, SII with help of ICMR will pursue early availability of this product for India. SII has alrey manufactured 40 million doses of vaccine, under at-risk manufacturing and stockpiling license from DCGI," apex health research body ded. 

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Commenting on association, ar Poonawalla, CEO of SII, world's largest vaccine manufacturer by volume, said, "ICMR has played a huge role in coming forward and strengning India's fight against COVID-19. collaboration will furr aid us in putting India at forefront of developing an immugenic and efficacious vaccine." pandemic has presented a chance to foster structural reforms in building robust public healthcare infrastructure. partnership furr testifies importance of private-public institutes coming toger in scaling up manment and containing spre of virus, he ded.    

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India's COVID cases

India witnessed a single-day increase of 47,905 infections taking country's COVID-19 case-lo to 86,83,916, while number of people who have recuperated from disease have surged to 80,66,501, according to Union Health Ministry data updated on Thursday. coronavirus death toll climbed to 1,28,121 with 550 new fatalities. number of active cases remained below 5 lakh for second consecutive day. re are 4,89,294 active cases of coronavirus infection in country. 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 at least 50% efficacy regulators are looking for. Earlier, speaking to ANI, AIIMS Randeep Guleria emphasised on need to keep vaccine at a low temperature, stating that Pfizer's vaccine has a lot of potential.

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" challenge with Pfizer vaccine is that it has to be kept at a very low temperature, -70 degree Centigre. That for low and middle-income countries would be a big challenge to maintain 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 or vaccines also come out. Very encouraging news in vaccine research field for all vaccine candidates in phase-III trials," he said.

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15:09 IST, November 12th 2020