Best printers for Home

Best Mixer Grinder

Best wired Earphones

Best 43 Inch TV in India

Best Wi Fi Routers

Best Home Theatre in India

Smart Watch under 5000

Best Laptops for Education

Best Laptop for Students

<ul><li>Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations.</li><li>On September 10, the Serum Institute of India had to pause the Phase II/Phase III human trials of Oxford’s <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> candidate across all 17 locations as a precaution, following a show-cause notice.</li><li>However, the Drugs Controller General of India, on September 15, asked the SII to resume human trials. </li><li>Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites. </li></ul>Serum Institute of India (SII) is likely to begin the <keyword id="9978218" type="UNKNOWN" weightage="20" keywordseo="Phase-III-human-trials">phase III human trials</keyword> of Oxford’s coronavirus vaccine at Sassoon General Hospital in Maharashtra on September 22, Hindustan Times <a href="https://www.hindustantimes.com/india-news/phase-3-human-clinical-trial-of-oxford-vaccine-begins-in-pune/story-mpfvHoWiH4lh3I452On7UP.html">reported. </a> “We have started the phase-III trials of the vaccine (candidate <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>). We will administer dose to 150 to 200 volunteers,” said Dr Muralidhar Tambe, Dean, Sassoon General Hospital. Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations. On September 10, the Serum Institute of India had to pause the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations as a precaution, following a show-cause notice<a href="https://www.businesstoday.in/coronavirus/breaking-covid-19-trials-paused-till-further-instructions-says-serum-institute/story/415686.html">, reported Business Today.</a> SII <a href="https://twitter.com/CNBCTV18Live/status/1303981172200882176">sai</a>d there have been no issues in India, and this is a precautionary measure, and it will restart the trial as soon as AstraZeneca does. AstraZeneca has resumed trials in the UK but not yet in the US. Drugs Controller General of India, on September 15, asked the SII to resume human trials. Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites. SII has signed two agreements for the supply of Covid-19 vaccines, the first being AstraZeneca-Oxford's candidate, for which the company has agreed to produce up to 1 billion doses for low and middle-income countries. SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Earlier, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India. The Serum Institute of India would introduce candidate vaccines from AstraZeneca and Novavax for COVID-19 at less than ₹250 per dose in India. The Pune-based institute <a href="https://www.hindustantimes.com/india-news/serum-institute-ties-up-with-bill-gates-foundation-gavi-to-speed-up-covid-19-vaccine-manufacture-process/story-h20YRO9mdooYA8ysqenE9L.html">partnered with </a>Bill &amp; Melinda Gates Foundation to offer up to 100 million doses, with the price capped at $3 for 92 low and middle-income countries (LMIC), including India. There are at least 30 COVID vaccine candidates in preclinical or clinical stages in India. While three of them are in the advanced stage of Phase I/II/III trials and 4 are in the advanced preclinical development stage, Union Health Minister, Dr Harsh Vardhan, told the Parliament. Vardhan believes India <a href="https://www.businessinsider.in/india/news/covid-vaccine-likely-by-early-2021-for-old-high-risk-first-harsh-vardhan/articleshow/78090587.cms">may</a> get a coronavirus vaccine by early 2021. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/lok-sabha-passes-amendments-to-foreign-contribution-regulation-act-makes-aadhaar-mandatory-for-foreign-contribution-towards-ngos/articleshow/78246944.cms">Lok Sabha passes amendments to Foreign Contribution (Regulation) Act — makes Aadhaar mandatory for foreign contribution towards NGOs</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/bhiwandi-building-collapse-death-toll-rises-to-17-including-eight-children/articleshow/78247063.cms">Bhiwandi building collapse: Death toll rises to 17, including eight children</a>

Oxford’s COVID-19 vaccine: Phase III human trials begin in India

<ul><li>The <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> has paused the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations. </li><li>The Drug Control General of India (DCGI) issued a show-cause notice, seeking an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear. </li><li>The notice was issued after <keyword id="6409874" type="COMPANY" weightage="20" keywordseo="astrazeneca">AstraZeneca</keyword> halted the late-trials of its coronavirus vaccine over safety concerns. </li></ul>The Serum Institute of India has paused the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations as a precaution, following a show-cause notice. SII<a href="https://twitter.com/CNBCTV18Live/status/1303981172200882176"> says</a> there have been no issues in India. It is a precautionary measure, and it will restart the trial as soon as AstraZeneca does. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front," SII said. The Drug Control General of India (DCGI), VG Somani, issued a show-cause notice to it asking for an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear. "The Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns," <a href="https://www.deccanchronicle.com/nation/in-other-news/100920/dcgi-issues-notice-to-serum-institute-over-astrazenecas-trial-suspens.html">the notice by DGCI read.</a> The DGCI further asked the institute as to why the authority did not suspend the permission given to SII for the clinical trials of Covishield. The notice was issued after AstraZeneca halted the late-trials of its coronavirus vaccine over safety concerns. According to<a href="https://www.businessinsider.com/astrazeneca-covid-19-vaccine-trial-paused-after-potential-adverse-reaction-2020-9?IR=T"> reports</a>, one of the participants in the United Kingdom reported a severe adverse reaction after being administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and the University of Oxford, on Tuesday. AstraZeneca was conducting human trials at over 60 locations including the US, Brazil and South Africa. SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Last month, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India. SEE ALSO: <a href="https://www.businessinsider.com/astrazeneca-covid-19-vaccine-trial-paused-after-potential-adverse-reaction-2020-9?IR=T">AstraZeneca's phase 3 coronavirus vaccine trial was just put on pause because a participant may have had an adverse reaction</a>

Oxford COVID-19 vaccine: SII pauses trials in India following show-cause notice

<ul><li>According to the government, over 30 vaccine candidates are being developed in India. </li><li>Serum Institute of India has entered phase II/III trials and is leading the vaccine development race in the country. </li><li>Whereas, both Bharat Biotech and Zydus Cadila are conducting <a href="https://health.economictimes.indiatimes.com/news/industry/human-clinical-trials-for-covid-19-vaccine-initiated-in-india-icmr/76969682">phase I/II human</a> trials right now. </li></ul>As India records over 1 million COVID-19 deaths, scientists in India are racing against time to develop an effective vaccine. There are 191 COVID-19 vaccine developments in the works around the world right now, and 41 of them are under clinical evaluation, according to the World Health Organisation. According to the Indian government, over 30 vaccine candidates are being developed in India. Three of them are in the advanced stages of the trial, while four are in the pre-clinical development stage. Serum Institute of India is leading the vaccine development race in the country. SII and the Indian Council of Medical Research (ICMR) are jointly conducting phase II/III trials of Oxford’s <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> in India. Here are the latest developments on COVID-19 vaccines in India: No major adverse side-effects reported so far in vaccine trial at PGI Chandigarh The late phase trials of the Oxford-AstraZeneca vaccine, known as Covishield in India, are well underway at the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, the institute said on Thursday The officials at the premier institute told IANS that no adverse side-effects among the volunteers have been observed so far. "Very few people developed fever or body ache post vaccine administration. It is expected and very normal after the vaccine dose is given. Nothing to get alarmed about," an official informed. The institute is listed as one of the 17 trial sites for conducting the second and third phases of human clinical trials of the Coveshield vaccine. The officials added that 53 participants in the trials have already completed seven days of post vaccination period without developing any major side-effects. They also informed that the institute has screened 97 volunteers till date and 65 of them have already been administered the first dose of the vaccine. Indian-origin researchers use bovine adenovirus to develop coronavirus vaccine Oct 8 (IANS) A team of Indian-origin researchers in the US is working to develop a unique Covid-19 vaccine that uses a bovine adenovirus that will protect all segments of the population, especially older adults. Bovine Adenovirus, also known as BAdV, is a member of the Adenoviridae family that causes disease in cattle. "Adenoviral vectors have emerged as a promising gene-delivery platform for a variety of therapeutic and vaccine purposes during the last two decades," said study author Suresh Kuchipudi from Penn State University in the US Moderna to apply for real-time reviews for its COVID-19 virus in Europe: Reuters US pharma giant Moderna said it will apply real-time reviews in Europe. It is in talks with European countries and is also planning to get approval from U.S. Food and Drug Administration. Real-time reviews will allow researchers to give feedbacks without waiting for studies to conclude, reported <a href="https://www.reuters.com/article/us-health-coronavirus-moderna/moderna-to-apply-for-eus-rolling-approval-for-covid-19-vaccine-idUSKBN26T21A" data-type="tilCustomLink">Reuters. </a> Government to map out cold chain storage facilities for COVID-19 vaccine delivery With the likelihood of a vaccine against coronavirus being available within months, the government has begun a massive exercise to map out cold chain storage facilities to ensure the vaccine is delivered quickly across the country. A national expert group is talking to public and private sector entities in the pharmaceutical sector, food processing industry and agro businesses as well as food delivery start-ups such as Swiggy and Zomato to identify cold storages or fridges at the taluka level that can stock and distribute the vaccine, sources with direct knowledge of the discussions said. India's drug controller reject Dr. Reddy's proposal to test Russian coronavirus vaccine India's drug controller has rejected Dr. Reddy's proposal to test Russian coronavirus vaccine in a large study stating early-age study to be small. An expert panel of Central Drugs Standard Control Organisation has asked Dr Reddy's to first conduct small study. Previously, CDSCO asked Dr Reddy's Laboratories to submit a revised protocol for conducting both phase 2 and phase 3 human clinical trials for the Russian vaccine against COVID-19, Sputnik V, in India, sources said Monday.The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI) late last week, seeking permission to conduct phase-3 human clinical trials of the Russian vaccine. India plans procure 400-500 million doses of vaccine for 25 crore people by 2021 Union Health Minister Harsh Vardhan said on Sunday that the Centre is working on plans to procure 400-500 million doses of Covid-19 vaccine, which will be administered to up to 25 crore people by July 2021. He also indicated that the frontline workers and those having underlying health conditions are in the top priority list of the government for vaccine administration, saying that his ministry is currently preparing a format in which states will submit lists of priority population groups to receive the vaccine, especially health workers engaged in the management of Covid-19. In India, three potential COVID-19 vaccines are under advanced clinical trials According to <a href="https://vaccine.icmr.org.in/covid-19-vaccine">ICMR</a>, there are three potential COVID-19 vaccines under human trials — Bharat Biotech’s COVAXIN, Oxford’s Covishield, and Zydus Cadila’s ZyCoV-D. Serum Institute of India has already begun phase III trials of Oxford’s vaccine candidate at 17 sites across the country. Whereas, both Bharat Biotech and Zydus Cadila are conducting <a href="https://health.economictimes.indiatimes.com/news/industry/human-clinical-trials-for-covid-19-vaccine-initiated-in-india-icmr/76969682">phase I/II human</a> trials right now. India likely to approve potential COVID-19 vaccine with 50% efficiency The Indian drug regulator, Central Drugs Standard Control Organization, earlier this week, said it is planning<a href="https://www.livemint.com/news/india/india-may-approve-covid-19-vaccines-that-show-50-efficacy-in-clinical-trials-11600764175238.html"> </a>on approving the COVID-19 vaccine that can protect 50% of the participants in phase III human trials. “To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%," the Central Drugs Standard Control Organization (CDSCO) The Health Ministry also launched a <a href="https://vaccine.icmr.org.in/">portal </a> on September 29 that will provide important information on vaccine development, ongoing clinical trials and progress made - both locally and globally. Previously, World Health Organization (WHO) chief Tedros Adhanom Ghebreyesus has <a href="https://www.livemint.com/news/india/who-chief-lauds-pm-modi-for-his-commitment-in-fight-against-covid-19-pandemic-11601181436330.html">lauded </a>Prime Minister Narendra Modi's assurance that India will use its vaccine production capacity in helping nations fight COVID-19. WHO chief said that the pandemic can be defeated only by mobilising resources for common good. The Indian government is optimistic about getting a COVID-19 vaccine by the start of 2021. Moreover, the Ministry of Health and information <a href="https://www.ndtv.com/india-news/dont-agree-with-rs-80-000-crore-figure-for-covid-vaccine-distribution-centre-2302956">believe </a>they’ve sufficient funds to distribute COVID-19 vaccines in the country. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/policy/economy/news/manufacturing-in-india-improved-for-a-second-straight-month-sees-fastest-pace-of-growth-in-over-8-years/articleshow/78422225.cms">Manufacturing in India improved for a second straight month — sees fastest pace of growth in over 8 years</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/news/reliance-has-bagged-nearly-half-of-all-private-equity-investments-in-india-this-year-and-that-doesnt-include-the-10-billion-from-facebook-and-google/articleshow/78422299.cms">Reliance has bagged nearly half of all private equity investments in India this year – and that doesn’t include the $10 billion from Facebook and Google</a>

India COVID-19 vaccine updates — Oxford's potential coronavirus vaccine reports no side affect so far in vaccine trial at PGI Chandigarh

<ul><li>In the phase of trials, the company will be enrolling over 1,000 subjects across multiple clinical study sites in India, it said in a regulatory filing. </li><li>The adaptive phase I/ II <keyword id="977427" type="PERSON" weightage="20" keywordseo="human-clinical-trials">human clinical trials</keyword> of ZyCoV-D have commenced with the first human dosing, it said, adding that "the adaptive phase I/II dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine." </li><li>Earlier this month, Zydus had received approval from domestic authorities to start human trials for its COVID-19 vaccine contender - the second Indian pharmaceutical firm to get such nod amid a surge in novel <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword> infections worldwide. </li></ul><keyword id="9577763" type="UNKNOWN" weightage="20" keywordseo="drug-firm-zydus-cadila">Drug firm Zydus Cadila</keyword> on Wednesday said it has started human clinical trials of its COVID-19 vaccine candidate ZyCoV-D. In the phase of trials, the company will be enrolling over 1,000 subjects across multiple clinical study sites in India, it said in a regulatory filing. The adaptive phase I/ II human clinical trials of ZyCoV-D have commenced with the first human dosing, it said, adding that "the adaptive phase I/II dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine." Earlier this month, Zydus had received approval from domestic authorities to start human trials for its COVID-19 vaccine contender - the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide. It got approval a few days after India's first indigenous COVID-19 vaccine candidate COVAXIN, developed by city-based <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> in collaboration with <keyword id="6364555" type="COMPANY" weightage="20" keywordseo="Indian-Council-of-Medical-Research">Indian Council of Medical Research</keyword> and National Institute of Virology, got the nod for human clinical trials from the Drug Controller General of India Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 356.50 apiece on BSE, up 0.81 per cent against their previous close. SEE ALSO: <a href="https://www.businessinsider.in/india/news/photographer-of-the-viral-black-panther-images-from-india-shares-his-story/articleshow/76830618.cms">INTERVIEW: Shaaz Jung opens up about the blood, sweat and years behind the viral images of a rare black panther</a> <a href="https://www.businessinsider.in/tech/news/intel-will-speed-up-mukesh-ambanis-5g-run-power-him-with-ai-and-possibly-a-jio-laptop/articleshow/76780290.cms">Intel will speed up Mukesh Ambani’s 5G run, power him with AI and possibly a Jio laptop⁠— all in return for massive amount of data</a>

Zydus Cadila begins human clinical trials of COVID-19 vaccine candidate

<ul><li>University of <keyword id="46985" type="COMPANY" weightage="20" keywordseo="Oxford">Oxford</keyword> and <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> has started human trials of a new experimental COVID-19 vaccine in Australia. </li><li>SpyBiotech, a UK company created by researchers from Oxford in 2017, has designed the vaccine shot, <a href="https://www.bloomberg.com/news/articles/2020-09-08/new-covid-19-vaccine-from-oxford-begins-early-stage-human-trials?srnd=premium-asia">reported Bloomberg.</a></li><li>This is the second potential coronavirus vaccine from Oxford under trial.</li><li>The Serum Institute of India — which is running the phase I/II trials of SpyBiotech’s shot — is soon going to enrol hundreds of participants. </li></ul>University of Oxford and Serum Institute of India has started human trials of a new experimental COVID-19 vaccine in Australia. SpyBiotech, a UK company created by researchers from Oxford in 2017, has designed the vaccine shot, <a href="https://www.bloomberg.com/news/articles/2020-09-08/new-covid-19-vaccine-from-oxford-begins-early-stage-human-trials?srnd=premium-asia">reported Bloomberg. </a> According to Sumi Biswas, CEO SpyBiotech, the Serum Institute of India — which is running the phase I/II trials of SpyBiotech’s shot — is going to enrol hundreds of participants in the future. “The vaccine uses a virus-like particle from the Hepatitis B antigen as a carrier, employing the company’s proprietary SpyCatcher/SpyTag “superglue” technology to attach the coronavirus spike protein to induce an immune response,” Biswas told Bloomberg in an interview. She further added,” The virus-like-particle has been used for decades in a licensed vaccine against Hepatitis B. SpyBiotech’s technology allows antigens to be bonded to virus-like-particles in a way that enhances stability and effectiveness.” SpyBiotech has reached an exclusive licensing deal with the Serum Institute of India. This is the second potential coronavirus vaccine from Oxford under trial. Oxford-Astrazeneca coronavirus vaccine candidate — ChAdOx1-S — is the most advanced vaccine candidate against COVID-19. ChAdOx1-S is under a Phase III trial in the US. Oxford is likely to end the human trials by November<a href="https://www.livemint.com/news/india/oxford-covid-19-vaccine-human-trials-to-end-by-november-mass-production-from-early-2021-11597314049068.html"> and begin production from early 2021</a>. Oxford has struck a deal with pharma giant Astra Zeneca to mass-produce the vaccine — and provide about 2 billion doses to the world if this trial is successful. SEE ALSO: <a href="https://www.businessinsider.in/india/news/workation-new-trend-in-travel-as-indians-find-unique-new-settings-for-work-from-home/articleshow/77990457.cms">Workation – From private villa at the beach to a pool with a view, Indians are finding unique new settings for ‘work from home’</a>

Oxford and Serum Institute of India begin human trials of a new COVID-19 vaccine in Australia

Russia's National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund on Wednesday announced that the <keyword id="9739267" type="UNKNOWN" weightage="20" keywordseo="Sputnik-V">Sputnik V</keyword> vaccine, the world's first registered vaccine against coronavirus created on the well-studied platform of human adenoviral vectors, demonstrated high efficacy. <div type="Article" hostid="261" msid="79130097" title="Pfizer’s COVID-19 vaccine is 90% effective in preventing coronavirus in those who haven’t been infected ever before, shows data from latest trials" mstype="2" mssubtype="0"></div> Currently Sputnik V Phase III clinical trials are approved and are undergoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India. A separate detailed study of the vaccine's safety and immunogenicity for elderly people is also being conducted. The confirmation is based on the first interim data from the largest double-blind, randomized, placebo-controlled Phase III clinical trials in Russia involving 40,000 volunteers. The trials evaluated efficacy among over 16,000 volunteers who received the vaccine or placebo 21 days after the first injection. As a result of a statistical analysis of 20 confirmed cases of coronavirus, the case split between vaccinated individuals and those who received the placebo indicates that the Sputnik V vaccine had an efficacy rate of 92 per cent after the second dose. Separately, in September the vaccine was first administered to a group of volunteers from the "red zones" of the Russian hospitals. The observation of additional 10,000 vaccinated volunteers representing medics and other high-risk groups under the civil use of the vaccine out of clinical trials also confirmed the vaccine's efficacy rate of over 90 per cent. The data received will be published by Gamaleya Center researchers in one of the world's leading peer-reviewed medical academic journals following an independent valuation of the data by leading epidemiology experts. Following the completion of Phase III clinical trials of the Sputnik V vaccine, Gamaleya Center will provide access to the full clinical trial report. As of November 11, as part of the clinical trials in Russia's 29 medical centres, more than 20,000 volunteers were vaccinated with the first dose and over 16,000 volunteers with the first and the second dose of the vaccine. In addition, as of November 11, no unexpected adverse events were identified as part of the research. Some of those vaccinated had short-term minor adverse events such as pain at the injection site, flu-like syndrome, including fever, weakness, fatigue, and headache. During the clinical trials, the safety of the vaccine is constantly being monitored; information is analysed by the Independent Monitoring Committee comprising of leading Russian scientists. Collection, quality control and data processing is conducted in line with the ICH GCP standards and involves active participation of Moscow's Health Department and Crocus Medical, the contract research organization (CRO). Observation of the study participants will continue for six months after which the final report will be presented. The research data will be provided by RDIF to the national regulators of countries interested in purchasing the Russian vaccine in order to streamline the registration process. Mikhail Murashko, Minister of Health of the Russian Federation said that the use of the vaccine and the results of clinical trials demonstrate that it is an efficient solution to stop the spread of the coronavirus infection, a preventive healthcare tool, and this is the most successful path to defeat the pandemic. Alexander Gintsburg, Gamaleya Center Director: "The publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine's efficacy gives way to mass vaccination in Russia against Covid-19 in the coming weeks. Thanks to the production scale up at new manufacturing sites, Sputnik V vaccine will soon be available for a wider population. This will break the current trend and lead to an eventual decrease in Covid-19 infection rates, first in Russia, then globally." Denis Logunov, Gamaleya Center Deputy Director said that positive interim results of Phase III give reasons to expect a successful outcome of Sputnik V clinical trials. "We will continue to process and analyse all the data and look to the future with optimism, expecting that results of our work will help end the pandemic sooner." Kirill Dmitriev, CEO, Russian Direct Investment Fund: "Sputnik V is the first registered vaccine against Covid-19 in the world, the vaccine is based on a safe and effective platform of human adenoviral vectors. More and more countries are recognising the human adenoviral vector platform and plan to include these vaccines, as the most studied and known, in their respective national vaccine portfolio. I would also like to stress the importance of international cooperation and close partnership among vaccine-developing states." He added, "Vaccines should be above politics. The world needs a diversified portfolio of high-quality vaccines with Sputnik V, based on the well-tested human adenoviral vector platform, being an important element of it." The safety of vaccines based on human adenoviruses was confirmed in more than 75 international publications and more than 250 clinical trials conducted during the past two decades (while the history of use of human adenoviruses in vaccine development started in 1953). Adenovirus vectors are genetically modified viruses of the regular flu that cannot reproduce in a human body. When Sputnik V vaccine is used, the coronavirus itself does not enter the body as the vaccine only contains genetic information about part of its outer protein coat, the so-called "spikes" forming its crown. This completely eliminates the possibility of getting infected as a result of vaccination while also causing the body's stable immune response. On September 4, The Lancet, one of world's leading medical journals, published a research paper on the results of Phase I and Phase II clinical trials of the vaccine that showed no serious adverse events and an effective immune response of those vaccinated. Requests for more than 1.2 billion doses of Sputnik V vaccine came from over 50 countries. The vaccine supplies for the global market will be produced by RDIF's international partners in India, Brazil, China, South Korea and other countries. The existing RDIF contracts with international partners enable the production of 500 million doses of the Sputnik V vaccine outside Russia annually. RDIF is now considering additional requests from a number of countries and companies to further increase its foreign production capacities. On August 11, the Sputnik V vaccine developed by the Gamaleya Center was registered by Russia's Health Ministry and became the world's first registered vaccine against Covid-19. SEE ALSO: <a href="https://www.businessinsider.in/politics/india/news/checkout-here-bihar-assembly-election-2020-results-and-updates-online/articleshow/79142084.cms">Bihar Election Results 2020: Final tally puts NDA in the majority with 125 seats as RJD remains the single largest party</a> <a href="https://www.businessinsider.in/india/news/psu-bank-employees-wage-revision-finalised-after-three-years-of-waiting-only-a-1500-increase-in-salary-for-officers/articleshow/79166497.cms">PSU bank employees wage revision finalised after three years of waiting — only a ₹1,500 increase in salary for officers</a> <a href="https://www.businessinsider.in/tech/apps/news/instagram-down-users-complain-of-frozen-timelines-and-likes/articleshow/79146012.cms">Instagram down for nearly 24 hours— users continue to complain about frozen timelines and likes</a>

Within days of Pfizer results, Russia claims Sputnik V vaccine demonstrates 92% efficacy

<ul><li>Russia is likely to sell 100 million doses of its COVID-19 vaccine — Sputnik-V — to Indian pharmaceutical Dr Reddy’s Laboratories</li><li>According to the Russian Direct Investment Fund, the deliveries can begin in the late 2020.</li><li>Sputnik V is under Phase III trials in Russia. Gamaleya Research Institute — a part of Russia’s Health Ministry — is testing the vaccine on over 40,000 people.</li></ul>Russia is likely to sell 100 million doses of its COVID-19 vaccine — Sputnik-V — to Indian pharmaceutical Dr Reddy’s Laboratories as soon as it receives regulatory approval in India,<a href="https://in.reuters.com/article/health-coronavirus-russia-reddys/russia-to-sell-covid-19-vaccine-to-indias-dr-reddys-laboratories-idINKBN2671DY?il=0"> reported Reuters. </a> "On regulatory approval in India, RDIF (Russian Direct Investment Fund) shall supply to Dr Reddy's 100 million doses of the vaccine. The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic," said a statement from the fund. The development comes after the Russian government sought India’s help, earlier this month, in manufacturing the Sputnik V vaccine and also to conduct Phase III trials in India. According to the Russian Direct Investment Fund, the deliveries can begin in the late 2020. "The agreement between RDIF and Dr Reddy's reflects the growing awareness of countries and organisations to have a diversified anti-COVID vaccine portfolio to protect their populations," RDIF added. Sputnik V is under Phase III trials in Russia. Gamaleya Research Institute — a part of Russia’s Health Ministry — is testing the vaccine on over 40,000 people. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/brinton-pharma-which-recently-got-dcgi-approval-to-launch-covid-19-drug-favipiravir-in-india-gets-10-crore-in-debt-funding/articleshow/78145260.cms">Brinton Pharma, which recently got DCGI approval to launch COVID-19 drug Favipiravir in India, gets ₹10 crore in debt funding</a>

India’s Dr Reddy’s Lab to get 100 million doses of Russia’s COVID-19 vaccine after regulatory approval

<ul><li>This comes barely 24 hours after on Monday The Lancet only published that a <keyword id="8904563" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine">Covid-19 vaccine</keyword> developed by scientists at the <keyword id="30725" type="COMPANY" weightage="20" keywordseo="Oxford-university">Oxford University</keyword> produces strong immune responses in both parts of the immune system, showed results of Phase I/II trial.</li><li>The results from the Chinese trial provide data from a wider group of participants than the phase 1 trial, which was published in May. Phase 1 trial involved 108 healthy adults and it demonstrated promising results. </li><li>These cells then produce the spike protein and travel to the lymph nodes where the immune system creates antibodies that will recognise that spike protein and fight off the <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword>. </li></ul> A phase 2 trial of a Covid-19 vaccine candidate conducted in China has found that the vaccine is safe and induces an immune response, according to a new study published in the journal The Lancet. This comes barely 24 hours after on Monday The Lancet only published that a Covid-19 vaccine developed by scientists at the Oxford University produces strong immune responses in both parts of the immune system, showed results of Phase I/II trial. The results from the Chinese trial provide data from a wider group of participants than the phase 1 trial, which was published in May. Phase 1 trial involved 108 healthy adults and it demonstrated promising results. "The phase 2 trial adds further evidence on safety and immunogenicity in a large population than the phase 1 trial. This is an important step in evaluating this early-stage experimental vaccine and phase 3 trials are now underway," said study researcher <keyword id="9613775" type="PERSON" weightage="20" keywordseo="feng-cai-zhu">Feng-Cai Zhu</keyword>, <keyword id="116759" type="COMPANY" weightage="20" keywordseo="Jiangsu">Jiangsu</keyword> Provincial Center for Disease Control and Prevention in China. The Ad5 vectored vaccine in this trial uses a weakened human common cold virus (adenovirus, which infects human cells readily but is incapable of causing disease) to deliver genetic material that codes for the SARS-CoV-2 spike protein to the cells. These cells then produce the spike protein and travel to the lymph nodes where the immune system creates antibodies that will recognise that spike protein and fight off the coronavirus. According to the researchers, 508 participants took part in the trial of the new vaccine. Of these, 253 received a high dose of the vaccine, 129 received a low dose and 126 received placebo. Approximately two-thirds of participants were aged 18-44 years, with a quarter aged 45-54 years, and 13 percent aged 55 years or older Participants were monitored for immediate adverse reactions for 30 minutes after injection and were followed for any injection-site or systemic adverse reactions within 14- and 28-days post-vaccination. The trial found that 95 per cent of participants in the high dose group and 91 per cent of the recipients in the low dose group showed either T cell or antibody immune responses at day 28 post-vaccination. The vaccine-induced a neutralising antibody response in 59 per cent and 47 per cent of participants, and binding antibody response in 96 per cent of participants, in the high and low dose groups, respectively, by day 28. The participants in the placebo group showed no antibody increase from baseline. "Since elderly individuals face a high risk of serious illness and even death associated with COVID-19 infection, they are an important target population for a COVID-19 vaccine," said Wei Chen from <keyword id="9274771" type="COMPANY" weightage="20" keywordseo="the-beijing-institute-of-biotechnology">the Beijing Institute of Biotechnology</keyword>. "It is possible that an additional dose may be needed in order to induce a stronger immune response in the elderly population, but further research is underway to evaluate this," Chen added. The authors noted that the trial was conducted in Wuhan, China, and the baseline immunity is representative of Chinese adults at that time, but other countries may have different rates of immunity which should be considered. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/coovid-vaccine-from-oxford-serum-institute-and-astrazeneca-shows-promising-immune-response/articleshow/77069321.cms">The COVID-19 vaccine from Oxford and Astrazeneca shows 'promising' results in early human trials</a> <a href="https://www.businessinsider.in/careers/news/from-intel-and-wipro-to-tcs-and-google-here-are-the-top-job-openings-in-the-multinational-companies/articleshow/77058769.cms">From Intel and Wipro to TCS and Google— Here are the top job openings in the multinational companies</a> <a href="https://www.businessinsider.in/tech/mobile/news/checkout-upcoming-affordable-smartphone-oneplus-nord-launch-price-specifications-features/articleshow/77061620.cms">OnePlus Nord launch price, specs and more – Everything we know about the upcoming affordable OnePlus smartphone</a>

You Searched For "Phase III human trials" and got 8 results

Oxford’s COVID-19 vaccine: Phase III human trials begin in India

BI India Bureau

Oxford COVID-19 vaccine: SII pauses trials in India following show-cause notice

BI India Bureau

India COVID-19 vaccine updates — Oxford's potential coronavirus vaccine reports no side affect so far in vaccine trial at PGI Chandigarh

BI India Bureau

Zydus Cadila begins human clinical trials of COVID-19 vaccine candidate

PTI

Oxford and Serum Institute of India begin human trials of a new COVID-19 vaccine in Australia

BI India Bureau

Within days of Pfizer results, Russia claims Sputnik V vaccine demonstrates 92% efficacy

IANS

India’s Dr Reddy’s Lab to get 100 million doses of Russia’s COVID-19 vaccine after regulatory approval

BI India Bureau

Chinese COVID-19 vaccine candidate produces immune response in phase 2 trial

IANS

Popular Keywords

Buying Guides