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Dr <keyword id="225564" type="PERSON" weightage="20" keywordseo="Anthony-Fauci">Anthony Fauci</keyword>, chief medical advisor to President Joe Biden, said that India is going through a very terrible situation right now. "They've had yesterday the largest number of cases that has ever been reported by any country. They have a situation there where there are variants that have arisen. We have not yet fully characterised the variants and the relationship between the ability of the vaccines to protect but we're assuming clearly, that they need vaccines," he said. "The CDC is helping out by consulting with them as they have in other countries in which there are situations and giving technical assistance. But it is a dire situation that we're trying to help in any way we can we just have to see how things go. And obviously, they need to get their people vaccinated because that's the only way we're going to turn that around," Dr Fauci said. <keyword id="6356037" type="COMPANY" weightage="20" keywordseo="white-house">White House</keyword> COVID-19 Response Coordinator Jeff Zients said that the US has a longstanding commitment to India's public health and is working closely with them in the COVID-19 response. "This is a global pandemic and India demonstrates the risk of what can happen if we don't get the pandemic under control everywhere. It's why we made the biggest investment in COVAX and we are committed to sharing vaccine supply as our confidence around our supply increases, we will explore those options," Zients said. The US is working closely with India, at both political and expert level, to identify ways to help address the current COVID-19 crisis in the country, the White House said on Friday. White House Press Secretary Jen Psaki, at the daily news conference, said that the US offers its deepest sympathy to the people of India who are clearly suffering during this global pandemic. "We are working closely with Indian officials at both political and experts' level to identify ways to help address the crisis," Psaki said. "We've made vaccine cooperation a big priority, including with our Quad partners. India is one of our Quad partners, of course, in discussing vaccine creation and distribution for the future. We've also provided for a billion dollars to COVAX," she said in response to a question. "From the earliest stages of the pandemic, we've provided India with emergency relief supplies, medical consumables, pandemic training for Indian state and local health officials, and ventilators, which has been part of our effort over the course of time, including USD 1.4 billion in health assistance to India to help them prepare for pandemics in the future and deal with the current one we're facing," Psaki said. Responding to a question, Psaki said there are ongoing discussions. "I don't have anything more to preview, but we are in touch with them at a range of levels about how we can help them get through this period of time," Psaki said. India added a record over 3.32 lakh new coronavirus cases in a single day taking the country's tally to 1,62,63,695, while active cases crossed the 24-lakh mark, according to the Union Health Ministry data updated on Friday. The death toll increased to 1,86,920 with a record 2,263 new fatalities. The country recorded a single day rise of 3,32,730 new cases, the data updated at 8 am showed. SEE ALSO: <a href="https://www.businessinsider.in/india/news/india-covid-19-first-wave-versus-second-wave/articleshow/82216963.cms">'We're in a much better situation' claims India's Principal Scientific Advisor as COVID-19 claims more lives than ever before</a> <a href="https://www.businessinsider.in/science/environment/news/worsening-air-quality-amid-the-surging-covid-19-cases-could-add-to-the-pressure-on-indias-healthcare-system/articleshow/82213498.cms">Air pollution is back with a vengeance as industries play catch up — and that could further worsen the COVID-19 pandemic</a> <a href="https://www.businessinsider.in/science/health/news/aiims-icmr-new-guidelines-for-treatment-of-covid-19-patients-with-moderate-case/articleshow/82211333.cms">Simplified: AIIMS, ICMR new guidelines for treatment of patients with ‘moderate’ case of COVID-19</a>

Faster vaccinations is the 'only way' out for India, US' chief medical advisor Fauci

<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>The final results of Pfizer and BioNTech’s COVID-19 vaccine show that it's 95% effective. </li><li>The only significant side effect, with a frequency of over 2%, was fatigue. </li><li>The company plans to file for Emergency Use Authorisation (EUA) with the US’ Food and Drug Administration (FDA) within the next few days. </li></ul>The COVID-19 vaccine being developed by Pfizer and BioNtech is 95% effective according to its <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">final analysis</a>. Even in adults over the age of 65 years, the efficacy was observed at 94%. “No serious safety concerns were observed in the COVID-19 vaccine trial,” said the <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">press note</a> issued by both companies. The phase 3 study only showed mild to moderate side effects that cleared up quickly. “The only significant side effect than that 2% in frequency was fatigue at 3.7%,” the study highlighted. How does the vaccine work? With a 95% efficacy rate, those who get the vaccine will be protected within 28 days of the first dose — and there is only a two-dose schedule. This is far more effective than the threshold laid out by the White House coronavirus advisor Anthony Fauci, who has previously stated that a vaccine that is 50% to 60% effective would be acceptable. When will the vaccine be able for the public? Now that the vaccine is ready for market as soon as it gets the required permissions, Pfizer and BioNTech plan to make up to 50 million doses before the end of the year and another 1.3 billion in 2021. According to the company, the vaccine’s efficacy is consistent across different ages, races and ethnicities. In light of the success, Pfizer plans to file for Emergency Use Authorisation (EUA) for the vaccine with the US Food and Drug Administration (FDA) within the next few days. It claims it has met all the safety data milestones required by the authorities. Why India shouldn’t rejoice just yet A year since the first COVID-19 case was detected, the success of a possible vaccine provides a ray of hope after the last seven grueling months of the pandemic. However, the Pfizer vaccine may not be suited for use in India since it requires storage at minus 70 degrees Celsius. According to the Director of the All India Institute of Medical Sciences (AIIMS) <a href="https://www.businessinsider.in/science/health/news/indian-covid-vaccines-can-survive-in-warmer-temperatures-pfizers-says-aiims-director/articleshow/79172255.cms">Randeep Guleria</a>, the Pfizer vaccine’s requirement of a lower storage temperature is something that India’s cold storage infrastructure may not be able to support for the population of 1.3 billion. However, Pfizer believes its expertise and existing cold-chain infrastructure will be enough to distribute the vaccine around the world in specially designed and temperature controlled thermal shippers that use dry ice. SEE ALSO: <a href="https://www.businessinsider.in/finance/banks/news/lakshmi-vilas-bank-customers-have-withdrawn-10000-crore-since-rbis-moratorium-was-announced-last-night/articleshow/79281857.cms">Lakshmi Vilas Bank customers have withdrawn ₹10,000 crore since RBI's moratorium was announced last night</a> <a href="https://www.businessinsider.in/careers/news/capgemini-hr-head-explains-why-the-french-it-major-is-going-crazy-hiring-in-india-and-around-the-world/articleshow/79277396.cms">EXCLUSIVE: Capgemini HR head explains why the French IT major is going crazy hiring in India and around the world</a> <a href="https://www.businessinsider.in/business/news/indiamart-and-justdial-in-legal-battle-over-copyright-violations/articleshow/79275178.cms">IndiaMart and JD Mart gear up for a legal battle over copyright infringement — even as Justdial calls IndiaMart’s allegations ‘baseless’</a>

Pfizer's new COVID-19 vaccine is 95% effective and the only severe side-effect to worry about is fatigue, according to the final results

BCCL <ul><li>Sanofi plans to get thousands of subjects onboard across the world for the trials of experimental coronavirus vaccines that it is developing with GSK. </li><li>Once enrolled, the company will start early-stage trials in September. </li><li>The pharma giant has already partnered with GlaxoSmithKline Plc (GSK) and is researching also exploring other options simultaneously. </li><li>It hopes to introduce the vaccine next year, reported Reuters.</li></ul> Sanofi, a French multinational pharmaceutical company, says it is working on two different projects to develop a vaccine for COVID-19. The pharma giant has partnered with GlaxoSmithKline Plc (GSK) and is researching other options as well. It hopes to introduce the vaccine by next year, <a href="https://in.reuters.com/article/health-coronavirus-sanofi-exclusive/exclusive-sanofi-to-enroll-thousands-for-its-coronavirus-vaccine-trials-idINKBN22I084">reported Reuters. </a> The plan is to get thousands of subjects on board across the world to test the experimental coronavirus vaccines that it is currently developing with GSK. Once enough people are enrolled, the company plans to start early-stage trials in September. The project is backed by the US Health Department’s Biomedical Advanced Research and Development Authority (BARDA). “We envisioned Phase I to actually have several hundreds of subjects, so it is really a phase I/II trial,” said John Shiver, head of vaccine research at Sanofi. Phase I of clinical trials normally constitute a small number of healthy volunteers and then the experimental vaccine is given to a large number of people for trial. However, Sanofi might decide to skip Phase 1 altogether given the urgent requirement. The company has <a href="https://www.cnbc.com/2020/04/17/if-sanofis-coronavirus-vaccine-works-ceo-says-it-can-produce-up-to-600-million-doses-next-year.html">promised to manufacture</a> 600 million doses of the <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> by next year. Moreover, it’s also negotiating with some countries to bring in advance purchase orders for these doses, said the report. Sanofi will use an S-protein COVID-19 antigen to target coronavirus’ spike protein — that helps coronavirus enter the human body. Where GSK will provide an adjuvant, which will reduce the amount of vaccine needed per dose. Apart from GSK, the French pharma giant is also working with the US-based Translate Bio Inc to develop another vaccine. Ever since China’s scientist released the genome of the novel coronavirus, researchers around the world have been racing to develop a vaccine that has killed 257,301 and infected 3.6 million people around the world so far. As of now, 10 out of 100 vaccine candidates have reached the clinical testing stage. There are at least 70 research efforts underway to develop a coronavirus vaccine, <a href="https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus-landscape-ncov.pdf">according to the World Health Organisation. </a> The front runner is the University of Oxford, which claimed that the clinical trial of the vaccine its developing is likely to finish by September. The world’s largest drugmaker, Serum Institute of India, has already started manufacturing the Oxford vaccine without prior approval. However, SII said it will not create a barrier in global supply by retaining the<a href="https://www.foreignaffairs.com/articles/world/2020-04-30/finding-vaccine-only-first-step"> intellectual property rights of the COVID-19 vaccine candidate. </a> See also: <a href="https://www.businessinsider.in/science/news/2-of-the-worlds-biggest-drugmakers-just-teamed-up-on-a-coronavirus-vaccine-and-theyre-aiming-to-launch-it-next-year/articleshow/75142796.cms">2 of the world's biggest drugmakers just teamed up on a coronavirus vaccine, and they're aiming to launch it next year</a> <a href="https://www.businessinsider.in/science/news/a-leading-coronavirus-vaccine-candidate-just-started-human-trials-in-the-us-pfizers-chief-scientist-told-us-how-it-could-be-ready-for-emergency-use-this-fall-/articleshow/75554678.cms">A leading coronavirus vaccine candidate just started human trials in the US. Pfizer's chief scientist told us how it could be ready for emergency use this fall.</a>

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Faster vaccinations is the 'only way' out for India, US' chief medical advisor Fauci

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

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Pfizer's new COVID-19 vaccine is 95% effective and the only severe side-effect to worry about is fatigue, according to the final results

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Sanofi, one of the largest drug makers, will test experimental coronavirus vaccine on humans starting September

BI India Bureau

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