She joined the Nuffield Department of Medicine at Oxford University in 1994 and became part of the Jenner Institute (within NDM) when it was founded in 2005. Germany warns of 'exponential' rise in Covid cases1, Volcano erupts near Iceland's capital Reykjavik2, Angry exchanges at US and China talks in Alaska3, Viral video exposes college basketball inequality4, Goldman Sachs bankers ask for 80-hour week cap5, Finland ranked happiest country in the world again6, French drugs haul 'was strawberry Haribo'7, Biden condemns anti-Asian racism in Atlanta visit8, Rich states 'block' vaccine plans for poor nations9, Why did China's most famous tech titan disappear?10. "There are some scientists who will happily work more or less on their own on one subject for a very long time… That's not the way I like to work. © 2021 BBC. Her urgency, in the face of Covid's death march around the world, might explain some of her more unorthodox working practices. Why is everyone fighting over the South China Sea? The University of Oxford’s Jenner Institute and Merck KGaA have developed a manufacturing process for the institute’s COVID-19 vaccine candidate, ChAdOx1 nCoV-19. Yet by the mid-1990s, she was in an academic job at the University of Oxford, looking at the genetics of malaria. She has been a researcher at Oxford for nearly 25... Dr Sandy Douglas is an academic clinician and holds a Wellcome Trust Postdoctoral Fellowship for Clinicians (i.e. The vaccine uses a non-replicating chimpanzee adenovirus to deliver a SARS-CoV-2 spike protein to induce an immune response. As researchers work at breakneck pace to develop a safe and effective vaccine for COVID-19, everyone is talking about one frontrunner: the Jenner Institute of Oxford University. Jenner Institute. Kylie Jenner attends The Metropolitan Museum of Art's Costume Institute benefit gala celebrating the opening of the Rei Kawakubo/Comme des Garcons: Art of … The Jenner Institute at Oxford University is working on a vaccine against COVID-19. I like to try to take into account ideas from lots of different areas," she told BBC Radio 4's The Life Scientific, earlier this year. Oxford vaccine: How did they make it so quickly? The Oxford Vaccine Centre’s COVID-19 vaccine trial is being run by the Jenner Institute and Oxford Vaccine Group. The Jenner Institute director, Prof Adrian Hill, said the malaria vaccine would be tested on 4,800 children in Africa next year after early trials yielded promising results. By continuing to use this site, you accept our use of cookies. What happened with the AstraZeneca vaccine? Professor Lambe’s area of expertise is vaccine development. The Jenner Institute and the Oxford Vaccine Group began the development of the vaccine candidate in January, and an initial phase of testing began on 160 healthy volunteers between 18 and 55. Two U.S. companies, Moderna and Inovio, have started small clinical … Prof Gilbert described the process as a series of small steps - rather than there being a big breakthrough moment. Professor Green heads the Nuffield Department of Medicine's Clinical Biomanufacturing Facility (CBF). "Sometimes I think she can be quite shy and reserved to people," one of her PhD students, told Profile. Previously, the Edward Jenner Institute for Vaccine Research was an independent research institute named after Edward Jenner, the inventor of vaccination. Emails come in as early as 4am, says Prof Lambe, who, explains that Prof Gilbert tends to work from very early in the morning until the late evening. She set up her own research group in a bid to create a universal flu vaccine, meaning a vaccine which would be effective against all the different strains. SARS-CoV-2 is the virus that causes COVID-19. One of the founding principles of the Institute is the exploitation of synergies in the development of human and veterinary vaccines whereby new vaccine approaches can be tested in parallel in different species. She is an experienced immunologist who develops vaccines against emerging and outbreak pathogens. "We're a university and we're not in this to make money.". The latest news and updates on Oxford's COVID-19 vaccine, Find out more about how the ChAdOx1 vaccine works and how it is being developed, Information about the ChAdOx1 vaccine trials, phases and locations. Jenner is one of the largest academic centers focused on nonprofit vaccine research. Getty Coronavirus Vaccine Still Underfunded "This is a full society press that we need," says Henderson. And when the Mers - Middle East respiratory syndrome - virus struck, she travelled to Saudi Arabia to try to develop a vaccine for this form of coronavirus. Her life became a little more complicated when she gave birth to triplets. The Jenner Institute was founded in November 2005 to develop innovative vaccines against major global diseases. It was co-located with the Compton Laboratory of the Institute for Animal Health on a campus in the village of Compton in Berkshire. Do you want to discover what's happening in the labs where we're testing, trailing, and make the starting material for our COVID-19 vaccine? elma.tchilian@jenner.ac.uk CD45 (the leukocyte common antigen) is known to function as a tyrosine phosphatase in leukocyte signaling. The gaze of the world is now on Prof Gilbert and the world's handful of other Covid vaccine architects, as they race against the clock. Their vaccine has been tested in six rhesus macaque monkeys at the National Institutes of Health’s Rocky Mountain Laboratory in Montana, that were then exposed to large volumes of the virus causing COVID-19. It even has its own pilot manufacturing plant that can make a batch of up to 1,000 doses. In 1798, English physician Dr. Edward Jenner proposed that inducing a mild cowpox infection could protect against smallpox – which he called a “vaccine,” from vaccinia, meaning cowpox. She is the Monsanto Senior Research Fellow at Ex... Dr Christina Dold has been part of the Oxford Vaccine Group since 2011. Uniquely it focuses both on … Jenner Institute Investigators, through the support of many funders, are developing new vaccine candidates against major global infectious diseases. But when you get to know her and you spend time with her, that's not the case at all.". Jenner Institute Investigators, through the support of many funders, are developing new vaccine candidates against major global infectious diseases. Their ChAdOx1 trials are currently assessing whether the vaccine will be effective in … What happened with the AstraZeneca vaccine? One reason the Oxford group led by Adrian Hill, the Jenner Institute’s director, is ahead of the game is because Hill has spent most of his career on vaccine development, primarily on malaria. This practice, and growing public familiarity with it, set the stage for acceptance of the first vaccine, which would change the course of disease. Video. image caption Prof Teresa Lambe, Prof Gilbert's colleague at the Les chercheurs se sont mis à l’ouvrage dès la mi-janvier 2020, dès que… En moins d’une semaine, l’horizon s’est subitement éclairci pour le vaccin d’Oxford-AstraZeneca. She oversees the immunology on Phase I and II trials of VLP and vectored vaccines, both in the UK, and in field trials in Africa. Born in Kettering, Northamptonshire in April 1962, Sarah Gilbert's father worked in the shoe business while her mother was an English teacher and member of the local amateur operatic society. Vaccines usually take decades to develop – so how is Oxford University's ChAdOx1 nCoV-1 vaccine trial moving so quickly? Angry exchanges at US and China talks in Alaska. Read about our approach to external linking. The Jenner Institute director, Prof Adrian Hill, said the malaria vaccine would be tested on 4,800 children in Africa next year after early trials yielded promising results. Lying just 60 miles from Westminster, but light-years removed in terms of its undramatic efficiency, stands Oxford University’s Jenner Institute, named … ", Trial shows Oxford Covid vaccine highly effective, My daughter's shielding - should she return to school? The Institute is supported by the Jenner Vaccine Foundation, a UK registered charity and advised by the Jenner Institute Scientific Advisory Board. The University of Oxford’s Jenner Institute and Oxford Vaccine Group have been at the forefront of scientific endeavour to develop vaccines for diseases of major global importance for more than 30 years. Please read our Cookie Policy for more information. Working with colleagues in the Jenner Institute research labs, the Clinical Biomanufacturing Facility and Centre for Clinical Vaccinology and Tropical Medicine, all situated on the Old Road Campus in Oxford, she is able to take novel vaccines from design to clinical development, with a particular interest in the rapid transfer of vaccines into GMP manufacturing and first in human trials. For the ChAdOx1 nCov-2019 trial, she has led the team of scientists studying the T cell responses produced in the body by vaccination and how these could protect against COVID-19. She is experienced at progressing preclinical concepts all the way through to clinical assessment. Nous voudrions effectuer une description ici mais le site que vous consultez ne nous en laisse pas la possibilité. In 2014, she led the first trial of an Ebola vaccine. Professor Gilbert holds the Saïd Professorship of Vaccinology and has been a part of Oxford’s vaccine community since 1994, working closely with Profe... We use cookies to give you the best experience of using this website. And that led to work on malaria vaccines. We are delighted to have received an approval from the MHRA for the use of our ChAdOx1 nCoV-19 vaccine in the UK - a major step towards the end of the COVID-19 pandemic. 5 talking about this. As Chinese scientists published the genetic structure of the new virus "over the weekend, the vaccine was pretty much designed. Edward Jenner, an English country doctor from Gloucestershire, administers the world’s first vaccination as a preventive treatment for smallpox, a disease that had killed millions of … She is a senior postdoctoral scientist, specialising in preclinical and Phase... Richard Tarrant, PhD and BSc, became a Qualified Person (QP) for the Clinical BioManufacturing Facility (CBF) in October 2018. As the researchers across the globe are racing against time to develop a coronavirus COVID-19 vaccine, Oxford's Jenner Institute, which has taken a lead in clinical trials of the vaccine, has expressed hope that COVID-19 vaccine … Heterologous prime-boost strategies are known to substantially increase immune responses in viral vectored vaccines. "We were quick," says her colleague at Oxford, Prof Teresa Lambe. Les chercheurs de l'institut Jenner, à l'Université d'Oxford, ont mis au point un vaccin vectorisé, baptisé ChAdOx1-nCoV-19 ou AZD1222, utilisant un adénovirus atténué du Chimpanzé, rendu incapable de se répliquer. Oxford University’s Jenner Institute and Oxford Vaccine Group developed AZD1222. Public donations of any size will be rapidly put to use in our frontline research. The Jenner Institute’s vaccine effort is not the only one showing promise. These findings can then be used to improve the vaccine development process, so that future vaccines offer greater protection against disease. Jenner’s methods obviously wouldn’t pass ethical muster today. Then the first batch went into manufacture by early April, as the rigorous testing regime expanded. Professor Gilbert holds the Saïd Professorship of Vaccinology. Jenner Institute blev grundlagt i 2005 i partnerskab mellem University of Oxford og Institute for Animal Health (efter 2012 som 'The Pirbright Institute'). "I did consider leaving science at that point and doing something different.". The BBC is not responsible for the content of external sites. The vaccine was developed at the Oxford Jenner Institute and is currently on trial in the UK, where over 4,000 participants are already enrolled into the clinical trial and enrolment of an additional 10, 000 participants is planned. Raising them is an experience which one friend suggested explains her "no nonsense approach". What happens to your body in extreme heat? Years ago, studying for her PhD, she considered packing in science altogether. China and Taiwan face off in pineapple war, Rare view inside Ethiopia's conflict zone. Our Institute focuses both on diseases of humans and livestock. "She's gonna hate it, absolutely hate it," says her friend, biochemist Dr Anne Moore. Clinical trials are an essential part of vaccine development. Meanwhile, at Oxford, Dr Gilbert rose through the ranks, becoming a professor at the university's prestigious Jenner Institute. Adrian Hill, director of the Jenner Institute at Oxford, ... noted that vaccine trials are especially hard when people are in lockdown. All three children chose to follow their own path, he says - although all ended up choosing to study biochemistry at university. This work principally involves measuring the antibody response after vaccination. As researchers work at breakneck pace to develop a safe and effective vaccine for COVID-19, everyone is talking about one frontrunner: the Jenner Institute of Oxford University. She leads the Jenner Institute programme in influenza vaccine development and now also works on vaccines for many different emerging pathogens, including Nipah, MERS, Lassa and CCHF. It comes down to careful planning, extraordinary logistics and a whole lot of help from partners around the world. Here we report on safety and immunogenicity of the poxvirus Modified Vaccinia Ankara (MVA) vectored vaccine expressing four Mycobacterium avium subspecies paratuberculosis antigens as a single dose or as a booster vaccine following a simian adenovirus (ChAdOx2) prime. Professor Adrian Hill, Director of the Jenner Institute said: ‘For the past 25 years, staff at the Jenner Institute have worked to develop vaccines using novel technologies to protect people around the world from diseases that claim many lives each year. The team, who started work on developing a vaccine to prevent COVID-19 on 20th January 2020 is led by Prof. Sarah Gilbert, Prof. Andrew Pollard, Prof. Teresa Lambe, Dr Sandy Douglas, Prof. Catherine Green and Prof. Adrian Hill. A vaccine candidate for COVID-19 has been identified by researchers from the Oxford Vaccine Group and Oxford's Jenner Institute. It was in September last year that I felt the first stirrings of optimism about the coronavirus vaccine. Janssen Vaccines –Jenner Institute complementary Vaccines Platform Technologies WHO Geneva, 21 July 2016 Janssen Vaccines: Olga Popova Jerome Custers Jenner Institute: Prof. Sarah Gilbert. Her team is working on measuring the immune response after vaccination against SARS-CoV-2. Oxford University’s Jenner Institute and Oxford Vaccine Group developed AZD1222. Why is everyone fighting over the South China Sea? In the meeting with her that day were Adrian Hill, a colleague in the Jenner vaccine institute, and Andrew Pollard. I was at the Edward Jenner institute in Oxford, standing behind a scientist as she looked at Author information: (1)The Edward Jenner Institute for Vaccine Research, Compton, Berkshire, UK. Prof Sarah Gilbert: The woman who designed the Oxford vaccine Smallpox was responsible for more human deaths than any other infectious agent. Oxford has over 100 researchers working on the urgent response to the Coronavirus outbreak. The Institute is a partnership between the University of Oxford and The Pirbright Institute and is the successor to the former Edward Jenner Institute for Vaccine Research. Un aboutissement pour l’équipe de chercheurs du Jenner Institute, un centre de recherche de l’université d’Oxford fondé en 2005, qui a conçu le produit. LONDON – Researchers at the Jenner Institute in Oxford have given an inside view of how they are accelerating clinical development of a COVID-19 vaccine and at the same time putting in place commercial manufacturing for when phase III efficacy data … "I mean, Sarah is the person in the room who does not want to be in the limelight. VideoWhat happened with the AstraZeneca vaccine? Oxford's coronavirus vaccine has been approved for use in a number of countries, marking an important milestone in the fight against COVID-19 . But when she progressed to her doctorate, at the University of Hull, she found the tunnel-like focus was not to her liking. Jenner Institute ledes 2020 af Adrian Hill. A vaccine for COVID-19, the viral illness caused by the novel coronavirus, may be within reach sooner than many experts predicted. Prof Gilbert quickly realised she might be able to use the same approach. Video. Amount: $100,000 Term: 19 Topic: Discovery and Translational Sciences Program: Global Health Grantee … And as long ago as 2014, they had developed a template for mass production of the coronavirus vaccine, if it is effective, that could provide a million doses. He also heads a group at the Wellcome Trust Centre for Human Genetics which studies genetic susceptibility factors for common bacterial diseases. It is the first such partnership to be formed since the Government launched its dedicated Vaccines Taskforce to help find, test and deliver a new coronavirus vaccine just two weeks ago. The Oxford Vaccine Group will be continuing with some of our non-COVID research, particularly our paediatric studies, during the COVID-19 pandemic. Speaking to Radio 4's Profile, one school friend recalled Sarah's silent steeliness - a trait which perhaps explains her decision, years later, to stick with her PhD despite her doubts. The vaccine has been engineered to express the SARS-CoV-2 spike protein. The Federal Communications Commission said on Thursday an investigation had found that a Brooklyn bitcoin mining operation interfered with T-Mobile US Inc's (TMUS.O) broadband network. Das Jenner Institute ist eine britische Forschungseinrichtung. Career Development fellowship). School, university friends and colleagues describe a conscientious, quiet and determined person and someone with "true grit". Le génome constitué d'ADN du virus permet d'insérer une séquence codant la protéine de surface S du SARS-CoV-2. The candidate vaccine was licensed to AstraZeneca for further development. Instituttet udvikler vacciner og udfører kliniske tests for sygdomme som malaria, tuberkulose, HIV og COVID-19. The first high-level meeting of the new US administration and Beijing opened with sharp rebukes. Funding of the institute continued until October 2005, when it was relaunche… Eventually though she decided to have "one more go at a scientific career… I needed the income". Jenner is one of the largest academic centers focused on nonprofit vaccine research. Date: October 2013 Purpose: to reduce the incidence of Rift Valley fever by developing one vaccine that can protect a variety of susceptible species including humans and cattle using a defective simian adenovirus as a safe vector that is easy and cheap to manufacture. More than 28 days later, all six were still healthy. Date: October 2013 Purpose: to reduce the incidence of Rift Valley fever by developing one vaccine that can protect a variety of susceptible species including humans and cattle using a defective simian adenovirus as a safe vector that is easy and cheap to manufacture. Canadian spy trial in China ends without verdict, Germany warns of 'exponential' rise in Covid cases. 14 talking about this. • Jenner's house in the village of Berkeley, Gloucestershire, is now a small museum, housing, among other things, the horns of the cow, Blossom. The Jenner Institute at the University of Oxford - named after the scientist that performed the first vaccination in 1796, and now home to some of the world's leading experts - … How Russia glosses over its Covid death toll, Atlanta shootings and how we talk about violence, Why the Dutch are the tallest people in the world. Development of innovative human and veterinary vaccines against major global diseases such as malaria, TB, HIV, Ebola. If Prof Sarah Gilbert had gone with her instincts, the latest coronavirus vaccine to show highly promising results might never have been. The vaccine, called AZD1222, has now progressed into late-stage Phase II/III clinical trials in more than 10,000 people from across the UK, including children and the elderly. Want to know more about our research into Coronavirus and COVID-19? Das Jenner-Institute wurde 2005 in Kooperation mit dem Institute for Animal Health in Oxford gegründet. The Jenner Institute was founded in November 2005 in partnership with the Institute for Animal Health. The Oxford COVID-19 vaccine team is working at unprecedented speed in a race against the global threat to human health that is coronavirus. Why is everyone fighting over the South China Sea? Emma Bolam is Head of Production at the Jenner Institute’s Clinical BioManufacturing Facility (CBF). COVID-19 is a disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). VideoWhy is everyone fighting over the South China Sea? The company had complained about interference to its 700 MHz LTE network in Brooklyn from radio emissions it said were coming from a Brooklyn residence mining for the cryptocurrency - verifying bitcoin transactions. Read about our approach to external linking. 56 talking about this. Clinical trials are an essential part of vaccine development. Jenner Institute er et britisk forskningsinstitut som inngår i Nuffield Department of Medicine ved University of Oxford.Instituttet har sitt navn etter den britiske immunologen Edward Jenner, som var en pioner innen vaksinasjon og bidro til å utvikle koppervaksinen.. Jenner Institute ble grunnlagt i 2005 i partnerskap mellom University of Oxford og Institute for Animal Health. The Edward Jenner Institute for Vaccine Research was an independent research institute named after Edward Jenner, the inventor of vaccination.It was co-located with the Compton Laboratory of the Institute for Animal Health on a campus in the village of Compton in Berkshire, England. This is because as part of these studies we give babies their routine primary immunisations on behalf of their GPs. What happened with the AstraZeneca vaccine? Professor Hill is Lakshmi Mittal and Family Professor of Vaccinology and Director of the Jenner Institute, which focuses on designing and developing vaccines for infectious diseases prevalent in developing countries, such as HIV/AIDS, malaria and tuberculosis. Regardless, smallpox vaccination became common in Europe and infection rates dropped dramatically by 1820. Professor Katie Ewer is senior immunologist for Oxford's ChAdOx1 nCov-2019 coronavirus, Ebola and pre-erythrocytic malaria vaccine trials. The Jenner Institute tested a vaccine for an earlier coronavirus last year, showing it was not harmful to humans. It took a few weeks to create a vaccine that worked against Covid in the lab. His own vaccine research programme has developed one of the most promising potential vaccines for malaria which is currently in large scale trials in infants in sub-Saharan Africa. Her chief research interest is the development of viral vectored vaccines that work by inducing strong and protective T and B cell responses. But such practices were not uncommon in the 18th century, and understandably so. Why did China's most famous tech titan disappear? The ability to create recombinant viral vector vaccines is a core function of Gilbert's research group at the Jenner Institute, which over the past few years has progressed work on many vaccines, including those for influenza and Zika virus and early stage trials for Middle East respiratory syndrome coronavirus vaccine, a helpful template for the work on a COVID-19 vaccine. Volcano erupts near Iceland's capital Reykjavik, Viral video exposes college basketball inequality, Goldman Sachs bankers ask for 80-hour week cap, Finland ranked happiest country in the world again, French drugs haul 'was strawberry Haribo', Biden condemns anti-Asian racism in Atlanta visit, Rich states 'block' vaccine plans for poor nations, 100 inspiring and influential women of 2020. 23 Nov: The University of Oxford, in collaboration with AstraZeneca plc, announces interim trial data from its Phase III trials that show its candidate vaccine, ChAdOx1 nCoV-2019, is effective at preventing COVID-19 (SARS-CoV-2) and offers a high level of protection. Get in touch with our news team, Oxford vaccine creator Professor Sarah Gilbert awarded RSA Albert Medal, New data show vaccines reduce severe COVID-19 in older adults, Coronavirus vaccination linked to substantial reduction in hospitalisation, real-world data suggests, Watch a 'COVID Conversation' with Sarah from June 2020, Prospective Continuing Education students, Prospective online/distance learning students. The University of Oxford’s Jenner Institute and Oxford Vaccine Group have been at the forefront of scientific endeavour to develop vaccines for diseases of major global importance for more than 30 years. She is the Oxford Project Leader for ChAdOx1 nCoV-19. Having completed her doctorate, she got a job with a brewing research centre, looking at how to manipulate brewing yeast, before moving on to work in human health. Clinical trials are an essential part of vaccine development. The candidate vaccine was licensed to AstraZeneca for further development. Her son Freddie describes his mother as always being supportive and having the children's best interests at heart. After occupying temporary laboratory space at the Institute for Animal Health from 1996, the institute moved to a newly completed laboratory building in 1998. "Some colleagues I had at the Jenner Institute always were a little bit intimidated by Sarah. We went pretty fast with it.". It was a decision that led us to the announcement on Tuesday morning that, according to the results of late stage trials, the University of Oxford's coronavirus vaccine is highly effective at stopping people developing Covid-19 symptoms. As a young student in biological sciences at the University of East Anglia, she was energised by the diversity of thought and experience in the department. His group led the first clinical trial of an Ebola virus vaccine targeting the outbreak of Ebola in West Africa. Their vaccine has been tested in six rhesus macaque monkeys at the National Institutes of Health’s Rocky Mountain Laboratory in Montana, that were then exposed to large volumes of the virus causing COVID-19. Professor Pollard obtained his medical degree at St Bartholomew’s Hospital Medical School, University of London in 1989 and trained in Paediatrics at Birmingham Children’s Hospital, UK, specialising in Paediatric Infectious Diseases at St Mary’s Hospital, London, UK and at British Columbia Children’s Hospital, Vancouver, Canada. Sie ist benannt nach Edward Jenner und forscht an Impfstoffen.. Geschichte. The vaccine uses a non-replicating chimpanzee adenovirus to deliver a SARS-CoV-2 spike protein to induce an immune response. There have been anti-vaccination movements at least since 1796, when Edward Jenner invented the smallpox vaccine. The pair agreed that the Serum Institute would start mass-manufacturing the vaccine ChAdOx1 nCoV-19 created by Jenner. The vaccine is being developed by the Jenner Institute, an independent research group working as part of the Oxford Vaccine Group. Her research focusses on studying samples from clinical trial volunteers to determine the strength of their immune response to the trial vaccines, and to work out which features of the immune response correspond to protection against disease. 265 en parlent. The second trial of that vaccine was just beginning when, in early 2020, Covid-19 emerged in China. And other questions. It even has its own pilot manufacturing plant that can make a batch of up to 1,000 doses. "From the beginning, we're seeing it as a race against the virus, not a race against other vaccine developers," she said earlier this year. He obtained his PhD at St Mary’s Hospital, London, UK in 1999 studying immunity to Neisseria meningitidis (meningitis) in children and proceeded to work on anti-bacterial innate immune responses in children in Canada before returning to his current position at the University of Oxford, UK in 2001. The Jenner Institute tested a vaccine for an earlier coronavirus last year, showing it was not harmful to humans. She had never meant to be a vaccine specialist. The pair agreed that the Serum Institute would start mass-manufacturing the vaccine ChAdOx1 nCoV-19 created by Jenner. Interim data suggests it affords 70% protection, but researchers say the figure may be as high as 90% by tweaking the dose. Jenner Institute. The vaccine candidate was developed by the University’s Jenner Institute who began trials in humans last week jointly with the University’s Oxford Vaccine Group. LONDON – Researchers at the Jenner Institute in Oxford have given an inside view of how they are accelerating clinical development of a COVID-19 vaccine and at the same time putting in place commercial manufacturing for when phase III efficacy data …

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