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What You Need to Know About Rabies
WHAT YOU NEED TO KNOW ABOUT RABIES ASSOCIATION OF IMMUNIZATION MANAGERS FEBRUARY 2021 Bavarian Nordic is a fully integrated, leading biotechnology company focused on the research, development, innovation, manufacturing and commercialization of vaccines for the prevention and treatment of life-threatening diseases 1 VIRAL DISEASE ALMOST ALWAYS FATAL IF UNTREATED Paralytic rabies Ascending spread of flaccid Classical (furious) rabies Onset of coma DEATH muscle weakness, bilateral Hyper-excitability, periods weakness of facial muscles, of confusion, hallucinations, sphincter involvement agitation and hydrophobia Coma (0–14 days) Acute neurological phase (2–7 days) Nonspecific symptoms Fever, malaise, chills, fatigue, First neurological signs insomnia, anorexia, headache, (>10 days) anxiety, irritability Prodromal phase (2–10 days) Exposure Bite or scratch from, or Incubation of virus mucosal contact with, (20–90 days) a rabid animal 1. Jackson et al. In Rabies (2nd edition). Chapter 7. 2007: 309–340; 2. WHO. Wkly Epidemiol Rec 2018; 93: 201–20; 3. Hemachudha et al. Lancet Neurol 2002;1:101–9; 4. WHO. Rabies: Fact Sheet. https://www.who.int/en/news-room/fact-sheets/Detail/rabies [accesseD July 2020]. PREVALENCE IN THE USA Rabies transmission in dogs has been virtually eliminated in the USA, in part due to widespread canine vaccination programs5 • As a result, wildlife has accounted for >90% of rabid animals reported in the USA since 19805-7 • Primary vectors in this region are skunks, foxes, raccoons, bats and mongooses (in Puerto Rico)5-7 • In the US, the primary rabies vector is the bat due to encounters with bats that may be less recognized e.g. -
T. Franklin Williams Scholars Program
Developing a New Generation of Medical Subspecialists with Expertise in Aging and Care of the Elderly T. Franklin Williams Scholars Program Report to T. Franklin Williams Scholars Program Evaluation Team ASP Geriatrics Steering Committee Integrating Geriatrics Project Evaluation Team May 2011 Submitted by: Erika D. Tarver Project Administrator Association of Specialty Professors 330 John Carlyle Road Suite 610 Alexandria, VA 22314 T: (703) 341-4540 F: (703) 519-1890 [email protected] Kevin P. High, MD Principal Investigator William R. Hazzard, MD Co-Principal Investigator Table of Contents Narrative Progress Report Application and Award Progress Summary of Success of T. Williams Scholars Program Appendices A. 2008 Scholars 24-Month Progress Reports Neena S. Abraham, MD (Note: This is Dr. Abraham’s final report) Steven G. Coca, DO Jeffrey G. Horowitz, MD Danelle F. James, MD Heidi Klepin, MD George C. Wang, MD 2009 Williams Scholars Progress Reports and Summary of 18-Month Questionnaire B. Peter Abadir, MD 12-month Progress Report C. Kathleen M. Akgun, MD 12-Month Progress Report Publication D. Alison Huang, MD 12-Month Progress Report Publication E. Eswar Krishnan, MD 12-Month Progress Report Publication F. Rohit Loomba, MD Publication G. Sharmilee Nyenhuis, MD 12-Month Progress Report Publication H. Peter P. Reese, MD 12-Month Progress Report Publication I. Erik B. Schelbert, MD 12-Month Progress Report Publication J. Helen Keipp Talbot, MD 12-Month Progress Report Publication K. Summary of 18-Month Questionnaire 2010 Williams Scholars Mentor Interviews and Summary of Six-Month Questionnaire L. Kellie Hunter-Campbell, MD Six-Month Mentor Interview M. -
Valneva and Bavarian Nordic Announce Marketing and Distribution Partnership
VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva and Bavarian Nordic Announce Marketing and Distribution Partnership Saint-Herblain, France, June 18, 2020 – Valneva SE, (“Valneva”), a specialty vaccine company, and Bavarian Nordic A/S (OMX: BAVA) today announced that they have signed a binding term sheet to establish a partnership for the marketing and distribution of their commercial products. The partnership will provide both companies with additional critical mass, significant commercial synergies and a market leadership position in the specialty vaccine industry. Under the agreed terms, Valneva will commercialize Bavarian Nordic’s marketed vaccines leveraging its commercial infrastructure in Canada, UK, France and Austria. Valneva will also take responsibility for Belgium and the Netherlands where it will set up new commercial operations. Bavarian Nordic will commercialize Valneva’s marketed products in Germany and Switzerland. The partnership includes vaccines that protect against rabies, Japanese Encephalitis, tick-borne encephalitis and cholera. The agreement follows Bavarian Nordic’s recent acquisition of two commercial vaccines from GlaxoSmithKline. The transition from current arrangements will commence later this year and through 2021 in line with existing distribution agreements. Valneva expects limited additional revenues in 2020 with more material impact from 2021 onwards. Thomas Lingelbach, CEO of Valneva, commented, “We are excited to join forces with Bavarian Nordic to continue to build our commercial business and to enhance our product offering to our customers. This partnership provides excellent synergy for both companies as well as greater breadth in our commercial portfolios.” Paul Chaplin, President & CEO of Bavarian Nordic, added, “We are pleased to collaborate with Valneva in the ongoing commercialization of our business. -
Written Statement for Dr. Anthony Fauci, Director, NIAID
DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH The Role of the National Institute of Allergy and Infectious Diseases Research in Addressing Ebola Virus Disease Testimony before the House Foreign Affairs Committee Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations Anthony S. Fauci, M.D. Director National Institute of Allergy and Infectious Diseases September 17, 2014 Mr. Chairman and Members of the Committee: Thank you for the opportunity to discuss the National Institutes of Health (NIH) response to the global health emergency of Ebola virus disease. I direct the National Institute of Allergy and Infectious Diseases (NIAID), the lead institute of the NIH for conducting and supporting research on infectious diseases, including viral hemorrhagic fevers such as those caused by Ebola virus infection. For over six decades, NIAID has made important contributions to advancing the understanding of infectious, immunologic, and allergic diseases, from basic research on mechanisms of disease to applied research to develop diagnostics, therapeutics, and vaccines. NIAID has a dual mandate that balances research addressing current biomedical challenges with the capacity to respond quickly to newly emerging and re-emerging infectious diseases, including bioterror threats. Critical to these efforts are NIAID’s partnerships with academia and pharmaceutical companies, and collaborations with other federal entities, particularly the Centers for Disease Control and Prevention, the Food and Drug Administration (FDA), the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense. OVERVIEW OF EBOLA VIRUS DISEASE Viral hemorrhagic fevers are severe illnesses that can be fatal and are caused by a diverse group of viruses including Marburg virus, Lassa virus, and Ebola virus. -
Journal Pre-Proof
Journal Pre-proof Neutralizing monoclonal antibodies for COVID-19 treatment and prevention Juan P. Jaworski PII: S2319-4170(20)30209-2 DOI: https://doi.org/10.1016/j.bj.2020.11.011 Reference: BJ 374 To appear in: Biomedical Journal Received Date: 2 September 2020 Revised Date: 6 November 2020 Accepted Date: 22 November 2020 Please cite this article as: Jaworski JP, Neutralizing monoclonal antibodies for COVID-19 treatment and prevention, Biomedical Journal, https://doi.org/10.1016/j.bj.2020.11.011. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Chang Gung University. Publishing services by Elsevier B.V. TITLE: Neutralizing monoclonal antibodies for COVID-19 treatment and prevention Juan P. JAWORSKI Consejo Nacional de Investigaciones Científicas y Técnicas, Buenos Aires, Argentina Instituto Nacional de Tecnología Agropecuaria, Buenos Aires, Argentina KEYWORDS: SARS-CoV-2, Coronavirus, Monoclonal Antibody, mAb, Prophylaxis, Treatment CORRESPONDING AUTHOR: Dr. Juan Pablo Jaworski, DVM, MSc, PhD. Consejo Nacional de Investigaciones Científicas y Técnicas Instituto de Virología, Instituto Nacional de Tecnología Agropecuaria Las Cabañas y de los Reseros (S/N), Hurlingham (1686), Buenos Aires, Argentina Tel / Fax: 054-11-4621-1447 (int:3400) [email protected] ABSTRACT The SARS-CoV-2 pandemic has caused unprecedented global health and economic crises. -
Bavarian Nordic Annual Report 2018 Management Commentary | Financial Statements
Unlocking the power of the ANNUAL immune system REPORT 2018 199425 2019 YEARS OF GREAT ACHIEVEMENTS IN THE VACCINE SPACE STIMULATING THE IMMUNE SYSTEM GIVING HOPE TO MILLIONS Management commentary | Financial statements CONTENTS MANAGEMENT FINANCIAL COMMENTARY STATEMENTS INTRODUCTION BUSINESS AND PIPELINE CONSOLIDATED FINANCIAL STATEMENTS Letter from the CEO & chairman .................... 4 Product pipeline.................................. 20 Consolidated income statements .................. 68 At a glance ....................................... 6 Infectious disease ................................ 22 Consolidated statements of comprehensive 25 years of great achievements .................... 8 Our partnership with Janssen ...................... 28 income .......................................... 68 Key developments................................ 10 Cancer immunotherapy ........................... 36 Consolidated statements of cash flow.............. 69 A word from the new CFO......................... 12 Chordoma........................................ 38 Consolidated statements of financial position Strategy track ................................... .16 – assets ......................................... 70 Financial results for 2018 ......................... .18 CORPORATE INFORMATION Consolidated statements of financial position The Bavarian Nordic share ........................ .46 – equity/liabilities ............................... 71 Corporate social responsibility .................... .48 Consolidated statements of changes in -
CP-162837 Johnson & Johnson Announces European Commission
News Release Media Contacts: Seema Kumar +1 908-405-1144 [email protected] Sarah Smith +44 7920 082012 [email protected] Investor Relations: Jennifer McIntyre +1 732-524-3922 Chris DelOrefice +1 732-524-2955 Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine This marks the first major regulatory approval of a vaccine developed by Janssen The Ebola vaccine regimen leverages Janssen’s AdVac® technology, plus Bavarian Nordic’s established MVA-BN® technology Janssen’s AdVac® technology is also being used to develop a vaccine candidate to prevent COVID-19 NEW BRUNSWICK, N.J., 1 July 2020 – Johnson & Johnson today announced that the European Commission (EC) has granted Marketing Authorisation for its Janssen Pharmaceutical Companies’ Ebola vaccine regimen for the prevention of Ebola Virus Disease. Enabled by this approval, Janssen is now collaborating with the World Health Organization (WHO) on vaccine pre-qualification, which should help accelerate registration of its preventive Ebola vaccine regimen in African countries and facilitate broader access to those most in need. Two Marketing Authorisation Applications (MAAs) were submitted to the European Medicines Agency (EMA) for the vaccines composing the two-dose regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo). Marketing Authorisation under exceptional circumstances has been granted following Accelerated Assessment of the MAAs and a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Janssen’s Ebola vaccine regimen is indicated for active immunization for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus species in individuals aged one year and above. -
HIV?AIDS Researchers at the NIH Clinical Center
The NIH Clinical Center treats a diverse group of patients from all over the world. It also draws researchers from different cultures and backgrounds. Learn more about some of the many researchers who conduct their work on the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) at the Clinical Center. Thomas C. Quinn, M.D., M.Sc., conducts research for the National Institute of Allergy and Infectious Diseases at the NIH Clinical Center. He is a senior investigator and chief of the International HIV/STD Section of the Laboratory of Immunoregulation. Dr. Quinn obtained his M.D. from Northwestern University. He was a research associate in infectious diseases in the NIAID Laboratory of Parasitic Diseases and completed a fellowship in infectious diseases at the University of Washington. Since 1981, he has been assigned to the division of infectious diseases at Johns Hopkins University, where he became a professor of medicine in 1991. Dr. Quinn is a member of the Institute of Medicine and the National Academy of Sciences and is a fellow of the American Association for the Advancement of Science. His major areas of research are: Definition of epidemiologic features of HIV-1 and HIV-2 infections in developing countries and the United States Assessment of biomedical interventions to control HIV, including circumcision, prevention of mother-to-child transmission, pre-exposure prophylaxis, and vaccine development Assessment of the frequency of Chlamydia trachomatis infections in selected populations using noninvasive sensitive nucleic-acid amplification assays for diagnosis Evaluations of interventions to control blinding trachoma due to Chlamydia trachomatis in sub-Saharan Africa See the full program description. -
That Record-Breaking Sprint to Create a COVID-19 Vaccine The
NATIONAL INSTITUTES OF HEALTH • OFFICE OF THE DIRECTOR | VOLUME 29 ISSUE 5 • SEPTEMBER-OCTOBER 2021 That Record-breaking The Intersection of Man and Machine Sprint to Create a Bionics Gives New Hope to Those Living With Physical Disabilities COVID-19 Vaccine BY MICHAEL TABASKO, OD BY MELISSA GLIM At the end of 2019, most people were looking forward to an exciting 2020, a new decade starting with those magic numbers, 20-20, that denote a sharpness of vision. There would be the Summer Olympics in Japan and the U.S. presidential election. Meanwhile, intramural scientists at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC) were designing vaccines for several coronaviruses using a promising, new platform based on messenger RNA (mRNA). Everything changed on a Saturday morning in early January. Chinese scientists CREDIT: TH0MAS BULEA (LEFT); NIH CLINCAL CENTER (RICHT) had isolated a new coronavirus that was (Left) The NIH pediatric exoskeleton for children with cerebral palsy and other movement disorders uses custom actuators causing a serious epidemic in China’s Wuhan from Agilik developed as part of a cooperative research and development agreement with NIH, along with embedded sensors and microcontrollers, to provide overground gait training while worn. (Right) Alexander Theodorakos, a participant province and released its genetic sequence to in a research protocol at the NIH Clinical Center that is evaluating the new pediatric exoskeleton, and Thomas Bulea, the the scientific community around the world. study’s principal investigator, discuss how the device changes the way the legs move when walking. Barney Graham, director of the VRC’s Viral Pathogenesis Laboratory (VPL), and If popular culture is any indication, the notion that bionic technology will VRC research fellow Kizzmekia Corbett someday redefine the boundaries of human function has long held our collective dropped everything and began using this fascination. -
Nci-Plan-2013.Pdf
THE NATIONAL CANCER PROGRAM MANAGING THE NATION’S RESEARCH PORTFOLIO AN ANNUAL PLAN AND BUDGET PROPOSAL FOR FISCAL YEAR 2013 National Cancer Institute U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Contents 1 Foreword 4 Provocative Questions 8 Center for Cancer Genomics 16 Introduction to Cancer Profiles 18 Pancreatic Ductal Adenocarcinoma 22 Colorectal Cancer 26 B-Cell Lymphoma 30 Renal Cell (Kidney) Cancer 34 GI Stromal Cancer 39 Research Focus: Comorbidities 42 Research Focus: Circulating Tumor Cells 44 Research Focus: Reducing Cancer Health Disparities 50 The Frederick National Laboratory for Cancer Research 61 Small Business Innovation Research, Small BusinessTechnology Transfer (SBIR, STTR) 66 NCI Center for Global Health 72 NCI-Designated Cancer Centers 83 Glossary of Terms 84 Budget FOREWORD The National Cancer Program MANAGING THE NATION’S RESEARCH PORTFOLIO his year marks the 75th anniversary of the founding of the National Cancer Institute, the first so-called “categorical institute” of what has become the National Institutes of Health, with its 27 Institutes and Centers. Over the years, the Congress and the public have generously supported the TNCI—and the NIH generally—with sustained budgetary increases. This was especially true for the NCI during the rapid expansion of its budget following the National Cancer Act of 1971 and for the NIH, including the NCI, during the 5-year doubling of its budget, launched in 1998. Both of these eras of rapid growth were remarkably fruitful. The first launched the pursuit of cancer genes and the molecular basis of oncogenesis, laying the foundation for the transformation of clinical oncology that is now occurring. -
NIHAA Update 1Velco111es Lerters and Eastern Europe and at the Undergradu 1968, a Period of Considerable Growth News from Its Readers
The Newsletter of the L NIH Alumni Association Summer 1999 Vol. 11, No. 2 date NIHAA Members Enjoy June Annual Meeting with Henney, Morella Alumni attendi ng the 1999 annual meeting of the NIH.AA were given a first-band briefing on FDA by Dr. Jane E. Henney, the receml y appointed FDA commissioner. Tbe audience also participated in a question and answer exchange witb Rep. Constance A. Morella (R-Md.), who was presented with tbe NIHAA 1999 Public Service Award. Almost I00 alumni attended the June 12 morning meeting at the Mary Woodard Lasker Center on the NIH campus. Henney, wbo was NCI deputy director for five of her lO years at NIH (1985-1995) spoke infonnalJy on some of FDA's principal concerns at this time: the agency's efforts to speed Shown at the NIHAA annual meeting are (from I} NIH alumna Dr. Jane E. Henney, FDA up review without sacrifice of quality commissioner, who spoke on "Back Home Again via Indiana, Kansas and New Mexico," and safeguards; tbe need for recruiting Dr. John F. Sherman, Rep. Constance A. Morella (R-Md.), who received the 1999 NIHAA Public Service Award, and Dr. William S. Jordan, Jr., outgoing NIHAA president. (see A flflual Meeting, p. 12) Director's Advisors Bat 6 for 7 in June Meeting In This Issue Page Choppin To Give Third Research Festival '99 J By Rich McManus NIHAA Shannon Lecture Ca/e11dar 5 The scorecard at the end of a daylong Dr. Purnell W. Cboppin, president of .News .from a11d about Nlf/A;/ me111be1:r (f session of lhe advisory committee to the Howard Hughes Medical lnstirure, the NIH director (ACD) on June 3 read A le11erjro1111he 11e111 Nlf/AIJ preside111 IO will deliver the third James A. -
Johnson & Johnson Joins World Health Organization in Efforts To
Johnson & Johnson Joins World Health Organization in Efforts to Prevent Spread of Ebola in West Africa May 13, 2021 Up to 200,000 Johnson & Johnson Ebola vaccine regimens will be made available as part of a WHO early access clinical program now underway in Sierra Leone Company's Ebola vaccine regimen also receives Prequalification from the WHO The Johnson & Johnson vaccine regimen is designed to be used proactively to induce immunity against Ebola in adults and children NEW BRUNSWICK, N.J., May 13, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) (the Company) today announced the World Health Organization (WHO) and the government of Sierra Leone have begun administering the Company's Ebola vaccine regimen as part of a WHO early access clinical program aimed at preventing further spread of Ebola in West Africa. The vaccine regimen, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) in collaboration with Bavarian Nordic A/S, is being donated to the WHO by Janssen for the purposes of the early access clinical program. Johnson & Johnson also announced that its Ebola vaccine regimen has received Prequalification from the WHO, which will help accelerate its registration in countries where Ebola is a persistent public health threat and facilitate broader access to people at risk of exposure to this virus. Health authorities in Guinea officially declared a new Ebola outbreak in February 2021 after the West African country experienced its first cases of disease since the end of the 2014-2016 Ebola outbreak – which was the worst on record. Preliminary data obtained through genetic sequencing suggest that the new outbreak was caused by the same virus strain also responsible for the 2014-2016 outbreak and was likely reintroduced by a survivor.