Parallel Outbreaks of Deadly Pathogens
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A Multicenter, Multi-Outbreak, Randomized, Controlled Safety And
2018 Ebola MCM RCT Protocol Page 1 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients with Ebola Virus Disease Short Title: 2018 Ebola MCM RCT Protocol Sponsored by: Office of Clinical Research Policy and Regulatory Operations (OCRPRO) National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Bethesda, MD 20892 NIH Protocol Number: 19-I-0003 Protocol IND #: 125530 ClinicalTrials.gov Number: NCT03719586 Date: 4 October 2019 Version: 7.0 CONFIDENTIAL This document is confidential. No part of it may be transmitted, reproduced, published, or used by other persons without prior written authorization from the study sponsor and principal investigator. 2018 Ebola MCM RCT Protocol Page 2 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 KEY ROLES DRC Principal Investigator: Jean-Jacques Muyembe-Tamfum, MD, PhD Director-General, DRC National Institute for Biomedical Research Professor of Microbiology, Kinshasa University Medical School Kinshasa Gombe Democratic Republic of the Congo Phone: +243 898949289 Email: [email protected] Other International Investigators: see Appendix E Statistical Lead: Lori Dodd, PhD Biostatistics Research Branch, DCR, NIAID 5601 Fishers Lane, Room 4C31 Rockville, MD 20852 Phone: 240-669-5247 Email: [email protected] U.S. Principal Investigator: Richard T. Davey, Jr., MD Clinical Research Section, LIR, NIAID, NIH Building 10, Room 4-1479, Bethesda, -
Influenza Booklet
Explaining Courtesy of Your Pinal County Board of Supervisors FOREWORD As members of the Pinal County Board of Supervisors, we ask each citizen to review this booklet as a first step towards pandemic influenza preparedness. This booklet contains the information needed to understand how to help prevent this disease and how to create a preparedness plan for your home and business. Recently it has been difficult to read a newspaper or watch a newscast without some mention of the avian influenza (flu) or influenza (flu) pandemic. Throughout history, flu pandemics have proven to have devastating effects on the health of our communities and economy. In 1918, the world was devastated by the Spanish Flu Pandemic. The Spanish flu killed around 675,000 Americans and tens of millions worldwide. Today, we are the first generation in history to anticipate a flu pandemic. Your federal, state, and local governments have been working for the past two years on plans to minimize the potentially devastating effects of a flu pandemic. Scientific experts throughout the world agree that it is simply a matter of time before the world sees its next flu pandemic. The avian flu is a potential, and some say likely, source of the next flu pandemic and as such its effects and transmission throughout flocks of poultry and wild birds is being closely monitored worldwide. The concern that health officials have regarding avian flu is that the effects closely mimic that of the devastating Spanish Flu Pandemic of 1918. At this point avian flu is only easily transmissible between birds. However, a mutation could take place at any time that would allow transmission between humans to occur as easily as it does each year for seasonal flu. -
The Next Influenza Pandemic: Lessons from Hong Kong, 1997
Perspectives The Next Influenza Pandemic: Lessons from Hong Kong, 1997 René Snacken,* Alan P. Kendal, Lars R. Haaheim, and John M. Wood§ *Scientific Institute of Public Health Louis Pasteur, Brussels, Belgium; The Rollins School of Public Health, Emory University, Atlanta, Georgia, USA; University of Bergen, Bergen, Norway; §National Institute for Biological Standards and Control, Potters Bar, United Kingdom The 1997 Hong Kong outbreak of an avian influenzalike virus, with 18 proven human cases, many severe or fatal, highlighted the challenges of novel influenza viruses. Lessons from this episode can improve international and national planning for influenza pandemics in seven areas: expanded international commitment to first responses to pandemic threats; surveillance for influenza in key densely populated areas with large live-animal markets; new, economical diagnostic tests not based on eggs; contingency procedures for diagnostic work with highly pathogenic viruses where biocontainment laboratories do not exist; ability of health facilities in developing nations to communicate electronically, nationally and internationally; licenses for new vaccine production methods; and improved equity in supply of pharmaceutical products, as well as availability of basic health services, during a global influenza crisis. The Hong Kong epidemic also underscores the need for national committees and country-specific pandemic plans. Influenza pandemics are typically character- Novel Influenza Viruses without ized by the rapid spread of a novel type of Pandemics influenza virus to all areas of the world, resulting In addition to true pandemics, false alarms in an unusually high number of illnesses and emergences of a novel strain with few cases and deaths for approximately 2 to 3 years. -
AVIAN INFLUENZA Working with Your Birds
How Do I Protect my Flock from AI? • Practice Biosecurity: disease prevention management: • People: Avoid visiting other poultry farms, bird shows and markets. If you do, shower, change clothing and footwear before AVIAN INFLUENZA working with your birds. Have visitors wear protective clothing and footwear and visa versa. “BIRD FLU” • Equipment: Do not loan or borrow equipment or vehicles from FREQUENTLY ASKED QUESTIONS other farms. If you do, wash and disinfect all equipment before and after use. Wash and disinfect your vehicle/trailers/crates (including tires and undercarriage) after leaving a poultry farm, show or market. Keep your bird houses, What Kind of Poultry pens, equipment and work areas clean and sanitary. Surveillance is Being Done Now? • • Birds: Keep a closed flock. Do not bring new birds from poultry AI has been a concern to the poultry industry long before the HP shows and markets back into the flock–this is a great way to H5N1 strain appeared. Monitoring in the U.S. for AI is routine and introduce any disease. Separate new birds away from the flock for will be continued. • 4 weeks to see if they show any signs of disease. Keep your birds In FL, through FDACS, testing is performed on commercial and separate from wild birds and from lakes or ponds that may be used backyard poultry and necropsies are performed on all poultry by wild water fowl. Take sick or dead birds to a diagnostic lab to submission to the laboratories. • determine cause of illness. Surveillance is performed at small animal sales, live bird markets • Rodents, wild birds: keep rodents and wild birds away from your and at fairs and exhibitions. -
Accelerating R&D for Emerging Infectious Diseases: Lessons
Accelerating R&D for Emerging Infectious Diseases: Lessons Learnt From Ebola Chao Li China CDC Jingyi Chen Harvard University Jiyan Ma Peking University Health Science Centre Yangmu Huang ( [email protected] ) Peking University Health Science Centre https://orcid.org/0000-0002-3660-1276 Research Article Keywords: Ebola Virus Disease, Emerging Infectious Disease, Research and Development Posted Date: July 2nd, 2020 DOI: https://doi.org/10.21203/rs.3.rs-38612/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/12 Abstract Objective: The R&D explosion for Ebola virus disease (EVD) during the 2014-2016 outbreak led to the successful development of high-quality vaccines performed by China and the U.S. This study aims to compare the R&D activities of Ebola-related medical products in two countries, as a way to present the inuential factors of R&D for emerging infectious disease (EID) and to provide suggestions for timely and ecient R&D response to the COVID-19 pandemic. Methods: In this comparative study, R&D activities were analyzed in terms of research funding, scientic research outputs, R&D timeline, and government incentive and coordinated mechanisms. Quantitative analysis was performed using data retrieved from national websites, clinical trial registries and databases.Qualitative semi-structured interviews were conducted to explore perspectives of fteen key informants from EID eld, especially of those involved in Ebola product development. Findings: The funding gap between China and the U.S. was signicant before 2014 and narrowed after the Ebola outbreak. Both research teams started basic studies prior to the Ebola outbreak; however, the U.S. -
Early Surveillance and Public Health Emergency Responses Between Novel Coronavirus Disease 2019 and Avian Influenza in China: a Case-Comparison Study
ORIGINAL RESEARCH published: 10 August 2021 doi: 10.3389/fpubh.2021.629295 Early Surveillance and Public Health Emergency Responses Between Novel Coronavirus Disease 2019 and Avian Influenza in China: A Case-Comparison Study Tiantian Zhang 1,3†, Qian Wang 2†, Ying Wang 2, Ge Bai 2, Ruiming Dai 2 and Li Luo 2,3,4* 1 School of Social Development and Public Policy, Fudan University, Shanghai, China, 2 School of Public Health, Fudan University, Shanghai, China, 3 Key Laboratory of Public Health Safety of the Ministry of Education and Key Laboratory of Health Technology Assessment of the Ministry of Health, Fudan University, Shanghai, China, 4 Shanghai Institute of Infectious Disease and Biosecurity, School of Public Health, Fudan University, Shanghai, China Background: Since the novel coronavirus disease (COVID-19) has been a worldwide pandemic, the early surveillance and public health emergency disposal are considered crucial to curb this emerging infectious disease. However, studies of COVID-19 on this Edited by: Paul Russell Ward, topic in China are relatively few. Flinders University, Australia Methods: A case-comparison study was conducted using a set of six key time Reviewed by: nodes to form a reference framework for evaluating early surveillance and public health Lidia Kuznetsova, University of Barcelona, Spain emergency disposal between H7N9 avian influenza (2013) in Shanghai and COVID-19 in Giorgio Cortassa, Wuhan, China. International Committee of the Red Cross, Switzerland Findings: A report to the local Center for Disease Control and Prevention, China, for *Correspondence: the first hospitalized patient was sent after 6 and 20 days for H7N9 avian influenza and Li Luo COVID-19, respectively. -
Avian Influenza Outbreaks in the United States Q&A
USDA Questions and Answers: Avian Influenza Outbreaks in the United States April 2015 Avian Influenza in the United States Q. Does highly pathogenic avian influenza currently exist in the United States? A. Since mid-December 2014, there have been several ongoing highly pathogenic avian influenza (HPAI) H5 incidents along the Pacific, Central and Mississippi Flyways. Cases in wild birds, captive wild birds, backyard poultry or commercial poultry have been reported in Arkansas, California, Iowa, Idaho, Kansas, Minnesota, Missouri, Montana, North Dakota, Nevada, Oregon, Utah, South Dakota, Washington, Wisconsin and Wyoming. Details are available on the APHIS website. The HPAI strains detected recently in these flyways are H5N2, H5N8 and H5N1, but primarily H5N2 in turkey flocks. Q. Can people catch these highly pathogenic avian influenza strains that are being detected in these outbreaks? A. CDC considers the risk to people from these HPAI H5 viruses in wild birds, backyard flocks, and commercial poultry, to be low. No human infections with these viruses have been detected at this time, however, similar viruses have infected people. It’s possible that human infections with these viruses may occur. While human infections are possible, infection with avian influenza viruses in general are rare and – when they occur – these viruses have not spread easily to other people. These reports of H5-infected wild birds and poultry in the United States do not signal the start of a pandemic. Q. How is USDA dealing with these HPAI outbreaks? A. The United States has the strongest AI surveillance program in the world so that the food supply remains safe. -
Avian Influenza Viruses in Hong Kong: Zoonotic Considerations
2 Avian influenza viruses in Hong Kong: zoonotic considerations K.F. Shortridge Abstract Since the mid-1970s, Hong Kong has functioned as an influenza sentinel post for southern China, a region identified as a hypothetical epicentre for the emergence of pandemic influenza viruses. Nineteen ninety-seven marked the coming-of-age of animal-influenza studies with the recognition in Hong Kong of an incipient pandemic situation brought about by the infection of chicken and humans with an avian influenza H5N1 (H5N1/97) virus. Slaughter of all poultry across the Hong Kong SAR possibly averted a pandemic. Tracking down the source of the H5N1/97 virus to geese and quail and precursor avian H5N1, H9N2 and H6N1 viruses revealed that it was a triple reassortant. This provided a framework for influenza-pandemic preparedness at the baseline avian level, H5N1-like viruses being recognized in chicken in 2001 and twice in 2002; at the human level, H9N2 and H5N1-like isolations were made in 1999 and 2003, respectively. In contrast to Europe and elsewhere, where outbreaks of disease in chicken (by H5 and H7 subtypes) often follow migratory bird activity in an area and the subsequent detection of low-pathogenic avian influenza (LPAI) and highly pathogenic avian influenza (HPAI) virus forms, in southern China, chicken and other poultry are raised in a permanent, year-round avian-influenza milieu as a consequence of duck-raising practices. Given this long-established milieu, the question is raised whether East- Asian avian influenza viruses comprise a group with a greater propensity for interspecies transmission and potential for pandemicity. -
Joint Press Release Between Africa Cdc and Who on The
Press Release No…… JOINT PRESS RELEASE BETWEEN AFRICA CENTRES FOR DISEASE CONTROL AND PREVENTION AND THE WORLD HEALTH ORGANIZATION ON THE SITUATION OF EBOLA VIRUS DISEASE OUTBREAK IN THE DEMOCRATIC REPUBLIC OF CONGO Addis Ababa, Ethiopia & Brazzaville, Republic of Congo, 19 July 2019. On 17 July 2019, the World Health Organisation (WHO) Director General, Dr Tedros Adhanom GheBreyesus, declared the ongoing EBola virus disease (EVD) outbreak in the Democratic RepuBlic of Congo (DRC) as a Public Health Emergency of International Concern (PHEIC). A PHEIC is defined in the IHR (2005) as, “an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response”i. As of 18 July 2019, the Ministry of PuBlic Health of the DRC reported 2,532 cases (2,438 confirmed and 94 probable) with 1,705 deaths and 718 cured. In declaring the DRC EVD outbreak a PHEIC, the WHO took into consideration the first confirmed case in Goma, a city of almost two million inhaBitants and close to the border with Rwanda, and the gateway to the rest of DRC and the world. Between 2009 and 2019, there have been five PHEIC declarations.ii Declaration of a PHEIC is a call to action. Therefore, it is time for the African continent and indeed the world to redouble our efforts in solidarity with the DRC to end this outBreak and Build a stronger health system. In view of the PHEIC declaration, Africa Centres for Disease Control and Prevention (Africa CDC) and the WHO Regional Office for Africa would like to reiterate the need for all Member States to adhere to the recommendations made, emphasising the following: • No country should close its borders or place any restrictions on travel and trade, including general quarantine of travelers from the Ebola-affected countries, currently the DRC. -
Avian Flu | Poultry Workers
QUICK CARDTM Avian Flu Poultry Workers Avian flu is a viral disease and it can be very contagious and even deadly in poultry (e.g., chickens, turkeys, ducks). Of great concern are the highly pathogenic avian influenza (HPAI) viruses (e.g., H5N1, H7N9) that have killed millions of birds and have infected humans in other countries. If avian flu viruses are detected in the U.S., take appropriate precautions. Signs of Avian Flu Illness in Birds Sudden death; lack of energy, appetite, and coordination; purple discoloration and/or swelling of various body parts; diarrhea; nasal discharge; coughing; sneezing; and reduced egg production and/or soft-shelled or misshapen eggs. Avian Flu Symptoms in Humans Range from fever, cough, sore throat and muscle aches to nausea, abdominal pain, vomiting, diarrhea, eye infections, difficulty breathing, pneumonia and severe respiratory disease. Symptoms may depend on which virus caused the infection but are often similar to those of human seasonal influenza. When Engaged in Depopulation Activities • Wash hands thoroughly (for at least 15 seconds) and frequently, preferably with soap and water (or an alcohol- based hand rub, if soap and water are not available). • Wear lightweight, disposable gloves or heavy-duty rubber work gloves that can be disinfected. Avoid touching your face with gloved hands. Wash hands after removing gloves and other personal protective equipment (PPE). • Wear disposable outer garments, coveralls or surgical gowns with long, cuffed sleeves and with a sealed apron. • Wear disposable shoe covers or boots that can be cleaned and disinfected. • Wear safety goggles and disposable head or hair cover. -
Episouth Weekly Epi Bulletin – N°104 10 March 2010 – 16 March 2010
EpiSouth Weekly Epi Bulletin – N°104 Département International & 10 March 2010 – 16 March 2010 Tropical The objective of the bulletin is to report new heath events occurring outside and inside EpiSouth area that have potential implications on EpiSouth population. It does not aim to provide an exhaustive review of international alerts. Since 2006, The French public health Institute (InVS) is issuing an online epidemic intelligence bulletin (Bulletin hebdomadaire International - BHI). In order to limit duplication and to make this already verified information available to a larger audience, information relating to health events of interest for EpiSouth population are translated and integrated in the relevant e-web sections. Despite all verifications, WP6 team would not be responsible for potential errors. The recipient is responsible for the cautious use of this information. Neither the European Commission nor any person acting on behalf of the Commission is liable for the use that may be made of the information contained in this report. Data maps and commentary used in this document do not imply any opinion of EpiSouth countries or its partners on the legal status of the countries and territories shown or concerning their borders. INDEX e-WEB n°104 . A(H5N1) Human influenza – Vietnam . A(H5N1) Avian influenza – Nepal, Romania . “OUTSIDE” Events: . Polio – Africa . “INSIDE” Events: none Location: Vietnam Event: A(H5N1) – Human Comments On 12 march 2010, Vietnamese health authorities reported a new human case of A(H5N1) influenza in Hanoi, in the province of Soc Son (map 1). The case was a 25 yrs old female, she presented symptoms on 7 march 2010, she was hospitalised in Bach Mai and is in a critical condition. -
1918 Spanish Influenza: the Secrets Remain Elusive Robert G
Proc. Natl. Acad. Sci. USA Vol. 96, pp. 1164–1166, February 1999 Commentary 1918 Spanish influenza: The secrets remain elusive Robert G. Webster Department of Virology and Molecular Biology, St. Jude Children’s Research Hospital, 332 North Lauderdale, Memphis, TN 38105 The worst pandemic of influenza ever recorded was caused by Phylogenetic analysis indicates that the 1918 HAs are mam- the 1918 Spanish influenza virus. Emotional reports of fit and malian-like and are located near the root of the human and healthy soldiers falling down on parade and dying the same or swine clades, whereas analysis of the antigenic and receptor the next day are recorded (1). An initial mild wave of infection binding sites indicates that the virus resembles the avian occurred in the spring of 1918 and the lethal wave appeared consensus. The pattern of glycosylation is similar to that found throughout the world, in the fall. At least 20 million persons in both avian and swine influenza viruses. Additional com- died worldwide and probably 10 times that number were plexity is added by the postulation that the H1N1 viruses were affected. The origin of this virus and the basis of high introduced into humans sometime between 1900 and 1915. pathogenicity have remained elusive for the virus is not Let us begin by considering the possible dates of introduc- available for study. tion into humans. Analysis of the HA places this date at about Interest in the causative agent of the 1918 pandemic is not 1905 (9, 10), and analysis of the nucleoprotein (NP) genes from new.