Lect 20

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Published on March 10, 2008

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Slide1:  Lecture No. 20 - April 22nd, 2004 International Aspects of Veterinary Vaccines and Diagnostics James Roth International Aspects of Veterinary Vaccines and Diagnostics April 22, 2004 :  International Aspects of Veterinary Vaccines and Diagnostics April 22, 2004 James A. Roth, DVM, PhD Department of Veterinary Microbiology and Preventive Medicine College of Veterinary Medicine Iowa State University, Ames, Iowa 50011 Phone 515 294 8459 E-mail jaroth@iastate.edu Worldwide Importance of Animal Health Professionals:  Worldwide Importance of Animal Health Professionals Need for food production Zoonotic diseases Food Safety Foreign animal diseases Emerging diseases Bioterrorism/Agroterrorism World Population Growth (United Nations Projection):  World Population Growth (United Nations Projection) Past and Projected Consumption Trends of Meat, to the Year 2020:  Past and Projected Consumption Trends of Meat, to the Year 2020 Use of Vaccines in the US:  Use of Vaccines in the US The US is the largest market for manufacturers of veterinary vaccines and accounts for 23% of the $2 billion per year in worldwide sales of veterinary biologics. North America and the European Union together account for almost 50% of the worldwide sales of veterinary biologics. Distribution and Use of Vaccines in the US:  Distribution and Use of Vaccines in the US There are over 1220 vaccine formulations approved by the USDA for use in domestic animals in the US. There are approximately 115 licensed manufacturers of veterinary vaccines in the US. Veterinary Vaccines Licensed for Production and Sale in the US:  Veterinary Vaccines Licensed for Production and Sale in the US Slide9:  Office International des Épizooties World Organisation for Animal Health created in 1924 in Paris OIE List A Diseases are::  OIE List A Diseases are: Transmissible diseases which have the potential for very serious and rapid spread, irrespective of national borders, which are of serious socio-economic or public health consequence and which are of major importance in the international trade of animals and animal products. OIE List B Diseases are::  OIE List B Diseases are: Transmissible diseases which are considered to be of socio-economic and/or public health importance within countries and which are significant in the international trade of animals and animal products. OIE List A Diseases that are Presently in the United States:  OIE List A Diseases that are Presently in the United States Blue tongue Vesicular stomatitis OIE List A Diseases that are not Presently in the United States:  OIE List A Diseases that are not Presently in the United States Foot and Mouth Disease Swine Vesicular Disease Rinderpest Peste des Petits Ruminants Contagious Bovine Pleuropneumonia Lumpy Skin Disease OIE List A Diseases that are not Presently in the United States:  OIE List A Diseases that are not Presently in the United States Rift Valley Fever Sheep Pox and Goat Pox African Horse Sickness African Swine Fever Hog Cholera Highly Pathogenic Avian Influenza Newcastle Disease Vaccines for OIE List A and Emerging Animal Diseases:  Vaccines for OIE List A and Emerging Animal Diseases September 16-18, 2002, Ames, Iowa The purpose of the meeting was to review the availability, safety and efficacy of veterinary vaccines for OIE List A diseases and for selected emerging animal diseases Publication: Vaccines for OIE List A and Emerging Animal Diseases. Developments in Biologicals, F. Brown and J. A. Roth, Eds. Vol 114, 295 pages, 2003 A Survey of Vaccines Produced for OIE List A Diseases in OIE Member Countries James A. Roth, Anna R. Spickler, Developments in Biologicals, F. Brown and J. A. Roth, Eds. Vol 114:5-25, 2003:  A Survey of Vaccines Produced for OIE List A Diseases in OIE Member Countries James A. Roth, Anna R. Spickler, Developments in Biologicals, F. Brown and J. A. Roth, Eds. Vol 114:5-25, 2003 A questionnaire was sent by the OIE to the Chief Veterinary Officer of all OIE member nations:  A questionnaire was sent by the OIE to the Chief Veterinary Officer of all OIE member nations For each OIE List A disease: Does your country manufacture a vaccine? Strain of organism used? Type of product? Adjuvant? Contact information for the manufacturer? Response:  Response Sixty-four countries responded 31 do not manufacture vaccines for list A disease 33 do manufacture vaccines for list A diseases Number of Vaccines:  Number of Vaccines African Horse Sickness African Swine Fever Bluetongue Classical Swine Fever Contagious Bovine Pleuropneumonia Foot and Mouth Disease Avian Influenza Lumpy Skin Disease 4 0 2 42 2 30 3 2 Number of Vaccines:  Number of Vaccines Newcastle Disease Peste des Petits Ruminants Rift Valley Fever Rinderpest Sheep and Goat Pox Swine Vesicular Disease Vesicular Stomatitis Virus >200 2 4 5 5 0 3 Slide21:  Office International des Épizooties World Organisation for Animal Health created in 1924 in Paris Slide22:  162 Member Countries (May 2002) Americas: 28 – Africa: 47 – Europe: 49 – Middle East: 12 – Asia: 26 OIE Objectives:  OIE Objectives To ensure transparency in the animal health situation throughout the world. To collect, analyse and disseminate scientific veterinary information. To contribute expertise and encourage international solidarity in the control of animal diseases. Within its mandate under SPS and WTO Agreement, to safeguard world trade by publishing health standards for international trade in animals and animal products. 5. To improve the legal framework and resources of Veterinary Services. Slide24:  INTERNATIONAL COMMITTEE Administrative Commission Specialist Commissions Code, Standards, Fish, Foot and Mouth Disease Regional Commissions Africa, Americas, Europe, Asia- Far East and Oceania, Middle East Central Bureau Director General Regional Activities Department Administrative and Financial Department Animal Health Information Department Publications Department Scientific and Technical Department International Trade Department OIE Information System:  OIE Information System Promotes transparency and improves knowledge of Global Animal Disease Situation OIE Early Warning System based on official reports from Member Countries Active search and verification of non official information Improve data quality at the field level OIE Global Information System Slide26:  The OIE Early Warning System OIE International Standards:  OIE International Standards International Animal Health Code - mammals, birds and bees International Aquatic Animal Health Code – fish, molluscs and crustaceans Manual of Standards for Diagnostic Tests and Vaccines Diagnostic Manual for Aquatic Animal Diseases Guidelines for the Surveillance of Animal Diseases OIE International Animal Health Code:  OIE International Animal Health Code The OIE International Animal Health Code is a reference document for use by authorities of veterinary departments, import/export services, and anyone involved in international trade. Manual of Standards:  Manual of Standards The purpose of the manual is to contribute to the international harmonization of methods for the surveillance and control of the most important animal diseases. Standards are described for laboratory diagnostic tests and the production and control of biological products for veterinary use across the globe. Aquatic Code:  Aquatic Code The Code provides detailed definitions of minimum health guarantees required of trading partners in order to avoid the risk of spreading aquatic animal diseases, and includes sections on import risk analysis and import/export procedures. The Bulletin:  The Bulletin The Bulletin, published in English, French and Spanish, contains data received each month from national Veterinary Services on the occurrence of new outbreaks of animal diseases, giving priority to the 15 diseases of OIE List A. World Animal Health in 2002:  World Animal Health in 2002 Part 1 compiles the most significant epidemiological events which occurred in 2002 including statistical data on new outbreaks of the most contagious and economically important diseases (OIE List A) which occurred during the year. World Animal Health in 2002:  World Animal Health in 2002 Part 2 is composed of tables providing data by country, on the impact of the 15 List A diseases and the 90 diseases of List B. The tables include the number of outbreaks, cases and death. Information on the Web www.oie.int:  Information on the Web www.oie.int Weekly Disease Information International Standards (Code, Manual, etc.) Veterinary biotechnology Database Scientific and Technical Review (contents and abstracts) General information Collaborating Centres and Reference Laboratories:  Collaborating Centres and Reference Laboratories Collaborating Centres Reference laboratories for diagnosis, control, research and training Slide36:  Institute for International Cooperation in Animal Biologics OIE Collaborating Centre for Diagnosis of Animal Disease and Vaccine Evaluation in the Americas USDA ISU Ames, Iowa USA Institute for International Cooperation in Animal Biologics:  Institute for International Cooperation in Animal Biologics USDA Animal and Plant Health Inspection Service, Veterinary Services Center for Veterinary Biologics National Veterinary Services Laboratories USDA Agriculture Research Service National Animal Disease Center Iowa State University College of Veterinary Medicine OIE/IICAB Veterinary Biologics Training Program, May 12-28, 2004:  OIE/IICAB Veterinary Biologics Training Program, May 12-28, 2004 Block 1: Basic Immunology and Principles of Vaccination (May 12-14) Block 2: Procedures for Ensuring Vaccine Safety and Efficacy (May 17-21) Block 3: Potency and Safety Testing and Diagnostic Test Kit Evaluation (May 24-26) Block 4: Tours of production facilities (for international government regulatory officials only) (May 27-28) Agroterrorism:  Agroterrorism The Soviet Union and Iraq are both known to have developed biological weapons targeting domestic animals and crops. Bin Ladin called for attacks on the U.S. economy. Homeland Security Presidential Directive 9: Defense of US Agriculture and Food:  Homeland Security Presidential Directive 9: Defense of US Agriculture and Food Published January 30, 2004 Directs the establishment of a “National Veterinary Stockpile containing sufficient amounts of animal vaccine, antiviral, or therapeutic products to appropriately respond to the most damaging animal diseases” Characteristics of an Effective Agent Against Animals:  Characteristics of an Effective Agent Against Animals Highly contagious, infectious, and pathogenic Survives well in environment Easy to obtain and grow Outbreak attributable to natural circumstances Cause an import ban by other countries Induce economic hardship Foreign animal disease (FAD) U.S. animals highly susceptible Potential Agroterrorism Pathogens:  Potential Agroterrorism Pathogens Foot-and-mouth disease virus African horse sickness virus African swine fever virus Avian influenza virus Hog cholera virus Lumpy skin disease virus Newcastle disease virus Peste des petits ruminants virus Rinderpest virus Vesicular stomatitis virus Others Potential Bioterrorism Pathogens:  Potential Bioterrorism Pathogens Zoonotic pathogens Rift Valley fever virus Eastern, Western, and Venezuelan Equine Encephalitis Nipah virus Bacillus anthracis Brucella spp. Burkholderia spp. Francisella tularensis Yersinia pestis Others Emerging Diseases:  Emerging Diseases Over the past 20 years an average of one new serious infectious disease threat of military importance has emerged every year somewhere in the world. HIV/AIDS and Ebola are examples. Causes of Infectious Disease Emergence:  Causes of Infectious Disease Emergence Deforestation Intensive animal housing Mixing of species Increased trade travel and migration Poor sanitation and hygiene War and civil disorder Climate change Over use of antibiotics Nipah Virus:  Nipah Virus Paramyxovirus first isolated in March 1999 in Malaysia Respiratory and neurologic syndrome in swine Encephalitis in humans (more than 200 cases, with more than 100 deaths) Initially mistaken for Japanese encephalitis virus Slaughter eradication program (more than a million pigs slaughtered) Agent:  Agent Paramyxovirus Related to Hendra virus New genus: Henipavirus Unusual among Paramyxoviruses Infection and fatal disease in several species Human, porcine, equine, canine, feline Photo from CDC Reservoir:  Reservoir Flying foxes (fruit bats) Carry the virus Are not affected Virus found in Urine Partially eaten fruit Migratory in most of SE Asia Slide51:  Nipah Field Investigations - Malaysia Major Challenges for Vaccine Development:  Major Challenges for Vaccine Development Biosafety level 4 pathogen Access to viral genetic material Foreign animal disease Recombinant vaccine work in BL2+ lab and BL3 Ag animal facility USDA Import permits Proprietary rights to vaccine vectors USDA APHIS Center for Veterinary Biologics approval for vaccine transport, use, and export Funding Nipah Virus Vaccine and Companion Diagnostic Test Development:  Nipah Virus Vaccine and Companion Diagnostic Test Development Collaborative project between Veterinary Research Institute of Malaysia ISU College of Veterinary Medicine US Centers for Disease Control and Prevention USDA Plum Island Animal Disease Center USDA APHIS National Veterinary Services Laboratories Canadian Food Inspection Agency Merial Animal Health Collaborators:  Collaborators Veterinary Research Institute, Ipoh, Malaysia Aziz Jamaludin, DVM, PhD; Jasbir Singh, DVM, MS Experience with Nipah virus diagnostics Supply known positive swine sera Design and conduct studies to evaluate vaccine and diagnostic test if there is another outbreak of Nipah Collaborators:  Collaborators Iowa State University, College of Veterinary Medicine James A, Roth, DVM, PhD; Ratree Platt, DVM, PhD Coordinate project Seek funding USDA ARS NIH Evaluate antibody and T cell responses to vaccine Evaluation of Antibody and T Cell Responses:  Evaluation of Antibody and T Cell Responses Biosafety Level 4 Agent Use 2 different recombinant vectors expressing F and G Proteins (eg. Canarypox virus and Human Adenovirus 5) Immunize pigs with one live virus vector, and use the other vector for in vitro antibody and CMI assays Assays for T Cell Mediated Immunity:  Assays for T Cell Mediated Immunity Monitor activation marker (CD25) expression on T cell subsets using flow cytometry following in vitro incubation with antigen Assay gamma interferon and IL10 production in vitro by lymphocytes after incubation with antigen Collaborators:  Collaborators Centers for Disease Control and Prevention, Atlanta, Georgia Paul Rota, PhD Provide plasmids with Nipah F and G genes Clone Nipah N gene into Bacculovirus expression vector Develop and validate ELISA to detect antibody vs Nipah N protein Conduct serum neutralization assays Collaborators:  Collaborators USDA ARS Plum Island Animal Disease Center Dan Rock, PhD; Greg Mayr, PhD Clone F and G genes into Pseudorabies virus and Human Adenovirus 5 vectors Confirm expression in vitro Immunize pigs to confirm expression in vivo and freedom from FMD Collaborators:  Collaborators USDA APHIS National Veterinary Services Laboratories Sabrina Swenson, DVM, PhD Monitor Project for APHIS Consult on serologic assays for antibodies to Nipah F, G, and N House pigs in BL3 Ag facilities for vaccine response studies Collaborators:  Collaborators Merial Limited, Duluth, Georgia; Lyon, France; Toronto, Canada Robert Nordgren, PhD, Jean-Christophe Audonnet, DVM, PhD Construct Canarypox vector expressing Nipah F and G proteins Manufacture bulk quantities of vaccine in USDA licensed facility Collaborators:  Collaborators Canadian Food Inspection Agency, Winnipeg, Canada Hana Weingartl, PhD Conduct vaccination challenge studies in BL4 animal facility Titrate Nipah virus in vaccinated challenged pigs Serum neutralization assays What to Remember:  What to Remember Role of the OIE List A diseases Disease reporting International Animal Health Code Manual of Standards Characteristics of effective agroterrorism agents Potential agroterrorism and zoonotic agents Causes of infectious disease emergence Importance of Agriculture in the U.S., 1997:  Importance of Agriculture in the U.S., 1997 Agricultural industry valued at $224 billion generated $1 trillion in agricultural activities in 1997 Exports account for $140 billion 860,000 jobs Heavily tied to other industries and sectors U.S. Animal Data, 2001:  U.S. Animal Data, 2001 Livestock Industry:  Livestock Industry Vulnerability Concentrated and intensive nature of US farming Livestock auctions Extensive inter/intrastate transport of animals Centralized feed supply and distribution Lack of on farm biosecurity and surveillance Limited, if any, immunity to FADs Expanded international trade and travel Infectious agents are widespread in other countries Slide72:  The OIE Global Information System OIE International Animal Health Code:  OIE International Animal Health Code The appendices of the Code provide a series of recommendations devoted to the hygienic collection and handling of semen and embryos, sanitation of hatcheries and incubators, and transport of animals. In addition, a series of model international health certificates is presented.

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