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Avian Influenza: The Threatening Pandemic

The purpose of this TriMark Publications report is to describe the threatening world pandemic caused by avian influenza, also known as bird flu. This report discusses the origins of the disease, the bird-to-human infection risks, the catastrophic health crisis avian flu poses, and the efforts by world governments and international health organizations to mitigate of the impact the threat to humans. The U.S., Asia and Europe are the focus of this study. Primary attention is paid to the clinical market segment and, separately, to the medical procedures and supplies for the influenza infection control market. An analysis of the technology trends and developing areas of influenza infection science is provided, along with a review of the market for pharmaceutical agents, vaccines and hospital supplies in clinical use. Activity in research-including the factors that influence infection control-are addressed in this review. Also discussed are changes that have stimulated this disease and patterns of information processing in assessing its spread. Several subjects related to the major elements of influenza treatment such as disposable plastic supplies, needles and lancets are discussed only briefly because they are considered entirely different fields or markets. The goal of this report is to review the potential threat of a human influenza pandemic resulting from the avian flu virus. It defines the responses that are now being undertaken worldwide by governmental authorities to contain the spreading bird flu.

Specifically, this study contains:

•  A comprehensive overview of the several categories of anti-influenza technology platforms that are or will be revolutionizing flu related healthcare in hospitals.
• Full descriptions of the public health measures involved in controlling the spread of avian influenza and the prevention of cross infection to humans.
• Analysis of the technological approaches undertaken by various world governments, as well as industry and end-user response to these ideas.
• Regulatory issues and legislation affecting use and marketing of influenza prevention and treatment products.
• Forecasts for each category of infection control.

Table of Contents

• 1. Overview5
  • 1.1Statement of Report5
  • 1.2Scope of Report5
  • 1.3Objectives5
  • 1.4Methodology6
  • 1.5Executive Summary6
  
  
• 2. The Basics of Human Influenza9
  • 2.1Influenza, the Disease9
    • 2.1.1Symptoms9
    • 2.1.2Transmission9
    • 2.1.3Public Health Factors10
    • 2.1.4Influenza Diagnosis10
  • 2.2Influenza Viruses11
    • 2.2.1Types, Subtypes and Strains11
      • 2.2.1.1Influenza Type A and its Subtypes12
      • 2.2.1.2Highly Pathogenic versus Lowly Pathogenic Avian Influenza A Viruses13
      • 2.2.1.3Human Influenza Viruses and Avian Influenza A Viruses13
        • 2.2.1.3.1 Influenza A H513
        • 2.2.1.3.2 Influenza A H713
        • 2.2.1.3.3 Influenza A H913
      • 2.2.1.4Influenza Type B14
      • 2.2.1.5Influenza Type C14
    • 2.2.2How Influenza Viruses Change: Drift and Shift14
    • 2.2.3Seasons and Human Influenza15
    • 2.2.4Risk Factors and Human Influenza16
    • 2.2.5Human Influenza Complications, Comorbidities and Dangers16
      • 2.2.5.1Flu complications in children and teenagers17
    • 2.2.6Human Influenza Prognosis17
  • 2.3Pandemic Influenza18
  • 2.4How Influenza Viruses Change18
  
  
• 3. The Basics of Avian Influenza19
  • 3.1Avian Influenza in Birds19
    • 3.1.1Avian Influenza Outbreaks in Poultry20
    • 3.1.2More Information About Avian Influenza Viruses21
  • 3.2Transmission of Influenza A Viruses between Animals and People21
  • 3.3Avian Influenza Infection in Humans22
    • 3.3.1Instances of Avian Influenza Infection in Humans22
    • 3.3.2Symptoms of Avian Influenza in Humans23
    • 3.3.3Antiviral Agents for Influenza23
  • 3.4Avian Influenza (H5N1)23
    • 3.4.1Avian Influenza (H5N1) Outbreaks23
  • 3.5All Types of Avian Influenza Worldwide Outside of Asia25
    • 3.5.1Canada25
    • 3.5.2Netherlands26
    • 3.5.3United States26
      • 3.5.3.1Delaware26
      • 3.5.3.2Texas26
      • 3.5.3.3Maryland26
      • 3.5.3.4International Response27
      • 3.5.3.5Available Options27
      
      
• 4. Epidemiology of Avian Influenza28
  • 4.1Worldwide Avian Influenza29
  • 4.2H5N1 Avian Influenza: Timeline32
  • 4.3U.S. Avian Influenza37
  
  
• 5. Influenza Diagnosis and Laboratory Issues38
  • 5.1"Classic" Methods for Influenza Diagnosis38
  • 5.2Example Lab: Yale New Haven Hospital (YNHH)40
  • 5.3Conventional PCR Assay for Sub-typing Influenza Virus41
    • 5.3.1Gel Analysis41
  • 5.4Real Time TaqMan PCR43
    • 5.4.1From PacMan to TaqMan-A Computer Game Revisited43
    • 5.4.2The Advantages of Real-Time TaqMan PCR Over Conventional Quantitative PCR45
  • 5.5Example Strategy for Avian Influenza46
  • 5.6Laboratory Safety Issues for H5N1 Viruses46
    • 5.6.1Biosafety Level 346
    • 5.6.2Biosafety Level 3-Ag51
    • 5.6.3CDC Criteria for Testing52
    • 5.6.4What Samples Are Needed?52
    
    
• 6.Preparedness53
  • 6.1Education53
  • 6.2Ethical and Legal Issues53
  • 6.3Worldwide55
    • 6.3.1Overarching Goals, Objectives and Actions for WHO and National Authorities, by Phase56
      • 6.3.1.1Interpandemic Period, Phase 1-Overarching Goal56
      • 6.3.1.2Interpandemic Period, Phase 2-Overarching Goal58
      • 6.3.1.3Pandemic Alert Period, Phase 3-Overarching Goal61
      • 6.3.1.4Pandemic Alert Period, Phase 4-Overarching Goal64
      • 6.3.1.5Pandemic Alert Period, Phase 5-Overarching Goal67
      • 6.3.1.6Pandemic Period, Phase 6-Overarching Goal70
    • 6.3.2Recommendations for Non-Pharmaceutical Public Health Interventions75
  • 6.4U.S.78
    • 6.4.1U.S. National Plan78
    • 6.4.2U.S. Locally87
      • 6.4.2.1Community Preparedness Leadership and Networking87
      • 6.4.2.2Surveillance88
      • 6.4.2.3Public Health and Clinical Laboratories88
      • 6.4.2.4Healthcare and Public Health Partners89
      • 6.4.2.5Infection Control and Clinical Guidelines90
      • 6.4.2.6Vaccine Distribution and Use90
      • 6.4.2.7Antiviral Drug Distribution and Use90
      • 6.4.2.8Community Disease Control and Prevention91
      • 6.4.2.9Public Health Communications91
      • 6.4.2.10Workforce Support: Psychosocial Considerations and Information Needs92
      • 6.4.2.11State Plans92
  • 6.5The Hospital Response92
    • 6.5.1Introduction92
    • 6.5.2Key Assumptions93
    • 6.5.3Arrival93
    • 6.5.4Triage94
    • 6.5.5Isolation95
    • 6.5.6Patient Movement96
    • 6.5.7Communication97
    • 6.5.8Medical Evaluation98
    • 6.5.9Diagnosis98
    • 6.5.10Treatment98
    • 6.5.11Potential for Surge99
  • 6.6Business Preparedness100
  • 6.7School Preparedness102
  • 6.8Individual Preparedness105
  
  
• 7. Economics of Avian Influenza109
  • 7.1Impact on Governments109
    • 7.1.1Worldwide Economic Impact of Avian Flu109
    • 7.1.2U.S. Nationally113
  • 7.2Impact of a Pandemic125
    • 7.2.1Supply Side Effect125
    • 7.2.2Demand Side Effect126
    
    
• 8. Fighting the Flu128
  • 8.1The Worldwide Pharmaceutical Industry128
    • 8.1.1FDA Approved Vaccines: Tamiflu and Relenza129
    • 8.1.2Stockpiling129
    • 8.1.3Total Avian Influenza Drug Market Size and Growth129
  • 8.2Funding129
  • 8.3Antiviral Agents for Influenza: Background Information129
    • 8.3.1Introduction129
      • 8.3.1.1Antiviral Usage Recommendation-2005-06129
    • 8.3.2Neuraminidase Inhibitors (Zanamivir, Oseltamivir)130
    • 8.3.3How do the Neuraminidase Inhibitor Drugs Work?130
    • 8.3.4How Effective are the Neuraminidase Inhibitor Drugs?130
      • 8.3.4.1Treatment130
      • 8.3.4.2Chemoprophylaxis130
      • 8.3.4.3Side Effects of the Neuraminidase Inhibitor Drugs130
      • 8.3.4.4Antiviral Resistance to the Neuraminidase Inhibitor Drugs131
    • 8.3.5Adamantane Derivatives (Amantadine, Rimantadine)131
      • 8.3.5.1Antiviral Activity: How do the Adamantane Drugs Work?131
      • 8.3.5.2How Effective are the Adamantane Drugs?131
        • 8.3.5.2.1 Treatment131
        • 8.3.5.2.2 Chemoprophylaxis131
      • 8.3.5.3Side Effects of the Adamantane Drugs132
      • 8.3.5.4Antiviral Resistance132
    • 8.3.6Adamantanes Compared with Neuraminidase Inhibitors132
    • 8.3.7Anti-Avian Influenza Drugs, Generics and Patents133
      • 8.3.7.1Taiwan133
      • 8.3.7.2India134
      • 8.3.7.3Other Countries135
    • 8.3.8Regulatory Issues135
    • 8.3.9New Anti-Avian Influenza Therapy135
    • 8.3.10Pharmaceutical Business Perspective136
      • 8.3.10.1A Market Dominated by GSK and Roche136
      • 8.3.10.2Generic Presence136
      • 8.3.10.3Challenging Tamiflu137
  • 8.4Other Treatment Requirements137
  • 8.5Business Opportunities138
  
  
  

 

INDEX OF FIGURES

Figure 2.1: Influenza Subtypes12

Figure 2.2: Timeline of Emergence of Influenza A Viruses in Humans15

Figure 2.3: Model of the Emergence of a Pandemic Virus18

Figure 3.1: Map of H5N1 Instances and Asian Migratory Bird Zones24

Figure 3.2: Map of H7N3 in British Columbia25

Figure 4.1: Nations with Confirmed Cases of H5N1 Avian Influenza29

Figure 4.2: World: Affected Areas with Confirmed Cases of H5N1 Avian Influenza Since 200330

Figure 4.3: World: Affected Areas with Confirmed Cases of H5N1 Avian Influenza Since January 200630

Figure 4.4: World: Areas Reporting Confirmed Occurrence of H5N1 Avian Influenza in Poultry and Wild Birds Since January 200631

Figure 4.5: World: Areas Reporting Confirmed Occurrence of H5N1 Avian Influenza in Poultry and Wild Birds Since 200331

Figure 4.6: Waterfowl Flyways of North America37

Figure 5.1: FDA-approved Kit-based Test38

Figure 5.2: Immunofluorescence-based Detection39

Figure 5.3: Uninfected and Infected Tissue Cultures39

Figure 5.4: TEM of Negatively Stained Influenza Virions (from Cultures)40

Figure 5.5: PCR Assay Graphic41

Figure 5.6: PCR assay42

Figure 5.7: "Amplicon" Generation42

Figure 5.8: The TaqMan 5'-3' Nuclease Assay43

Figure 5.9: TaqMan Amplification Plot44

Figure 5.10: TaqMan Fluorescent Reaction Components45

Figure 5.11: Biosafety Level 3-Ag-Full Tyvek Body Suit51

Figure 6.1: Signage: Informing Staff93

Figure 6.2: Signage: Informing Patients94

Figure 6.3: Respiratory Etiquette Kit95

Figure 6.4: Isolation96

Figure 6.5: Communication Scheme97

Figure 6.6: Surge99

INDEX OF TABLES

Table 2.1: Probability of Influenza Diagnosis Using Office-Based Testing11

Table 2.2: Prescribing Guidelines for Treating Influenza11

Table 2.3: Influenza Virus Types12

Table 2.4: H5N1 Cases and Deaths, 2003-200515

Table 4.1: Phase 3 is the Current WHO Phase of Alert28

Table 4.2: Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO, 2003-200629

Table 4.3: Early (Pre Wave I) Events in Asia, 1996, 1997 and 200332

Table 4.4: Wave I32

Table 4.5: Wave II33

Table 4.6: Wave III34

Table 5.1: Methods for Influenza Diagnosis38

Table 5.2: Summary of Current Clinical Virology Laboratory Tests for Influenza40

Table 6.1: Interpandemic Period, Phase 1-Planning and Coordination56

Table 6.2: Interpandemic Period, Phase 1-Prevention and Containment56

Table 6.3: Interpandemic Period, Phase 1-Health System Response57

Table 6.4: Interpandemic Period, Phase 1-Communications58

Table 6.5: Interpandemic Period, Phase 2-Planning and Coordination58

Table 6.6: Interpandemic Period, Phase 2-Situation Monitoring and Assessment59

Table 6.7: Interpandemic Period, Phase 2-Prevention and Containment59

Table 6.8: Interpandemic Period, Phase 2-Health System Response60

Table 6.9: Interpandemic Period, Phase 2-Communications61

Table 6.10: Pandemic Alert Period, Phase 3 - Planning and Coordination61

Table 6.11: Pandemic Alert Period, Phase 3-Situation Monitoring and Assessment62

Table 6.12: Pandemic Alert Period, Phase 3-Prevention and Containment62

Table 6.13: Pandemic Alert Period, Phase 3-Health System Response63

Table 6.14: Pandemic Alert Period, Phase 3-Communications64

Table 6.15: Pandemic Alert Period, Phase 4-Planning and Coordination64

Table 6.16: Pandemic Alert Period, Phase 4-Situation Monitoring and Assessment65

Table 6.17: Pandemic Alert Period, Phase 4-Prevention and Containment65

Table 6.18: Pandemic Alert Period, Phase 4-Health System Response66

Table 6.19: Pandemic Alert Period, Phase 4-Communications67

Table 6.20: Pandemic Alert Period, Phase 5-Planning and Coordination67

Table 6.21: Pandemic Alert Period, Phase 5-Situation Monitoring and Assessment68

Table 6.22: Pandemic Alert Period, Phase 5-Prevention and Containment68

Table 6.23: Pandemic Alert Period, Phase 5-Health System Response69

Table 6.24: Pandemic Alert Period, Phase 5-Communications70

Table 6.25: Pandemic Period, Phase 6-Planning and Coordination70

Table 6.26: Pandemic Period, Phase 6-Situation Monitoring and Assessment71

Table 6.27: Pandemic Period, Phase 6-Prevention and Containment72

Table 6.28: Pandemic Period, Phase 6-Health System Response73

Table 6.29: Pandemic Period, Phase 6-Communications74

Table 6.30: National Measures (Living or Traveling Within an Affected Country)75

Table 6.31: International Measures (for Entering or Exiting a Country)77

Table 6.32: State and Local Planning Checklist-Community Preparedness Leadership and Networking87

Table 6.33: State and Local Planning Checklist-Surveillance88

Table 6.34: State and Local Planning Checklist-Public Health and Clinical Laboratories89

Table 6.35: State and Local Planning Checklist-Healthcare and Public Health Partners89

Table 6.36: State and Local Planning Checklist-Healthcare and Public Health Partners90

Table 6.37: State and Local Planning Checklist-Vaccine Distribution and Use90

Table 6.38: State and Local Planning Checklist-Antiviral Drug Distribution and Use91

Table 6.39: State and Local Planning Checklist-Community Disease Control and Prevention91

Table 6.40: State and Local Planning Checklist-Public Health Communications91

Table 6.41: State and Local Planning Checklist-Workforce Support: Psychosocial Considerations and Information Needs92

Table 6.42: Arrival93

Table 6.43: Triage94

Table 6.44: Isolation95

Table 6.45: Patient Movement96

Table 6.46: Communication97

Table 6.47: Medical Evaluation98

Table 6.48: Diagnosis98

Table 6.49: Treatment98

Table 6.50: Surge99

Table 6.51: Plan for the Impact of a Pandemic on Your Business100

Table 6.52: Plan for the Impact of a Pandemic on Your Employees and Customers101

Table 6.53: Establish Policies to be Implemented During a Pandemic101

Table 6.54: Allocate Resources to Protect Your Employees and Customers During a Pandemic101

Table 6.55: Communicate to and Educate Your Employees102

Table 6.56: Coordinate with External Organizations and Help Your Community102

Table 6.57: Planning and Coordination:103

Table 6.58: Continuity of Student Learning and Core Operations104

Table 6.59: Infection Control Policies and Procedures104

Table 6.60: Communications Planning104

Table 6.61: Items to have on Hand for an Extended Stay at Home107

Table 6.62: Immunizations FAQ107

Table 6.63: WHO Global Plan for Pandemic Preparedness110

Table 7.1: Assumptions Underlying Estimates of the Supply-Side Impact of an Avian Flu Pandemic126

Table 7.2: Assumed Declines in Demand, by Industry, in the Event of an Avian Flu Pandemic127

Table 8.1: Top 30 Pharmaceutical and Biotech Companies Ranked by Healthcare Revenue ("Big Pharma")128

Table 8.2: Recommended Daily Dosage of Influenza Antiviral Medications for Treatment and Prophylaxis133

Table 8.3: Examples of Preparedness Supplies138

 

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