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James A. Roth, DVM, PhD, DACVM
Center for Food Security and Public
Health
College of Veterinary Medicine
Iowa State Univer...
 Potential for FMD introduction
 Impact of FMD
 Response to FMD
 Secure Food Supply Plans
 FMD vaccines
 Science and...
FMD is the major
animal disease
preventing world trade
of animals and animal
products
Mortality may be low
but morbidity i...
World Organization for Animal Health (OIE) has
 178 member countries:
 96 countries are endemic
(“have it”) and have nev...
 1870, 1880 and 1884: Due to importation
of infected animals
 Since the development of a Federal system of
inspection an...
 Traditional Response Goals
 Focus: Eradication with no vaccination
 …the killing of the animals which are affected and
those suspected of being affected in the herd and,
where appropriate,...
 The size, structure, efficiency, and
extensive movement inherent in the U.S.
and North American livestock industries
wil...
9
Herd size:
 >5,000 cow dairies
 >70,000 calf ranches
 >50,000 cattle feedlots
 >20,000 sows
United States Animal Agriculture
Industry is Unique
Extensive mobility of
animals, products,
feed
• ~1,000,000 swine in
tr...
Inshipments of Hogs to Iowa and to All
US States for Selected Years
87% of
Inventory
|--43,000 Operations--|
50% of
Inventory
 ~5 million feral swine
 ~30 million deer
 All exports of cattle, swine, sheep, goats
and their uncooked products will be
stopped
 Prices will plummet
 Stop move...
Total U.S. Pork Exports, Value
(2003 – 2012)
$6.3 Billion
$5.5 Billion
Total value of U.S. dairy exports $6.7 billion
Total lbs. U.S. milk solids
exported
3.91 billion
Percent U.S. milk product...
 Biosecurity
 Stop Movement
 Stamping Out
 Slaughter of all clinically affected and in-
contact susceptible animals (w...
 Vaccine antigen concentrate to be
formulated into vaccine
 Shared by U.S., Canada, and Mexico
 Supplies are based on t...
 Biosecurity
 Stop Movement
 Stamping Out
 Slaughter of all clinically affected and in-
contact susceptible animals (w...
Source: AASV website www.aasv.org
First case April, 2013
4,458 Positive Biological Accessions by March 12, 2014
 Type O FMD
UK Uruguay
• 1.7 million cattle
• No vaccination
• 6,000,000 head
killed
• Cost ~ $10 billion
US dollars
• FM...
Stamping Out
with
No Vaccination
Highly
circumscribed and
limited outbreak
Small number of
animals
Stamping Out
with Emerg...
0
50
100
150
200
250
300
350
400
450
500
550
600
650
700
750
Days
Country, Year of Outbreak
U.S. Disease Freedom
Recogniti...
FMD Detection in the United States:
Types of an FMD Outbreak
Type 6:
Catastrophic
North
American
Response Shifts from Emph...
 Widespread areas of infection are detected
involving a large portion of the United
States
 Too many animals are affecte...
 It becomes apparent that FMD is
widespread, and will not be eradicated
within a year
 Transition from an emergency erad...
 FAD PReP/NAHEMS
Guidelines: Vaccination
for Contagious Diseases
 APPENDIX A: Foot-and-
Mouth Disease (April 2011,
93 pa...
 Vaccination protects from clinical signs
of disease
 Vaccination does not prevent infection
and establishment of persis...
 FMD vaccines to be used in the US can be
used as marker vaccines (DIVA vaccines)
 DIVA = Detect Infection in Vaccinated...
 Killed virus vaccine
 7 distinct serotypes
 Not cross protective
 Approximately 65 Subtypes
 Cross-protection varies...
High Priority:
 O Manisa
 O PanAsia-2
 O BFS or Campos
 A-Iran-05
 A24 Cruzeiro
 A22 Iraq
 Asia 1 Shamir
 SAT 2 Sa...
 National repository of critical veterinary
supplies, equipment, and services
 Homeland Security Presidential Directive ...
Tier 1:
 African swine fever*
 Classical swine
fever*
 Foot-and-mouth
disease*
 Avian influenza
(any strain that is
hi...
 Approximately $2.5 million per year
10 diseases
98 million cattle
60 million swine
8.6 million sheep/goats
4.3 mill...
 A White Paper (134
pages) Prepared by the
Center for Food Security
and Public Health at ISU
for:
 National Pork Board
...
 International commercial manufacturers of
killed FMD vaccine (none in US)
 More doses of FMD vaccine are used in livest...
 New technology FMD vaccines that could
be safely manufactured in the U.S. and
which are based on a platform that allows
...
 Immediate Availability:
Finished vaccine held in
vendor‐managed‐inventory and
ready for shipment within 24
hours
 Short‐Term Availability:
 Vaccine antigen concentrate
(VAC) held in vendor
managed‐inventory ready to be
formulated int...
 Long‐Term Availability
 Vaccine production initiated at the beginning
of the outbreak for the specific outbreak
strain(...
 Secure funds to enable the surge
capacity need for FMD vaccines
mandated in HSPD 9 to be met
 Estimated at $150 million...
 Secure Food Supply Plans
 USDA Foot-and-Mouth Disease Response Plan "The Red
Book"
 Phases & Types of an FMD Outbreak
...
Questions, Comments: jaroth@iastate.edu
 A not for profit company with the
mission to increase availability of
vaccines for transboundary diseases
 Funded by De...
 USDA Permit for sale and
distribution of Biogenesis Bago
FMD vaccine
 Can Only be imported and used
with authorization ...
 Vaccinated animals must be permanently
and uniquely identified with pink metal ear
tags (or acceptable alternative)
 Ac...
 Secure Food Supply Plans for eggs, turkeys,
milk and pork.
 Cooperative effort involving USDA, State
Officials, Produce...
 Biosecurity
 Stop Movement
 Stamping Out
 Slaughter of all clinically affected and in-
contact susceptible animals (w...
 Biosecurity
 Stop Movement
 Stamping Out
 Slaughter of all clinically affected and in-
contact susceptible animals (w...
 21 to 60 day withdrawal time before
slaughter
 There is no withdrawal time for milk
after use of FMD vaccine
 FMD is not a public health or food safety
problem
 Animals which pass ante-mortem and post-
mortem inspection by USDA F...
 Advantages
 Large operations located in countries with
endemic FMD perform continued vaccine
production for FMD strains...
Dr. James A. Roth - FMD Vaccination: Preparedness, Availability, and Limitations
Dr. James A. Roth - FMD Vaccination: Preparedness, Availability, and Limitations
Dr. James A. Roth - FMD Vaccination: Preparedness, Availability, and Limitations
Dr. James A. Roth - FMD Vaccination: Preparedness, Availability, and Limitations
Dr. James A. Roth - FMD Vaccination: Preparedness, Availability, and Limitations
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Dr. James A. Roth - FMD Vaccination: Preparedness, Availability, and Limitations

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FMD Vaccination: Preparedness, Availability, and Limitations - James Roth, DVM, Director, Center for Food Security and Public Health and Executive Director, Institute for International Cooperation in Animal Biologics, Iowa State University, from the 2014 NIAA Annual Conference titled 'The Precautionary Principle: How Agriculture Will Thrive', March 31 - April 2, 2014, Omaha, NE, USA.

More presentations at http://www.trufflemedia.com/agmedia/conference/2014_niaa_how_animal_agriculture_will_thrive

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Transcript of "Dr. James A. Roth - FMD Vaccination: Preparedness, Availability, and Limitations"

  1. 1. James A. Roth, DVM, PhD, DACVM Center for Food Security and Public Health College of Veterinary Medicine Iowa State University
  2. 2.  Potential for FMD introduction  Impact of FMD  Response to FMD  Secure Food Supply Plans  FMD vaccines  Science and vaccinology  Vaccines used worldwide  New technology vaccines  Surge capacity need  Potential sources of FMD vaccine
  3. 3. FMD is the major animal disease preventing world trade of animals and animal products Mortality may be low but morbidity is high High mortality associated with some strains and some control methods Results in persistent infections (carrier state) in cattle Foot-and mouth disease: THE MOST contagious disease of animals Japan UK Korea Egypt
  4. 4. World Organization for Animal Health (OIE) has  178 member countries:  96 countries are endemic (“have it”) and have never been free of FMD  66 countries free of FMD  11 countries have free zones either with or without vaccination  5 countries were free and recently suffered from a re-emergence of FMD Leon, E. A. Transboundary and Emerging Diseases. 59 (Suppl. 1) pages 1-14, 2012
  5. 5.  1870, 1880 and 1884: Due to importation of infected animals  Since the development of a Federal system of inspection and quarantine of imported livestock, no outbreak has been attributed to admission of live animals  1902, 1908, 1914, 1924 (two separate outbreaks) and 1929  All outbreaks were controlled by stop movement and stamping out http://www.wrlfmd.org/fmd_genotyping/north_america.html
  6. 6.  Traditional Response Goals  Focus: Eradication with no vaccination
  7. 7.  …the killing of the animals which are affected and those suspected of being affected in the herd and, where appropriate, those in other herds which have been exposed to infection by direct animal to animal contact, or by indirect contact of a kind likely to cause the transmission of the causal pathogen. All susceptible animals, vaccinated or unvaccinated, on an infected premises should be killed and their carcasses destroyed by burning or burial, or by any other method which will eliminate the spread of infection through the carcasses or products of the animals killed.
  8. 8.  The size, structure, efficiency, and extensive movement inherent in the U.S. and North American livestock industries will present unprecedented challenges in the event of an FMD outbreak
  9. 9. 9 Herd size:  >5,000 cow dairies  >70,000 calf ranches  >50,000 cattle feedlots  >20,000 sows
  10. 10. United States Animal Agriculture Industry is Unique Extensive mobility of animals, products, feed • ~1,000,000 swine in transit daily • 400,000 to 500,000 to slaughter • ~400,000 cattle in transit per day • Auction markets, fairs, exhibitions? • Sheep, goats, others?
  11. 11. Inshipments of Hogs to Iowa and to All US States for Selected Years
  12. 12. 87% of Inventory
  13. 13. |--43,000 Operations--| 50% of Inventory
  14. 14.  ~5 million feral swine  ~30 million deer
  15. 15.  All exports of cattle, swine, sheep, goats and their uncooked products will be stopped  Prices will plummet  Stop movement orders will be issued for the affected area in the U.S.
  16. 16. Total U.S. Pork Exports, Value (2003 – 2012) $6.3 Billion
  17. 17. $5.5 Billion
  18. 18. Total value of U.S. dairy exports $6.7 billion Total lbs. U.S. milk solids exported 3.91 billion Percent U.S. milk production exported 15.5%* Percent of U.S. whey proteins exported 56% Percent of U.S. skim milk powder/nonfat dry milk exported 58% Percent of U.S butterfat exported 10.7%
  19. 19.  Biosecurity  Stop Movement  Stamping Out  Slaughter of all clinically affected and in- contact susceptible animals (within 24 hours or as soon as possible)  Trace back/Trace forward  28 days prior to outbreak  Rapid Diagnostics  Vaccination  Vaccinate to kill/slaughter; Vaccinate to live
  20. 20.  Vaccine antigen concentrate to be formulated into vaccine  Shared by U.S., Canada, and Mexico  Supplies are based on the old model of selective and restricted use of vaccine  USDA: “Emergency vaccine stocks are far below what would be required to address a single livestock dense state or multi- state outbreak”
  21. 21.  Biosecurity  Stop Movement  Stamping Out  Slaughter of all clinically affected and in- contact susceptible animals (within 24 hours or as soon as possible)  Trace back/Trace forward  28 days prior to outbreak  Rapid Diagnostics  Vaccination  Vaccinate to kill/slaughter; Vaccinate to live
  22. 22. Source: AASV website www.aasv.org First case April, 2013 4,458 Positive Biological Accessions by March 12, 2014
  23. 23.  Type O FMD UK Uruguay • 1.7 million cattle • No vaccination • 6,000,000 head killed • Cost ~ $10 billion US dollars • FMD free • Type A FMD • 10.6 million cattle • 24 million doses • 6,900 head killed • Cost - $243.6 million US dollars • FMD free with vaccination
  24. 24. Stamping Out with No Vaccination Highly circumscribed and limited outbreak Small number of animals Stamping Out with Emergency Vaccination to Slaughter/Kill Animals that proceed to slaughter Animals that are depopulated and processed Stamping Out with Emergency Vaccination to Live Preserves the integrity of the food supply chain Longer time to effect an eradication Animals complete their productive lifespan Closes international export markets Vaccination to Live with no Stamping Out Routine production procedure Time to eradicate is indefinite Export agreements would be developed Limits the production of key industries
  25. 25. 0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 Days Country, Year of Outbreak U.S. Disease Freedom Recognition - Effective Date OIE Disease Freedom Recognition Length of Outbreak Japan United Kingdom France United Kingdom Japan (VAX) 2000 2001 2001 2007 2010 Time to Regain FMD-Freedom Source: USDA-APHIS FMD Response, Ready Reference Guide – Overview of FMD Freedom and Vaccination, March 2013
  26. 26. FMD Detection in the United States: Types of an FMD Outbreak Type 6: Catastrophic North American Response Shifts from Emphasis on Stamping-Out to Emphasis on Alternate Strategies (duration of FMD response) Size of FMD Outbreak (in terms of animals, premises, and jurisdictions affected) Six Types of FMD Outbreaks 30
  27. 27.  Widespread areas of infection are detected involving a large portion of the United States  Too many animals are affected to implement or continue stamping out  Sufficient vaccine and resources are not available to effectively use vaccine to control the outbreak
  28. 28.  It becomes apparent that FMD is widespread, and will not be eradicated within a year  Transition from an emergency eradication response to a long term control program eventually leading to eradication, perhaps including vaccinate-to-live
  29. 29.  FAD PReP/NAHEMS Guidelines: Vaccination for Contagious Diseases  APPENDIX A: Foot-and- Mouth Disease (April 2011, 93 pages) http://cfsph.iastate.edu/emerg ency-response/fad-prep.php
  30. 30.  Vaccination protects from clinical signs of disease  Vaccination does not prevent infection and establishment of persistent infection in cattle  Reliable detection of persistently infected animals delays return to FMD free status  There is no evidence that persistently infected cattle can transmit infection under natural conditions
  31. 31.  FMD vaccines to be used in the US can be used as marker vaccines (DIVA vaccines)  DIVA = Detect Infection in Vaccinated Animals  Do not induce antibody to virus Non-Structural Proteins (NSPs)  Infection after vaccination induces antibody to NSPs  Test for antibody to NSPs to detect infected herds for eradication and to eventually prove disease freedom
  32. 32.  Killed virus vaccine  7 distinct serotypes  Not cross protective  Approximately 65 Subtypes  Cross-protection varies between strains within a serotype  It is essential to isolate virus and identify the serotype to select the correct vaccine
  33. 33. High Priority:  O Manisa  O PanAsia-2  O BFS or Campos  A-Iran-05  A24 Cruzeiro  A22 Iraq  Asia 1 Shamir  SAT 2 Saudi Arabia (or equivalent) Medium Priority:  A Argentina 2001  A Iran 96  A Iran 99  A Eritrea  A Iran 87 or A Saudi Arabia 23/86  A Malaysia 97 (or Thai equivalent)  O Taiwan 97 (pig- adapted strain)  SAT 1 South Africa  SAT 2 Zimbabwe Low Priority: • A 15 Bangkok related strain • A Kenya • A87 Argentina related strain • SAT 1 Kenya • SAT 2 Kenya • SAT 3 Zimbabwe • C Noville (http://www.wrlfmd.org/ref_labs/fmd_ref_lab_reports.htm)
  34. 34.  National repository of critical veterinary supplies, equipment, and services  Homeland Security Presidential Directive 9 (2004)  Directed Secretary of Agriculture to establish the NVS  Required the NVS to deploy within 24 hours “sufficient amounts of animal vaccine, antiviral, or therapeutic products to appropriately respond to the most damaging animal diseases affecting human health and the economy”
  35. 35. Tier 1:  African swine fever*  Classical swine fever*  Foot-and-mouth disease*  Avian influenza (any strain that is highly pathogenic or has zoonotic significance)*  Virulent Newcastle disease* Tier 2:  Heartwater  New World screwworm  Rift Valley fever*  Venezuelan equine encephalitis* Tier 3:  African horse sickness  Contagious bovine pleuropneumonia and contagious caprine pleuropneumonia  Glanders and melioidosis  Henipaviruses (Hendra and Nipah)*  Rinderpest* and peste des petits ruminants*  Tropical bont tick *Biological threats that need to be considered in program priorities and countermeasure stockpile requirements.
  36. 36.  Approximately $2.5 million per year 10 diseases 98 million cattle 60 million swine 8.6 million sheep/goats 4.3 million horses 1,816 million poultry
  37. 37.  A White Paper (134 pages) Prepared by the Center for Food Security and Public Health at ISU for:  National Pork Board  National Cattlemen’s Beef Association  National Milk Producers Federation http://www.cfsph.iastate.edu/Secure-Food-Supply/index.ph
  38. 38.  International commercial manufacturers of killed FMD vaccine (none in US)  More doses of FMD vaccine are used in livestock worldwide than for any other disease  USDA tested and permitted for importation (meet the same standards as other USDA licensed vaccines) (only one company in Argentina)  Emergency exemption from licensure (unproven safety and efficacy for use in the U.S.)
  39. 39.  New technology FMD vaccines that could be safely manufactured in the U.S. and which are based on a platform that allows various capsid serotypes/topotypes to be inserted into the vaccine  HAd5 vectored FMD vaccines (one strain conditionally licensed)  Leaderless killed FMD‐LL3B3D vaccines  Alphavirus vectored FMD vaccines  Plasmid DNA FMD vaccines
  40. 40.  Immediate Availability: Finished vaccine held in vendor‐managed‐inventory and ready for shipment within 24 hours
  41. 41.  Short‐Term Availability:  Vaccine antigen concentrate (VAC) held in vendor managed‐inventory ready to be formulated into finished vaccine and shipped to the U.S.
  42. 42.  Long‐Term Availability  Vaccine production initiated at the beginning of the outbreak for the specific outbreak strain(s) of FMD virus  Enter into contracts with international manufacturers of FMD vaccines for surge capacity production of commercially available FMD vaccines  Seek USDA licensure of new technology FMD vaccines that could be safely manufactured in the U.S. and which are based on a platform that allows various capsid serotypes/topotypes to be inserted into the vaccine
  43. 43.  Secure funds to enable the surge capacity need for FMD vaccines mandated in HSPD 9 to be met  Estimated at $150 million/year for 5 years to help protect an approximately $100 billion (annual cash receipts) animal industry.
  44. 44.  Secure Food Supply Plans  USDA Foot-and-Mouth Disease Response Plan "The Red Book"  Phases & Types of an FMD Outbreak  NAHEMS Guidelines: Continuity of Business  NAHEMS guidelines: Vaccination for contagious diseases;  Appendix A: Vaccination for Foot-and-Mouth Disease  FMD Vaccine Surge Capacity for Emergency Use in the United States  Inactivation of Foot-and-Mouth Disease Virus in Milk Products  Foot and Mouth Disease in Pigs - Progression of Lesions
  45. 45. Questions, Comments: jaroth@iastate.edu
  46. 46.  A not for profit company with the mission to increase availability of vaccines for transboundary diseases  Funded by Department of Homeland Security, Science and Technology Directorate,
  47. 47.  USDA Permit for sale and distribution of Biogenesis Bago FMD vaccine  Can Only be imported and used with authorization of the Chief Veterinary Officer of the US  Importation and distribution will be managed by the National Veterinary Stockpile
  48. 48.  Vaccinated animals must be permanently and uniquely identified with pink metal ear tags (or acceptable alternative)  Accurate vaccination records must be maintained as directed by USDA APHIS Veterinary Services  Records must be available to other regulatory authorities as required
  49. 49.  Secure Food Supply Plans for eggs, turkeys, milk and pork.  Cooperative effort involving USDA, State Officials, Producers, Processors, and Academia  The overall goals of the Secure Food Supply projects include:  Avoid interruptions in animal/animal product movement to commercial processing from farms with no evidence of infection during a foreign animal disease outbreak;  Provide a continuous supply of safe and wholesome food to consumers; and  Maintain business continuity for producers, transporters, and food processors through response planning.  http://www.cfsph.iastate.edu/Secure-Food- Supply/index.php
  50. 50.  Biosecurity  Stop Movement  Stamping Out  Slaughter of all clinically affected and in- contact susceptible animals (within 24 hours or as soon as possible)  Trace back/Trace forward  28 days prior to outbreak  Rapid Diagnostics  Vaccination  Vaccinate to kill/slaughter; Vaccinate to live 55
  51. 51.  Biosecurity  Stop Movement  Stamping Out  Slaughter of all clinically affected and in- contact susceptible animals (within 24 hours or as soon as possible)  Trace back/Trace forward  28 days prior to outbreak  Rapid Diagnostics  Vaccination  Vaccinate to kill/slaughter; Vaccinate to live 56
  52. 52.  21 to 60 day withdrawal time before slaughter  There is no withdrawal time for milk after use of FMD vaccine
  53. 53.  FMD is not a public health or food safety problem  Animals which pass ante-mortem and post- mortem inspection by USDA FSIS are safe for human consumption, even if they may be in the pre-clinical stage of FMD infection  Regulations regarding feeding garbage to swine must be strictly enforced.
  54. 54.  Advantages  Large operations located in countries with endemic FMD perform continued vaccine production for FMD strains in their region  Indefinite delivery, indefinite quantity (IDIQ) contracts with NVS are possible  Disadvantage  May not be outbreak (high) potency  May be fully contracted to other customers and unavailable for emergency vaccine production
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