The aim of the workshop is to develop criteria that can assist EuFMD member nations to decide if, and how, to implement emergency vaccination as a control measure for FAST diseases. The development of criteria will initially focus on Foot and Mouth Disease (FMD) but could later be adapted to emergency vaccination for control of other FAST diseases.

1. Vaccination criteria for Bulgaria (Breakout room 1)
● Population density of susceptible animals/census available/ general situation of husbandry
● Culling capacity
● Disposal capacity
● Resources
- human
- equipment
- PPE
● Acceptance of regionalization
● Predict possible evolution
● Speed of decision making process
● Social impact. Public reaction
● Economic impact related to restrictions to trade with animals and products /small holdings and big
holdings
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2. Additional data needed for vaccination criteria (Breakout room 1)
● Information about the trade
● Pathways of disease evolution
● Number of affected holdings and species
● Did the virus spread in wildlife?
● Real census
● Movement patterns, illegal animal movements?
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3. Vaccination criteria for Spain (I)(Breakout room 2)
● Epidemiological situation - investigation: capacity to collect and analyze epi information to assess the evolution of the
disease and therefore adapt the control measures, including decision for vaccination, along the time.
● Trade and regionalization – it’s important to focus on one area so that the rest of the country (non-affected areas) can
remain free and therefore maintain movements to intracommunity trade and with thirds countries.
● Socio-economic consequences: acceptability of the policy by sector and stakeholders (impact on the sectors and their
opinions); also consider welfare issues. Involvement of all stakeholders, including citizenship and social dimension.
Consider awareness of customers (products from vaccinated animals) and their opinion, to ensure their confidence.
● Biosecurity conditions at the farms and areas to be vaccinated, vaccination alone could be inefficient.
● Cost/benefit analysis – ideally performed during peacetime but also possibly during outbreak times - to better estimate
the impact of vaccination (limitation of assessment under stress with no time for proper/complete analysis)
● Consider density of livestock and farms in affected areas and specific types of productions (eg: extensive
production of pigs in west-Spain, which poses a challenge for the control of the virus)
● Resources: material, economic and personal (well trained teams working at high speed and under BSC conditions)
resources available to ensure the completion of the vaccination plan.
● Also consider destruction capacity of culled animals (if suppressive vaccination was chosen), if this capacity is
overwhelmed it could be necessary to apply vaccination.
● Composition of the sector in the area to be vaccinated (density of animals/farms, spp present, etc.)
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EXERCISE ONLY

4. Additional data needed for vaccination criteria (Breakout room 2)
● Information from epi investigations.
● Information on resources to be mobilized in case it is necessary.
● Information on farms /animals, livestock production systems, biosecurity, etc.
● Traffic densities and distribution of main roads and pathways – consider other possible ways of spread of the
disease to apply complementary measures (vaccination only is not enough)
● Farms with endangered species or animals of high economic value or sentimental value (pets) – increased
pressure to perform vaccination to protect these animals and farms, include this in the cost/benefit analysis.
● Role of wildlife – distribution of wild animals and densities surrounding affected areas.
● Social impact on farmers – it’s important to listen to their opinion
● Impact assessment from a wide point of view (multi-criteria assessment).
● Impact of the disease and restrictions on other businesses (rural and agricultural activities, tourism, etc) and
including restrictions of movements to citizens – increased pressure to perform vaccination to minimize the
impact of restrictions.
● Opinion of trade partners on regionalization.
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EXERCISE ONLY

5. Vaccination criteria for Denmark (Breakout room 3)
● Most important: probability to manage outbreak based on model output
● Rendering/killing capacity
● Probability of contacts to be positive/quality/sort of contacts (day 3)
● Number of contacts (day 3)
● Rate of spread (day 14)
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EXERCISE ONLY

6. Additional data needed for vaccination criteria(Breakout room 3)
Timing of contacts
Capacity for killing, rendering, vaccination,
Livestock density
Species and ethics NOT important for the technical group
Based on the scenario likely to vaccinate at day 14, but not t 3 and 90.
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EXERCISE ONLY

7. Vaccination criteria for Austria (Breakout room 4)
● Capacity to cull and destruct all herds in 1km in 48h
● Population density
● Vaccination capacity
● Surveillance capacity
● Epidemiological situation, epidemic curve
● High risk period
● Economical consequences
● Animal welfare opposition
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EXERCISE ONLY
Click to add text

8. Additional data needed for vaccination criteria (Breakout room 4)
● Capacity of the authorities to manage the outbreaks
○ Rendering
○ Vaccination
○ Surveillance
● Population data
● Epidemiological investigations data:
○ HRP
○ Infected herds: movements and traffic
○ Epidemic curve
● Economical situation
● Public position towards animal welfare
● Simulation outputs
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EXERCISE ONLY
Click to add text

9. Vaccination criteria for Denmark (Breakout room 5)
● Species involved – cattle or not
● IP’s - how many are from DC and how many are unexpected
● Culling and rendering capacity
● Capacity for screening visits – information on how many IP’s are detected by surveillance
● Farm/animal densities – 250 animals/km2 (up to 300-400)
○ For comparison 2000 animals/km2 in NL during the outbreak
○ What is considered “high density”
● Ethical considerations on culling
○ How will the public react on culling
■ Of infected farms
■ Of neighboring farms
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EXERCISE ONLY

10. FMD vaccination
Experience to control the FMD
outbreak in NL in 2001
Annemarie Bouma
10 March 2022

12. FMD eradication in the Netherlands
Number of FMD cases in the Netherlands
1
10
100
1000
10000
100000
1000000
1
9
3
5
1
9
3
8
1
9
4
1
1
9
4
4
1
9
4
7
1
9
5
0
1
9
5
3
1
9
5
6
1
9
5
9
1
9
6
2
1
9
6
5
1
9
6
8
1
9
7
1
1
9
7
4
1
9
7
7
1
9
8
0
1
9
8
3
1
9
8
6
1
9
8
9
1
9
9
2
1
9
9
5
1
9
9
8
2
0
0
1
Year
Number
of
cases
Start vaccination campaign
End vaccination campaign

13. 4
4
4
Non-vaccination policy European Union
• Classical swine fever, foot and mouth disease
• Large susceptible population
• CSF outbreak in 1997-1998
• 429 holdings infected
• >1200 farms pre-emptively culled
• Pre-emptive culling of farms in 1km zone
• Lasted 1 year
•  12 million pigs culled
• Total costs: ± 1 billion euro

14. FMD outbreak 2001
• Last case NL: 1984
• Start FMD epidemic in UK in February 2001
• Movement restrictions for susceptible animals in NL
• 21.03: first outbreak detected NL : farm-dense area (cattle, pigs,
sheep, goats)
• 3 and 10 km protection and surveillance zone
• Movement restrictions NL, zone
• Culling infected herds
• Pre-emptive culling of all herds in 1 km zone

15. Control strategy 2001
• 21.03: first outbreak; already 7 cases
• Order for ID-Lelystad (manufacturer): 500,000 doses (in stock)
• 22.03: permission from EC to vaccinate in zone around new
outbreaks;
• if destruction capacity is not sufficient
• Vaccination ok, but animals have to be killed and destroyed
• Pre-emptive culling becomes difficult
• 26.03: first vaccination 1 km zone
• 01.04: 12 outbreaks in central part of NL
• Experts: pre-emptive culling within 48 h
• Too many farms, too short notice → destruction capacity

16. FMD outbreak 2001
- Situation quickly deteriorating:
- Culling of infected farms was feasible
- Not sufficient destruction capacity available for pre-emptive culling
0
1
2
3
4
21/03/01 28/03/01 04/04/01 11/04/01 18/04/01 25/04/01

17. Control strategy 2001
• 03.04: 3 outbreaks in one day
• Vaccination in 2 km zone around each outbreak
• Experts / veterinarians suggested larger zone: easier said than
done → huge increase, and when area to extended: unnecessary
destruction of thousands of healthy animals
• Nevertheless, outbreaks not particularly under control
• Policy makers considered vaccination of larger area in affected part
of NL

18. Control strategy 2001
• 05.04: protective vaccination in area central part NL
• Permission of EC
• Goal: buy time for culling and destruction
• Organisation vaccination campaign:
• Competent Authority
• Animal Health Service (Deventer) personnel, whole organisation

19. Vaccinati
on area
Control strategy 2001
• Discussion NL which area: epidemiological situation, availability of
vaccines, personnel, …
• Borders of designated area:
• IJssel
• railway
• ‘remote’ area
• Chosen because of presumed
contact structure

20. Control strategy 2001
• Designated area
• 1300 herds to be vaccinated
• 450 km2
• After vaccination: all vaccinated animals brought to slaughterhouses
for culling and destruction
• Logistical reasons
• No risk of subclinical spread: within the area, certain time after
vaccination, assumed that virus shedding reduced/absent when
infected
• Regaining freedom from FMD (shorter period)
• Serological examination of cattle to determine ‘vaccine effectiveness’
(research)

21. Serological examination vaccinated animals
Final screening: 6 positive animals on 6 farms
• 3 times negative on re-sampling
• 2 times singleton reactor
• 1 time born before 1991

22. Control strategy 2001
• 23.05: all animals in vaccinated area killed and removed
• ± 270,000 animals culled
• 26.06: NL free from FMD
• Several law suits about vaccination
• Discussion about the vaccination to cull policy vs vaccination to live
policy

23. UK The Netherlands
• First case in EU: unexpected
• At detection already 40 cases
• No preventive culling at start of
epidemic
• No vaccination
• Alert and movement
restrictions
• At detection possibly 6 herds
already infected
• Immediately preventive culling
1km zone and contact herds
• Vaccination

24. Policy Ministry of Agriculture, Nature Food
Quality
• (Ethically) acceptable disease control
• Facilitation of a sustainable and profitable agricultural business
Responsible for control of notifiable diseases
• Contingency plan:
• EU AHR
• FMD and CSF: emergency vaccination strategy included;
‘vaccination to live’ policy
• Transparent about control measures:
• Stakeholders
• Parliament

25. Future
• Accepted policy
• Trade issues
• Sectors foresee difficulties regarding trade of products from
vaccinated animals: in EU and with third countries
• Willingness to allow vaccination in future?
• We hope it will not be necessary

26. Vaccination and policy
making of control Foot
and Mouth Disease
Marcel Spierenburg DVM LLM
NVWA Incident- and Crisiscentre for
Animal diseases and Zoonoses

27. Dutch Policy Ministry of Agriculture, Nature and Food Quality
(LNV)
• (Ethically) acceptable disease control
• Facilitation of a sustainable and profitable agricultural business
Responsible for control of notifiable diseases
• Contingency plan:
• EU regulations
• Foot and mouth disease (FMD) and classical swine fever (CSF):
emergency vaccination strategy included
• Transparent about control measures:
• Stakeholders
• Parliament

28. 2
2
2
Dutch contingency plan
• Culling infected farm and
contact farms
• Standstill entire country 72
hours
• Pre-emptive culling 1km
radius (at the start of an
epidemic)
• Tracing
• Protection zone (3km) and
surveillance zone (10km)
• Screening all farms in
protection zone
• Restrictions for visitors on
locations with susceptible
animals
• Vaccination
• Regionalisation

29. 3
3
Vaccination — general concept
• Emergency vaccination for life (protective vaccination)
• Vaccinated animals will not be destroyed
• In line with AHL Reg (EU) 2016/429 and
Reg (EU) 2020/687 and future Delegated Act
Use of veterinary medicinal products for disease control
Freedom at least 6 months after ending vaccination campaign
In NL use of DIVA vaccines (differentiating infected from vaccinated
animals)

30. 4
4
Vaccination — concerns
• Is vaccination effective?
Vaccination is an effective alternative to pre-emptive culling, both
from an economical and epidemiological point of view.*
• Economic consequences?
Market acceptance by trade partners of products of vaccinated
animals can limit the economic consequences*.
*Backer, Bergevoet et al., 2009: Vaccination against Foot-and-Mouth Disease
Differentiating strategies and their epidemiological and economic consequences

31. 5
Vaccination — decision making
• Minister takes decision whether to vaccinate and how, based on
epidemiological, economical and social implications
• Risk analysis from group of veterinary experts on best control
strategy:
• Should vaccination be carried out?
• In which areas should vaccination be carried out?
• Can groups of animals be excluded from vaccination?
• Submission of vaccination plan to European Commission and MS

32. 6
Vaccination — decision making
Risk analysis from group of veterinary experts for implementing
emergency vaccination for FMD:
Guidance criteria for implementing emergency vaccination:
• -Veterinary factors: livestock density, virus type, animal species,
vaccine availability, personnel to carry out emergency vaccination,
• Economic factors: financial consequences animal disease control
strategy, trade bans, export restrictions.
• Ethical factors: kill as few uninfected animals as possible.

33. 7
Vaccination — decision making
Guidance criteria for implementing emergency vaccination:
Advantages implementing emergency vaccination:
• Culling of fewer healthy uninfected animals (no pre-emptive culling
necessary anymore).
Disadvantages Implementing emergency vaccination:
• Vaccination in the initial phase less effective than preventive
culling because production of immune response (7-14 days).
- Vaccinated animals can still become infected
• Longer term trade restrictions and additional EU requirements for
processing products from vaccinated animals resulting in lower
yield

34. 8
8
• No vaccination during 72 hours stand-still
• Tracking and tracing
• Culling infected farms and direct contact farms
• Preemptive culling: 1 kilometer around infected farms
• Transport bans, zones and all the other measures
• Contract pharmaceutical company: virus identification & order
vaccine, standby contract 24H/7D, choice FMD virus vaccin strains
EURL/NRL/OIE ref lab for FMD
Vaccination — onset

35. 9
9
Vaccination— strategy
• Vaccination of as few animals as possible
• All susceptible animals in a 2 km radius
• All ages
• Single vaccination only
• Vaccination to let live
• Commercial and non-commercial holdings
• Cattle
• Sheep & goats
• Pigs
• Deer
• Zoo-animals
• Wildlife and laboratory animals are exempted from vaccination

36. 10
10
Vaccination — zones
• 2 km ring vaccination
around infected farms
• Vaccination zone:
area with vaccination rings
• 10 km vaccination
surveillance zone
• No vaccination
• Veterinary measures
movement restrictions

37. 11
11
Vaccination — screening
• NSP-ELISA: distinction between vaccinated and infected animals
• Sampling during vaccination (10% prevalence, 95% confidence)
• End-screening (30 days after last vaccination)
• Cattle and sheep in vaccination zone :
• Clinical examination and serological testing of all animals
• Pig farms in vaccination zone :
• Clinical examination and serological samples (5% prevalence,
95% confidence)
• Follow-up testing of animals reacting positive (samples to National
Reference lab WBVR Lelystad)

38. 12
Vaccination – ongoing challenges
• Acceptance of emergency vaccination / ‘vaccination to live’ as an
effective tool for FMD control.
• National and international acceptance of products from vaccinated
animals.
• Review of EU conditions for trade in vaccinated animals and animal
products based on scientific risk assessment.
• Dealing with consequential losses for primary holdings and processing
industry.

39. National level
• Discussions with the stakeholders e.g.
• Producers: Dutch Federation of Agriculture and Horticulture (LTO
Nederland), Producer organization pigholders (POV)
• Process industry (slaughterhouses, dairy industry, canning
industry)
• Retailers
• Pet owners
• Main topics
• Compensation for indirect costs
• Compensation for losses due to labeling/processing and loss of
value for products of vaccinated animals
• Policy of Ministry:
• Financial losses due to problems with marketing products from
vaccinated animals are for producers (normal business risk)

40. International level: third countries / OIE
• Ministry
• Lobby to change the OIE manual with respect to time to regain
free status
• Acceptance of products by third countries
• Certificates
• Bilateral agreements between trading countries
• Sector
• Lobby with trading partners

41. • Thank you for your
attention!
• Questions?
15