TECHNIQUE

Protective Emergency Vaccination for Foot-and-Mouth Disease (Disease Investigation & Control - Treatment and Care)

Summary Information
Type of technique Health & Management / Disease Investigation & Control / Treatment & Care / Techniques:
Synonyms and Keywords  
Description For the EU, as set out in COUNCIL DIRECTIVE 2003-85-EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease, ‘protective vaccination’ is defined as " emergency vaccination carried out on holdings in a designated area in order to protect animals of susceptible species within this area against airborne spread or spread through fomites of foot-and-mouth disease virus and where the animals are intended to be kept alive following vaccination" (LEU6 - W19.Sept07.w1)
  • The 1999 document "Strategy for Emergency Vaccination against Foot and Mouth Disease (FMD) Report of the Scientific Committee on Animal Health and Animal Welfare (European Union) indicates that the area of 'protective' emergency vaccination should be as small as possible (but sufficiently large that it is unlikely that unvaccinated animals outside this area will be infected by airborne virus), and its shape should be related to the geographical and meteorological situation. The inner boundary of the vaccination area should be clearly defined; on the basis of the available epidemiological data, it may include a part of the surveillance zone (i.e. an area 'at risk'), but not the protection zone. (D35.w1 - full text available)

COUNCIL DIRECTIVE 2003-85-EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease Article 52 states:

Protective vaccination

1. Member States applying protective vaccination shall ensure that:
(a) the vaccination zone shall be regionalised in accordance with Article 45, where necessary in close cooperation
with neighbouring Member States;

(b) vaccination shall be carried out swiftly and in conformity with the rules of hygiene and bio-security so as to avoid the spread of foot-and-mouth disease virus;

(c) all measures applied in the vaccination zone shall be carried out without prejudice to the measures provided
for in Section 7;

(d) where the vaccination zone includes parts of or the entire protection or surveillance zone:

(i) the measures applicable for the protection zone or surveillance zone in accordance with this Directive shall be maintained within that part of the vaccination zone until such measures have been removed in accordance with Article 36 or Article 44;

(ii) after the measures applied in the protection zone and surveillance zone have been removed, the measures applicable for the vaccination zone as provided for in Articles 54 to 58 shall continue to apply.

2. Member States applying protective vaccination shall ensure that the vaccination zone is surrounded by a surveillance area (surveillance zone as defined by OIE) of at least 10 km width from the perimeters of the vaccination zone:

(a) in which vaccination is prohibited;

(b) in which intensified surveillance is carried out;

(c) in which the movement of animals of susceptible species is subject to controls by the competent authorities;

(d) which remains in place until the foot-and-mouth disease and infection free status is recovered in accordance with Article 61.

(LEU6 - W19.Sept07.w1)
  • Articles referenced in the section of LEU6 quoted above:
    • Articles 36 and 44 indicate the conditions required before removal of measures in the protection zone and the surveillance zone, respectively. (LEU6 - W19.Sept07.w1)
    • Article 45 discusses regionalisation. (LEU6 - W19.Sept07.w1)
    • Articles 54 to 58 set out measures regarding movements of vaccinated animals; treatment of meat and milk from vaccinated animals; clinical and serological surveillance of vaccinated animals; actions if vaccinated herds are found to have been infected with FMDV; and continuing restrictions until FMD-free status has been restored. (LEU6 - W19.Sept07.w1)
    • Article 61 sets out the conditions for recovery of FMD-free status after use of vaccination as part of the control measures. (LEU6 - W19.Sept07.w1)]

Note:

  • The usual disease control measures (including stamping out) should be continued irrespective of when vaccination commences.
  • Clinical inspections should always precede the administration of vaccine and suspect signs must be reported.
  • If a case of foot and mouth disease is encountered during the application of protective emergency vaccination, then vaccination must be suspended and control measures (slaughter and quarantine restrictions etc.) taken.
  • Animals would be vaccinated from the outer border of the zone inwards to the inner boundary.
  • Personnel involved in vaccination should follow zoo-sanitary measures to minimise the risk that they might spread infection between holdings.

(D35.w1 - full text available)

Appropriate Use (?)

The 1999 document "Strategy for Emergency Vaccination against Foot and Mouth Disease (FMD) Report of the Scientific Committee on Animal Health and Animal Welfare (European Union)" suggested that indications for the use of this emergency vaccination programme would be if a large number of the following criteria applied to an outbreak (D35.w1 - full text available):

  • High population density of susceptible animals
  • Significant number of pigs involved
  • Evidence of movement of potentially infected animals or products out of the protection zone
  • High predicted airborne spread of virus from infected premises
  • Suitable vaccine available
  • Widespread distribution of outbreaks
  • Suitable vaccine available
  • Unknown origin of outbreaks
  • Incidence slope of outbreaks rising rapidly
  • Widespread distribution of outbreaks
  • Strong public reaction to total stamping out policy
  • Acceptance of regionalisation after vaccination.

A predominance of the opposite circumstances would indicate that the use of emergency vaccination may not be a necessary/appropriate adjunct to other measures such as slaughter, movement restrictions, quarantine and disinfection to control an outbreak of FMD.

(D35.w1 - full text available)

COUNCIL DIRECTIVE 2003-85-EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease gives the following statements regarding the use of emergency vaccination in EU member states the following criteria for implementation of emergency vaccination (W19.Sept07.w1 - full text included):

Article 50 Decision on introducing emergency vaccination
1. It may be decided to introduce emergency vaccination where at least one of the following conditions applies:
(a) outbreaks of foot-and-mouth disease have been confirmed and threaten to become widespread in the Member State where such outbreaks have been confirmed;
(b) other Member States are at risk due to the geographical situation of or the prevailing meteorological conditions in relation to reported outbreaks of foot-and-mouth disease in a Member State;
(c) other Member States are at risk due to epidemiologically relevant contacts between holdings on their territories and holdings keeping animals of susceptible species in a Member State where there are outbreaks of foot-and mouth disease;
(d) Member States are at risk due to the geographical situation or the prevailing meteorological conditions in a neighbouring third country where there are outbreaks of foot-and-mouth disease.
  • Reduces number of premises on which rapid slaughter and disposal is required, thereby allowing "stamping out" operations to concentrate on premises with animals which are known to be infected or which are considered to be Dangerous Contact Animals.
Notes
  • The OIE Terrestrial Animal Health Code Sixteenth Edition Chapter 2.2.10 - Foot and mouth Disease [Text available in Wildpro], states that a vaccinated area can be considered free of FMD:
  • "3 months after the slaughter of all vaccinated animals where a stamping-out policy, emergency vaccination and serological surveillance are applied in accordance with Appendix 3.8.7."; or
  • "6 months after the last case or the last vaccination (according to the event that occurs the latest), where a stamping-out policy, emergency vaccination not followed by the slaughtering of all vaccinated animals, and serological surveillance are applied in accordance with Appendix 3.8.7., provided that a serological survey based on the detection of antibodies to nonstructural proteins of FMDV demonstrates the absence of infection in the remaining vaccinated population."
  • Allows animals to enter the food chain rather than being culled and disposed of.
  • Allows preservation of high-genetic-value stock. (D35.w2)
  • The choice of what to do with vaccinated animals could wait until after the disease was eradicated; in the mean time they could be kept quarantined. Possible choices include:
    • a limited period of movement restriction (e.g. 30 or 60 days);
    • prolonged movement restriction (to avoid all possibility of vaccinated carrier animals transmitting infection to unvaccinated stock);
    • cull of vaccinated animals for a rapid return to "FMD free" status.
  • (J3.102.w7, J3.131.w1, J70.12.w1).
Complications/ Limitations / Risk
  • Disease control considerations:
    • Increased risk of disease spread associated with increased contact between animals and personnel involved in vaccination.(J3.131.w1, J16.22.w1).
    • Need to ensure vaccinated animals were not moved outside the vaccinated zone except under special licence (J3.131.w1).
    • Some animals may be in the early incubation stages of FMD at the time when they are vaccinated, and a small proportion may become carriers (D36.Para124). Ruminants, including cattle, with or without developing clinical disease, and including animals which have been vaccinated and then been in contact with live FMD virus may carry live FMD virus in the pharynx, for up to three years (cattle), nine months (sheep), less than nine months (goats) (J42.118.w1). However, good-quality vaccines, if given a sufficient length of time prior to exposure to live virus, may reduce the incidence of the development of the carrier state in vaccinated animals (W18.Apl01.sib1). 
      • Note: "follow-up outbreaks, caused by the presence of vaccinated carrier animals, have never been observed." (P5.40S.w2).
  • Economic considerations:
    • Immediate costs associated with vaccination (D35.w2).
    • Extended loss of export trade from the vaccinated zone, due to export restrictions on seropositive animals, related to the problems of identifying carriers (J3.131.w1).
      • Note: The OIE Terrestrial Animal Health Code Sixteenth Edition Chapter 2.2.10 - Foot and mouth Disease [Text available in Wildpro], states that a vaccinated area can be considered free of FMD within 
      • "6 months after the last case or the last vaccination (according to the event that occurs the latest), where a stamping-out policy, emergency vaccination not followed by the slaughtering of all vaccinated animals, and serological surveillance are applied in accordance with Appendix 3.8.7., provided that a serological survey based on the detection of antibodies to nonstructural proteins of FMDV demonstrates the absence of infection in the remaining vaccinated population." (B493.2.2.10.w1)
    • Need to ensure vaccinated animals were not moved outside the vaccinated zone except under special licence (J3.131.w1).
    • "Possible generation of a surplus of meat" (J3.131.w1).
    • "There are no fully validated serological tests to distinguish between antibody produced by vaccination and that resulting from recovery from infection." (J42.118.w1).
  • Safety considerations:
    • Risk of stress, particularly to highly pregnant animals, during gathering and handling for vaccination (D36.Para200).
    • Hazards to both animals and humans in trying to gather animals in inclement weather such as fog or snow (D36.Para200).
Equipment / Chemicals required and Suppliers
  • Vaccine. An emergency vaccine should be a vaccine of high potency containing antigen of a strain which is antigenically appropriate. It should provide a sufficient level of protection after the application of a single dose. However, if the field strain is antigenically different from the available vaccine strain and there is no alternative strain available it may be necessary to implement a second round of vaccination.
    • Formulated foot and mouth disease emergency vaccines (inactivated antigens being stored as concentrates over liquid nitrogen) must have been validated as potent vaccines.
    • High potency is essential (at least 6 PD50 E.P.) to achieve rapid development of immunity and a broad antibody response in vaccinated animals. Therefore, in circumstances when there is a lack of homology between a field virus and the vaccine strain then the broader response induced by a highly potent vaccine can compensate in part for the lack of antigenic homology.
    • Oil-adjuvanted inactivated vaccines should be used whenever possible since they can be expected to produce an acceptable immune response in all foot and mouth disease susceptible species, whereas aluminium hydroxide adjuvanted vaccines are effective in ruminants but not in pigs.
    • The vaccine strain used should be as homologous as possible with the field strain; diagnostic procedures on FMDV isolates should include the provision of information about the degree of relationship to vaccine strains.
    • Non-structural proteins should not be present in the vaccines because this could interfere with differential diagnostic tests. Batches must be tested to verify this.
    • (D35.w1 - full text available)
  • Cold chain facilities must be available for the storage and distribution of vaccine so that it is, at all times, kept under cool temperature conditions, as specified in the European Pharmacopoeia .(D35.w1 - full text available)
Expertise level / Ease of Use Vaccination teams and equipment. A sufficient number of well trained vaccinators and the required equipment to ensure the rapid administration of vaccine to the animals must be immediately available according to prior contingency planning.

May be undertaken by trained personnel not required for other facets of the response.

Cost/ Availability
  • Sufficient vaccine would be needed to vaccinate all animals within the designated vaccination area.
  • Suitable concentrated inactivated FMDV vaccines are stored in vaccine banks such as the International Vaccine Bank at Pirbright and the European Vaccine Bank. Emergency vaccines held in highly concentrated form in virus banks (e.g. at Pirbright) contain large numbers of vaccine doses and vaccines may be made available by 48 hours following request. (J70.12.w1).
Legal and Ethical Considerations
Author Debra Bourne
Referee Suzanne I Boardman
References B493 - Terrestrial Animal Health Code Sixteenth Edition (B493.2.2.10.w1, B493.App3.8.7.w2) - full text of these sections provided
J3.102.w7, J3.131.w1, J16.22.w1, J42.118.w1, J70.12.w1
P5
.40S.w2
D35
.w1 - full text provided, D35.w2 - full text provided, D36.Para124
LEU1
, LEU3, LEU6 - COUNCIL DIRECTIVE 2003-85-EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease - full text provided
W18
.Apl01.sib1
W19
.Sept07.w1 - full text provided

Return to Top of Page