EUROPEAN UNION The European Union IPA 2013 programme for Kosovo KOSOVO TECHNICAL ASSISTANCE FOR THE ANIMAL HEALTH DEPARTMENT OF THE KVFA AND THE FOOD AND VETERINARY LABORATORY (KOSOVO) REF: EuropeAid/133795/DH/SER/XK Deliverable 2.4 Vaccination strategy and plans for notifiable and non-notifiable diseases February 2016 Consortium Agrotec SpA / IZSVe / NIRAS 1 / 18
This document has been produced with the financial assistance of the European Union The contents of this publication are the sole responsibility of the author / contractor / implementing partner and are in no way be taken to reflect the views of the European Union. Consortium Agrotec SpA / IZSVe / NIRAS 2 / 18
Vaccination strategy for notifiable and non-notifiable diseases Vaccination is a key control for many diseases and many vaccines are available. However, government resources are limited and come from the general public, so governments should only participate in vaccination campaigns under certain circumstances. 1) There must be a justification for government involvement in the control of that disease 2) The disease must be actually present or at high risk of introduction 3) There must be an effective vaccination available 4) There must be a realistic chance of the vaccination campaign leading to a sustainable decrease in the disease Diseases to be included in the surveillance strategy assessment A total of 59 diseases have been assessed. This number is made up from three sources. 1) The list of 50 diseases agreed between KAHL and KFVA at the start of the project (see D0.0 and D8.1) as being a priority for surveillance and lab diagnosis 2) Diseases for which KFVA has some degree of control program (either in the annual work plan or otherwise) that are not in the KAHL/KFVA agreed list. This adds 4 diseases. 3) Diseases listed in Schedule 1 of the Kosovan veterinary law that are not in the KAHL/KFVA list. This adds 5 diseases. These separate lists are available in other project deliverables (e.g. 2.0 and 8.1) and the full list of diseases included for assessment is shown in Table 1 below. Deriving the appropriate vaccination strategy A step by step approach has been taken to derive the recommend strategy for each disease. This is described in detail below. Consortium Agrotec SpA / IZSVe / NIRAS 3 / 18
Table 1: List of diseases included for assessment of surveillance and vaccination strategies KAHL/KFVA List Multiple species diseases and infections Anthrax Aujeszky's disease Bluetongue Brucellosis (Brucella abortus) Brucellosis (Brucella melitensis) Brucellosis (Brucella suis) Crimean Congo haemorrhagic fever Foot and mouth disease Infection with Trichinella spp. Q fever Rabies Toxoplasma West Nile fever Cattle diseases and infections Bovine babesiosis Bovine genital campylobacteriosis Bovine spongiform encephalopathy Bovine tuberculosis Bovine viral diarrhoea / Mucosal Disease Enzootic bovine leucosis Infectious bovine rhinotracheitis Lumpy skin disease Trichomonosis Sheep and goat diseases and infections Border Disease Caprine arthritis encephalitis Enzootic abortion of ewes (Chlamydophila abortus) Maedi Visna Ovine epididymitis (Brucella ovis) Peste de petits ruminants Scrapie Sheep and goat pox Swine diseases and infections African swine fever Classical swine fever Swine vesicular disease Consortium Agrotec SpA / IZSVe / NIRAS 4 / 18
Avian diseases and infections Avian Influenza in poultry (HPAI and LPNAI) Campylobacter in poultry High pathogenic avian influenza in birds other than poultry including wild birds Newcastle disease Salmonellosis in poultry Bee diseases, infections and infestations Aethina tumida (Small hive beetle) Infestation of honey bees with Acarapis woodii Infestation of honey bees with Tropilaelaps spp Melissococcus plutonius (European foulbrood) Nosemosis Paenibacillus larvae (American foulbrood) Varroa spp. (Varroosis) Fish diseases Epizootic haematopoietic necrosis Infectious haematopoietic necrosis Spring viraemia of carp Viral haemorrhagic septicaemia Other diseases Leishmaniosis Existing KFVA Control program not otherwise included Cattle diseases and infections Clostridial diseases in cattle (mostly Blackleg) Sub-clinical mastitis Sheep and goat diseases and infections Clostridial diseases in sheep and goats (mostly Type B and D) Other diseases Echinococcosis Kosovo Vet Law Schedule 1 not otherwise included African horse sickness Contagious bovine pleuropneumonia Rift Valley fever Rinderpest Vesicular stomatitis Consortium Agrotec SpA / IZSVe / NIRAS 5 / 18
The list of diseases was filtered using the criteria that there is a justification for government involvement the disease is or may be present in Kosovo or the risk of introduction and spread is high that a vaccine is available and effective there is a public benefit to vaccination (there may also be a private benefit but some of the benefit must be public) The first step was to exclude those diseases for which government intervention is not justified. Justification for government intervention The criteria used for assessing the justification of government intervention are those that are described in Deliverable 3.1.1 In summary they are Is there a human health risk? Is there a threat to national food security? Is there a nationally significant threat to trade in livestock or livestock products? Is there a nationally serious threat to livestock production that farmers/vets cannot control without government resources? Is there a significant threat to the livelihoods of specific groups of poor farmers? Does inaction or inappropriate action by some farmers create a serious problem for other farmers Is there a regional control program or an EU requirement for control? When assessed against these criteria, the 11 diseases met none of them and so were excluded from further assessment. These are shown in Table 2. This list includes clostridial diseases in cattle and small ruminants for which vaccination has been provided until recently by KFVA. This should be stopped immediately; the benefits are entirely to the individual producer with no impact on others. Consortium Agrotec SpA / IZSVe / NIRAS 6 / 18
Table 2: Diseases that did not meet any of the justification for government intervention KAHL/KFVA List Cattle diseases and infections Bovine babesiosis Bovine viral diarrhoea / Mucosal Disease Sheep and goat diseases and infections Border Disease Fish diseases Epizootic haematopoietic necrosis Spring viraemia of carp Viral haemorrhagic septicaemia Existing KFVA Control program not otherwise included Cattle diseases and infections Clostridial diseases in cattle (mostly Blackleg) Sub-clinical mastitis Sheep and goat diseases and infections Clostridial diseases in sheep and goats (mostly Type B and D) Kosovo Vet Law Schedule 1 not otherwise included Rinderpest Vesicular stomatitis Of the remaining 48 diseases, many are not present in Kosovo or is there a realistic risk of introduction or when they are, vaccination is not appropriate and when it is that there are no public benefits. The decision process is illustrated in Fig 1 below. The full list of the 48 diseases with the decision criteria for reach is included as Annex A. This policy decision process leads to a total of 11 diseases for which vaccination may be considered in Kosovo as shown in Table 3. These require a detailed assessment taking local conditions and other factors into account. Vaccination for each disease is discussed in more detail following Table 3. The outcomes are that an official at least partly government funded programme is required (5 diseases), that owners be required to vaccinate at their own expense (2 diseases) that there is insufficient information on which to make a decision or that there is insufficient justification given the current knowledge in Kosovo (4 diseases) Consortium Agrotec SpA / IZSVe / NIRAS 7 / 18
Fig 1: Policy decision process for vaccination strategies Diseases to be assessed (59) Justification for govt. intervention (Yes: 48) Present in Kosovo or high risk of introduction (Yes: 34) Vaccine available and effective (Yes: 15) Public benefit of vaccination (Yes: 11) Detailed assessment required No (11) No (14) No (19) No (4) Official vaccination program recommended (5) Compulsory vaccination paid by owner recommended (2) Inadequate data for decision or insufficient justification (4) Consortium Agrotec SpA / IZSVe / NIRAS 8 / 18
Disease Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) Government intervention justified Table 3: Diseases for which vaccination may be considered Present in Kosovo Risk of introduction and spread Risk of persistence Impact Vaccine available Vaccine effective Socioeconomic benefit of vaccination Multiple species diseases and infections Anthrax Yes Yes Endemic High Medium Yes Yes Public Bluetongue +/- Uncertain High Low Medium Yes() Yes () Public / Private Brucellosis (Brucella abortus) Yes Uncertain Endemic? High Medium Yes Yes Public Brucellosis (Brucella melitensis) Yes Yes Endemic High High Yes Yes Public Q fever Yes Yes Endemic High Med Yes() Yes () Public Rabies Yes Uncertain High High High Yes Yes Public Toxoplasma +/- Yes Endemic High Medium to low Yes Yes Public/ Private Cattle diseases and infections Bovine tuberculosis Yes Yes Endemic High Low Yes () Yes () Public Swine diseases and infections Classical swine fever Yes Uncertain High High Medium Yes Yes Public / Private Avian diseases and infections High or Newcastle disease +/- Uncertain Endemic High Medium Yes Yes Public / Private Salmonellosis in poultry Yes Yes Endemic High Medium Yes Yes Public Consortium Agrotec SpA / IZSVe / NIRAS 9 / 18
Anthrax Anthrax vaccination is justified around confirmed outbreaks and should be available and supplied by the government. The use of vaccination in this way is included in Administrative Instruction 06/2008. The previous policy of vaccinating all cattle in municipalities bordering other territories has now been dropped but a replacement policy does not seem to be well developed. Unfortunately, records are not adequate to permit and assessment of how many confirmed outbreaks are detected a year so allowing an estimate of what is needed. What is needed is an estimate of how many outbreaks are recorded every year (this will vary depending on weather and other conditions), sufficient vaccine be ordered and then vaccination carried out around outbreaks annually for a defined number of years (often 5 years is used). Note that the initial response to an outbreak should include treating exposed and at-risk animals with prophylactic antibiotics. As the vaccine used is a modified live vaccine (usually the Sterne strain), vaccination in these animals must wait until after the prophylactic course of antibiotics. Bluetongue Bluetongue vaccination is undertaken only in response to identified outbreaks. This is because introductions are sporadic making routine vaccination unlikely to be economically justified and because the vaccine must be matched to the circulating strain. It is also probable that the cold winter in Kosovo will reduce the likelihood of persistence as the more common vectors will not survive the winter. A system is required to obtain vaccine if it is required and to identify the strain circulating in the case of an introduction. As much of the benefit of vaccination is gained by the owners, a cost sharing system should be considered. Brucella abortus Vaccination of cattle against Brucella abortus is only justified if the prevalence is above a threshold level. At present, there is no information on which to make this decision. The annual seroprevalence sample shows that currently around 1% of cattle are sero-positive on the RBT test. However, this is not a definitive test in cattle as it has known specificity issues. Nor can any serology test differentiate between infection with B. abortus and B. melitensis. The latter is clearly present in Kosovo and would be expected to infect cattle, so some of the sero-prevalence in cattle will be due to B. melitensis. But how much is not clear as sample have not been properly collected and tested by culture to identify the causal organism in sero-positive cattle. There is insufficient information to make a decision to start vaccination of cattle against B. abortus. Brucella melitensis Vaccination against B. melitensis in small ruminants is ongoing and a separate assessment has been produced and proposal made. Q fever Vaccination against Q fever is possible in ruminants. But it should only be carried out in known problem herds or flocks. These would be identified by human cases. Q fever is not frequently diagnosed in Kosovo. There is no current justification for Q fever vaccination in Kosovo. Rabies Rabies vaccination is ongoing in Kosovo. Oral rabies vaccination (ORV) of foxes has been undertaken for 5 years and has now stopped. Follow up surveillance suggests that the vaccination should have been effective but reintroduction from neighbouring territories may occur. Vaccination of dogs is routine, with all dogs supposed to be vaccinated annually. Vaccine is supplied to PVPs by KFVA. No canine rabies has been reported from Kosovo for many years but it is present in neighbouring territories so vaccination is required and recommended. This should be annual boosters for adults and vaccination at the correct age for puppies. This is the current and correct approach. However, there is no gathering of data ion how many dogs are vaccinated Consortium Agrotec SpA / IZSVe / NIRAS 10 / 18
annually and little data on the structure of the owned dog population of Kosovo to allow an estimation of the coverage being achieved. The effectiveness of this vaccination program is unknown and should be established. Toxoplasmosis This is a ubiquitous organism and not capable of eradication. Flocks with a history of abortions due to toxoplasmosis can be vaccinated but this should be done privately. Bovine tuberculosis (BTB) Vaccination against bovine tuberculosis (BTB) is not yet fully proven but is expected to be available soon. However, the apparently low levels of BTB in Kosovo would not justify this except perhaps in problem herds. It will be better to test and slaughter initially. However, there is much doubt around the results of BTB testing in Kosovo, so the data are not adequate to propose a vaccination strategy even when the vaccine becomes available. Classical swine fever (CSF) Vaccination against classical swine fever (CSF) is routinely carried out in Kosovo with free vaccine offered to pig keepers. The disease may not be present in Kosovo, but it is present in neighbouring countries which justifies continuing vaccination. This should include annual vaccination of all pigs and vaccination of piglets at an age when maternal antibodies will have waned. This vaccine can be provided and paid for by KFVA as this is a serious disease with transboundary potential and there is an EU funded regional control and eradication program. Presently, here is inadequate follow up to determine if the coverage achieved is likely to provide sufficient herd immunity to prevent spread. This should be properly investigated but obtaining a representative sample from pigs is not simple in Kosovo because of the communities mostly involved in pig rearing and the reluctance of pig keepers and PVPs to allow or undertake such sampling. Vaccination should cease when neighbouring territories are shown to be free and surveillance in Kosovo indicates an absence of circulating antibodies either through active surveillance or reliable primary surveillance. Newcastle disease This is requires a degree of judgement. As the disease has no human impact and Kosovo does not currently export poultry products (or intend to do so in the near future), there is little public impact of this disease. However, it is EU regulated and any outbreak would require culling and compensation. So vaccination is to an extent in the public interest if the disease would otherwise occur (Newcastle disease virus is usually present in wild birds so outbreaks can occur at any time). However, any outbreak would cause great loss to producers, so they also have a strong incentive to vaccinate and benefit most from this unless they know they can rely on compensation. In this situation, where vaccination is permitted but compensation also exists, there can be a moral hazard in that producers know they are in effect insured against losses by the state to some extent. The very large commercial producers almost all vaccinate when it is allowed and smaller scale producers often rely heavily on their birds for income and so tend to vaccinate when the vaccine is available. It is medium to large scale producers (the majority in Kosovo) who work on small margins anyway and may be more prepared to take a risk of an outbreak by not spending money and relying on compensation if they are unlucky. A decision on the vaccination an official policy against Newcastle disease is not simple. On the one hand it protects the state against losses. On the other hand, it subsidises producers. The issue really needs to be discussed with the local poultry producers associations(s). The initial proposal is that vaccination should be compulsory in all flocks of 100 birds in size and that this should be paid for by the keeper. Government would have a role in taking and testing samples to ensure that this is being complied with. Consortium Agrotec SpA / IZSVe / NIRAS 11 / 18
Salmonellosis in poultry There is clear evidence of significant levels of infection with salmonella in commercial laying flocks in Kosovo. This is likely to be a significant public health issue although the Public Health Institute has no specific data on this. Supplying eggs that may be infected with salmonella is comparable to supplying a dangerous product to the public and the supplier should be liable for damages caused. Vaccination against salmonellosis in poultry should be made compulsory but should be undertaken and paid for by the poultry farmers who have commercial egg laying flocks over a certain size. But this should also be linked to a proper surveillance system and enforcement of biosecurity measures such as cleaning and disinfection of poultry houses. These costs again should be borne by the poultry owners apart from the costs of collecting and testing samples. Summary of recommended official vaccination programs Official vaccination programs are recommended for the following diseases Anthrax Disease Brief description of type of vaccination program Vaccination around proven outbreaks Bluetongue Brucellosis in small ruminants Rabies Classical swine fever Newcastle disease Salmonellosis in poultry Population vaccination with strain matched vaccine in the face of outbreaks. A cost sharing option should be considered. Annual population vaccination. Revised strategy to be determined. Annual adult dog population vaccination and vaccination of puppies at the appropriate age Annual adult population vaccination and vaccination of piglets at the appropriate age. Needs to be determined through discussion with industry. Initial proposal is compulsory vaccination of flocks 100 birds paid for by owners Vaccination of laying flocks, paid for by owners Monitoring of effectiveness All vaccination programs funded by KFVA should be monitored for effectiveness. At present, this is only the case for B. melitensis Rev-1 vaccination in small ruminants. Consortium Agrotec SpA / IZSVe / NIRAS 12 / 18
Annex A Decision criteria for vaccination strategy Consortium Agrotec SpA / IZSVe / NIRAS 13 / 18
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Disease Government intervention justified Present in Kosovo Risk of introduction and spread Risk of persistence Impact Vaccine available Vaccination effective Socio-economic benefit of vaccination Multiple species diseases and infections Anthrax Yes Yes Endemic High Medium Yes Yes Public Aujeszky's disease +/- No Low High High Yes Yes Bluetongue +/- Uncertain High Low Medium Yes() Yes () Public / Private Brucellosis (Brucella abortus) Yes Uncertain Endemic? High Medium Yes Yes Public Brucellosis (Brucella melitensis) Yes Yes Endemic High High Yes Yes Public Brucellosis (Brucella suis) Yes No Low High High No () No () Public Crimean Congo haemorrhagic fever Yes Yes Endemic High High No Foot and mouth disease Yes No Low High High Yes Yes () Public Infection with Trichinella spp. Yes Uncertain High High High No No Q fever Yes Yes Endemic High Med Yes() Yes () Public Rabies Yes Uncertain High High High Yes Yes Public Toxoplasma +/- Yes Endemic High Medium to low Yes Yes Public/ Private West Nile fever +/- Uncertain Medium Low Medium No Public Cattle diseases and infections Bovine genital campylobacteriosis +/- Uncertain Medium High Medium Yes Yes () Private Bovine spongiform encephalopathy Yes No Low Low High No Public Bovine tuberculosis Yes Yes Endemic High Low Yes () Yes () Public Enzootic bovine leucosis Yes Uncertain Medium High Low No Infectious bovine rhinotracheitis +/- Uncertain Medium High Med Yes Yes Private Lumpy skin disease Yes No Low High High Yes Yes Private / Public Trichomonosis +/- Uncertain Medium High Medium Yes Yes () Private Consortium Agrotec SpA / IZSVe / NIRAS 15 / 18
Disease Government intervention justified Present in Kosovo Risk of introduction and spread Risk of persistence Sheep and goat diseases and infections Caprine arthritis encephalitis Yes Uncertain Medium High Impact Medium to High Vaccine available No Vaccination effective Socio-economic benefit of vaccination Enzootic abortion of ewes (Chlamydophila abortus) Yes Yes Endemic High Medium Yes Yes () Private Maedi Visna Yes Uncertain Medium High Medium to High No Ovine epididymitis (Brucella ovis) Yes Uncertain Uncertain High Medium No Private Peste de petits ruminants Yes No Low High High Yes Yes Public / Private Scrapie +/- Uncertain Medium High Low No Sheep and goat pox Yes No Medium High High Yes Yes Public / Private Swine diseases and infections African swine fever Yes No Med High High No Classical swine fever Yes Uncertain High High Medium Yes Yes Public / Private Swine vesicular disease Yes No Low High Low No Avian diseases and infections Avian Influenza in poultry (HPAI and LPNAI) Yes No Med Med High Yes Yes () Public Campylobacter in poultry Yes Yes Endemic High Medium No High pathogenic avian influenza in birds other than poultry including wild birds Yes Uncertain Medium to Low Medium High No High or Newcastle disease +/- Uncertain Endemic High Medium Yes Yes Public / Private Salmonellosis in poultry Yes Yes Endemic High Medium Yes Yes Public Consortium Agrotec SpA / IZSVe / NIRAS 16 / 18
Disease Government intervention justified Present in Kosovo Risk of introduction and spread Risk of persistence Impact Vaccine available Bee diseases, infections and infestations Aethina tumida (Small hive beetle) Yes No Low High High No Infestation of honey bees with Acarapis woodii Yes Uncertain No Infestation of honey bees with Tropilaelaps spp Yes Uncertain No Melissococcus plutonius (European foulbrood) Yes Uncertain No Nosemosis Yes Uncertain No Paenibacillus larvae (American foulbrood) Yes Yes Endemic No Varroa spp. (Varroosis) Yes Uncertain No Vaccination effective Socio-economic benefit of vaccination Fish diseases Infectious haematopoietic necrosis Yes Yes No () Other diseases Echinococcosis Yes Yes Endemic High Medium No Leishmaniosis Yes Uncertain High High Medium No Kosovo Vet Law Schedule 1 not included African horse sickness Yes No Negligible Medium Medium Yes Yes () Private Contagious bovine pleuropneumonia Yes No Negligible High High Yes Yes Public Rift Valley fever Yes No Negligible Negligible High Yes Yes () Public Consortium Agrotec SpA / IZSVe / NIRAS 17 / 18
This document has been produced with the financial assistance of the European Union The contents of this publication are the sole responsibility of the author / contractor / implementing partner and are in no way be taken to reflect the views of the European Union. Consortium Agrotec SpA / IZSVe / NIRAS 18 / 18