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Porcine reproductive and respiratory syndrome (PRRS) is among the most devastating diseases affecting the pig industry. Despite vaccines having been available for decades, the remarkable genetic variability of this virus, leading to poor cross-protection, has limited their efficacy, and other measures must be adopted to effectively control the viral circulation. Some recent studies have investigated the factors involved in viral spreading and persistence, at least at the local level. However, despite the topic's relevance, no statistically grounded evidence is currently available evaluating the variables more involved in porcine reproductive and respiratory syndrome virus (PRRSV) epidemiological success at a broader scale, such as the European scale. In the present study, an extensive phylodynamic and phylogeographic analysis was performed on more than 1000 ORF5 sequences to investigate the history, dynamics and spreading patterns of PRRSV within European borders. Moreover, several potential predictors, representative of swine population features and trade, human population, economy and geographic characteristics, were evaluated through a specifically designed generalized linear model (GLM) to assess their weight on viral migration rate between countries over time. Although pig stock density, mean PRRSV strain genetic diversity, investments in agriculture (including a likely role of vaccination) and farmer education were involved to a certain extent, the major determinant was proven to be by far the live pig trade. Providing a robust depiction of PRRSV European molecular epidemiology patterns and determinants, the present study could contribute to a more rational allocation of limited resources based on an effective prioritization of control measures., (© 2022 The Authors. Transboundary and Emerging Diseases published by Wiley-VCH GmbH.)

Immunocompromise is a common condition in cats, especially due to widespread infections with immunosuppressive viruses, such as feline immunodeficiency virus (FIV) and feline leukaemia virus (FeLV), but also due to chronic non-infectious diseases, such as tumours, diabetes mellitus, and chronic kidney disease, as well as treatment with immunosuppressive drugs, such as glucocorticoids, cyclosporins, or tumour chemotherapy. In this review, the European Advisory Board on Cat Diseases (ABCD), a scientifically independent board of experts in feline medicine from eleven European countries, discusses the current knowledge and rationale for vaccination of immunocompromised cats. So far, there are few data available on vaccination of immunocompromised cats, and sometimes studies produce controversial results. Thus, this guideline summarizes the available scientific studies and fills in the gaps with expert opinion, where scientific studies are missing. Ultimately, this review aims to help veterinarians with their decision-making in how best to vaccinate immunocompromised cats.

Vaccination is currently one of the most relevant control strategies in poultry production to reduce infectious disease-induced economic losses and decrease antimicrobial use. Besides intrinsic vaccine efficacy, a proper administration is fundamental to achieve an adequate coverage and protection. Hatchery vaccination is becoming the standard approach for routine vaccination because of administration easiness, the possibility to standardize and optimize the overall process, and the lower impact on animal welfare compared with different types of on-farm vaccination. However, a continuous maintenance, refinement, and training of the personnel are the key to success. In the present work, the effect of longitudinal hatchery audits, performed using a standardized, expert-developed questionnaire was evaluated in 169 hatcheries, located in 11 European countries, over a period of more than 4 yr. A dedicated tablet-based application was implemented for data collection, storage, and analysis, and the obtained scores were used in the evaluation, reporting to the hatchery management and improvement of critical points. A positive significant association was demonstrated between the variation in global and process-specific hatchery scores and the number of performed audits. Similarly, when the longitudinal nature of the data (i.e., multiple visits) was accounted for using linear mixed models, including the hatchery and country as random factors, a significant trend in performance improvement was observed visit after visit, although with certain differences based on the specific score and country. The present study demonstrates the benefits of an objective evaluation of hatchery performances through a standardized questionnaire, followed by the discussion on the major required actions. The widespread application of this approach should lead to a significant improvement in vaccine administration performances, with direct consequences on infectious disease occurrence and animal production performances, and indirectly on therapeutic and control-related costs., (Copyright © 2020. Published by Elsevier Inc.)

Canine leishmaniosis is an important vector-borne zoonosis caused mainly by Leishmania infantum. Diagnosis and treatment of affected individuals can be particularly complex, hindering infection control in endemic areas. Methods to prevent canine leishmaniosis include the use of topical insecticides, prophylactic immunotherapy and vaccination. Four vaccines against canine leishmaniosis have been licensed since 2004, two in Brazil (Leishmune®, the production and marketing licence of which was withdrawn in 2014, and Leish-Tec®) and two in Europe (CaniLeish® and LetiFend®). After several years of marketing, doubts remain regarding vaccine efficacy and effectiveness, potential infectiousness of vaccinated and infected animals or the interference of vaccine-induced antibodies in L. infantum serological diagnosis. This review summarises the scientific evidence for each of the vaccines commercially approved for canine leishmaniosis, while discussing possible weaknesses of these studies. Furthermore, it raises the need to address important questions related to vaccination impact in Leishmania-endemic countries and the importance of post-marketing pharmacological surveillance., (© 2020 John Wiley & Sons Ltd.)

Human rabies vaccines have been shown to induce partial protection against members of phylogroup I bat lyssaviruses. Here, we investigated the capacity of a widely used rabies inactivated vaccine (Rabisin, Boehringer-Ingelheim) for veterinary use to cross-protect mice experimentally infected with European bat lyssavirus 1 (EBLV-1b), European bat lyssavirus 2 (EBLV-2), and Bokeloh bat lyssavirus (BBLV) occurring in Europe. For each lyssavirus, we investigated the efficacy of two different doses of vaccine against two viral doses administrated by either central or peripheral routes. In parallel, seroconversion following pre-exposure vaccination was investigated. In this study, we demonstrated that the three investigated bat isolates were pathogenic, even at low dose, when inoculated by the central route but were not/less pathogenic when administrated peripherally. The Rabisin vaccine was capable of significantly cross-protecting mice inoculated intramuscularly with EBLV-1b and EBLV-2 and intracerebrally with BBLV. The level of rabies neutralizing antibodies induced by the Rabisin was quite high against the bat lyssaviruses, but with no significant differences between immunization with 1 and 5 IU/dose. The study emphasizes that the quality of rabies-inactivated vaccines for veterinary use is of utmost importance to optimize the cross-protection of pets against phylogroup I bat lyssaviruses occurring in Europe., Competing Interests: The authors declare no conflict of interest.

The use of the rabies vaccine for post-exposure prophylaxis started as early as 1885, revealing a safe and efficient tool to prevent human rabies cases. Preventive vaccination is the basis for the control of canine-mediated rabies, which has already been eliminated from extensive parts of the world, including Europe. Plans to eliminate canine-mediated human rabies by 2030 have been agreed upon by international organisations. However, rabies vaccines are not efficacious against some divergent lyssaviruses. The presence in European indigenous bats of recently described lyssaviruses, which are not neutralised by antibody responses to existing vaccines, as well as the declaration of an imported case of an African lyssavirus, which also escapes vaccine-derived protection, leaves the European health authorities unable to provide efficacious protective vaccines to some potential situations of human exposure. All these circumstances highlight the need for a universal pan-lyssavirus rabies vaccine, able to prevent human rabies in all circumstances.

The oral rabies vaccination (ORV) programme is the most widespread vaccination programme that is implemented in the European Union and targets wildlife diseases. The size of the project requires significant financial resources, so a cost-benefit analysis is necessary to establish the economic value of the project. We summarized all ORV costs during the period 2011-2016 in Croatia, calculated all established benefits and presented the cost-benefit ratio (CBR). Additionally, we analysed all components included in the ORV and rabies control programme (surveillance, preventive human treatment and vaccination of dogs) to find possibilities to increase the benefits. According to our results, in the period 2011-2016, the CBR was only 0.05, and the majority of the cost was derived from the preventive vaccination of dogs (72.3%). With the implementation of 2- or 3-year vaccination intervals, the CBR can be increased to 1.46 or 1.92, respectively, confirming positive economic value. This study shows the importance of analysing all rabies control and eradication components based on the specific characteristics of a particular country to determine the factors that can be modified to potentially improve the benefits of ORV., (© 2019 Blackwell Verlag GmbH.)

The best preventive strategy for canine leishmaniasis is, to date, unknown. In the last few years, new preventive measures have become available in Europe, including vaccination against leishmaniasis and the use of domperidone. The objective of the present study was to evaluate the efficacy and safety of the different preventive measures available against leishmaniasis in client-owned dogs. A database search of medical records was carried out in 52 private veterinary practices located in endemic areas of canine leishmaniasis in Spain, Italy and Portugal. Healthy seronegative dogs were included in the study. Serology was repeated at least 6 months later, and was used to retrospectively classify dogs into healthy, infected or sick. A total of 1647 dogs were included in the study. The use of preventive measures in this population was widespread. The single most utilized measure was repellents alone in 45.7% of dogs, followed by the combination of repellents and vaccination in 23.0%, repellents and domperidone in 11.3%, vaccination alone in 4.2%, vaccination and domperidone in 2.7%, domperidone alone in 2.3%, and the combination of the three measures in 0.2% of dogs. No preventive measure was applied in 10.7% dogs. The incidence of clinical leishmaniasis in the group with no preventive treatment applied was 12.5%. In the groups where prevention was applied, the reported incidence was the following: 10.1% for the vaccination only group, 4.5% for repellents only group, 4.0% for repellents + vaccination group, and 0.5% for repellents + domperidone group. No dogs in the groups of domperidone, vaccination + domperidone, and combination of the three measures developed clinical leishmaniasis. All preventive measures resulted in a significantly lower incidence of leishmaniasis compared to not applying any measure, except for vaccination alone. The majority of preventive strategies used, with exception of vaccination alone, decreased the incidence of leishmaniasis significantly. Adverse events, mild and self-limiting in most of the cases, were reported in 5.2% of dogs and were significantly more common in dogs following vaccination. In conclusion, this is the first large-scale field study investigating the efficacy and safety of the preventive measures used routinely against leishmaniasis in client-owned dogs. Most preventive strategies used, with exception of vaccination alone, had some benefit over not applying any preventive. In this field study, the use of repellents showed a good degree of protection in dogs living in endemic areas of canine leishmaniasis. Although lower numbers of dogs are included, the use of domperidone appeared to provide additional protection. The role of vaccination and its combination with other preventive strategies needs further study., (Copyright © 2018 Elsevier B.V. All rights reserved.)

As campylobacteriosis is one of the most important foodborne infections, a European Union (EU)-27 level cost-effectiveness model has been developed on the socio-economic costs and benefits of applying certain control measures for the reduction of Campylobacter in broiler meat. This is expected to be a gold standard for food safety policymakers in the EU; hence, the validity of its modelling assumptions is essential. The authors of the present paper conducted an independent review of model input parameters on health and economic burden and found that the model most probably overestimated the burden of human campylobacteriosis. A discounted, quality-adjusted life year (QALY)-based European estimate has been developed for human campylobacteriosis and resulted in 15.23 QALY loss per 1000 human gastroenteritis cases. Country-specific cost of illness estimates have been developed for various countries in the EU-27. Based on these model adaptations, a selected Campylobacter control strategy was re-assessed and its high cost-effectiveness was confirmed at the EU level, and also in all but three Member States. Bacteriocin treatment or vaccination of the animals, two alternative control measures were also re-evaluated, and these strategies seemed to be far less cost-effective than the investigated strategy. Putative barriers to the rapid implementation of the investigated Campylobacter control strategy are discussed, and potential solutions are proposed. Further research is required on stakeholder perspectives pertaining to the realistic barriers and implementation opportunities.

Antimicrobial use in pig farming is influenced by a range of risk factors, including herd characteristics, biosecurity level, farm performance, occurrence of clinical signs and vaccination scheme, as well as farmers' attitudes and habits towards antimicrobial use. So far, the effect of these risk factors has been explored separately. Using an innovative method called multiblock partial least-squares regression, this study aimed to investigate, in a sample of 207 farrow-to-finish farms from Belgium, France, Germany and Sweden, the relative importance of the six above mentioned categories or 'blocks' of risk factors for antimicrobial use in pig production. Four country separate models were developed; they showed that all six blocks provided useful contribution to explaining antimicrobial use in at least one country. The occurrence of clinical signs, especially of respiratory and nervous diseases in fatteners, was one of the largest contributing blocks in all four countries, whereas the effect of the other blocks differed between countries. In terms of risk management, it suggests that a holistic and country-specific mitigation strategy is likely to be more effective. However, further research is needed to validate our findings in larger and more representative samples, as well as in other countries.

Although rabies incidence has fallen sharply over the past decades in Europe, the disease is still present in Eastern Europe. Oral rabies immunization of wild animal rabies has been shown to be the most effective method for the control and elimination of rabies. All rabies vaccines used in Europe are modified live virus vaccines based on the Street Alabama Dufferin (SAD) strain isolated from a naturally-infected dog in 1935. Because of the potential safety risk of a live virus which could revert to virulence, the genetic composition of three commercial attenuated live rabies vaccines was investigated in two independent laboratories using next genome sequencing. This study is the first one reporting on the diversity of variants in oral rabies vaccines as well as the presence of a mix of at least two different variants in all tested batches. The results demonstrate the need for vaccine producers to use new robust methodologies in the context of their routine vaccine quality controls prior to market release.

Harmonisation of regulations in the European Union and the European Economic Area, as of January 1, 2012, has led to an increase in the number of rescue dogs imported to Norway from Eastern European countries, in particular Romania. Today the only requirements for dogs entering Norway are rabies vaccination and prophylactic Echinococcus multilocularis treatment. The aim of this study was to investigate the antibody levels to rabies virus in vaccinated rescue dogs and to examine if the dogs had sufficient antibody response according to the recommended titre ≥0.5 IU/ml by the World Organisation for Animal Health (OIE). A significant proportion (53%, 95% CI (41% to 65%)) of imported rescue dogs from Eastern Europe were found to have inadequate titres after rabies vaccination. Moreover, 41 per cent of the dogs had antibody levels below or equal to 0.2 IU/ml, and among these, 14 dogs had titres ≤0.1 IU/ml, which is considered negative in the fluorescent antibody virus neutralisation assay. This study indicates that the present regulation increases the risk of introducing rabies from member states where rabies is still prevalent to countries considered free from rabies., (British Veterinary Association.)

Bluetongue virus serotype 8 (BTV-8) was responsible for a large outbreak among European ruminant populations in 2006-2009. In spring 2008, a massive vaccination campaign was undertaken, leading to the progressive disappearance of the virus. During surveillance programmes in Western Europe in 2010-2011, a low but significant number of animals were found weakly positive using BTV-specific real-time RT-PCR, raising questions about a possible low level of virus circulation. An interference of the BTV-8 inactivated vaccine on the result of the real-time RT-PCR was also hypothesized. Several studies specifically addressed the potential association between a recent vaccination and BTV-8 RNA detection in the blood of sheep. Results were contradictory and cattles were not investigated. To enlighten this point, a large study was performed to determine the risks of detection of bluetongue vaccine-associated RNA in the blood and spleen of cattle using real-time RT-PCR. Overall, the results presented clearly demonstrate that vaccine viral RNA can reach the blood circulation in sufficient amounts to be detected by real-time RT-PCR in cattle. This BTV-8 vaccine RNA carriage appears as short lasting., (© 2013 Blackwell Verlag GmbH.)

Nineteen alternatives to antimicrobial agents were ranked on perceived effectiveness, feasibility and return on investment (ROI) from 0 (not effective, not feasible, no ROI) to 10 (fully effective, completely feasible, maximum ROI) by 111 pig health experts from Belgium, Denmark, France, Germany, Sweden and Switzerland. The top 5 measures in terms of perceived effectiveness were (1) improved internal biosecurity, (2) improved external biosecurity, (3) improved climate/environmental conditions, (4) high health/Specific Pathogen Free/disease eradication and (5) increased vaccination. The top 5 measures in terms of perceived feasibility were (1) increased vaccination, (2) increased use of anti-inflammatory products, (3) improved water quality, (4) feed quality/optimization and (5) use of zinc/metals. The top 5 measures in terms of perceived ROI were (1) improved internal biosecurity, (2) zinc/metals, (3) diagnostics/action plan, (4) feed quality/optimization and (5) climate/environmental improvements. Univariate linear regression showed that veterinary practitioners rank internal biosecurity, vaccination, use of zinc/metals, feed quality optimization and climate/environmental on average highest, while researchers and professors focused more on increased use of diagnostics and action plans. Financial incentives/penalties ranked low in all countries. Belgian respondents ranked feed quality significantly lower compared to the German respondents while reduction of stocking density was ranked higher in Belgium compared to Denmark. Categorical Principal Component Analysis applied to the average ranking supported the finding that veterinary practitioners had a preference for more practical, common and already known alternatives. The results showed that improvements in biosecurity, increased use of vaccination, use of zinc/metals, feed quality improvement and regular diagnostic testing combined with a clear action plan were perceived to be the most promising alternatives to antimicrobials in industrial pig production based on combined effectiveness, feasibility and ROI., (Copyright © 2015 Elsevier B.V. All rights reserved.)

In April 2013 the mouse antibody serum neutralization test (SNT) was formally incorporated into European Pharmacopoeia monograph 0451 for potency testing of inactivated veterinary rabies vaccines. The SNT is designed to replace the highly variable and pain and distress causing NIH mouse rabies challenge assay. The adoption of the SNT meets the European ambition (i.e., EC and CoE) to replace, reduce and/or refine laboratory animal testing. However, regulatory acceptance and use of 3R models, such as the SNT, remains challenging. This paper aims at clarifying the process of acceptance and use of the SNT. For this purpose it reconstructs the process and reveals barriers and drivers that have been observed by involved stakeholders to have played a role. In addition it extracts lessons to stimulate regulatory acceptance in similar future processes. The incorporation of the SNT into the monographs went relatively quick due to a thorough test development and pre-validation phase, commitment and cooperation of relevant stakeholders and a strong project coordination of the international validation study. The test was developed by the Paul Ehrlich Institut; a leading European OMCLs. This facilitated its European regulatory use. The use by industry is in a critical phase. At this stage product specific validation and the question whether the SNT will be accepted outside Europe are important influencing factors.

The SAG2 vaccine (RABIGEN® SAG2) is a modified live attenuated rabies virus vaccine, selected from the SAD Bern strain in a two-step process of amino acid mutation using neutralizing monoclonal antibodies. The strain is genetically stable and does not spread in vivo or induce a persistent infection. Its absence of residual pathogenicity was extensively demonstrated in multiple target and non target species (such as wild carnivores and rodent species), including non-human primates. The efficacy of SAG2 baits was demonstrated according to the EU requirements for the red fox and raccoon dog. The use of safe and potent rabies vaccines such as SAG2 largely contributed to the elimination of rabies in Estonia, France, Italy and Switzerland. Importantly, these countries were declared free of rabies after few years of oral vaccination campaigns with SAG2 baits distributed with an appropriate strategy. The excellent tolerance of the SAG2 vaccine has been confirmed in the field since its first use in 1993. No safety issues have been reported, and in particular no vaccine-induced rabies cases were diagnosed, after the distribution of more than 20 million SAG2 baits in Europe.

In veterinary medicine, herd-specific vaccines are primarily used in farm animals if traditional vaccines are either unavailable or do not perform as expected. As autogenous products, these vaccines are exempt from Directive 2001/82/EC, and therefore the production and use of herd-specific vaccines are regulated differently in each member state of the European Union (EU). This study is an overview of the diverse legal statuses of herd-specific vaccines among European countries. The study was conducted by analyzing legal documents, tailored questionnaires answered by subject-related authorities from sixteen European countries, and related literature. These analyses revealed that tremendous heterogeneity exists with respect to the legal requirements for the production and use of herd-specific vaccines among the countries that were examined. In particular, certain countries have detailed and precise regulations for these vaccines, whereas the legislation regarding these vaccines is vague or even nonexistent in other nations. The implementation of standardized definitions, guidelines for vaccine use in the field, and regulations for vaccine production are essential prerequisites for achieving legal consistency across Europe. These measures would also help countries enact pertinent national legislation with less divergence regarding the production and use of herd-specific vaccines and ensure the existence of comparable safety and quality standards for these vaccines among European countries., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Inter-country travel of companion animals provides an opportunity for introduction of zoonotic pathogens, such as rabies virus and Echinococcus spp. Regulations are in place to control this threat, but Schengen Agreements mean that border controls between some European countries are minimal, and animals may enter countries without any checks that they have been appropriately treated. Veterinarians provide an important source of information for people intending to travel with their pets. We conducted a telephone survey to investigate provision of correct advice to someone intending to travel with their dog to Norway. Mainland Norway is considered free of both rabies and E. multilocularis and is a signatory to the Schengen Agreement. Ten randomly selected veterinary clinics were surveyed in Austria, Belgium (Wallonia), Finland, France, Germany, Norway, Sweden, Switzerland and United Kingdom. The information provided was scored as correct, incorrect or incomplete. The information provided by secondary information sources (website or government agency), which the clinic had referred the caller to, was also assessed (correct, incorrect, incomplete). Whilst the majority of clinics provided appropriate information regarding rabies, many clinics did not provide correct information regarding treatment for E. multilocularis. Less than one in 10 clinics provided the correct information regarding both pathogens directly at the time of calling. The correct information was obtained, once taking into account secondary sources, just 62% of the time. Countrywise, most clinics in Finland provided correct advice, either directly or indirectly via referring the caller to another source, whilst the majority in Belgium, Germany and France did not. The apparent paucity of readily accessible, correct advice for owners intending to travel with their dogs is concerning. The compulsory treatment regulations are only as good as the checks that ensure compliance, and this is also lacking in some countries., (2012 Blackwell Verlag GmbH)

In 2011, the 79th General Session of the World Assembly of the World Organisation for Animal Health (OIE) and the 37th Food and Agriculture Organization of the United Nations (FAD) Conference adopted a resolution declaring the world free from rinderpest and recommending follow-up measures to preserve the benefits of this new and hard-won situation. Eradication is an achievable objective for any livestock disease, provided that the epidemiology is uncomplicated and the necessary tools, resources and policies are available. Eradication at a national level inevitably reflects national priorities, whereas global eradication requires a level of international initiative and leadership to integrate these tools into a global framework, aimed first at suppressing transmission across all infected areas and concluding with a demonstration thatthis has been achieved. With a simple transmission chain and the environmental fragility of the virus, rinderpest has always been open to control and even eradication within a zoosanitary approach. However, in the post-1945 drive for more productive agriculture, national and global vaccination programmes became increasingly relevant and important. As rinderpest frequently spread from one region to another through trade-related livestock movements, the key to global eradication was to ensure that such vaccination programmes were carried out in a synchronised manner across all regions where the disease was endemic - an objective to which the European Union, the United States Agency for International Development, the International Atomic Energy Agency, the African Union-Interafrican Bureau of Animal Resources, FA0 and OIE fully subscribed. This article provides a review of rinderpest eradication, from the seminal work carried out by Giovanni Lancisi in the early 18th Century to the global declaration in 2011.

The bluetongue (BT) epidemic that has prevailed in Europe since 2000 is the first example of continental spread of the BT virus (BTV) in large naive populations of susceptible animals. Based on the results of intensive surveillance and research in countries of the southern Mediterranean that were affected by the infection early on in the epidemic, a new strategy for prevention and control of the disease was developed to limit direct losses and to reduce the consequences due to movement restrictions. The basic innovations that were introduced were the use of mass vaccination of all domestic ruminant species to limit the spread of BTV and the use of intensive active surveillance to limit, as far as possible, the zone where movement restrictions must be applied. The novel strategy that was adopted dramatically reduced the number of clinical outbreaks in southern Europe and the Mediterranean Basin and ensured safer animal trade. In 2006, the first BTV-8 epidemic occurred, this time in north-western Europe. During this epidemic, affected countries adopted a 'wait and see' approach. No vaccination was implemented until 2008 and, in many instances, the movement of animals was authorised within restricted areas, thereby facilitating the spread of infection. The delay in administering vaccination was due to the decision to avoid the use of modified live virus vaccines, although this type of vaccine performed satisfactorily in the previous BT epidemics in southern Europe. Bluetongue has demonstrated that the infectious agents present in southern Africa can easily spread to the Mediterranean Basin, which should be considered a single entity as far as the epidemiology of animal diseases is concerned. Therefore, any effective strategy for the prevention and control of animal disease in Europe must take into account this reality and recognise the need for regional surveillance networks that include all the countries that border the Mediterranean.

Changes in the formulation of the Leptospira components of dog vaccines are being considered in Europe, following changes in North America. This article discusses the options for change and recommends the continued inclusion of serovars Icterohaemorrhagiae and Canicola plus the inclusion of serovars Bratislava and Grippotyphosa (for mainland Europe only). If other serovars, such as Pomona, are to be considered in the future, then there is a need for additional clinical, cultural and serological studies across Europe to support their inclusion.

Switzerland and the European Union have a non-vaccination policy for many animal diseases relevant for trade. Because of the relatively low animal density, disease control measures in Switzerland focus on the immediate culling of infected animals. However, the use of vaccines as a supporting measure can represent an effective option to promptly contain an epidemic and to reduce the number of animals to be killed. A prerequisite for the success of vaccination is its early, rapid and purposeful implementation. Vaccinations can be cost-intensive and can entail restrictions in international trade. For the choice of the appropriate control measure it is therefore important to thoroughly assess the epidemiology, the economic consequences of the control measures and the acceptance of these measures by the environment. Because of their special epidemiology, vaccination has clear advantages as a preventive measure for vector-borne diseases.

Freedom from extraneous agents is a high priority for any medicinal product. For veterinary vaccines, extraneous agents testing is addressed by different regulations of the European Pharmacopoeia and guidelines issued by the European Medicines Evaluation Agency. This article provides a brief review of the relevant texts., (2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.)

In Europe, two main regulatory texts regulate the immunogenicity requirements of vaccines, the European Pharmacopoeia and the guidelines of the European Medicines Evaluation Agency (EMEA). This article outlines these requirements and the regulatory challenges., (Copyright 2009 Elsevier Ltd. All rights reserved.)

The objective of this study was to develop and evaluate new baits for the oral delivery of vaccine preparations to 2-4 month-old wild boar piglets. Baits were prepared using a matrix composed of wild boar feed, wheat flour, paraffin, sacarose and cinnamon-truffle powder attractant with polyethylene capsules dipped into the matrix to introduce vaccine formulation. Physical stability studies demonstrated that baits were stable for at least three days at temperatures as high as 42 degrees C. Recombinant Escherichia coli expressing the membrane-displayed BM95-MSP1a fusion protein were used to test bacterial viability in the baits and the antibody response in orally immunized wild boar. The E. coli viability was not significantly affected after bait incubation at 25 and 37 degrees C for 96h. Bait acceptance studies using artificial feeders in the field showed that baits were accepted by 2-3month-old animals, the preferred age for vaccination. Orally immunized wild boar piglets excreted recombinant E. coli in the feces and developed antibody titers to recombinant BM95-MSP1a protein, thus confirming that vaccine composition was released and reached the wild boar gastrointestinal track. The results of these experiments support the use of these baits for oral delivery of vaccine formulations to 2-4month-old wild boar piglets.

The objective of this study was to determine the degree of protection conferred by a Lelystad-like modified live virus (MLV) vaccine against a heterologous wild-type porcine reproductive and respiratory syndrome virus (PRRSV) isolate of the same cluster. For this purpose, fourteen 3-week-old piglets were divided into three groups: Group A pigs were vaccinated with a modified live virus vaccine, Group B pigs were used as positive controls, and Group C pigs as negative controls. Twenty-eight days after the last dose of vaccine, all pigs in Groups A and B were inoculated with the Spanish PRRSV strain 5710. To evaluate efficacy, clinical signs were recorded and the presence of challenge virus was determined by virus isolation in blood samples and nasal swabs collected at various time points post-challenge (p.c.) and in tissue samples collected at necropsy 24 days p.c. After challenge, moderate clinical signs were observed in pigs from Groups A and B. In addition, all vaccinated pigs were viremic at least once, although viremia tended to be more sporadic in this group than in Group B pigs. PRRSV was detected in at least one tissue sample from four out of five pigs from Group A and in all pigs from Group B. The results indicate that the protection conferred by the MLV vaccine used in this study against a closely related virulent strain was only partial. The findings suggest that the degree of genetic homology of ORF5 between MLV vaccine and challenge isolate is not a good predictor of vaccine efficacy.

Over the last fifteen years or so, classical rabies in terrestrial wildlife has been eliminated from large areas of Western Europe. Over the next few years, terrestrial rabies is likely to occur only east of a line from the Baltic Sea to the Black Sea; the overall aim is to eliminate terrestrial rabies from the whole European Union. Elimination of rabies from the less rich countries of Eastern Europe, and the protection of Europe against a resurgence of rabies in the longer term requires modifications to existing OIE and WHO strategies. Here we discuss the options available to eliminate rabies in wildlife while taking account of financial cost, and how to maintain a 'cordon sanitaire' along the eastern boundary of the EU in order to protect the rabies-free areas from rabies incursion. Minimising financial costs at the national level is obviously essential, considering the competing priorities for development and health. This could be achieved either by increasing external funding (for example by the EU) and/or by changing the currently agreed vaccination strategy to reduce costs; any such change must not substantially reduce the chances of rabies elimination. A cordon sanitaire might be placed outside the economic area of the EU, to protect the whole of the EU, or it might be placed within the easternmost countries to ensure logistical consistency of vaccination. Policy must also anticipate an emergency due to rabies breaking out in a previously freed region. Strategic planning may be complicated by the increasing range and abundance of the raccoon dog, an introduced species that is increasingly important as a host for fox rabies. It is argued here that models help to evaluate altemative strategies, exploring options for optimising costs by minimising bait density and frequency or by reducing the vaccination area.

Following the implementation of oral rabies vaccination of foxes (ORV) in Western Europe, a continuous decrease in rabies incidence was reported, and eventually rabies was eliminated. Once fox rabies is eliminated in a given area, re-infection from neighbouring infected countries is a permanent threat. As a result, countries need to maintain a vaccination belt along common borders until rabies is also eliminated in sufficiently large border regions of neighbouring infected countries. In a theoretical approach EU member states were taken as a prime example, assuming that they were rabies-free but that neighbouring countries were still infected. Using GIS, a 50 km deep vaccination belt beyond the front of the rabies endemic zone was installed in countries bordering those regions. The annual cost for the prevention of re-infection of the EU territory was calculated considering current EU recommendations (vaccination twice per year, aerial and complementary hand distribution, bait density of 30 baits per km2). Minimum and maximum prices for commercial available oral rabies vaccine baits, aircraft and rabies surveillance were considered for the calculation of costs. The total vaccination area which needed to be established was about 251,000 km2. Using mainly fixed-wing aircraft, the annual cost for ORV including rabies surveillance varied between a minimum of 10 and a maximum of 16M Euro, depending on the cost of vaccine bait. If helicopters were used exclusively, the maximum cost increased to about 32M Euro. Depending on the length of the border to infected regions, countries will have to pay up to 25% of the total cost. Countries which need to install a vaccination belt will never have a rabies-free status because of the likely occurrence of rabies cases in border zones.

The past 10-20 years have seen exponential growth in the volume of trade in horses and equine germplasm; and the extent of global horse movements has increased significantly in the last 4 years. In preparing for the transport of elite Olympic horses to Hong Kong in 2008, it will be very important to be as fully informed as possible of the disease situation in both the exporting and importing country, import and re-entry requirements, as well as having a vaccination strategy to protect against particular diseases. In this context the review describes the equine vector-borne disease situation in Europe, Asia, Africa and South America and provides estimates of the number of horse movements between these countries, as well as information on import requirements and vaccination strategies.

A marketing authorisation for a veterinary vaccine is granted after the quality, safety and efficacy of the product have been assessed in accordance with legal standards. The assessment includes complete characterisation and identification of seed material and ingredients, laboratory and host animal safety and efficacy studies, stability studies, and post-licensing monitoring of field performance. This assessment may not be possible during the emergence of a new animal disease, but several mechanisms exist to allow for the availability of products in an emergency animal health situation, e.g. autogenous biologics, conditional licences, experimental and emergency use authorisations, the importation of products in use elsewhere in the world and pre-approved vaccine banks. Using the emergence of bluetongue in northern Europe as an example, the regulatory issues regarding the temporary authorisation of animal vaccination are described. Several conditions must be fulfilled before a temporary authorisation can be granted, e.g. inactivated vaccines should be used in order to exclude reversion to virulence and reassortment between vaccine viruses and/or field strains of the bluetongue virus; decision-making must be supported by scientific evidence and risk analysis; there must be a complete census of the susceptible animals that were vaccinated; vaccination protocols must be adhered to and there must be a scheme allowing for registration, delivery and follow-up of vaccination, and monitoring, analysis and, possibly, adjustment of field use of the vaccination. This temporary authorisation must be replaced by a full authorisation as quickly as possible.

An unprecedented global epidemic of highly pathogenic avian influenza virus H5N1 has and continues to present enormous challenges to the international community for control in the animal reservoir. Enhanced biosecurity, good surveillance, both passive and active, supplemented by strong veterinary services, can reduce the risk for incursion and subsequent spread in free countries. Surveillance of mortality and laboratory testing among wild birds are useful early indicators of incursion of the virus into areas in which domestic poultry are not infected. Conventional control methods used widely in Europe and the Middle Eastern region involve stamping-out, zoning, quarantine, movement restrictions, enhanced surveillance and disinfection. Use of preventive vaccination is increasing in the region. In the Russian Federation, all backyard poultry considered to be at high risk for infection have been vaccinated since 2006. Several countries in the Middle East permit the use of vaccine, although rarely as part of a formal statutory programme. In the European Union, conventional approaches for control have proved effective, but both emergency and preventive vaccination could be used. Application of such programmes would have to be preceded by an evaluation of the risks for introduction and spread and might be restricted.

Several European countries have initiated national and regional control-and-eradication campaigns for bovine viral diarrhea virus (BVDV). Most of these campaigns do not involve the use of vaccines; in Germany, vaccination is used only in states in which it is considered necessary because of high BVDV prevalence. In European countries without organized BVDV control programs, vaccination is commonly used to control BVDV. Diagnostic test strategies are fundamental to all control-and-eradication campaigns; therefore, the purpose of this review is to describe how the available diagnostic tests are combined into test strategies in the various phases of control-and-eradication campaigns in Europe. Laboratory techniques are available for BVDV diagnosis at the individual animal level and at the herd level. These are strategically used to achieve 3 main objectives: 1) initial tests to classify herd status, 2) follow-up tests to identify individual BVDV-infected animals in infected herds, and 3) continued monitoring to confirm BVDV-free status. For each objective or phase, the validity of the diagnostic tests depends on the mode of BVDV introduction and duration of infection in test-positive herds, and on how long noninfected herds have been clear of BVDV. Therefore, the various herd-level diagnostic tools--such as antibody detection in bulk milk or in blood samples from young stock animals, or BVDV detection in bulk milk--need to be combined appropriately to obtain effective strategies at low cost. If the individual diagnostic tests are used with due consideration of the objectives of a specific phase of a BVDV control program, they are effective tools for controlling and eradicating BVDV in regions not using vaccination and where vaccination is a part of the control or eradication program.

For several decades after the first description of bovine viral diarrhea and its causative agent (BVDV) the economic impact of the infection was underestimated and in addition there were no suitable diagnostics and procedures for a systematic control at hand. Today, there are several estimates on the real economic impact of the infection and during the last 15 years the serological and virological laboratory diagnosis of BVDV infections has improved. Also, successful procedures aimed at eradicating BVDV infections by using a strict test and removal policy for animals persistently infected (PI) with BVDV accompanied by movement restrictions for infected herds have been implemented in the Scandinavian countries. The success of these efforts has encouraged other European countries to follow the same procedures. However, the Scandinavian control strategy might-for a number of reasons-not be acceptable for all European countries. In such cases, the test and removal strategy, with its fundamental elements of biosecurity, removal of PI animals and monitoring of herd status, in combination with systematic vaccination, might be an acceptable compromise. The impact of the BVDV-free status of regions and nations on international trade is not yet clear. In any case, biosecurity measures will be of utmost importance for individual control programs as well as multiple control programs to co-exist in Europe.

A full history of the management practices and the prevalence of upper respiratory tract disease (URTD) at 218 rescue shelters, breeding establishments and private households with five or more cats was recorded. Oropharyngeal and conjunctival swabs and blood samples were taken from 1748 cats. The prevalences of feline herpesvirus (FHV), feline calicivirus (FCV), Chlamydophila felis and Bordetella bronchiseptica were determined by PCR on swab samples. An ELISA was applied to determine the prevalence of antibodies to B. bronchiseptica. The rates of detection by PCR of each pathogen in the cats in catteries with and without ongoing URTD were, respectively, FHV 16 per cent and 8 per cent; FCV 47 per cent and 29 per cent; C. felis 10 per cent and 3 per cent; and B. bronchiseptica 5 per cent and 1.3 per cent; the seroprevalences of B. bronchiseptica were 61 per cent and 41 per cent, respectively. There was evidence that FHV, FCV and B. bronchiseptica played a role in URTD. The risk factors associated with the disease were less than excellent hygiene, contact with dogs with URTD, and larger numbers of cats in the cattery or household.

Within the European Economic Area (EU member states plus Norway, Iceland and Liechtenstein), veterinary vaccines must comply with EU regulations and relevant monographs of the European Pharmacopoeia. Since 1996, three European monographs specific for fish have been adopted; concerning oil-adjuvanted, injectable vaccine for salmonids against furunculosis, as well as bacterins against classical vibriosis (Listonella anguillarum) or cold-water vibriosis (Vibrio salmonicida) in salmonids. The regulatory requirements laid down in these monographs include the use of seronegative fish for in vivo safety testing; conduct of vaccination trials in which experimental challenge is administered by injection, and minimum relative protection to be achieved at a given level of control mortality. Several aspects of these requirements are being questioned. This concerns the relevance of injection challenge methods as opposed to waterborne challenge; the validity of relative protection assessed at 60 % control mortality (RPS6) as compared to protection calculated at the endpoint of mortality (RPSendpoint), and poor test power due to low numbers of fish per treatment group. There is a strong need for future efforts to refine the methods for documentation and testing of fish vaccines, and to assure their suitability for the intended purpose.

Sets of serum and milk samples were collected from various countries and prepared, lyophilised and distributed by 1 laboratory to 12 reference laboratories in Europe. The serum sets contained the three European bovine herpesvirus 1 (BHV1) reference serum samples (EU1, EU2 and EU3), serum samples from naturally and experimentally BHV1-infected cattle, from vaccinated, and vaccinated-challenged cattle, from uninfected cattle, and a series of serum dilutions. In addition, sets of milk samples were distributed. The samples were tested for antibodies against BHV1 in virus neutralisation tests, in gB-specific ELISAs, in indirect ELISAs and in gE-specific ELISAs. It was found that the virus neutralisation test and the gB-specific ELISAs were most sensitive for the detection of antibodies in serum, whereas for assaying milk samples the indirect ELISAs were the tests of choice. The results show that the quality of most laboratories appeared to be adequate, but that one laboratory performed considerably below an acceptable level of quality. Four samples from the panel have been proposed that might be selected as reference sera in addition to the three European reference samples.

Recent devastating outbreaks of foot-and-mouth disease (FMD) in Europe have reopened the discussion about the adequacy of the non-vaccination strategy implemented by the EU in 1991. Here we describe the evaluation of a new commercially available test kit for the discrimination between vaccination and infection. The test is based on the detection of antibodies against the recombinant non-structural (NS) protein 3ABC. In contrast to immunization with vaccines free of 3ABC, these antibodies are elicited as a consequence of infection. Testing more than 3600 negative sera from several countries revealed a specificity of > 99% for bovine, ovine, and porcine samples. Antibodies specific for 3ABC can be detected as soon as 10 days post-infection. As compared with the occurrence of antibodies against structural proteins of FMDV, anti-3ABC antibodies can be detected 5-10 days later, depending on the species. No anti-3ABC antibodies were detected in sera from vaccination experiments or in field sera from vaccinated animals. However, anti-3ABC antibodies can be detected in vaccinated animals upon challenge. These results provide evidence that this test can facilitate the use of vaccines in new strategies against FMD.