vaccine; vaccination; temporary authorisation; regulatory issues; emerging disease; animal health
Abstract :
[en] 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.
Disciplines :
Veterinary medicine & animal health
Author, co-author :
Saegerman, Claude ; Université de Liège - ULiège > Département des maladies infectieuses et parasitaires > Epidémiologie et analyse des risques appl. aux sc. vétér.
Hubaux, M.
Urbain, B.
Lengele, L.
Berkvens, D.
Language :
English
Title :
Regulatory issues surrounding the temporary authorisation of animal vaccination in emergency situations: the example of bluetongue in Europe
Alternative titles :
[fr] Questions réglementaires liées à l’autorisation temporaire de vacciner les animaux en situation d’urgence : l’exemple de la fièvre catarrhale du mouton en Europe
Publication date :
2007
Journal title :
Revue Scientifique et Technique. Office International des Epizooties
ISSN :
0253-1933
eISSN :
1608-0637
Publisher :
Office International des Epizooties, Paris, France
Anderson R.M. & May R.M. (1991). - Infectious diseases of humans: dynamics and control. Oxford University Press.
Anon. (1996). - Pharmacovigilantie: anaphylaxie bij runderen. Onverenigbaarheid tussen vaccins en antibiotica: mogelijke aanleiding tot ernstige shockreacties [Pharmacovigilance. Anaphylaxis in bovines - incompatibility of vaccines and antibiotics: a possible reason for severe allergic reactions]. Press release from Mycofarm, Boehringer, Pfizer and Vétoquinol. Mycofarm, Turnhout, 3 pp.
Anon. (1998). - Report on the incursion and evolution of bluetongue in Greece in 1998. Ministry of Agriculture, DG of Veterinary Services, Department of Infectious Diseases, Greece.
Barnouin J. & Vourch G. (2004). - Les maladies émergentes: un défi pour le développement durable des productions animales. INRA Prod. anim., 17 (5), 355-364.
Benkirane A. (2001). - Surveillance épidémiologique et prophylaxie de la brucellose des ruminants : l'exemple de la région Afrique du Nord et Proche-Orient. Rev. sci. tech. Off. int. Epiz., 20 (3), 757-767.
Braverman Y., Chizov-Ginzburg A., Pener H. & Wilamowski A. (2004). - Susceptibility and repellency of Culicoides imicola and Culex pipiens to lambda-cyhalothrin. Vet. ital., 40 (3), 336-339.
Bréard E., Hamblin C., Hammoumi S., Sailleau C., Dauphin G. & Zientara S. (2004). - The epidemiology and diagnosis of bluetongue with particular reference to Corsica. Res. vet. Sci., 77, 1-8.
Bréard E., Sailleau C., Coupier H., Mure-Ravaud K., Hammoumi S., Gicquel B., Hamblin C., Dubourget P. & Zientara S. (2003). - Comparison of genome segments 2, 7 and 10 of bluetongue viruses serotype 2 for differentiation between field isolates and the vaccine strain. Vet. Res., 34, 777-789.
Brown C. (2001). - Importance des maladies émergentes pour la santé publique et animale et pour les échanges commerciaux. 69th General Session of the International Committee of the World Organisation for Animal Health (OIE), 27 May-1 June, Paris, document 69 SG/9. OIE, Paris, 6 pp.
Cameron A.R. (2004). - The impact of current and proposed changes to general guidelines on bluetongue surveillance of the Office International des Epizooties. Vet. ital., 40 (4). 693-696.
Caracappa S., Torina A., Guercio A., Vitale F., Catabro A., Purpari G., Ferrantelli V., Vitale M. & Mellor P.S. (2003). - Identification of a novel bluetongue virus vector species of Culicoides in Sicily. Vet. Rec., 153 (3), 71-74.
Center for Veterinary Biologics (CVB) (2006). - Code of Federal Regulations, Title 9 - Animals and Animal Products, Parts 101 to 123. Ames, Iowa, United Stales of America. Available at http://www.aphis.usda.gov./vs/cvb/ html/cfr.html (accessed on 28 October 2006).
Centers for Disease Control and Prevention (CDC) (1998). - Preventing emerging infectious diseases. A strategy for the 21st Century. Center for disease control and prevention, US Department of health and human services, Atlanta, Georgia, October.
De Mallos C.C., de Mattos C.A., Osbum B.I. & MacLachlan N.J. (1994). - Heterogeneity of the L2 gene of field isolates of bluetongue virus serotype 17 from the San Joaquin Valley of California. Virus Res., 31, 67-87.
Di Emidio B., Nicolussi P., Pana C., Ronchi G.F., Monaco F., Savini G., Ciarelli A. & Caporale V. (2004). - Efficacy and safety studies on an inactivated vaccine against bluetongue virus serotype 2. Vet. ital., 40 (4), 640-644.
Dubourget P. & Bolon A. (2005). - Inactivated bluetongue vaccine. Workshop: EU funded research in bluetongue, 10-11 March, Brussels, Belgium.
Dulac G.C., Dubuc C., Myers D.J., Afshar A. & Taylor E.A. (1989). - Incursion of bluetongue virus type 11 and epizootic haemorrhagic disease of deer type 2 for two consecutive years in the Okanagan Valley. Can. vet. J., 30, 351.
Dungu B., Gerdes T. & Smit T. (2004). - The use of vaccination in the control of bluetongue in southern Africa. Vet. ital., 40 (4), 616-622.
Enserink M. (2006). - Emerging infectious diseases. During a hot summer, bluetongue virus invades northern Europe. Science, 313 (5791), 1218-1219.
European Commission (2000). - Possible use of vaccination against bluetongue in Europe. Report of the Scientific Committee on Animal Health and Animal Welfare. Health & Consumer Protection Directorate-General. Adopted 27 June. Doc. Sanco/C3/AH/R19/2000.
European Commission (2001). - Decision 2001/433/EC of 21 May 2001 for purchase by the Community of bluetongue vaccine and restocking of the Community bank. Off. J. Eur. Communitics, L 154, 61-62.
European Council (1981). - Council Directive 81/852/ECC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products. Off. J. Eur. Communities, L 317, 53-98.
European Council (2000). - Directive 2000/75/EC of 20 November, laying down specific provisions for the control and eradication of bluetongue. Off. J. Eur. Communities, L 327, 74-83.
European Food Safety Authority (EFSA) (2006). - Bluetongue serotype 8 epidemic bulletin by EFSA epidemiology working group. Available at: http://www.efsa.europa.eu/en/in_focus/bluetongue/outbreak_overview.html (accessed on 28 October 2006).
European Food Safety Authority (EFSA) (2006). - Opinion of the Scientific Committee on a request from EFSA related to the early identification of emerging risks. EFSA J., 375, 1-14.
European Medicines Agency (2006). - Guideline on the procedure for accelerated assessment pursuant to article 39 (8) of regulation (EC) No. 726/2004. Committee for Medicinal Products for Veterinary Use, London, United Kingdom, 18 May. Doc. Ref. EMEA/CVMP/32995/2006.
European Parliament and the European Council (2001). - Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products. Off. J. Eur. Communities, L 311, 1-66.
European Parliament and the European Council (2004). - Directive 2004/28/EC of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products. Off. J. Eur. Communities, L 136, 58-84.
European Parliament and the European Council (2004). - European Regulation 726/2004/EC of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off. J. Eur. Communities, L 136, 58-84.
Ferrari G., De Liberato C., Scavia G., Lorenzetti R., Zini M., Farina F., Magliano A., Cardeti G., Scholl F., Guidoni M., Scicluna M.T., Amaddeo D., Scaramozzino P. & Autorino G.L. (2005). - Active circulation of bluetongue vaccine virus serotype 2 among unvaccinated cattle in central Italy. Prev. vet. Med., 68 (2-4), 103-113.
Février J. (2004). - European Union policy for the control and eradication of bluetongue. Vet. ital, 40 (4), 682.
Flanagan M. & Johnson S.J. (1995). - The effects of vaccination of Merino ewes with an attenuated Australian BTV serotype 23 al different stages of gestation. Aust. vet. J., 72, 455-457.
Foley P.L. & Hill R.E. Jr (2005). - Regulatory considerations for marker vaccines and diagnostic tests in the US. Biologicals, 33 (4), 253-256.
Food and Agriculture Organization of the United Nations (FAO) (2000). - Preliminary data on veterinary vaccine production/needs in some countries of the Near East. FAO Regional Office for the Near East, Cairo. Egypt.
French T.J. Marshall J.J. & Roy P (1990). - Assembly of double-shelled. viruslike particles ol bluetongue virus by the simultaneous expression of four structural proteins. J. Virol. 64 (12). 5695-5700.
French T.J. & Roy P. (1990). - Synthesis of bluetongue virus (BTV) corelike particles by a recombinant baculovirus expressing the two major structural core proteins of BTV J. Virol., 64 (4), 1530-1536.
Fu H., Leake C.J., Mertens P.P.C. & Mellor P.S. (1999). - The barriers to bluetongue virus infection, dissemination and transmission in the vector, Culicoides variipennis (Diptera: Ceratopogonidae). Arch. Virol., 144, 747-761.
Gerbier G., Hendrikx P., Roger F., Zientara S., Biteau-Coroller F., Grillet C., Badler T. & Albina E. (2004). - Bluetongue control using vaccines: experience of the Mediterranean islands. Vet. ital., 40 (4), 611-615.
Giovannini A., Calistri P., Nannini D., Paladini C., Santucci U., Patta C. & Caporale V. (2004). - Bluetongue in Italy: Part II. Vet. ital., 40 (3), 252-259.
Giovannini A., MacDiarmid S., Calistri P., Conte A., Savini L., Nannini D. & Weber S. (2004). - The use of risk assessment to decide the control strategy for bluetongue in Italian ruminant populations. J. Risk Anal., 24 (6), 1737-1753.
Giovannini A., Paladini C., Calistri P., Conte A., Colangeli P., Santucci U., Nannini D. & Caporale V. (2004). - Surveillance system of bluetongue in Italy Vet. ital., 40 (3), 369-384.
Gomulski L.M., Meiswinkel R., Delecolle J.C., Goffredo M. & Gasperi G. (2005). - Phylogeny of the subgenus Culicoides and related species in Italy, inferred from internal transcribed spacer 2 ribosomal DNA sequences. Med. vet. Entomol., 20 (2), 229-238.
Guyot H., Mauroy A., Thiry E., Losson B., Bodmer M., Kirten P., Rollin F. & Saegerman C. (2007). - Fièvre catarrhale ovine, chez les ruminants. Description clinique des cas vécus dans le Nord de l'Europe durant l'été et l'automne 2006. Bulletin GTV, 39, 89-96.
Hallet L. (2003). - Les modes de collaboration entre vété rinaires officiels, vétérinaires privés et organisations d'éleveurs. In Veterinary Services: organisation, quality assurance, evaluation (E. Correa Melo & F. Gerster, eds). Rev. sci. tech. Off. int. Epiz., 22 (2), 523-532.
Hammoumi S., Bréard E., Sailleau C., Russo P., Grillet C., Cetre-Sossah C., Albina E., Sanchis R., Pepin M., Guibert J.M. & Zientara S. (2003). - Studies on the safety and immunogenicity of the South African bluetongue virus serotype 2 monovalent vaccine: specific detection of the vaccine strain genome by RT-PCR. J. vet. Med., B, infect. Dis. vet. public Hlth, 50 (7), 316-321.
Heidner H.W, Iezzi L.G., Osburn B.I. & MacLachlan N.J. (1991). - Genetic variation and evolutionary relationships amongst bluetongue viruses endemic in the United States. Virus Res., 21, 91-109.
Hill R.E. (2004). - Regulation of conditionally licensed biologicals in the United States. Dev. Biol.(Basel). 117, 147-152.
Hill R. E., Foley P.L., Carr M.Y., Eisken L.A., Gatewood D.M., Ludeman L.R. & Wilbur L.A. 12003). - Regulatory considerations for emergency use of non-USDA licensed vaccines in the United Stales. Dev. Biol. (Basel), 114, 31-52.
Hill R.E., Foley P.L., Carr M.Y., Eisken L.A., Galewood D.M., Ludeman L.R. & Wilbur L.A. (2005). - Regulatory considerations for emergency use of non-USDA licensed vaccines in the United States. Workshop: EU funded research in bluetongue, 10-11 March, Brussels, Belgium.
Hunter P. & Modumo J. (2001). - A monovalent attenuated serotype 2 bluetongue virus vaccine confers homologous protection in sheep. Onderstepoort J. vet. Res., 68, 331-333.
Hupet R (2002). - La communication relative au risque : principes généraux. Épidémiol. Santé anim., 41, 189-200.
Kettle D.S. (1962). - The bionomics and control of Culicoides and Leptoconops (Diptera, Ceratopogonidae Heleidae). Annu. Rev. Entomol., 7, 401-418.
King L.J. (2004). - Emerging and re-emerging zoonotic diseases: challenges and opportunities. Technical Item I. In Proc. 72nd General Session of the International Committee of the World Organisation for Animal Health (OIE), Paris, France, 23-28 May. OIE, Paris, Doc. 72 SG/9.
Kirkland P.D., Zhang N., Hawkes R.A., Li Z., Zhang F., Davis R.J., Sanders D.A., Li H., Zhang K., Ben J., He G.F., Hornitzky C.L. & Hunt N.T. (2002). - Studies on the epidemiology of bluetongue virus in China. Epidemiol. Infect., 128, 257-263.
Le Gall F.G. (2006). - Economic and social justification of investment in animal health and zoonoses. Technical Item II. In Proc. 74th General Session of the International Committee of the World Organisation for Animal Health (OIE), Paris, France, 21-26 May 2006. OIE, Paris, Doc. 74 SG/10.
Lefèvre P.-C. & Mellor P.S. (2007). - Bluetongue. In Infectious and parasitic disease of livestock. Lavoisier, Provigny, France, in press.
MacLachlan N.L. (1994). - The pathogenesis and immunology of bluetongue virus infection of ruminants. Comp. Immunol. Microbiol. infect. Dis., 17, 197-206.
Meiswinkel R. (2006). - The Culicoides vector of bluetongue disease in Limburg, the Netherlands. International Society for Infectious Diseases. Available at: www.promedmail.org (accessed on 28 October 2006).
Mellor P.S. (2005). - Development of a safe, efficacious bluetongue virus vaccination strategy for Europe. Workshop: EU funded research in bluetongue, 10-11 March, Brussels, Belgium.
Mellor P.S. & Boorman J. (1995). - The transmission and geographical spread of African horse sickness and bluetongue viruses. Ann. trop. Med. Parasitol., 89 (1), 1-15.
Mellor P.S., Boorman J. & Baylis M. (2000). - Culicoides biting midges: their role as arbovirus vectors. Annu. Rev. Entomol., 45, 307-340.
Mellor P.S. & Wittmann E. (2002). - Bluetongue virus in the Mediterranean basin 1998-2001. Vet. J., 164, 20.
Menens P.P.C., Attoui H. & Bamford D.H. (eds) (2006). - The RNAs and proteins of dsRNA viruses, Institute for Animal Health, Pirbright. Available at: www.iah.bbsrc.ac.uk/dsRNA_virus_proteins/Orbivirus.htm (accessed on 28 October 2006).
Miranda M.A., Borras D., Rincon C. & Alemany A. (2003). - Presence in the Balearic Islands (Spain) of the midges Culicoides imicola and Culicoides obsoletus group. Med. vet. Entomol., 17, 52-54.
Monaco F., Bonfini B., Zaghini M., Antonucci D., Pini A. & Savini G. (2004). - Vaccination of cattle using monovalent modified-live vaccine against bluetongue virus serotype 2: innocuity, immunogenicity and effect on pregnancy. Vet. ital., 40 (4), 671-675.
Monaco F., De Luca N., Morelli D., Pisciella M., Palmarini S., Di Giandomenico M. & Savini G. (2004). - Field vaccination of cattle using a bivalent modified-live vaccine against bluetongue virus serotypes 2 and 9: effect on milk production. Vet. ital., 40 (4), 661-663.
Monaco F., De Luca N., Spina P., Morelli D., Liberatore I., Citarella R., Conte A. & Savini G. (2004). - Virological and serological response of cattle following field vaccination with bivalent modified-live vaccine against bluetongue virus serotypes 2 and 9. Vet. ital., 40 (4), 657-660.
Morse S.S. (1995). - Factors in the emergence of infectious diseases. Emerg. infect. Dis., 1, 7-15.
Morse S.S. (2004). - Factors and determinants of disease emergence. In Emerging zoonoses and pathogens of public health concern (L.J. King, ed.). Rev. sci. tech. Off. int. Epiz., 23 (2), 443-451.
Oberst R.D., Stott J.L., Blanchard-Channell M. & Osbum B.I. (1987). - Genetic reassortment of bluetongue virus serotype 11 strain in the bovine. Vet. Microbiol., 15, 11-18.
O'Connell L. (2001). - Transmission rates of bluetongue virus by Culicoides biting midges. In Proc. of the Royal Entomological Society International Symposium on insects and disease, 10-12 September, University of Aberdeen. Abstracts book.
O'Connell L. (2002). - Entomological aspects of the transmission of arboviral diseases by Culicoides biting midges. Ph.D. thesis of the University of Bristol., 176 pp.
Osburn B.I. (1994). - The impact of bluetongue virus on reproduction. Comp. Immunol. Microbiol. infect. Dis., 17, 189-196.
Panagiotatos D.E. (2005). - Review of bluetongue virus incursions, vectors, surveillance and epidemiological features in Eastern Europe in the period 1998-2004. Workshop: EU funded research in bluetongue. 10-11 March, Brussels. Belgium.
Pastoret P.-P. & Mackay D. (2002). - Regulatory considerations for emergency use of vaccines in the European Union. Vaccines for OIE list A and emerging animal diseases, Scheman Conference Center, Ames, Iowa, USA, 16-18 September.
Pattison J. (1998). - The emergence of bovine spongiform encephalopathy and related diseases. Emerg. infect. Dis., 4 (3), 390-394.
Pearson L.D. & Roy P. (1993). - Genetically engineered multi-component virus-like particles as veterinary vaccines. Immunol. Cell Biol., 71 (5), 381-389.
Purse B.V., Mellor P.S., Rogers D.J., Samuel A.R., Mertens P.P. & Baylis M. (2005). - Climate change and the recent emergence of bluetongue in Europe. Nat. Rev. Microbiol., 3(2), 171-181.
Qin Q., Tai Z., Wang L., Luo Z., Hu J. & Lin H. (1996). -Bluetongue epidemiological survey and virus isolation in Xinjiang, China. In Bluetongue disease in Southeast Asia and the Pacific. Australian Centre for International Agricultural Research, Canberra, 67-71.
Rodhain F. (2003). - Emergences de maladies à transmission vectorielle. Épidémiol. Santé anim., 43, 33-49.
Roy P. (1992). - Bluetongue virus proteins. J. gen. Virol., 73, 3051-3064.
Roy P. (1996). - Multiple gene expression in baculovirus system. Third generation vaccines for bluetongue disease and African horse sickness disease. Ann. N.Y. Acad. Sci., 23, 318-332.
Roy P., Bishop D.H.L., LeBois H. & Erasmus B.J. (1994). - Long-lasting protection of sheep against bluetongue challenge after vaccination with virus-like particles: evidence for homologous and partial heterologous protection. Vaccine, 12, 805-811.
Saegerman C. (2006). - Epidémiosurveillance des événements rares chez les bovins en Belgique. Ann. Méd. vét., 150 (S), 4-9.
Saegerman C., Berkvens D., Godfroid J. & Walravens K. (2007). - Bovine brucellosis. In Infectious and Parasitic Disease of Livestock, Lavoisier, Provigny, France, in press.
Saegerman C., Berkvens D., Speybroeck N., Roels S., Vanopdenbosch E. & Thiry E. (2003). - Amélioration de la détection d'une maladie émergente : exemple de l'encéphalopathie spongiforme bovine. In Épidémiologie des maladies émergentes (special issue). Épidemiol. Santé anim., 44, 61-77.
Saegerman C., Claes L., Dewaele A., Desmecht D., Rollin F., Hamoir J., Gustin P., Czaplicki G., Bughin J., Wullepit J., Laureyns J., Roels S., Berkvens D., Vanopdenbosch E. & Thiry E. (2003). - Differential diagnosis of neurologically expressed disorders in Western European cattle. In Risk analysis of prion diseases in animals (C.I. Lasmézas & D.B. Adams, eds). Rev. sci. tech. Off. int. Epiz., 22 (1), 83-102.
Samal S.K., Elhussein A., Holbrook F.R., Beaty B.J. & Ramig R.F. (1987). - Mixed infection of Culicoides-variipennis with bluetongue virus serotype 10 and serotype 17 -evidence for high-frequency reassortment in the vector. J. gen. Virol., 68, 2319-2329.
Samal S.K., Livingstone C.W. Jr, McConnell S. & Ramig R.F. (1987). - Analysis of mixed infection of sheep with bluetongue serotype 10 and 17: evidence for genetic reassortment in the vertebrate host. J. Virol., 61, 1086-1091.
Satta G., Goffredo M., Sanna S., Vento L., Cubeddu G. P. & Mascherpa E. (2004). - Field disinfestation trials against Culicoides in north-west Sardinia. Vet. ital., 40 (3), 329-335.
Savini G., Goffredo M., Monaco F., de Santis P. & Meiswinkel R. (2003). - Transmission of bluetongue virus in Italy. Vet. Rec., 152, 119.
Savini G., Goffredo M., Monaco F., Di Gennaro A., Cafiero M.A., Baldi L., De Santis P., Meiswinkel R. & Caporale V. (2005). - Bluetongue virus isolations from midges belonging to the Obsoletus complex (Culicoides, Diptera: Ceratopogonidae) in Italy. Vet. Rec., 157, 133-139.
Schumacher C.L. (2005). - Available products, not licensed in Europe. European Technology Platform for Animal Health. Working Group 2, Brussels, October 12, 2005. Available at: http://www.ifahsec.org/Europe/EUPlatform/ Minutes/WG2/WEB-C.%20Schumacher.ppt (accessed on 18 June 2006).
Scott J.L., Oberst R.D., Channell M.B. & Osburn B.I. (1987). - Genome segment reassortment between two serotypes of bluetongue virus in a natural host. J. Virol., 61, 2670-2674.
Scott J.L., Osburn B.I. & Barber T.L. (1982). - Recovery of dual serotypes of bluetongue virus from infected sheep and cattle. Vet. Microbiol., 7 (3), 197-207.
Slingenbergh J., Gilbert M., de Balogh K. & Wint W. (2004). - Ecological sources of zoonotic diseases. In Emerging zoonoses and pathogens of public health concern (L.J. King, ed.). Rev. sci. tech. Off. int. Epiz., 23 (2), 467-484.
Standfast H.A., Muller M.J. & Wilson D.D. (1985). - Mortality of Culicoides brevitarsis fed on cattle treated with Ivermectin. In Bluetongue and related Orbiviruses (T.L. Barber & M.M. Jochim. eds). Alan R. Liss Inc., New York, 519-525.
Takamatsu H., Mellor P.S., Mertens P.P.C., Kirkham P.A., Burroughs J.N. & Parkhouse R.M.E. (2003). - A possible overwintering mechanism for bluetongue virus in the absence of the insect vector. J. gen. Virol., 84, 227-235.
Taylor W.P. (1986). - The epidemiology of bluetongue. Rev. sci. tech. Off. int. Epiz., 5 (2), 351-356.
Thiry E., De Clercq K., Saegerman C. & Vermeersch J.P. (2002). - La vaccination contre la fièvre aphteuse : perspectives. Bull. GTV, 14, 117-121.
Thiry E., Saegerman C., Guyot H., Bodmer M., Kirten P., Losson B., Rollin F., Czaplicki G., Toussaint J.F., De Clercq K., Dochy J.M., Dufey J., Gilleman J.L. & Messeman K. (2006). - Clinical cases of bovine bluetongue in Belgium. Vet. Rec., 159 (10), 327.
Toma B. & Thiry E. (1999). - Qu'est-ce qu'une maladie émergente ? Épidémiol Santé anim., 44, 1-11.
Toussaint J.-F., Sailleau C., Mast J., Houdart Ph., Czaplicki G., Demeestere L., VandenBussche F. Van Dessel W., Goris N., Bréard E., Bounaadja L., Thiry E., Zientara S. & De Clercq K. (2007). - Bluetongue in Belgium, 2006. Emerg. infect. Dis., 13 (4), 614-616.
Townley P., Baker K.P. & Quinn P.J. (1984). - Preferential landing and engorging sites of Culicoides species on a horse in Ireland. Equine vet. J., 16, 117-120.
United States Department of Agriculture (USDA) (2005). -Overview of the Mediterranean basin bluetongue disease outbreak, 1998-2004. Center for Emerging Issues, Animal and Plant Health Inspection Service, USDA. Available at: http://www.aphis.usda.gov/vs/ceah/cei/taf/emergingdiseasenotice_files/ bluetongue_medbasin_ednotice_sep_04_files/bluetongue_med_basin_jan_05_updale. htm (accessed on 28 October 2006).
Urakawa T., French T.J., Adachi Y., Fukusho A., LeBlois H., Flamand M., Menens P. & Roy P. (1994). - Synthesis of recombinant baculoviruses expressing the outer capsid protein VP2 of five BTV serotypes and the induction of neutralizing antibodies to homologous and heterologous BTV serotypes. Virus Res., 31, 149-161.
Van Boxstael S., Vereecken K., Huyghebaert A., Noteborn H. & Saegerman C. (2005). - Development of a system for pro-active identification of food-related emerging risks. In Proc. Tenth Conference on Food Microbiology, University of Liège, 23-24 June, 102-103.
Venter G.J., Gerdes G.H., Mellor P.S. & Paweska J.T. (2004). - Transmission potential of South African Culicoides species for live-attenuated bluetongue virus. Vet. ital., 40 (3), 198-203.
Veronesi E., Hamblin C. & Mellor P.S. (2005). - Live attenuated bluetongue vaccine viruses in Dorset Poll sheep, before and after passage in vector midges (Diptera: Ceratopogonidae). Vaccine. 23, 5509-5516.
Verwoerd D.W. Louw H. & Oellermann R.A. (1970). - Characterization of bluetongue virus ribonucleic acid. J. Virol., 5, 10-17.
Webster W.R., Gard G.P., St George T.D. & Kirkland P.D. (1992). - The Australian bluetongue control strategy. In Bluetongue, African horse sickness and related Orbivirus (T.E. Wahon & B.I. Osburn, eds). CRC Press. 843-850.
Weiss R.A. & McMichael A.J. (2004). - Social and environmental risk factors in the emergence of infectious diseases. Nature Med., 10 (12), suppl., 70-76.
Wittmann E.J., Mellor P.S. & Baylis M. (2001). - Using climate data to map the potential distribution of Culicoides imicola (Diptera: Ceratopogonidae) in Europe. Rev. sci. tech. Off. int. Epiz., 20 (3), 731-740.
World Organisation for Animal Health (OIE) (2006). - Handistatus II. Multiannual animal disease status for bluetongue. Available at: http://www.oie.int/hs2/report.asp (accessed on 28 October 2006).
World Organisation for Animal Health (OIE) (2006). Bluetongue delected for the first time in Northern Europe. Press release, 23 August. Available at: http://www.oie.int/eng/press/en_060823.htm (accessed on 28 October 2006).
World Organisation for Animal Health (OIE) (2006). - Bluetongue in Northern Europe: an OIE Reference Laboratory makes a hreakthrough in identifying the vector causing the disease. Press release, 23 October. Available at: http://www.oie.int/eng/press/en_061023.htm (accessed on 28 October 2006).
World Organisation for Animal Health (OIE) (2006). - Bluetongue. Chapter 2.2.13. In Terrestrial Animal Health Code, 15th Ed. OIE, Paris. Available at: htip://www.oie.int/eng/normes/mcode/en_chapitre_2.2.13.htm (accessed on 28 October 2006).
Zientara S. (2005). - Epidémiosurveillance des maladies à transmission vectorielle. Deux exemples : West Nile et fièvre catarrhale des ovins. In Proceedings of the Symposium of the Epidemiology and Animal Health Association IAESA: Association d'Epidémiologie et de Santé Animale], Faculty of Veterinary Medicine, University of Liège, 12 May, 22-33.
