Available products, not licensed in Europe : Available products, not licensed in Europe European Technology Platform for Animal Health
Working Group 2,
Bruxelles, October 12, 2005
Carolin L. Schumacher
Aim and Objectives of the European Technology Platform Global Animal Health : Aim and Objectives of the European Technology Platform Global Animal Health
Aim: « To facilitate and accelerate the development and distribution of the most effective tools for controlling animal diseases of major importance to Europe and the rest of the world, thereby improving human and animal health, food safety and quality, animal welfare, and market access, contributing to achieve the Millenium Development Goals ». Objectives:
Protect Europe from the incursion of epidemic animal diseases and zoonoses.
Deal rapidly and effectively with outbreaks in Europe should they occur.
Assist in speed of access to market, facilitation of world trade and the
alleviation of poverty by reducing the impact of these diseases in developing
countries.
Reduce worldwide levels of disease and thereby indirectly protect Europe from
disease spread by people or trade.
Available products, not licensed in the Europe : : Available products, not licensed in the Europe : ? Which Animal Disease ?
? Animal Health priorities in the EU ?
? EU Animal Health Producers
? Animal Health Products available in the EU ?
? Animal Health Products not available in the EU
? Diseases for which no products are available?
? Which Animal Disease ? : ? Which Animal Disease ?
Animal Diseases listed in the OIE list (~100 multi- or single species w/o diseases of aquatic diseases)?
Notifiable Animal Diseases of the EU for which outbreaks have been reported recently (~12 in 2004)?
Notifiable Animal Diseases not present in the EEC?
Animal diseases for which antigen banks are set up or vaccine stock piles are considered (I.e. USDA survey for stock piling of vaccines for exotic diseases to the USA)
Animal Disease prioritized for EU (I.e. AUSVETPLAN) because of their frequency and likelihood of occurrence, facility of spread, their potential economic or human health impact, potential for emergence, etc.?
Other?
Currently, there does not appear to be community-wide consensus or an established model or risk analysis method allowing Animal Disease Prioritization in the EU
Available products, not licensed in the Europe : : Available products, not licensed in the Europe : ? Which Animal Disease ?
? Animal Health priorities in the EU ?
? EU Animal Health Producers
? Animal Health Products available in the EU ?
? Animal Health Products not available in the EU
? Diseases for which no products are available?
? Animal Health priorities in the EU ? : ? Animal Health priorities in the EU ? It is a known disease or Animal Health problem (resistance, animal welfare) that does not occur (in endemic form) in the EU, and for which it is considered to be in the interest for the EU to be free of the disease.
It is a variant form of an endemic disease or serious emerging disease, which, if established in the EU, would have a serious socio-economical or public health impact (emerging, exotic).
It is a serious infectious or non-infectious disease, for which existing therapeutics may, on the evidence available at the time, be unavailable, unsuitable or in the process of becoming unsuitable (bacterial/parasite resistance).
It is a known endemic disease, but is occurring in such a severe outbreak form that an emergency response is required to ensure that there is neither a large-scale epidemic of national significance nor serious loss of market access.
It is a disease for which vaccination is a key element of the primary or potential (secondary) element of the response
Other?
Currently, there does not seem to exist a community-wide accepted method allowing Animal Health Prioritization in the EU
Available products, not licensed in the Europe : Available products, not licensed in the Europe ? Which Animal Disease ?
? Animal Health priorities in the EU ?
? EU Animal Health Producers ?
? Animal Health Products available in the EU ?
? Animal Health Products not available in the EU?
? Diseases for which no products are available ?
EU Animal Health Producers (non-exhaustive) : EU Animal Health Producers (non-exhaustive) Bayer
Boehringer Ingelheim
CEVA
Fort Dodge Animal Health
Impfstoffwerk Dessau Tornau
Intervet
Laboratorios Hipra
MERIAL
Novartis Animal Health
Pfizer
Schering-Plough Animal Health
Vetoquinol
Virbac
Others
Major Producers of Animal Health Products outside the EU (non-exhaustive) : Major Producers of Animal Health Products outside the EU (non-exhaustive) Arriah, Russia
Onderstepoort Biological Products, South Africa
Biogenesis, Argentina
Botswana Vaccine Institute, Botswana
Indian Immunologicals Limited, India
Vetal, Turkey
Many others in various regions of the world Currently, no updated, exhaustive catalogue of animal health producers within and outside the EU and a complete list of their products exists.
Further, only some countries have sourcing policies for selected products/tools susceptible to serve as primary or secondary response to address animal health emergencies of major importance in the EU.
Available products, not licensed in the Europe : Available products, not licensed in the Europe ? Which Animal Disease ?
? Animal Health priorities in the EU ?
? EU Animal Health Producers ?
? Animal Health Products available in the EU ?
? Animal Health Products not available in the EU?
? Diseases for which no products are available ?
Available products, licensed anywhere in Europe (non-exhaustive) : Available products, licensed anywhere in Europe (non-exhaustive) Equine Influenza (Fort Dodge, Intervet, Merial, Schering Plough)
Rabies - parenteral and oral (Intervet, Merial, Schering Plough, Virbac)
Aujeszky’s (Intervet, Merial, Boehringer Ingelheim, Laboratorios Hipra)
Classical Swine Fever:
Intervet CSF virus E2-subunit antigen;
Merial Chinese (lapinised) strain of live attenuated virus;
Pfizer E2 protein marker vaccine;
Riemser Arzneimittel AG Chinese (lapinised) strain of live attenuated virus - EU CSF vaccine bank and a bait vaccine for CSF vaccination of wild boar.
Porcine reproductive and respiratory syndrome: Fort Dodge, Intervet, MERIAL
Swine Influenza: Laboratorios Hipra, Merial
Foot & Mouth Disease:
Bayer inactivted types 0, A, C, Asia1, SAT1, SAT2, SAT3 AlOH or double oil emulsion
Intervet inactivted types 0, A, C, Asia1, SAT1, SAT2, SAT3 AlOH or double oil emulsion
Merial inactivted types 0, A, C, Asia1, SAT1, SAT2, SAT3 AlOH or double oil emulsion
Brucella melitensis (Vetoquinol live B; melitensis Rev.1 for goat and sheep)
Looping Ill, Central European (tick-borne) Encephalitis: Schering-Plough Animal Health
Avian Influenza
Intervet H7N1, H7N7, H5N2, H5N6;
Merial H5N9, H6N2, H7N1, H7N3, H9N2
Gumboro: (Fort Dodge, Intervet, Laboratorios Hipra, Merial, Schering-Plough)
NewCastle: (Fort Dodge, Intervet, Laboratorios Hipra, Merial, Schering-Plough)
Infectious Bursal Disease: Fort Dodge, Intervet, Laboratorios Hipra, Merial Schering Plough
Salmonella enteridis: Intervet, Laboratorios Hipra, Lohmann, Merial
Available products, not licensed in the Europe (non-exhaustive) : Available products, not licensed in the Europe (non-exhaustive) ? Which Animal Disease ?
? Animal Health priorities in the EU ?
? EU Animal Health Producers ?
? Animal Health Products available in the EU ?
? Animal Health Products not available in the EU?
? Diseases for which no products are available ?
African Horse Sickness (Orbivirus) : African Horse Sickness (Orbivirus)
Merial, France: Inactivated AHS serotype 4, adjuvant, not currently in production, but master seed etc. preserved.
Onderstepoort Biological Products, South Africa: Attenuated, live AHS virus, South African isolates – seven serotypes - Combination 1 – serotypes 1, 3 & 4; Combination 2 – serotypes 2, 6, 7 & 8.
Société de Productions Biologiques et Pharmaceutiques Veterinaires, Morocco: Attenuated, live AHS serotype 4 virus
Veterinary Serum and Vaccine Research Institute, Egypt: Killed oil emulsion, Vryhied type (serotype 4) and S2 type (serotype 2).
Unknown manufacturer, Sudan: Attenuated, live AHS virus, various serotypes, First dose – 1, 3, 4 & 5 , Second dose – 2, 6, 7 & 9.
Anthrax (B. anthracis) : Anthrax (B. anthracis) Colorado Serum Company, Denver, CO, USA: Non-capsulated naturally avirulent (“live”) Sterne 34F2 strain of B. anthracis
Onderstepoort Biological Products Ltd, Onderstepoort, South Africa:Non-capsulated naturally avirulent (“live”) Sterne 34F2 strain of B. anthracis
Biogenesis, Buenos Aires, Argentina: Non-capsulated naturally avirulent (“live”) Sterne 34F2 strain of B. anthracis
Botswana Vaccine Institute, Gaborone, Botswana:Non-capsulated naturally avirulent (“live”) Sterne 34F2 strain of B. anthracis
Avian Influenza : Avian Influenza Lohmann Animal Health, USA: USDA-CVB conditional license (H1, H2, H3, H4, H5, H6, H7, H9, H10)
MERIAL Limited, USA: Fowlpox-vectored H5 Trovac 5, H5 AI insert from AI virus A/turkey/Ireland/83 [H5N8]
China:
H5N2 inactivated,
recombinant fowlpox-H5 with A/turkey/Ireland/83 cDNA insert and H5N1 cDNA inserts from A/goose/Guangdong/3/96 H5N1 AI (injectable 1 day old chicken)
Reverse genetics influenza A inactivated vaccine using internal genes from human influenza strain (PR8) and H&N from A/goose/Guangdong/3/96 H5N1 AI (vaccination of individual birds)
Pakistan: H7
Bluetongue Vaccine (Orbivirus) : Bluetongue Vaccine (Orbivirus) MERIAL SAS, Lyon, France: Liquid, inactivated mono or multivalent vaccine for sheep containing Bluetongue Virus strains 2 & 4. Strains 16 and 9 in development, indications for efficiacy in bovines. Product commercialised under ATU in France, Italy, Spain and Portugal.
Onderstepoort Biological Products, Onderstepoort, South Africa : A freeze-dried polyvalent vaccine containing live attenuated bluetongue virus strains for sheep. The vaccine is presented as a series of three separate injections with different serotypes of bluetongue virus in each bottle.
A – 1, 4, 6, 12 & 14
B – 3, 8, 9, 10 &11
C – 2, 5, 7, 13, &19
Other monovalent or multivalent vaccines can be produced on request, as done for Italy and France (ATU).
Colorado Serum Co., Denver, Colorado, USA Modified live virus of serotype 10
Central Veterinary Control & Research Institute, Ankara, Turkey
Freeze-dried monovalent Bluetongue BTV-4 vaccine for sheep, Live, attenuated and lyophilised vaccine
Biopharma, Marocco: monovalent Bluetongue BTV-4 vaccine for sheep, Live, attenuated
Brucellosis (Brucella abortus) : Brucellosis (Brucella abortus)
Biogenesis, Argentina: Bio-Brucelosis 19, Freeze-dried Brucella abortus strain 19.
Colorado Serum Company, USA: RB-51 Brucella abortus vaccine, live culture (strain S 19?)
Merial, Brazil: Anabortina B-19 - Abortisec bovine, Strain 19, live culture
Onderstepoort Biological Products, South Africa: Live Brucella abortus strain 19 vaccine for Cattle
Schering-Plough Animal Health, Uruguay?: Brucella abortus RB-51 Beceras
Strain RB-51, live culture
Veterinary Serum and Vaccine Research Institute, Egypt: Brucella abortus vaccine (strain 19), Brucella abortus strain 19, live culture.
Contagious bovine pleuropneumonia (CBPP) Mycoplasma mycoides mycoides : Contagious bovine pleuropneumonia (CBPP) Mycoplasma mycoides mycoides
Botswana Vaccine Institute, Gaborone: Live, avirulent Mycoplasma mycoides strain T1-44/2 (Panvac modified strain)
Onderstepoort Biological Products, South Africa: Live, avirulent, freeze-dried culture of Mycoplasma mycoides strain T1-44 (PANVAC).
Unknown manufacturer, Sudan: Live avirulent culture of Mycoplasma mycoides strain T1-44.
Equine encephalomyelitis (Western, Eastern and Venezuelan) : Equine encephalomyelitis (Western, Eastern and Venezuelan) Colorado Serum Company, USA: Encephalitis vaccine, eastern and western, Bivalent, formalin-inactivated EEE and WEE viruses with adjuvant, also combinations with Tetanus Toxoid.
Fort Dodge, USA:
Trivalent, formalin-inactivated EEE, WEE and VEE viruses with adjuvant
Bivalent, formalin-inactivated EEE and WEE viruses with adjuvant.
Also combinations vaccines are produced with tetanus toxoid, equine influenza, Rhinopneumonitis, West Nile virus and tetanus toxoid.
Intervet, USA:
Bivalent, formalin-inactivated EEE and WEE viruses with adjuvant.
Trivalent, formalin-inactivated EEE, WEE and VEE viruses with adjuvant plus tetanus toxoid.
Also combinations produced with tetanus toxoid, equine influenza and rhinopneumonitis
Schering-Plough Animal Health, USA: Bivalent, formalin-inactivated EEE and WEE viruses with adjuvant plus tetanus toxoid, also combination with tetanus toxoid and equine influenza (EWTF).
Haemorrhagic septicaemia (P. multocida) : Haemorrhagic septicaemia (P. multocida)
Indian Immunological Ltd, India: Formalin-inactivated culture of Pasteurella multocida adjuvants with aluminium hydroxide.
Intervet, India: Formalin-inactivated culture of Pasteurella multocida.
Veterinary Research Institute, Ipoh, Malaysian Department of Veterinary Services, Malaysia: Formalin-inactivated culture of Pasteurella multocida.
Veterinary Research Institute, Lahore, Government of Punjab, Pakistan: Formalin-inactivated culture of Pasteurella multocida
Heaertwater (Ehrlichia ruminantium - previously Cowdria ruminantium) : Heaertwater (Ehrlichia ruminantium - previously Cowdria ruminantium)
Onderstepoort Biological Products, South Africa: Heartwater – infective blood
Frozen Cowdria ruminantum-infected sheep blood.
Japanese Encephalitis (Flavivirus) : Japanese Encephalitis (Flavivirus)
Nisseiken, Japan:
JE vaccine (TC origin) (for equine use).
JE live vaccine (for porcine use).
JE inactivated vaccine (for porcine use).
Kyoto Biken Laboratory Inc, Japan:
Japanese encephalitis live vaccine (for porcine use).
Japanese encephalitis inactivated vaccine (for porcine use).
Combined Getah virus and Porcine parvovirus live vaccines also produced.
Also: China, South Corea, Taiwan
Lumpy Skin Disease (Capripox) : Lumpy Skin Disease (Capripox)
Onderstepoort Biological Products, South Africa: Freeze-dried, live, attenuated sheeppox virus (Nethling type) vaccine for cattle.
Veterinary Serum and Vaccine Research Institute, Egypt: Sheep pox vaccine, live, attenuated Ismailia strain.
Peste des petits ruminants (Morbillivirus) : Peste des petits ruminants (Morbillivirus)
Biological Products Division, Nepal: PPRV 75/1 homologous strain.
Botswana Vaccine Institute, Gaborone, Botswana: Live PPR 75/1 strain.
Central Veterinary Control and Research Institute, Turkey: Freeze-dried PPR vaccine Attenuated Nigeria 75/1 strain PPR virus.
Veterinary Serum and Vaccine Research Institute, Egypt: P.P.R. vaccine (Egypt 87)
Live, attenuated Egypt 87 strain PPR virus (freeze-dried).
VETAL Veterinary Vaccines and Pharmaceuticals, Turkey: Pest des petits ruminants TC vaccine (freeze-dried), Attenuated PPR virus, strain Nig 75/1.
Potomac Fever (Erlichia risticii) : Potomac Fever (Erlichia risticii)
Boehringer Ingelheim, USA: Inactivated Ehrlichia risticii bacterin
Fort Dodge, USA: Inactivated Ehrlichia risticii bacterin
Intervet, USA: Inactivated Ehrlichia risticii bacterin
Merial, USA: Inactivated Ehrlichia risticii bacterin
Novartis, USA: Inactivated Ehrlichia risticii bacterin
Pfizer, USA: Inactivated Ehrlichia risticii bacterin
Schering-Plough Animal Health, USA: Inactivated Ehrlichia risticii bacterin
Rift Valley Fever : Rift Valley Fever Onderstepoort Biological Products Ltd, Onderstepoort, South Africa
Inactivated Rift Valley fever vaccine for sheep and cattle, Formalin-inactivated BHK21 tissue culture of South African isolate.
Live attenuated Rift Valley fever virus VACCINE(Smithburn strain)
Veterinary Serum and Vaccine Research Institute (Egypt)
Inactivated RVF vaccine, Inactivated ZH-501 strain
Live RVF vaccine, Attenuated Smithburn strain
Kenya
Rinderpest : Rinderpest Abic Ltd, Israel: Live, attenuated rinderpest virus.
Botswana Vaccine Institute, Botswana: Live, attenuated rinderpest virus RPKO/BK (thermostable)
Central Veterinary Control and Research Institute, Turkey: Freeze-dried attenuated KABETE O strain rinderpest virus.
Indian Immunologicals Ltd, India: Live, attenuated rinderpest virus (tissue culture).
National Institute of Animal Health, Japan: Live, attenuated Ako strain
Onderstepoort Biological Products, South Africa: Live, attenuated Kabete “O” strain
Unknown manufacturer, Sudan: Live, attenuated Kabete “O” strain
Veterinary Research Institute, Lahore, Government of Punjab, Pakistan: Live, attenuated rinderpest virus (TCRV/CTV)
Veterinary Serum and Vaccine Research Institute, Egypt: Rinderpest vaccine, lyophilised, physiological saline solution.
VETAL Veterinary Vaccines and Pharmaceuticals, Turkey: Live rinderpest TC vaccine W. Plowright (tissue culture, freeze-dried)
Sheep Pox : Sheep Pox Abic Ltd, Israel: Live RM-65 strain.
Indian Immunologicals Ltd, India: Live, attenuated sheep pox virus, Romanian strain, grown on lamb testicle cells.
Société de Productions Biologiques et Pharmaceutiques Veterinaires, Morocco: Live Romanian strain
Unknown manufacturer, Sudan: Live Kenya O 240 strain
Veterinary Research Institute, Lahore, Government of Punjab, Pakistan: Live Sheep pox vaccine
Veterinary Serum and Vaccine Research Institute, Egypt: Live Sheep pox vaccine, Kenyan strain
VETAL Veterinary Vaccines and Pharmaceuticals, Turkey: Adapted sheep pox virus propagated in cell culture (lamb kidney).
Veterinary Vaccine Production Centre, Saudi Arabia: Live
Vesicular Stomatitis : Vesicular Stomatitis C.A. Laboratorios Asociados, Venezuela: Serotype New Jersey, killed, oil-emulsion adjuvant.
Empresa Colombiana de Productos Veterinarios S.A., Colombia: Inactivated, serotypes Indiana and New Jersey, oil-emulsion adjuvant
Limor de Colombia, Colombia: Serotypes Indiana and New Jersey, oil-emulsion
Wesselbron disease : Wesselbron disease Onderstepoort Biological Products, South Africa: Freeze-dried, live, attenuated Wesselsbron virus vaccine.
West Nile Virus (Flavivirus) : West Nile Virus (Flavivirus) Fort Dodge Animal Health, USA: West Nile – Innovator: Inactivated West Nile virus.
Merial Inc., Duluth, USA: Recombitek: Live canarypox vector, WNV genetic material insert.
Available products, not licensed in the Europe : Available products, not licensed in the Europe ? Which Animal Disease ?
? Animal Health priorities in the EU ?
? EU Animal Health Producers ?
? Animal Health Products available in the EU ?
? Animal Health Products not available in the EU?
? Diseases for which no products are available ?
No vaccine CURRENTLY available (1) : No vaccine CURRENTLY available (1) African swine fever
Borna disease
Bovine spongiform encephalopathy
Bovine tuberculosis (due to mycobacterium bovis)
Contagious equine metritis
Dourine
East coast fever
Epizootic lymphangitis
Equine babesiosis
Equine encephalosis
Getah virus
Glanders
Hendra virus
Jembrana disease
Maedi/visna
No vaccine CURRENTLY available (2) : No vaccine CURRENTLY available (2) Menangle virus (porcine paramyxovirus)
Nairobi sheep disease
Nipah virus
Pulmonary adenomatosis
Scrapie
Screw-worm fly
Sheep scab
Surra
Swine vesicular disease
Teschen disease (sorcine polioencephalomyelitis)
Transmissible gastroenteritis
Trichinellosis
Vesicular exanthema.
Available products, not licensed in Europe: Subjects suggested for inclusion into the SRA : Available products, not licensed in Europe: Subjects suggested for inclusion into the SRA Development of a risk-based consistent model to evaluate Global Animal Health Priorities (endemic, exotic, emerging) and the risk they pose for the European Union. Identification and prioritization of Animal Diseases of major socio-economic or public health importance for Europe.
Mapping available industries and products within the EU and on a global level where products/tools to address EU animal health priorities can be sourced. Evaluation of suitability of products available within and outside the EU. Develop a comprehensive, risk-based sourcing strategy for all EU animal health priorities.
Identify gaps and important weaknesses in available tools and sources, map available research, technologies, and existing patents within the EU and on a global level.
Develop a proposition allowing to focus research to increase the knowledge base and product availability for the EU on prioritized animal diseases. Research should focus on areas where there is a real need and a real market, proposed technologies should fit well with their intended environment of use.
Sources: : Sources: Tweddle, N.E. (2004); Sourcing Vaccines for Emergency Responses to terrestrial Animal Diseases in Australia: A Discussion Paper. Office of the Chief Veterinary Officer. Australian Government, Department of Agriculture, Fisheries and Forestry, Canberra.
Roth JA and Spickler AR (2002). A survey of vaccine produced for OIE List A diseases in OIE member countries. IABs: Developments in Biologicals; Eds: F. Brown, J. Roth; Vol 114; KARGER 2003.
Peta Hitchens; Thesis presented in partial fulfillment for the degree of the Master of Veterinary Public Health Management, Faculty of Veterinary Science, University of Sydney; December 2004.
J. F. Annelli (2005); USDA-APHIS Veterinary Vaccine Stockpile Survey for Animal diseases not present in the USA.
Dictionnaire des Médicaments Vétérinaires, 13e Edition, 2005.
EEC's Animal Disease Notification System (ADNS), 3 Jan 2005. http://europa.eu.int/comm/food/animal/diseases/adns/adns_2004.pdf
Various WEB sites of AH producers, government agencies and non-governmental organizations.