Press Pack. Ceva launches VECTORMUNE AI, a novel technology vaccine for H5 Avian Influenza protection

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1 Press Pack Ceva launches VECTORMUNE AI, a novel technology vaccine for H5 Avian Influenza protection

2 Content 1) Summary 2) Definition of the vaccine 3) Safety 4) Efficacy 5) Additional advantages 6) Vectormune AI: Summary of features and benefits a) Broad protection b) Day old vaccination in the hatchery c) Long lasting protection d) Safety 7) Bibliography 8) Contacts

3 1. Summary Ceva Santé Animale today launched Vectormune AI, a vaccine for poultry against Avian Influenza, in Egypt following license approval from the USDA in April Ceva expect to launch Vectormune AI in several countries where Avian Influenza is endemic over the coming months. The vaccine is suitable for broilers, layers, and breeders. It has been developed using contemporary science and novel technology which has been applied to a 50 year old proven vaccine, a frozen Marek s vaccine (HVT). The science developed has managed to by-pass Maternally Derived Antibodies which prevent day-old chicks from taking up vaccines and securing immunity to strains of AI at an early age. Moreover, the application of the vaccine within the controlled environment of a hatchery when the chick is one day old, means that chicks are protected earlier in their lives, are at significantly less risk of infection during their lives and will live, healthily and productively to provide safe proteins (eggs and meat) to consumers. Vectormune AI s protection has been evaluated against different strains of the AI virus (H5N1), isolated from around the world belonging to different clades (categories of strains) of this rapidly spreading and fast mutating virus. Its efficacy is well proven ensuring a survival rate of between 80 and 100% in trial flocks, no matter the provenance of the AI strain. Once vaccinated the vaccine remains in the chick. Avian Influenza remains a major threat to the global poultry industry. Amongst the different strains of this mobile and fast changing virus, the H5 and H7 strains carry the highest risk to birds. The spread of these strains of virus are inducing high levels of mortality in infected birds and there is a risk of the virus jumping to humans and affecting human health. Governments of producing and importing nations are seeking a powerful and effective vaccine which has the capacity to reduce mortality within a flock to ensure that commercial chickens are healthy and that their protein (eggs/meat) is safe to eat. Speaking at the launch of the product, attended by over 300 representatives of the Egyptian poultry industry and leading figures from the Animal Health Services Food and Agriculture Of the United nations (FAO) and World Organisation for Animal Health (OIE), CEVA CEO Marc Prikazsky said: Avian Influenza threatens the livelihood of millions of poultry producers and deprives communities of an important source of animal proteins. The disease is also zoonotic and therefore directly threatens the human population who live in close proximity too flocks. Today s launch is, I hope, the first step towards eradicating this disease and improving the lives and livelihoods of millions of people world-wide.

4 2. Definition of the vaccine: Vectormune AI is a novel technology which uses a frozen Marek s vaccine (HVT) to express a key protective H5N1 Avian Influenza antigen (the Haemagglutinine or HA protein) for use in chickens. Once injected in the bird, the Marek s HVT vaccine replicates and the HA gene is expressed inducing immunity against the field virus. Vectormune AI prevents clinical signs and mortality, and reduces the shedding of the challenging virus considering both level of re-excretion and percentage of re-excreting birds. Vectormune AI is injected in to day-old chicks by subcutaneous route on the back of the neck: 0.2ml per bird. Prior to use, the vaccine need to be reconstituted with Ceva sterile diluent which is a specific diluents for Marek s vaccines. Vectormune AI is stored in frozen form in a liquid nitrogen dewar. 3. Safety: The Marek s HVT is a naturally apathogenic virus and has been widely and intensively used by poultry producers worldwide for more than 50 years to protect chickens against Marek s disease. No adverse reactions or side effects have ever been reported. The donor virus is the H5N1 type named A/swan/HU/4999/2006). One of its genes, the Haemagglutinine (HA) gene, has been selected for its capacity to induce strong protection against Avian Influenza virus infection. Work began developing the product in Japan in 2002 and the product entered the regulatory approval process in the US in Following four years of trials and registration procedures, all the USDA requirements necessary for the registration of a GMO type vaccine in the United States were met and a USDA license was obtained in April Authorization for the Egyptian market was obtained in May Efficacy: The efficacy of Vectormune AI has been demonstrated through several experiments and field trials conducted by Ceva and independent research institutes. It was demonstrated that Vectormune AI is highly effective in combating the spread of avian Influenza for the reasons below. As a result of the improved efficacy of Vectormune AI Ceva believes that were the vaccine to be applied across Egypt mortality rates amongst broilers and layers could fall from the endemic level of c8% to a normal rate of c2.5% bringing tangible benefits to farmers and populations reliant on poultry for their livelihood or nourishment. 1) The capacity to counteract the Interference with maternal Immunity. Maternal immunity impairs significantly the efficacy of any conventional vaccine against Avian Influenza especially when they

5 are applied at early age. Thanks to the vector technology, Vectormune AI can be successfully injected as early as the first day of age regardless the immune status of the chickens. This is because of the nature of the Marek s HVT virus used as a vector. This by-passes maternally derived antibodies thus ensuring immunity at a significantly early stage in the chick s development. 2) The broad protection. According to our experience Vectormune AI is not affected by the changes in antigenicity of the H5N1 high pathogenic viruses. It has demonstrated the same high level of efficacy against challenge with 8 different clades of H5N1 HPAIV from different geographic origins: Clades in Indonesia, clades in Egypt with A and B variants (Egypt 2007, Egypt 2008), in Bangladesh as well as against the Mexican H5N2 HPAIV for instance. 3) The convenience for Hatchery vaccination, since there is no impact of maternal immunity, vaccination can be done as early as possible in a more reliable way at the hatchery using manual or automatic injection equipment. 4) The capacity to induce a lifelong immunity. The vector is an herpes virus (Marek s HVT) and consequently remains in the vaccinated birds through out their lives. 5) The possibility to induce reliable and long lasting immunity just by giving one shot in the hatchery eliminates the need for farm vaccination and associated major risks of breach of biosecurity and transmission of the disease. 6) The onset of immunity is short. A very high level of protection has been demonstrated in chickens with Maternal Immunity as soon as 2 weeks after injection. 7) Laboratory experiments have also demonstrated efficacy of Vectormune HVT-AIV in ducks and in turkeys. 8) Since Vectormune AI exclusively uses the HA antigen of AI viruses to induce protection a DIVA (Differentiation between Infected and Vaccinated Animals) serological testing procedure can be used for confirmation of proper vaccination and does not interfere with the monitoring of the spreading of the field virus which is the key to eradication of the disease. 5. Additional advantages of Vectormune AI: 1. The onset of immunity is short. A very high level of protection has been demonstrated in chickens with Maternal Immunity as soon as 2 weeks after injection. (ref) 2. Laboratory and field experiments have demonstrated efficacy of Vectormune AI in broiler as well as layer types of chickens 3. Laboratory experiments have also demonstrated efficacy of Vectormune HVT-AIV in ducks and in turkeys. 4. Since Vectormune AI exclusively uses the HA antigen of AI viruses to induce protection a DIVA (Differentiation between Infected and Vaccinated Animals) serological testing procedure can be used for confirmation of proper vaccination.

6 6. Summary of features and benefits VECTORMUNE AI PRESS PACK November 19th, 2012 a. Broad protection: Demonstrated protection against different H5 avian influenza viruses isolates from several geographical origins and clades b. Convenience: Hatchery application at Day One of Vectormune AI is possible regardless the maternal derived antibody status of the chicks. c. Long lasting protection: based on the Marek s virus HVT which remains in the bird for life. d. Safety: The vaccine strain does not spread, shed or revert to virulence The vaccine does not replicate in the respiratory tract The vaccine uses an aqueous adjuvant, safer than an oily one used in classical inactivated vaccines. 7. Bibliography 1. J. De Vrieese, M. Steensels, V. Palya, Y. Gardin, K. Moore Dorsey. D Lambrecht, S. Van Borm and T V den Berg. Passive protection afforded by maternally derived antibodies in chickens and the antibody interference with the protection elicited by avian influenza inactivated vaccines in progeny. Avian Diseases 2010, 54: Jeong-Ki Kim, Ghazi Kayali, David Walker and coll. Puzzling inefficacy of H5N1 influenza vaccines in Egyptian poultry. PNAS June 15, 2010, 17:24, Riks Maas, Sigrid Rosema, Diana van Zoelen, Sandra Venema. Maternal immunity against avian influenza H5N1 in chickens limited protection and interference with vaccine efficacy. Avian Pathology, Feb 2011, 40(1), F. Rauw, V.Palya, S. Van Borm and coll. Further evidence of antigenic drift and protection efficacy afforded by a recombinant HVT H5 vaccine against challenge with two antigenically divergent Egyptian clade 2; 2.1 HPAI H5N1 strains. Vaccine 29 (2011) Marisa Peyre, Hamid Samaha, Yilma Jobre Malonnen and coll. Avian influenza vaccination in Egypt: limitations of the current strategy. Journal of Molecular and genetic Medicine, Dec 2009,vol 3 n 2, S.Marangon, M. Cecchinato and I. Capua. Use of vaccination in Avian influenza control and eradication. Zoonoses and Public Health. 55 (2008) D.E. Swayne, D.L. Suarez. Current developments in avian influenza vaccines, including safety of vaccinated birds as food. EV BIOL. Basel, Karger, 2007, vol 130, R.L. Witter, K. Nazerian, H.G.Purchase, G.H. Burgoyne, Isolation of turkeys of a cell associated herpes virus antigenically related to Marek s disease virus.am.j.vet.res, vol 31, N 3, March 1970, J. De Vriese, Y. Gardin, V. Palya, K. Moore Dorsey, B. Lambrecht, S. Van Borm, T. van den Berg. Efficacy of a rhvt-ai vector vaccine in broilers, with passive immunity against HVT and AIV, against challenge with H5N1 HPAIV challenge Proceedings XVI WVPA Congress, Marrakech, Morocco.

10. De Vriese J., Gardin, Y., Palya, V. and van den Berg, T.

inactivated vaccines in progeny 2009. Proceedings XVI WVPA Congress, Marrakech, Morocco. 11. J.

Efficacy of a rhvt-ai vector vaccine in broilers with passive immunity against HVT and AIV, against

7 10. De Vriese J., Gardin, Y., Palya, V. and van den Berg, T. Passive protection afforded by MDA in chickens and their interference with the protection elicited by AI inactivated vaccines in progeny Proceedings XVI WVPA Congress, Marrakech, Morocco. 11. J. De Vriese, Y. Gardin, V. Palya, K. Moore Dorsey, B. Lambrecht, S. Van Borm, T. van den Berg. Efficacy of a rhvt-ai vector vaccine in broilers with passive immunity against HVT and AIV, against challenge with H5N1 HPAIV Poster. Symposium on Avian Influenza, Athens, Georgia, USA. 8. Product communication Corporate Advert Scientific Information book Corporate Movie

8 9. Contacts Yannick GARDIN DVM, Innovation Strategy in Biology Director Biology Business Unit Paola CRUZ-DOUSDEBES DVM, Corporate Product Manager Poultry Corporate Marketing Ceva Santé Animale is a global veterinary health company focused on the research, development, production and marketing of pharmaceutical products and vaccines for pets, livestock, swine and poultry. It is the 9th largest veterinary company in the world. Visit For other details contact: Martin Mitchell, Group Communications Director, Tel: +33 (0) martin.mitchell@ceva.com

YOU THINK INFLUENZA IS FATAL? THINK AGAIN.

YOU THINK INFLUENZA IS FATAL? THINK AGAIN. HVT vector vaccine for H5 Avian Influenza protection Avian influenza Avian influenza remains a major threat for the global poultry industry. Among the different