FIREWALL. The trivalent flu protection

Transcription

1 FIREWALL The trivalent flu protection

2 Profile Influenza Pathogen: Influenza A virus, Orthomyxoviridae Subtypes are classified depending on the presence of hemagglutinin (HA) and neuraminidase (NA) on the surface of the cell membranes of the virus Frequent viral pathogen of the respiratory tract Clinical course: The disease can affect pigs and piglets at any age Acute form: - Fever, coughing, dyspnea, apathy, anorexia Chronic form: - Virus circulates within the herd - Slow spread of infection amongst the animals - Unspecific clinical signs such as lethargy and reproductive disorders (return to oestrus, abortions) Diagnosis: Virus detection (nasal swabs, lung tissue samples) Antibody detection Therapy: None Focus on prophylaxis Prophylaxis: Regular vaccination intervals with RESPIPORC FLU You can find background information and the latest research on influenza at

3 WALL Don t treat. Prevent! Lung of a pig infected with the Swine influenza subtypes H1N1, H1N2, H3N2 Healthy lung of a pig immunized with RESPIPORC FLU RESPIPORC FLU : influenza protection using the triple firewall

4 FIRE Influenza?! Don t hesitate Seroprevalence in selected European countries Intensity High Medium ) ) ) Low ) Prevalence (in %) ) H1N1 H1N2 H3N ) ) Current monitoring of the influenza situation among European swine populations shows that it s a problem that transcends borders and is likely to itensify due to the European-wide transport and trading of animals. 1) Mastin, A. et al. (2011). Prevalence and risk factors of swine influenza infection in the English pig population. PLoS Curr. 3 2) Loeffen, W. L. et al. (2009). Population dynamics of swine influenza virus in farrow-to-finish and specialised finishing herds in the Netherlands. Vet Microbiol 137 3) Markowska-Daniel I. et al (2012). Serological evidence of co-circulation of different subtypes of swine Influenza virus in Polish pig herds. Bull Vet Inst Pulawy 56 4) Dürrwald, R. and Schlegel, M. (personal communication) 5) van Reeth et al (2008). Seroprevalence of H1N1, H3N2 and H1N2 influenza viruses in pigs in seven European countries in Influenza Other Respir Viruses 2 6) Hervé et al. (2011), RESAVIP (2014) 7) Simon-Grifé, M. et al. (2011). Seroprevalence and risk factors of swine influenza in Spain. Vet Microbiol 149

5 WALL vaccinate! REDUCES THE VIRUS LOAD IN THE LUNGS 1400 RESPIPORC FLU significantly reduces clinical signs and boosts herd health. d1=day 1 after infection d1 d3=day 3 after infection Figure 1 shows mean viral lung load (EID50/10 mg) in H1N1, H1N2, and H3N2 challenged vaccinated and unvaccinated pigs (N=84). For vaccinated pigs, the viral lung load was significantly reduced for all subtypes. 8) Virus load EID50/10mg d1 d3 RESPIPORC FLU d1 d3 H1N1 d3 H1N2 d1 d3 H3N2 Vaccinated control group Non-vaccinated groups RESPIPORC FLU vaccinated vs. non-vaccinated PREVENTION OF INFECTION- RELATED FEVER Figure 2 displays body temperature after aerosol challenge with the three subtypes H1N1, H1N2, and H3N2 in vaccinated and unvaccinated pigs (N=84). The body temperature of vaccinated pigs was significantly lower compared to the unvaccinated control group. 9) Body temperature vaccinated animals H1N1 H1N2 H3N Hours Development of body temperature during course of trial REDUCES RETURN TO OESTRUS RATE Figure 3 shows percentage of animals returning to oestrus before and after vaccination with RESPIPORC FLU. The return to oestrus was reduced significantly for vaccinated sows. 10) The study was conducted in accordance with the guidelines set forth in Par 11 (5) of the German Animal Health Law. In this study, 113 pig holdings with in total sows were included. 11) Return to oestrus rate in % % before vaccination 9.9 % after vaccination 8) Mann-Whitney-U Test, p<0,005 9) Mann-Whitney-U Test, p<0,005 Significant results were obtained 24 hours post infectionem (p.i.) for infections with H1N2 and H3N2, respectively, and 28 hours p.i. for infection with H1N1. 10) T-Test, p<0,05 11) Data on file

6 FIRE IDT Biologika GmbH: 90 years of expertise in vaccines 1921 The beginnings of IDT Biologika Founding of the Bacteriological Institute of Anhalt, Dessau, Germany. Focus: veterinary and bacteriological analysis to fight tuberculosis Focus on research and manufacturing Vaccines and sera for livestock, e.g. live vaccine against duck plague and goose influenza, vaccines against virus infections in fur-bearing animals, canines and felines. Development of a rabies vaccine which significantly contributes to eradication of rabies in Germany and neighbouring countries After World War II Manufacturing of vaccines and diagnostics for the prevention of epidemics in the newly named Research Institute for Vaccines. These include a swine erysipelas serum, tuberculin and hormone products Privatisation of company Integration into Klocke Group Expansion of research and manufacture Company is renamed to IDT Biologika RESPIPORC FLU. Marketing authorisation for Europe (granted under the centralised procedure) 2012 Internationalization of animal health business Following the company s successful establishment of its animal vaccines in Germany, plans for the internationalization of the animal health business are launched. Focus markets include neighboring Western and Eastern European countries as well as USA, China, and Southeast Asia. 2013/14 Expertise and expansion for animal health Growing product portfolio. Approval gained for the world s first vaccine against edema disease in swine; acquisition of Riemser Pharma GmbH s research section for animal health.

7 WALL The development of RESPIPORC FLU 90s Subtype H1N2 of the Swine influenza virus, type A, first appears and begins to spread among the European pig population Lack of cross-protection by bivalent vaccines How the trivalent vaccine was developed Isolation of one current strain of Swine influenza subtypes H1N1, H1N2 and H3N2 each Sequencing and phylogenetic analysis of these strains Cultivation using cell cultures and de-activation using differentiated methods Use of a new and modern adjuvant: carbomer safe and well-tolerated Laboratory and clinical trials with RESPIPORC FLU Verification of effective protection against heterologous field strains of H1N1, H1N2 and H3N2 as well as against a new field strain of H1N2 (Cloppenburg/IDT/4777/05) that contains N2 from H3N2. Significantly reduces viral load in the lungs Triple protection against influenza Development of a new vaccine Milestone: January 14, 2010 granting of a community marketing authorisation for RESPIPORC FLU (European Medicines Agency [EMA]) Virus cultivation in cell cultures Safe and well-tolerated adjuvant 3 in 1: three different subtypes combined in one vaccine 20 years of experience in the field of influenza reserach by IDT Biologika IDT: expertise in influenza The scientists behind the development of RESPIPORC FLU, are members of national and international research groups (FluResearchNet, ESNIP3).* Thanks to their commitment, IDT Biologika GmbH provides free influenza virus tests of nasal swabs, BALF and lung tissue. These and similar international collaborations ensure the quick ability to act to epidemiological changes among the European pig population. * R Dürrwald and M Schlegel (2014) Milestone: April 10, 2014 EMA approval for the latest production technology for efficient virus cultivation

8 RESPIPORC FLU vaccination schedule 1st shot 2nd shot booster shot Weeks AT LEAST 4 MONTHS OF PROTECTION against subtypes 20 H1N1, H1N2, and H3N2 Immunity developed For sows: Vaccination and booster can be conducted at any gestation period and also through lactation. Vaccination of the sow two weeks before farrowing will protect the piglets until 33rd day of life. For piglets: Vaccination possible from the 56th day of life. We support animals and people with bold, sustainable and novel animal health concepts founded on more than 90 years of experience. RESPIPORC FLU3 Suspension for injection for pigs. Qualitative and Quantitative Composition: Each dose of 2 ml contains: Active substances: Strains of inactivated Influenza A virus/swine/bakum/ IDT1769/2003 (H3N2) log 2 GMNU 1 Haselünne/IDT2617/2003 (H1N1) log 2 GMNU 1 Bakum/1832/2000 (H1N2) log 2 GMNU 1 1 GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine Adjuvant: Carbomer 971 P NF 2.0 mg Excipient: Thiomersal 0.21 mg Clinical particulars: Target species: Pigs. Indication for use: Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection. Onset of immunity: 7 days after primary vaccination. Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above. Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth. Contraindications: None. Adverse reactions: A transient slight swelling may occur after vaccination at the site of injection in a small number of pigs, regressing within 2 days. On occasions, a slight transient rectal temperature increase might occur after vaccination. Amounts to be administered and administration route: For intramuscular use. Piglets: Primary vaccination: 2 injections of one dose (2 ml) - From the age of 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 6 months or - Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months. Gilts and sows: Primary vaccination: see above. A booster is possible at each stage of pregnancy and lactation. When vaccination is performed 14 days prior to farrowing with one dose (2 ml), it provides mater nally-derived immunity to the piglets which protects them from clinical signs of influenza at least until day 33 after birth. Maternally-derived immunity in the piglets interacts with antibody induction. Gener ally, maternally-derived antibodies induced by vaccination last for approx. 5-8 weeks after birth. In particular cases of multiple contacts of the sows with antigens (field infections + vaccination) the anti bodies transmitted to the piglets may last until week 12 of life. In the latter case piglets should be vaccinated after the age of 96 days. Withdrawal period: Zero days. Marketing authorisation holder: IDT Biologika GmbH, Am Pharmapark, Dessau-Rosslau, Germany. IDT Biologika GmbH Am Pharmapark D Dessau-Roßlau Germany Tel