TRUSTWORTHY POULTRY CEVAC CORYMUNE RANGE. Unique combination vaccines to protect against Coryza and Salmonella. Supported by CEVAC CORYMUNE 4K

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1 CEVAC CORYMUNE RANGE Unique combination vaccines to protect against Coryza and Salmonella TRUSTWORTHY POULTRY CEVAC CORYMUNE RANGE Supported by CEVAC CORYMUNE 4K Unique broad combination vaccine against Infectious Coryza and Salmonella Mild adjuvant to optimize bodyweight development Suitable for early vaccination CEVAC CORYMUNE 7K Unique broad combination vaccine for protection against infectious Coryza, Salmonella, ND, IB and EDS Simplifi es the vaccination schedule and includes salmonella protection Broad Salmonella and infectious Coryza protection Booster adjuvant for long lasting immunity CEVAC CORYMUNE RANGE - 1

2 CEVAC CORYMUNE RANGE Unique combination vaccines to protect against Coryza, Salmonella, ND, IB and EDS The increase of more concentrated flocks due to the rapid growth of global poultry production has led to increased exposure and pathogen spread. Layer and breeder farms battle pathogens that commonly include Infectious Coryza (IC), Newcastle disease (ND), Infectious Bronchitis (IB), and Egg drop syndrome (EDS). Producers must control Salmonella bacteria before it affects bird health (Salmonella Gallinarum) and spreads food borne diseases in humans. In the majority of people infected by Salmonella Enteridis, contamination can be traced back to eggs or poultry meat, leading to an immediate loss of trust in, and economic impact on, both the poultry producers and the industry as a whole. While vaccination has proven to be a very effective tool to control these diseases, the stress incurred with multiple vaccinations can cause growth delay, loss in fl ock uniformity, and eventually lower egg production. In response, Ceva has developed a unique broad combination range of vaccines to control these major diseases while also controlling the risk of poultry, egg and meat Salmonella contamination by Salmonella Enteritidis and Salmonella Gallinarum. 2- CEVAC CORYMUNE RANGE

3 UNIQUE COMBINATION VACCINES FOR PROTECTION AGAINST THE MAJOR POULTRY DISEASES CEVAC CORYMUNE 4K Broad Infectious Coryza protection Serovars A, B and C Salmonella Entertidis protection Mild adjuvant suitable for early vaccination No extra vaccinations needed for Salmonella protection CEVAC CORYMUNE 7K Broad Infectious Coryza protection Serovars A, B and C Salmonella Entertidis protection Cross protection against Salmonella Gallinarum Booster adjuvant suitable for prolonged immunity Strong, long-lasting immunity for IB, ND and EDS* No extra vaccinations needed for Salmonella protection CEVA EGGS PROGRAM: SAFER & SIMPLER VACCINATION Ceva s EGGS Program is a comprehensive package of services and Standard Operating Procedures (SOPs) designed to optimize the preparation, application and monitoring of poultry vaccines. Unique equipment like the Desvac IMVAC has been developed to achieve precise injection of vaccines into the breast muscle of each bird while ensuring safety for both the bird and operator. Supported by *Following live priming for IB and ND CEVAC CORYMUNE RANGE - 3

4 SALMONELLA MAJOR CAUSE OF FOOD BORNE DISEASES. Human Salmonella is a major cause of food borne illness around the world. In many cases, human infection traces back to poultry meat or eggs, with Salmonella Enteritidis the main serovar found. Salmonella Enteritidis can infect the ovaries of a bird and the egg before the shell is formed. Birds positive for Salmonella spread the bacteria to other birds via manure and dust. In the past, the increase of human Salmonellosis linked to egg contamination in the UK (1988) and more recently in the US (1) had a huge negative impact on the image of the poultry industry and producers. Controlling Salmonella is not easy; vaccination is a key part of a well-designed control plan that must be in place. The use of Salmonella vaccines have proven to be very effi cacious in reducing the risk of Salmonella spreading between fl ocks (horizontal) and, in case of inactivated vaccines, in reducing the risk from breeders to progeny (vertical). This effectiveness is the reason that Salmonella vaccines are used successfully in the European Union, US and in other parts of the world. REDUCTION OF SHEDDING OF SALMONELLA ENTERITIDIS 1 In this trial, Salmonella-negative commercial pullets were divided in two groups. The vaccinated group received Cevac Corymune 4K at 11 weeks and Cevac Corymune 7K at 15 weeks. The control group did not receive any Salmonella vaccine. At week 39, a massive oral challenge (1 1 CFU/bird, 1 ml) was given. External shedding of the challenge strain was measured at 4 and 1 days post challenge. Vaccinated group Control group Caecal content Non quantifi able days post challenge Faeces Non quantifi able days post challenge Faeces Non quantifi able 1 6 Vaccination with Cevac Corymune 4K & Cevac Corymune 7K induced a 1, to 1 million times reduction factor in the amount of Salmonella Enteritidis spread, reducing the risk of spreading of Salmonella in the environment and between fl ocks. 4- CEVAC CORYMUNE RANGE

5 CROSS PROTECTION AGAINST SALMONELLA GALLINARUM 2 In an independent laboratory, commercial brown layer pullets were vaccinated with Cevac Corymune 4K at 5 weeks and revaccinated with Cevac Corymune 7K at 9 weeks of age. Another group served as a control group. At 12 weeks of age the birds were challenged with a massive amount of Salmonella Gallinarum by oral route. The mortality of the birds was monitored during 4 weeks post vaccination. The results are listed below. No of birds a Cumulative mortality after SG challenge 31a 31a 31a 12b 12b 12b 5 2b *Letter with different subscript indicates signifi cant difference Corymune group Non vaccinated control Vaccination with Cevac Corymune 4K & Cevac Corymune 7K signifi cantly reduced mortality after a strong Salmonella Gallinarum challenge, proving Cevac s Corymune strong cross protection against Salmonella Gallinarum CEVAC CORYMUNE RANGE - 5

6 INFECTIOUS CORYZA Infectious Coryza is a widely recognized and commonly found respiratory disease caused by Avibacterium paragallinarum. The disease is global, but major cases found in the southern hemisphere cause economic losses due to increased mortality, severe decline of egg production (to over 4%) or decline in bodyweight development. Symptoms include nasal discharge, swollen sinuses, watery eyes, facial oedema, diffi culty breathing and drop in egg production. According to the Page classifi cation, 3 serovars of Avibacterium paragalllinarum are potentially involved. Serovar A, B and C, all are described as causing clinical signs. Vaccination combined with good biosecurity has proven to be very effi cacious in controlling Infectious Coryza. Cevac Corymune 4K & Cevac Corymune 7K contain the serovars, A, B and C of Avibacterium paragallinarum, offering a broad infectious Coryza protection. 6- CEVAC CORYMUNE RANGE

7 CEVAC CORYMUNE 4K & CEVAC CORYMUNE 7K TRIAL RESULTS 3 In a trial carried out using commercial brown layer pullets, the birds were divided into a vaccinated and a control group. The vaccinated group received Cevac Corymune 4K at 11 weeks followed by a booster vaccination with Cevac Corymune 7K at 15 weeks. Both groups were challenged at weeks, 35 weeks and 55 weeks with high doses of virulent Avibacterium paragallinarum, serovar A, B and C. The clinical signs of Coryza were then monitored for 1 week post challenge. Protection rate (%) Infectious Coryza challenge ( weeks) in commercial pullets vaccinated using Cevac Corymune 4 K and Cevac Corymune 7 K A B C Challenge serotype Controls vaccinated Protection rate (%) Infectious Coryza challenge (35 weeks) in commercial pullets vaccinated using Cevac Corymune 4 K and Cevac Corymune 7 K A B C Challenge serotype Controls vaccinated Infectious Coryza challenge (55 weeks) in commercial pullets vaccinated using Cevac Corymune 4 K and Cevac Corymune 7 K Protection rate (%) A B C Challenge serotype Controls vaccinated Cevac Corymune 4K & Cevac Corymune 7K provides good clinical protection at, 35 and 55 weeks of age against serovar A, B and C after a severe Infectious Coryza challenge. CEVAC CORYMUNE RANGE - 7

8 NEWCASTLE DISEASE VIRUS (NDV) Newcastle disease, due to avian paramyxovirus, is one of the most devastating diseases in poultry, and in many countries remains a major risk for the poultry industry. Control of NDV is ensured by biosecurity and a well-designed vaccination program. Clinical and economic losses are due to respiratory problems, lameness, declines in egg production and high mortality. According to several regulations, outbreaks of Newcastle Disease virus immediately effects export business. NEWCASTLE DISEASE PROTECTION TION OF CEVAC CORYMUNE 7K 4 Commerical brown pullets were split in two groups and used to check the protection of Cevac Corymune 7K and the commercial reference inactivated vaccine (ND, IB EDS) against a velogenic viscerotropic NDV (Herts) strain challenge at 4 weeks. Both groups received three live vaccines during the rearing period. Cevac Corymune 7K or the reference vaccine were applied at 15 weeks by intramuscular route. There were two non-vaccinated control groups, one commercial group and one group with SPF birds. The results of the challenge are displayed below. Cevac Corymune 7 K: efficacy of its booster effect against a ND challenge at 4 weeks of age 1 9 Protection rate (%) L + Corymune L + ND IB EDS K Controls (commercial) Controls (SPF) Cevac Corymune 7K protects against a strong NDV challenge and effi cacy was shown to at least 51 weeks of age*. This protection is similar to a basic ND, IB EDS inactivated vaccine. *51 weeks was shown in other trial, results available on request. 8- CEVAC CORYMUNE RANGE

9 INFECTIOUS BRONCHITIS VIRUS (IBV) Infectious Bronchitis virus (IBV), due to a Coronavirus, is a disease with major economic impact. IBV is an acute, highly contagious viral respiratory disease of chickens characterized by tracheal rales, coughing, and sneezing. The disease can also affect the kidneys or the ovary system. In egg layers and breeders IBV causes a severe decline in egg production, poor egg shell quality, birds not developing a proper ovary system (false layers), wet litter and a variety of other clinical signs. The severity of egg production decline depends on the virulence of the virus and other non-specific factors. Egg production may improve after 2-3 weeks but reaches only sub-optimal levels and can cause soft-shelled eggs or misshapen eggs. EFFICACY OF CEVAC CORYMUNE 7K AGAINST AN IB CHALLENGE In this trial commercial brown layer pullets were used; the two vaccinated groups received 3 live IB vaccines (Mass type) and Cevac Corymune 7K or a basic ND, IB EDS combination vaccine as inactivated booster vaccine. The control group was not vaccinated for IB. At week 29 all groups received an IB challenge (M41 strain) by intra-tracheal route. All groups were observed for 1 weeks post-challenge on production effects and clinical signs; the results are displayed below. Average weekly egg production (%) Cevac Corymune 7 K efficacy against IB challenge at 29 weeks of age IB challenge * Age (weeks) L+ Corymune, ch L+ NDIBEDS, ch no IB vacc, ch Cevac Corymune 7K provided signifi cant protection against production drops caused by IB challenge and protection was similar to reference vaccine consisting of IB, ND & EDS at 29 weeks of age. CEVAC CORYMUNE RANGE - 9

10 EGG DROP SYNDROME (EDS) EDS, which is caused by an adenovirus, is an important disease affecting laying hens. Egg drop syndrome strongly affects egg production and results in loss of color for brown eggs, quickly followed by production of thin-shell eggs, soft-shell eggs or shell-less eggs. The drop in egg production can be very rapid and extend over weeks. Outbreaks usually last 4-1 weeks and egg production can decline up to 4%. Birds of all ages in production of all ages are sus- ceptible, making long-lasting immunity important. EFFICACY OF CEVAC CORYMUNE AGAINST EDS 6 In a trial using commercial layer pullets, birds were split up in three groups. One group was vaccinated with Cevac Corymune 4K at week 12& Cevac Corymune 7K at 15 weeks; the other two groups served as challenged non vaccinated controls and unchallenged vaccinated control groups. At week 4 a heterlogous challenge (Mc Ferran strain) was applied to the birds. 4 weeks post-challenge the production was observed for 4 weeks. Production data is shown below. Average weekly egg production (%) Cevac Corymune 7 K efficacy against EDS challenge at 4 weeks of age EDS challenge Age (weeks) Cevac C4K + C7K Challenged controls Unchallenged CK + C7K Cevac Corymune 7 provided strong protection against Egg drop syndrome until at least 41 weeks of age. C 1- CEVAC CORYMUNE RANGE

11 SAFETY PROFILE OF CEVAC CORYMUNE 4K AND CEVAC CORYMUNE 7K The best way to ensure proper long-lasting protection resulting in good egg production is to use an inactivated vaccine containing mineral oil as adjuvant, as Cevac Corymune 7K is designed. Mineral oil used as adjuvant can cause local tolerance issues when injected to the bird. Great care was taken to ensure perfect tolerance of Cevac Corymune 4K and Cevac Corymune 7K has an Aluminium hydroxide as adjuvant for use in younger birds. FIELD TRIAL In a fi eld trial two fl ocks were compared for bodyweight development after vaccination with inactivated vaccines. The Cevac Corymune vaccinated fl ock was vaccinated at week 12 with Cevac Corymune 4K followed by Cevac Corymune 7K at 16 weeks. The control fl ock received a standard Coryza vaccine at week 12 followed by a Coryza and a ND IB EDS inactivated vaccine at week 16. All vaccines were applied through intra muscular route. The bodyweight was measured weekly from week 11 to week 24 and is shown below. 19 Bodyweight development (g) after vaccination with Cevac Corymune Bodyweight in gram st vaccination 2nd vaccination 9 11 wks 12 wks 13 wks 14 wks 15 wks 16 wks 17 wks 18 wks 19 wks wks 21 wks 22 wks 23 wks 24 wks Average Weight (control group) Average Weight (Cevac Corymune group) Cevac Corymune 4K & Cevac Corymune 7K have an excellent safety profi le, the vaccines did not influence bodyweight development comparined to pullets receiving a placebo or receiving a monovalent Coryza or Coryza combination vaccine. CEVAC CORYMUNE RANGE - 11

12 RECOMMENDED VACCINATION SCHEDULE 1st application (8-12 weeks of age)* Cevac Corymune 4K Booster application between 2 to 4 weeks before onset of production 14 to 18 weeks of age* Cevac Corymune 7K Administration and dosage Intramuscular route (breast muscles) or subcutaneously route (under the skin of the neck)..5 ml per bird *Flexible regarding the epidemiological fi eld situation CEVAC CORYMUNE 4K AND CEVAC CORYMUNE 7K Convenience by combining protection against Salmonella, Infectious Coryza, ND, IB and EDS to reduce the number of bird handlings Broad protection against Salmonella Enteritidis and Salmonella Gallinarum Strong, long-lasting immunity against ND, IB and EDS Clinical protection against the 3 serovars - A, B and C - of Infectious Coryza No extra vaccinations needed to protect against Salmonella, which protects both your poultry AND your company s reputation 1: R62, report REG : Penha Filho R.A.C. et al., Avian Pathology 9, 38(5), : R62, report REG : Reg. fi le C66.4..E.1 Oct. 5: R62, report REG : Registration fi le C66.4..E.1 Oct. 6 COMPOSITION: CEVAC CORYMUNE 4K contains an inactivated combination of Avibacterium paragallinarum, serovars A, B and C and Salmonella Enteritidis strain, homogenized with aluminum hydroxyde and thiomersal as a preservative.-indication: CEVAC CORYMUNE 4K is recommended for the active immunization of breeder and laying-type chickens fl ocks against infectious coryza caused by Avibacterium paragallinarum and Salmonella Enteritidis infection. The program should be completed 4 to 6 weeks later, using an oil-adjuvant inactivated vaccine against the same diseases. -ADMINISTRATION and DOSAGE: CEVAC CORYMUNE 4K should be administered to breeder and laying-type pullets, between 8 to 12 weeks of age. The vaccine must be injected subcutaneously (under the skin of the neck) or by intramuscular route (breast or thigh muscles) at the dose of,5ml per bird.- GENERAL PRECAUTIONS: Satisfactory protection can be achieved in well-developed, healthy birds only. Use sterile injection equipment. Keep the vaccine at room temperature (15 to 25 C) for 3 to 4 hours before use. Shake the bottle well before and during use. Check the accuracy of the syringe to ensure that the correct dose is delivered. Once a bottle has been opened, its content must be used up within 24 hours; otherwise, it should be discarded.-warning: Do not mix the vaccine with others vaccines or pharmaceutical products. If the vaccine is accidentally injected to the operator, urgent medical attention is required.-storage: Between 2 C and 8 C, protected from light. Do not freeze. COMPOSITION: CEVAC CORYMUNE 7K contains an inactivated combination of Avibacterium paragallinarum, serovars A, B and C, Salmonella Enteritidis strain, La Sota strain of Newcastle disease virus, Massachussetts strain of infectious bronchitis virus and B8/78 strain of the EDS virus, homogenized with oil adjuvant and thiomersal as a preservative.- INDICATION: CEVAC CORYMUNE 7K is recommended for the active immunization of breeder and laying-type chickens flocks against infectious coryza caused by Avibacterium paragallinarum, Salmonella Enteritidis infection, Newcastle disease, infectious bronchitis and egg drop syndrom 76.The birds should be previously immunized with live vaccines against. Newcastle diseases and infectious bronchitis and 4 to 6 weeks before, with an inactivated vaccine against infectious coryza and Salmonella Enteritidis infection.-administration and DOSAGE: CEVAC CORYMUNE 7K should be administered to breeder and laying-type pullets, 2 to 4 weeks before the onset of lay, between 14 to 18 weeks of age. The vaccine must be injected subcutaneously (under the skin of the neck) or by intramuscular route (breast muscles) at the dose of,5ml per bird.-general PRECAUTIONS: Satisfactory protection can be achieved in well-developed, healthy birds only. Use sterile injection equipment. Keep the vaccine at room temperature (15 to 25C) for 3 to 4 hours before use. Shake the bottle well before and during use. Check the accuracy of the syringe to ensure that the correct dose is delivered. Once a bottle has been opened, its content must be used up within 24 hours; otherwise, it should be discarded.-warning: Do not mix the vaccine with others vaccines or pharmaceutical products. If the vaccine is accidentally injected to the operator, urgent medical attention is required.-storage: Between 2 C and 8 C, protected from light. Do not freeze. Ceva Santé Animale S.A. / / contact@ceva.com