GVP ASKAN

PASSPORT Guidance for Foot-and-Mouth Disease Vaccination

Life forward

Your partner offers premium-quality & efficient Foot-and-Mouth Disease vaccines using Boehringer Ingelheim formulated product

Inactivated and purified vaccine AFTOVAXPUR

Adjuvant: aluminium hydroxide & saponin

Route: subcutaneous

Duration Of Immunity (DOI): 6 months Shelf-life: 24 months

Your partner’s Foot-and-Mouth Disease vaccines: • Present a high level of protection and a good safety profile. • Are formulated from a broad spectrum strain mix permanently updated to match local & regional epidemiology. • Benefit from Boehringer Ingelheim’s portfolio of vaccine

strains, the largest in the world. • Are certified by local authorities.

Good Vaccination Practice engages all stakeholders to maximize animals protection Foot-and-Mouth Disease (FMD) is highly contagious. Good vaccines and proper vaccination practices are essential to achieve the right level of protection in the herd. Applying Good Vaccination Practice means: • Getting the best protection for animals from Boehringer Ingelheim highly potent vaccines. • Reducing the risk of virus spread in case of an FMD outbreak. • Minimizing adverse reactions.

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Observing the herd after vaccination

Recording vaccination data

Cleaning your equipment

Respecting vaccination protocol, injection sites and route of administration

Staff training Selecting the right vaccine

Respecting the cold chain

Getting ready to vaccinate

Assembling appropriate materials

Preparing successful vaccination

Property of Boehringer Ingelheim Animal Health France

Looking after your herd

Vaccination can only be fully efficient if the whole herd is vaccinated so ALL healthy animals must be vaccinated.

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In order to generate good herd immunity, to respect animal welfare and to avoid incidents: • If possible, maintain separate stables to isolate and observe any new animals purchased (quarantine) and vaccinate before moving them to the herd. • Restrain animals to be vaccinated calmly, using headlocks if available. • Handle animals firmly to avoid sudden movement and to ensure that the vaccine is correctly injected. • In hot climates, vaccinate animals when it is cool (night & early morning); this can reduce stress and post-vaccination reactions. • Clearly identify vaccinated animals to be able to monitor vaccination status.

Do not vaccinate sick animals. Pregnant animals can be vaccinated, provided they are handled gently.

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Before vaccination

Staff training Selecting the right vaccine

Respecting the cold chain

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Before vaccination

Staff training Selecting the right vaccine

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Selecting the right vaccine All Boehringer Ingelheim FMD vaccines are authorized by National animal health authorities. • Always purchase the required vaccine from a reliable veterinary source and avoid buying more than necessary for the operation. • Always carefully read the label on the vaccine bottle to make sure that the proper vaccine is selected. • Always check the color, general appearance, consistency (homogeneous without precipitates), batch number and expiry date. Staff training All staff must be fully trained and educated in Good Vaccination Practice before administering vaccine.

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Before vaccination

Respecting the cold chain

Always respect biosecurity measures before entering your farm (see p. 24-31 for details) Farm entry

Transport

from the site of purchase to the farm: • Protect vaccines from direct sunlight at all times. • Store vaccines in a cool box between +2°C and +8°C and avoid contact between vaccine bottles and ice packs.

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Avoid storing the vaccine in front of the cooling system

Avoid storing the vaccine in the door of the refrigerator

Avoid storing the vaccine against the inside and back walls

Farm storage

Always store vaccines at temperatures between +2°C and +8°C. Regularly monitor the refrigerator's temperature. Do not freeze vaccines; freezing can make vaccines ineffective. If you suspect the cold chain has not been maintained, refer to your Veterinarian or to your commercial representative. FIRST IN, FIRST OUT. Rotate your stock: place new stock behind old stock. Always record level of vaccine stocks.

+3°C

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Vaccination day

Getting ready to vaccinate

Assembling appropriate materials

Preparing successful vaccination

Respecting vaccination protocol, injection sites and route of administration

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Vaccination day

Getting ready to vaccinate

Select the vaccine as recommended by your Veterinarian.

Always re-check expiry date before use.

Only take out the number of vaccine bottles that will be used within an hour.

Use a clean cool box to transport vaccine from refrigerator to animals, maintaining a temperature between +2°C and +8°C. Avoid contact with ice packs.

Only remove one bottle of vaccine at a time when vaccinating.

Do not warm the vaccine before use.

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Vaccination day

Assembling appropriate materials

1 air-bleed needle

1 vaccine-uptake needle

Do not use the vaccine-uptake needle to inject animals.

Materials must be clean, sterile and appropriate!

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Needles • Use sterile needle.

Syringes / guns • Use sterile syringes/guns and only for the vaccine being administered. • Adapt the size of syringe or gun to the volume of vaccine to inject.

• Adapt needle size to size of animal (see chart p. 17 & 19). • Protect needles and vaccine from dust particles that can cause local reactions (abscesses).

The best practice is to change the needle between each animal. If not possible, do not vaccinate too many animals with the same needle (to keep the needle sharp and to avoid transmission of disease). And when changing the needle, be sure it is firmly attached to the syringe.

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Vaccination day

Preparing successful vaccination

Always shake AFTOVAXPUR vaccine vigorously.

Always shake AFTOPOR vaccine gently (double-oil emulsion) to ensure homogeneity and to avoid air bubbles.

Always clean and then disinfect the rubber cap.

Insert the needle without injecting air and withdraw vaccine from the bottle under cleanest possible conditions. Use another needle to vaccinate the animals.

Push the piston gently to remove any trapped air.

Remove and clean any dirt from site of injection.

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Make sure the correct dose is adminis- tered and if in doubt always revaccinate.

Avoid combining AFTOVAXPUR or AFTOPOR with other vaccines.

Dispose of any unused vaccine left in the syringe and avoid reinjecting it into the bottle. Avoid vaccination in the rain as water can wash dust and debris into the needle hole. Do not expose vaccine bottles to direct sunlight during vaccination. Keep bottles in a cool box.

Open today, use today.

Put all unopened vaccine bottles back into the refrigerator.

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Vaccination day - swine

Respecting vaccination protocol

Piglets

Primary course of vaccination*

1 month

*and for adults imported or previously vaccinated with other vaccine

8 - 12 weeks

weeks later 4

Revaccinate 4 months every

1 st injection

2 nd injection

Sows

1 month

1 month before farrowing

I nsemination / mating

Farrowing

Vaccinating too early and with only one shot can have an impact on the proper development of immunity.

Before the first vaccination, it's recommended to check the level of Maternally Derived Antibodies (MDA) at a serology laboratory, as they could interfere with vaccine uptake. If so, it is advisable to postpone the vaccination schedule between 1 and 4 weeks. In case of any queries, please contact your Veterinarian who could advise the best vaccination protocol linked to the last Post-Vaccination Monitoring (PVM) carried out in the country/region according to the FAO/WOAH Guidelines.

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Injection sites and route of administration AFTOPOR - Intramuscular

Piglets Injection site: neck or ham

Needle size * : 19G x ⁵⁄₈ ” (or 19G x 1” according to the age of the animals)

Injection site: neck Needle size * : 17G x 1” to 18G x 1 ½ ” Sows & boars

The appropriate site is where the vaccine will be effective with the least possible stress and pain to the animal.

Intramuscular route

Skin Subcutaneous tissue Muscle

Insert the needle at ± 90° angle to the skin surface, from up to down, to avoid liquid to exit backwards.

Adult: 18G x 1 ½ ’’

Needle size*

Young: 19G x 1’’

*  - Diameter: The higher the G value, the smaller the diameter - Length: 1” = 1 inch 26 mm

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Vaccination day - ruminant

Respecting vaccination protocol

For calves, lambs & kids

Primary course of vaccination*

1 month

12 weeks Starting at

2 nd injection weeks later 4

*and for adults imported or previously vaccinated with other vaccine

1 st injection

For heifers, cows, sheep & goats

Revaccinate

months 6

every

Vaccinating too early and with only one shot can have an impact on the proper development of immunity.

Before the first vaccination, it's recommended to check the level of Maternally Derived Antibodies (MDA) at a serology laboratory, as they could interfere with vaccine uptake. If so, it is advisable to postpone the vaccination schedule between 1 and 4 weeks. In case of any queries, please contact your Veterinarian who could advise the best vaccination protocol linked to the last Post-Vaccination Monitoring (PVM) carried out in the country/region according to the FAO/OIE PVM Guidelines.

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Injection sites and route of administration

AFTOVAXPUR - Subcutaneous

Nuchal ligament Spine Jugular furrow

Shoulder

Subcutaneous site

Intramuscular site

AVOID

Subcutaneous route

Skin Subcutaneous tissue Muscle

Insert the needle in a skin fold of the neck, from up to down, to avoid liquid to exit backwards.

Adult: 17G x ⁵⁄₈ ’’

⁄₈ ’’

Needle size*

Young: 19G x

*  - Diameter: The higher the G value, the smaller the diameter - Length: 1” = 1 inch 26 mm

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After vaccination

Cleaning your equipment

Recording vaccination data

Observing the herd after vaccination

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After vaccination

Cleaning your equipment

1

After use, clean and then sterilise guns and syringes thoroughly by boiling them for 30 minutes Store in a clean protective container between two rounds of vaccination Sterilise all equipment in boiling water for 30 minutes the day before the next vaccination • Do not use chemical sterilisation methods, as the residues could damage the vaccine.

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3

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Recording vaccination data

During and/or after vaccination, fill in the vaccination record file with the following data:

IDENTITY OF VACCINATOR

DATE OF VACCINATION

TYPE OF VACCINE

BATCH NUMBER

QUANTITY USED

VOLUME / DOSE / ANIMAL

IDENTITY OF ANIMALS VACCINATED

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Observing the herd after vaccination

After vaccination, you should always walk around your herd to observe and record any post-vaccination reactions. The following clinical signs may occasionally be noted: • Swelling at vaccination site in some animals. This may reduce over a period of 4 weeks post-vaccination. • Slight increase of body temperature for around 4 days post-vaccination. Other post-vaccination reactions (rapid breathing, anaphylactic shock, prostration, puffy eyes…) are rare and will occur soon after injection.

Always present affected animals to the Veterinarian for proper diagnosis, treatment and report through the Manufacturers’ pharmacovigilance procedure. 23

Making Biosecurity a reflex!

FARM ENTRY: - Have only one entrance, if possible. - Strictly control access. - Use a wheelbath if possible or make available proper equipment (bucket of disinfectant, brush, water and hose).

BEFORE ENTRY Farm management, workers and visitors must: - Park cars away from animal buildings when possible.

- If not possible, use a disinfectant wheelbath or clean and disinfect manually tyres and wheel arches.

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Remember, good Biosecurity can protect the farm from FMD and from many other diseases too!

Implement pest control measures to trap and eliminate insects and rodents before they can enter buildings.

Always use a disinfectant footbath before entering AND exiting your barns.

Ensure your farm boundaries are secured with all fences properly maintained.

Do not let any external farm machinery or equipment enter the farm under any circumstances (as they may introduce contaminated organic matter e.g. faecal material on wheels).

Property of Boehringer Ingelheim Animal Health France

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Making Biosecurity a reflex!

PEOPLE

Arrival at the farm

Ensure visitors have not recently been on a farm with suspected FMD. Keep a record of all visitors (date, names, purpose, car plate, duration). Ensure FARM TEAM and VISITORS clean and then disinfect hands, arms and footwear. Provide all visitors with overalls and boots. Only take onto the premises what is needed for work. Leave everything that cannot be easily washed and disinfected in the car (e.g. watch, rings...).

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Apply Biosecurity measures to workers & family; they can be vectors of contamination too!

Departure from the farm

Ensure FARM TEAM and VISITORS clean and then disinfect hands, arms and footwear. Leave working clothes on the farm and always wash clothes at a high temperature to prevent contamination.

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Making Biosecurity a reflex!

ANIMALS

Physical segregation • Always maintain separate barns to isolate and observe any new animals. • Prevent contact between sick and healthy animals.

Animal control • Monitor your herd thoroughly.

• Do not use grazing fields or water troughs in common with other farms.

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Make sure your workers apply these recommendations too!

EQUIPMENT

Do not share any materials or equipment with other farmers. Use soap or detergent then disinfectant for contaminated equipment and materials. Ensure all visible dirt is removed from clothing and equipment before disinfection and/or washing at high temperature. Place inside a sealed bag any equipment that cannot be cleaned/ disinfected (papers, documents, mobile phone…). Leave all waste items on the farm for safe disposal later.

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Making Biosecurity a reflex!

CLEANING & DISINFECTION

CLEANING Removing visible contamination

1

Remove dirt and impurities • Use soap or detergent

The disinfectant should be approved, effective against FMD virus, kept fresh and made up to the correct concentration.

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DISINFECTION Killing any remaining virus

2

Refer to your country’s operating instructions/ procedures for disinfectants.

Select the appropriate disinfectant.

Minimum concentration

Disinfectant

Respect instructions for use according to manufacturer’s recommendations.

Washing soda (Na2CO3) Citric acid Virkon ©

4% 0,2% 1%

Immerse items in disinfectant. Do not just splash disinfectant over the surface.

Ensure disinfectant is in contact with all surfaces of all items, for the correct contact time. Standard recommendation is to allow a contact time of at least 10 minutes. Always refer to manufacturer’s instructions.

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What to do in case of an FMD outbreak ?

Strict biosecurity measures

• Report the outbreak to your local Veterinary officer and your commercial representative. • Do not move animals in or out of your farm. • Do not allow visitors into your farm. • In an FMD endemic country, isolate any animals with FMD clinical signs within a pen (if possible) or move to an isolation facility (taking care to disinfect any vehicle used to do this). Do not forget to call the Veterinarian. • For large farms, prepare in advance a contingency plan and avoid within farm movements.

DO NOT FORGET: Everything on the farm may be in contact with the FMD virus and could potentially spread the disease.

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Follow your country’s FMD control policy regarding isolation, reporting, testing, slaughtering and vaccination.

If your national policy mandates vaccination: revaccinate all animals

One injection, unless: • Animals have never been vaccinated. •You have doubts about the vaccination status of the animals.

If so, repeat complete primary vaccination protocol: 2 shots 4 weeks apart.

The FMD virus is very resistant so you MUST reinforce cleaning and disinfection measures

Before disinfection, all items must be thoroughly cleaned (removing all dirt and mud) otherwise the disinfectant may not kill the FMD virus.

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Vaccination

PURCHASE AUTHENTIC VACCINE

STORAGE AT +2 +8°C

RESPECT PROTOCOL, DOSE AND ROUTE OF INJECTION

CLEAN AND STERILE MATERIAL

SHAKE AFTOVAXPUR VIGOROURLY AND INJECT SUBCUTEOUS

SHAKE AFTOPOR GENTLY AND INJECT INTRAMUSCULARLY

OPENED TODAY / USED TODAY

RECORD VACCINATION DATA

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Vaccination

NO USING AFTER EXPIRY DATE

NO FREEZING

NO CONTACT WITH FROZEN ICE PACKS

NO WARMING

NO MIXING WITH OTHER VACCINE

NO UNDERDOSING

NO REBOTTLING

Animals

NO ANIMAL STRESS (ESPECIALLY PREGNANT)

NO SICK ANIMALS VACCINATION

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Biosecurity

SECURED FENCES

ACCESS CONTROLED

OUTSIDE CARPARK

HANDS CLEANING AND DISINFECTION

VACCINATION IN QUARANTINE AREA (3 WEEKS) FOR NEW ANIMALS

NO CONTACT SICK / HEALTHY ANIMALS

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In case of FMD outbreak

3 DAYS QUARANTINE BETWEEN FARM VISIT

NO ANIMAL MOVEMENT IN OR OUT

NO OTHER FARM VISIT

NO VISITORS

NO SHARING MATERIAL, FEED/WATER

DISINFECTING USING FOOTBATH

ITEMS DISINFECTION BY IMMERSION

VISITORS RECORDING

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Acknowledgements

The Veterinary Public Health of Boehringer Ingelheim would like to thank most sincerely Dr Donald King, Head of the World Reference Laboratory for FMD, Pirbright UK , Dr David Paton and Dr Nick Lyons of EuFMD and Dr Jef Hammond (ex Head of the World Reference Laboratory for FMD, Pirbright UK) for their expert review of this booklet.

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