Arvac Vaccine Terms & Conditions

Use of ARVAC for protection of stallions against Equine Viral Arteritis for the 2025 Breeding Season

Approval of Arvac
Due to the unavailability of the EU authorised Equine Viral Arteritis (EVA) vaccine, Equip Artervac emulsion for injection for horses and ponies, (Zoetis Belgium S.A), for the 2025 breeding season, use of the live attenuated vaccine (LAV) ARVAC, will be permitted under special import licence. Import and use of the vaccine requires adherence to strict biosecurity measures.
All veterinarians and stallion owners considering use of the vaccine should carefully consider the requirements associated with use of the vaccine as set out below.

Application Process
Veterinarians should contact Veterinary.medicines@agriculture.gov.ie as soon as possible, and no later than 1st November, to indicate their intention to apply for a licence. This initial communication should include the location of the proposed quarantine facility and the number of stallions to be vaccinated.
Veterinary Medicines will provide an application form to the PVP. Part of the licence approval will include an inspection of the proposed quarantine facility by DAFM to verify that the site is fit for purpose and that appropriate systems are in place to ensure compliance with the conditions of the licence.

Please note that timely expression of interest by Veterinarians will be needed to ensure efficient allocation of staff to manage the process of pre quarantine inspection of premises, especially in RVOs where demand on resources at this time of year can be particularly high.

Requirements of the Licence

1. Serology and virology testing of all stallions, by named PVP, immediately prior to vaccination and under the supervision of an official veterinarian. Samples to be submitted to the Irish Equine Centre.
2. All horses in a designated quarantine facility will be vaccinated on the same day under the supervision of an official veterinarian.
3. A minimum 30-day quarantine period during which the requirements of isolation will be adhered to
4. Testing of stallions (PCR blood testing) at the conclusion of the 30-day quarantine period.
5. Release of an animal from quarantine shall not occur until a notification is issued by DAFM that negative PCR blood results have been received and criteria for release have been met.
6. If the blood sample at day 30 test positive by PCR, the stallion will not be released. A repeat blood sample is to be taken no earlier than 48 hours later. If that result is negative, the stallion can be released.
7. At the end of isolation all stallions must be inspected by the RVO VI before restriction is removed.
8. A nominated PVP will be named on the licence and will be responsible for the administration of the product. The named PVP will be the only veterinary professional permitted contact with the horses for the full quarantine period. The PVP may continue to have contact with other horses (outside the quarantine facility) as long as there is full adherence to hygiene protocols and biosecurity requirements .Further obligations of the PVP are listed below.
9. A dedicated person must be nominated as the person in charge of the quarantine facility and is responsible for overseeing the adherence to quarantine requirements. This person will be named on the licence. Obligations of the nominated person are listed below.
10. Attending named private veterinary practitioner (PVP) shall arrange biosecurity training for all dedicated staff prior to vaccine usage, with written records kept and made available for inspection.
11. Dedicated attending PVP shall design vaccine storage, usage, disposal, and quarantine protocols.
12. The Department of Agriculture, Food, and the Marine reserves the right to unannounced visits to the isolation facilities at any time during the quarantine period.

Quarantine Requirements

1. Vaccinated stallions shall have dedicated staff and dedicated equipment for the full period of their quarantine
2. The isolation facility shall be free from other kept animals
3. The isolation premises shall be secured to ensure that access to the yard is restricted to dedicated staff only (this applies to the dedicated attending PVP and dedicated RVO VI)
4. All staff must sign in and sign out. Clear records must be kept of all staff movements on and off the facility and made available for inspection at the request of the RVO
5. Appropriate signage must be put in place to prevent accidental entry of any other farm staff to the isolation facility.
6. If any other staff accidentally access the quarantine area, these staff must adhere to same restrictions as dedicated staff from that point forward.
7. It must not be possible for other horses or other kept animals to approach within 100 metres of the isolation facility, including dedicated exercise paddocks, while it is in use.
8. Manure/bedding material from stallions vaccinated with Arvac must be stored in such a way that other equines cannot access it, sprayed with a suitable disinfectant, not stored in a yard or field neighbouring susceptible equines, and is not spread in fields or paddocks bordering grazing pasture of susceptible equines for a minimum period of 3 months post vaccination.
9. A dedicated change area will be provided where hygiene protocol and donning and doffing of PPE/ change of clothes can be carried out at time of entry and exit of quarantine facility.
10. Gloves and boot covers shall be used when handling the restricted horses.
11. Dedicated staff shall have appropriate dedicated clothing or overalls for use in the facility, this clothing or overalls must remain in the isolation facility.
12. All needles and syringes are for single use in individual horses only
13. All used needles, syringes, or any other equipment used shall remain in the quarantine area until the end of the quarantine period. Equipment not for disposal shall be thoroughly cleaned and sanitised before return to general use.
14. During the period of isolation, the attending PVP shall notify the RVO VI of any vaccine associated side-effects, including (but not limited to) injection site reactions and swellings, neck stiffness, inappetence and/or pyrexia (elevated body temperatures).
15. During the period of isolation, the attending PVP shall notify the RVO VI of any signs of clinical disease.
16. In the event of any vaccinated stallion requiring emergency veterinary care, any attending PVP must adhere to all isolation conditions as laid out above. If emergency veterinary care is required, the RVO VI shall be notified immediately and made aware of the nature of the problem.
17. In the event any horse needs to be hospitalised, the equine hospital must put in place suitable biosecurity restrictions for the period of hospitalization. If emergency hospitalization is required, the RVO VI shall be notified immediately and made aware of the nature of the problem.
18. At the end of the isolation period all stables must be cleaned and disinfected
19. Similarly, all equipment used during isolation period must be cleaned and disinfected
20. All vaccinated stallions shall adhere to any sampling protocols laid down by DAFM Virology division for a period of 6 months post vaccination. The person responsible for the quarantine unit in seeking the licence acknowledges and agrees to the following as further conditions of the licence
21. The PVP named on the licence in seeking the licence acknowledges and agrees to the following:
    • Arvac is not authorised for use in the European Union and the import licence has been granted is an exceptional measure
    • Arvac will only be used in accordance with the conditions of the Article 110 licence issued by the Department of Agriculture, Food and the Marine and in accordance with Regulation 4(4) of the Control on Animal Vaccines Regulations 2014
    • No liability shall attach to the Minister for Agriculture, Food and the Marine for any adverse events which may arise in the treated animal(s) (or any other animal that comes into contact with the treated animal) as a result of the use of Arvac and undertakes to indemnify the Minister of same
    • The PVP will inform the owner (or his or her agent) of the animal to be treated of all possible risks involved in treating an animal with Arvac
    • The PVP must adhere to a strict hygiene policy at entry and exit and a no-fomite regimen and in doing so will be permitted to treat other animals (outside of the quarantine facility) alongside overseeing the quarantined horses.
22. Obligations of the dedicated person nominated as the person in charge of the quarantine facility and responsible for overseeing the adherence to quarantine requirements include;
    • Ensures they are familiar with and have read the 2024 ITBA International Codes of Practice for the Control of Equine Infectious Diseases, with special reference to Equine Viral Arteritis and have made themselves aware of the clinical signs of this disease.
    • Undertakes to comply with all aspects of the Code of Practice, including those recommendations relating to both imported and domestic mares, diagnosis, and control of infection.
    • They understand that ARVAC may only be used in accordance with a vaccine licence issued by DAFM and may only be administered by the Veterinary Practitioner named in the vaccine licence
    • Undertakes to ensure that any horse vaccinated with ARVAC is completely isolated from all animals, other than other horses vaccinated with ARVAC, from the date of vaccination as per the conditions laid out on the licence
    • Undertakes to notify DAFM immediately of any adverse reactions that are noted following vaccination of horses with Arvac and of any and all signs of illness that occur in vaccinated horses during the 30 days post vaccination.