ANNEX IISupplementary provisions
ANNEX II Criteria for the use of a vaccine to prevent and control a category A disease in animals PART 1 1. Vaccination of kept animals 1. Number of establishments where the category A disease has been confirmed or suspected; 2. Type of establishments where the category A disease has been confirmed or suspected; 3. Number of animals kept in the establishments where the category A disease has been confirmed or suspected; 4. Species affected and risk of disease spread to humans; 5. Presence of the disease in wild animals; 6. Density of animals of listed species in the areas where the disease is present; 7. Density of establishments keeping animals of listed species in the areas where the disease is present; 8. Origin of the outbreak(s); 9. Traceability and possibility to perform contact tracing; 10. Incidence slope of outbreaks; 11. Simulation models used to assess when and if vaccination is relevant, if such information is available; 12. Capacity of killing and killing and disposal schedule in establishments where animals are killed; 13. Movement of potentially infected animals or products out of the restricted zone established pursuant to Delegated Regulation (EU) 2020/687; 14. Rate of airborne or vector-borne spread of the disease agent from the establishments or area where the category A disease has been confirmed; 15. Effectiveness of other disease control measures taken and available resources to implement them; 16. Level of preparedness and capacity of the competent authorities and other personnel concerned; 17. Economic assessment: cost–benefit analysis; 18. Trade concerns: consequences on disease freedom status of the Member State concerned and trade restrictions likely to be imposed by third countries or territories as a consequence of vaccination. 2. Vaccination of wild animals In addition to the criteria provided for in point 1, the following criteria shall be considered: 1. mortality in wild animals due to the category A disease; 2. knowledge of the population and ecological dynamics of the affected wild animals; 3. size of the affected area (where animals affected are found); 4. the risk of spread of the disease to additional listed species of wild animals or beyond the above area; 5. the risk of spread of the category A disease to kept animals or to humans; 6. the availability of vaccines and vaccination systems to distribute the vaccine among the target population; 7. the possibility to control the vaccination and to establish a surveillance system to detect the specific disease agent and to assess the effectiveness of vaccination. PART 2 SIMPLIFIED ASSESSMENT OF THE VACCINATION STRATEGY 1. Number of establishments where the category A disease has been confirmed or suspected; 2. Type of establishments where the category A disease has been confirmed or suspected; 3. Number of animals kept in the establishments where the category A disease has been confirmed or suspected; 4. Species affected; 5. Capacity of killing and killing and disposal schedule in establishments where animals are killed; 6. Rate of airborne or vector-borne spread of the disease agent from the establishments or area where the category A disease has been confirmed.