A risk-based mutual insurance premium framework for establishing indices of vulnerability to the intentional introduction of transboundary animal diseases.

Biological agents as weapons of agro-crime or agro-terrorism pose threats to peace and economic stability. Such agents pre-exist worldwide as hazards, adversely affecting animal health, as well as imposing substantial burdens on many nations. Few studies have quantified the global risks and vulnerabilities of countries and regions to potential terrorist or criminal operations targeting animal health. We present here a risk-based mutual insurance premium framework for animal health outcomes built upon the World Organisation for Animal Health (WOAH) quantitative risk assessment paradigm. Our objective was to generate dimensionless and relative domain indices related to release and exposure for several biological factors, as well as to assess the preparedness and response ability of each country. We also considered disease-specific measures relating to pathogens, targeted animal populations, the ongoing disease situation, within- and among-country peace or conflict, disease-specific control measures, and the availability of technical tools and personnel for successful disease management. National economic, political, and research and development competencies were used to assess each WOAH Member's potential for resilience. We formulated indices of vulnerability for 25 WOAH Members selected from five worldwide regions; initially, against four transboundary infectious animal diseases that target diverse animal species. We developed these indices using variables obtained from public databases arising from multiple intergovernmental organizations. Subsequently, we compared the relative vulnerability indices among countries for each given disease using three different index building methods: arithmetic mean, distance matrix, and principal component analysis (PCA). The PCA-based approach provided the greatest ability to discriminate among the components and among countries and regions. Due to its transparency and reliance on publicly available datasets, the risk premium framework proposed herein may readily be adjusted by policymakers and agencies and utilized to improve risk management strategies against agro-crime or agro-terror events, as well as for unintentional disease introductions.

Considerations for design and implementation of vaccine field trials for novel foot-and-mouth disease vaccines.

Vaccines are commonly used to control Foot-and-Mouth Disease (FMD) in endemic regions and form an important part of contingency plans for FMD-free countries. Conventional FMD vaccines have numerous limitations, and the U.S. government supports the development of next-generation vaccines. In the U.S., vaccine efficacy is typically demonstrated through experimental vaccination and challenge of animals using the World Organization for Animal Health (OIE) standards. Although conventional challenge and immunogenicity studies provide useful information, they have limitations and results do not always accurately predict field performance. Consequently, there is a need to test next-generation vaccines under field conditions to gain a better understanding of field performance to inform policy decisions and support their viability as a commercial product. In June 2017, an expert consultation was organised to discuss and define an optimal field study design for novel FMD vaccines. Cattle were the primary species considered, although parallel strategies for swine and small ruminants were also discussed. Many methodological and logistical considerations in the study design were identified, including: (1) study site selection and the importance of baseline studies to understand exposure risk, (2) ethics of using a placebo and assessing equivalence with conventional vaccines, (3) merits of using individual randomised versus cluster randomised trials, (4) preventive versus reactive vaccination, and (5) methods of randomisation and blinding. The proposed optimal study design was a multicentre (i.e. farm), three-arm, double-blind randomised controlled trial comparing groups receiving the novel vaccine to a conventional vaccine group and a placebo group. Large farms in areas of high exposure risk were identified as ideal study sites, and the primary study outcome was susceptibility to disease or infection, during a six-month observation period, following a single dose of vaccine. This report provides a summary of the important issues to consider when designing a field efficacy study in livestock and proposes a study design that could be utilised for novel FMD vaccines.