Appendix 20

Appendix 20

Report of the Chairman of the EUFMD Research Group on the: 1. Sessions of the FAO EUFMD Research Group at (i) Greifswald, Insel-Riems, Germany, 20-23 September 2005 and (ii) Paphos, Cyprus, 17-19 October 2006. 2. FAO EUFMD RG WORKPLAN 2006-2008 Kris De Clercq, Chairman of the EUFMD Research Group

Item 1 - Lessons learnt from the recent events in FMD control and Regional risk situation

- Studies on the importance of each of the transmission routes for farm to farm infection in the 2001 epidemic in the UK indicates that efficiency gains in biosecurity could be an effective means to significantly reduce transmission and could strongly contribute to the control of an epidemic. - There is great potential for full genome sequencing in FMD epidemiology, e.g. to identify the main routes of transmission between farms. - Significant quantities of animal products are brought by air traffic into European countries every day by passengers from FMD endemic countries. - Turkey should be encouraged to continue to organise sero-surveillance in Thrace region and to extend active surveillance studies in Eastern Anatolia. - Sero-monitoring of virus circulation and FMDV vaccination in the Caucasus: The objectives of the serosurvey were to estimate the level and describe the geographical distribution of antibodies to structural (SP) and non-structural proteins (NSP) and to interpret the findings in relation to the effect of vaccination and evidence for circulating infection.

Item 2 - Virus transmission, the art of understanding FMD spread

- Modelling airborne spread of FMDV is very complex and valid estimates require combining laboratory findings, good field work, modelling and experience of past outbreaks. - The inverse age effect of FMD in cattle was reported. This needs to be further evaluated, including looking at susceptibility and differences in infectivity, and a possible association with strain-dependency. The relevance of the findings for contingency planning should be evaluated.

Item 3 - Vaccine development, production and selection

- There is an urgent need to test the ability of vaccine strains to protect against heterologous strains and correlate it to the results of in-vitro methods like r-values, sequences and MAb-binding profiles. - There is insufficient knowledge on the duration of immunity, in particular in respect to heterologous strains.

Item 4 - Vaccine control: Validation, Quality Control and Quality Assurance

- It is not possible to discriminate between a vaccine with a PD50 of 3, 6 or 10 based on the outcome of a single potency trial. - Statistical validation of alternative potency methods is needed to make any further revision of the FMD Ph.Eur. Monograph possible. - A positive correlation was found between IFN-gamma response in cattle and protection against clinical disease.

Item 5 - Vaccine application, contingency planning and simulation exercises

- Vaccination reduces virus replication and virus excretion in cattle pigs and sheep, which would potentially reduce transmission during an outbreak. - Anti-viral agents have been shown to inhibit FMDV replication both in vitro and in vivo and may have potential for use in controlling the spread of infection during an outbreak. - In order to rapidly apply vaccination in crisis situations, governments should identify areas where FMD emergency vaccination will be necessary if an FMD outbreak occurs. - Decision support systems (DSS) can be used in planning for epidemics, risk mapping, estimate the required size of vaccine banks and resource allocation as well as exploring different strategies such as stamping out, vaccination and combinations of these. The use of mathematical models during outbreaks to predict spread has proved more controversial. - A working group on FMD simulation exercises should produce a standard for the core components that national simulation exercises should contain and a standard format for reporting the results and outputs of such exercises.

Item 6 - Diagnostics: Diva tests

- Serum panels for evaluating different DIVA tests have been created for several FMD susceptible species (cattle, pigs and small ruminants); - Clinical disease in pigs might be required to generate a good antibody response to NSP.

In order to reliably estimate sensitivity and specificity parameters for different DIVA tests in pigs, more data is needed on the occurrence of subclinical infection in vaccinated pigs and on the performance of the tests in these herds. - Studies to address knowledge gaps in validation data from sheep, goats, water buffalo and pigs should be supported, in particular data should be generated on the specificity of NSPEs in vaccinated animals of those species. - Probang-sampling followed by RT-PCR is insufficiently sensitive unless three serial samples are tested. - Serosurveillance can substantiate rather than demonstrate freedom from infection after an outbreak. Different combinations of tests can be used in series to improve the overall diagnostic specificity but sensitivity remains a limiting factor in achieving the required level of confidence within small herds. - Possible solutions to the “small herd problem” include: (i) not vaccinating them; (ii) vaccinating them but increasing the number of small herds “sampled” to increase the probability of detecting infection or (iii) applying a vaccinate-to-kill policy. - Preliminary results on the use of a new software tool to optimise herd sensitivity whilst maintaining a minimum herd specificity by altering the numbers of samples taken per herd and the cut point at which a farm would be considered positive shows that the current NSPEs are fit for purpose to substantiate freedom of FMD at a 5% prevalence at herd level and 2% prevalence between herds. - There needs to be a much better understanding of the interpretation of NSP data and the use of serological profiling and cluster analysis for differentiating true and false positive outbreak clusters.

Workshop on the design and interpretation of post Foot-and-Mouth Disease (FMD)vaccination serosurveillance by NSP tests, 2007.

Item 7 - Diagnostics: Confidence in results: Quality Control/Quality Assurance

- Validation, including investigations of field samples, of novel diagnostic platforms either based on genome or antigen detection should be conducted with high priority. - Guidelines for use of field-based tests should be established as part of contingency plans. - The proficiency tests concentrated on a wide distribution of a live virus proficiency panel along with the distribution of a serology and antigen detection ELISA panel based on inactivated materials. - The serology proficiency panel was applicable to both non-structural and structural protein antibody tests and the priority serotypes were O, A, Asia 1 and SAT 2.

- Inter-laboratory testing exercises provide a valuable opportunity to compare tests. It is important that participants are given individual feedback concerning their performance and consideration needs to be given to follow-up in relation to discrepancies identified.

In this respect there is a need for a clear procedure to be followed taking into account the relationship with the CVO. - Future studies should aim to harmonise serology used for monitoring the efficacy of vaccination. - A simple method can be established within each laboratory for correlating confidence in a given qualitative test result to the quantitative read-out of the test itself. Item 8 - Laboratory bio-security - Under special conditions it will be of advantage to allow laboratories not meeting the security standards for FMD laboratories adopted in 1993 to carry out the laboratory diagnosis of FMD with methods, which do not require the propagation of virus. However, these exceptions should not compromise the efforts to exclude the escape of FMDV from laboratories in FMD – free countries.

Item 9 - Virus inactivation studies

- A scenario tree for the analysis of a risk assessment on the risk of FMDV in pork from vaccinated animals was established and it was concluded that the risk of FMDV in pork from vaccinated pigs was low, however, the uncertainties inherent in the assessment is significant. Item 10 – Wildlife

- In all recent European outbreaks wildlife were not implicated in the spread of FMD and the outbreaks could be controlled without any specific action devoted to wild species, native or exotic. - Although a high proportion of gazelle have been seropositive after being involved in FMD outbreaks in Israel, the prevalence of antibodies dropped indicating that the virus did not circulate on its own within the gazelle population.

Item 11 - FAO EUFMD RG WORKPLAN 2006-2008

Theme Task (blue italic = associated task)

1. Global Surveillance 1.1 Global surveillance maps/models

1.2 Establish regular risk reporting – virus types circulating in Iran,

Pakistan, Afghan... FG, KS, DP (link) 3 monthly Ongoing

1.3 Improving delivery of viruses from risk areas

1.4 Priority antigens for the European Ag banks

1.5 Minimum size of vaccine stocks in EU vaccine banks – position paper

1.6 Type C vaccination/eradication position paper Expert consultation in 2007 Who Draft/freque ncy Completion

Liaison person DP to actions between CA, FAO and OIE Yearly progress Ongoing

report

Secretariat, WRL Yearly report on Ongoing

gaps/progress WRL 6 months Every 2 years Ongoing

AD, (Paul Barnett), KS, AEF Outline Progress report 2006 2007 (preGeneral Session)

KS, DP, KDC, SoA (+FAO colleagues) Progress report Gen Ses 2007 Closed Session - 2007

1.7. Procedure for naming of FMD strains/subtypes DP (Nick Knowles) Closed Session - 2007

2. Prevention Strategy for prevention of FMD entry into Europe – group should review risks and interventions KS, FM/MB, AEF Progress report Gen Ses 2007

Closed Session - 2007 3. Sero- Design sero-monitoring in vaccination zones –Thrace and Trans- KDC, MB, DS, NB, by Feb- 2007. Ongoing

monitoring Caucasus - refine, re-design - support future official status (Thrace)

4. EQA FMD Diagnostics 4.1. Establish EQA support for 2007– virus detection and serology (Phase XX)

4.2. Harmonisation of the serology used for monitoring the efficacy of vaccination 5. PVS 5.1. Test/optimise guidelines on the use of NSP tests through simulation at workshop (using selected scenarios) KM, CP Results – Closed Session

DP, KDC, BH, EB, KS, AEF Meet to coordinate with CRL. Closed Session - 2007

DP, EB, AD, KDC Progress report Gen Ses 2007 Closed Session - 2007

KDC, DP, AD, EB, DS, AEF Progress report Gen Ses 2007 Closed Session - 2007

5.2. Complete analysis on sheep and pigs, buffalo KDC, DS, GG Progress report Gen Ses 2007 Closed Session - 2007

5.3. Substantiate freedom from infection: position paper KS, AEF, DP, BH, PW Nov 2006 Gen Ses 2007

6. DSS Decision support systems – develop position paper on validity, applicability, gaps 7. Biosecurity Biosecurity guidelines – follow up required: - table with gaps between standards of FAO and OIE

8. Virus inactivation Inactivation studies - Milk and milk products: combination with Pakistan study? - Meat and meat products: follow-up needed SoA, AD, PW, (IAHDon King), Progress report Gen Ses 2007 Closed Session - 2007

9. Pen-side test Pen-side tests position paper Secretariat (links also with CA) Progress report Gen Ses 2007

Closed Session - 2007 BH, SoA, HY, AEF Jan 2007 Gen Ses 2007

DS, Scott Reid, HY Gen Ses 2007

10. LCP Laboratory Contingency Plans: to be placed on the website

Scaling up diagnostic capacity: Workshop on upscaling serology –Secretariat (link to CA) Gen Ses 2007

Check timetable-

11. Potency test only interesting for eastern European countries, particularly that are not candidate countries Secretariat, GG, CA

Potency test evaluation (Turkey) - FMD_ImproCon Link person KDC CA will send around as Manual end 2007

- Position paper on potency tests in pigs - do we require vaccines to be tested in pigs, and are there new alternatives? *link to China AD, AEF, DP-Zidong*, BH SoA(epidemiology) Progress report Gen Ses 2007 Closed Session - 2007

12. Sample transport Sample transport guidelines – to be sent around BH (Nigel Ferris)

13. Meeting Closed meeting (October 2007) (Egypt / the Netherlands) Secretariat KDC

EB Progress report Gen Ses 2007

SoA: Soren Alexanderson; EB: Emiliana Brocchi; MB: Mark Bronsvoort; NB: Naci Bulut; KDC: Kris De Clercq; AD: Aldo Dekker; AEF: Alf-Eckbert Füssel; FG: Francis Geiger; GG: Georgi Georgev; BH: Bernd Haas; KM: Koen Mintiens; FM: François Moutou; DP: David Paton; CP: Carsten Pötzsch; DS: Donal Sammin; KS: Keith Sumption; PW: Preben Willeberg; HY: Hagai Yadin. CA = Co-ordination Action – FMD and CSF laboratories (DG-Res); CRL: European Community Reference Laboratory; WRL: World Reference Laboratory

Gen Ses 2007

Open meeting Italy (Sardinia, Sicily)