Elements of FMD post-vaccination monitoring programme / Éléments du programme de surveillance post-vaccination contre la fièvre aphteuse

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Workshop: harmonization of the FMD vaccination strategy in the North Africa / Atelier : harmonisation de la stratégie de vaccination contre la fièvre aphteuse en Afrique du Nord 30-31 mars 2016 - Tunis Elements of FMD post-vaccination monitoring programme / Éléments du programme de surveillance post-vaccination contre la fièvre aphteuse Labib BAKKALI KASSIMI ANSES Laboratoire de Santé Animale de Maisons-Alfort Laboratoire OIE et National de référence pour la fièvre aphteuse

Control of FMD is a complex process Control of animal movement and trade Active and/or passive surveillance Early warning and detection system Establishment of a contingency plan Vaccination (emergency/preventive) Post-vaccination monitoring (PVM) Actor 1 Actor 2 M1 M2 M4 M3 Eliminate FMD Farmer Farm Monitor the epidemiological situation Actor 4 Actor 3 FMD monitoring and surveillance Network Adapt measures ü Analyze ü Assess ü Decide Ms

Vaccination is one of the most important components of FMD control Why vaccinate Ø to reduce clinical disease Ø to eliminate virus circulation Ø to maintain FMD freedom Ø to regain FMD freedom Be aware Ineffective vaccination program Effective vaccination program

Factors affecting vaccination program effectiveness Be aware Match to circulating strain(s) Vaccine strain Prior exposure Age Vaccination strategy Vaccination campaign Health condition Host factors Vaccination Program Effectiveness Application Cold chain Time since vaccination Trained vaccinators Potency Stability Vaccine characteristics Vaccine composition and adjuvant Purity Shelf life

Need a post vaccination monitoring program (PVM) PVM monitor continuously Follow up of the performance Ø PVM is necessary to optimise the vaccination programme, and the use of limited resources in attaining expected objectives, Ø Important component in vaccine-based FMD control (PCP stage 2-3), Ø A requirement for countries seeking official recognition by OIE (endorsed national control programmes or freedom with vaccination)(pcp stage 3 and beyond)

Objectives of post vaccination monitoring (PVM) Objectives? ü Determine vaccination coverage ü Evaluation of immune response ü Demonstrate impact of vaccination ü Demonstrate FMD freedom ü Evaluate vaccine performance ü Identify causes of ineffective vaccination ü Optimize vaccination strategy and program ü Optimize use of resources ü Improve quality of vaccines

Checklist for PVM ü Vaccine characteristics (expected serological response: purity, duration Abs, protective titer) ü Desired percent of vaccination coverage, ü Desired percent protection, ü Representative sample ü Awareness of livestock owners, ü Training in effective sampling, preservation and shipment of samples, ü Training of lab staff and adequate Lab capacity, (Accuracy, turnaround time, )

Who needs to be Involved in PVM? ü Decision makers : set up the objectives of PVM and assign resources, ü Epidemiologists and statisticians : select and design the appropriate methods and carry out data analyses, ü Field veterinarians, nongovernment organisations and animal health workers : collect samples, ü Veterinary diagnostic laboratories : share information on the performance of the serological tests, carry out the diagnostic analysis and participate in the interpretation of the serological test results, ü FMD Reference Laboratories for additional advices if needed.

PVM tools Serological surveillance: ü Animal identification system ü Sampling design based on farming system and means ü Day post vaccination for sampling (30dpv) ü Sample size (CI 95%) ü Test to be used (SP and NSP) ü Reference sera Virological surveillance: ü Clinical and passive surveillance (regular field investigations) ü Probang test (if NSP positive) Data analysis and interpretation: ü Specificity and sensitivity of the tests ü Context of production system, delivery system and epidemiological situation ü Vaccination coverage and protection

PVM tools : serological surveillance

Tests for Serological surveillance Antibodies against SP Ø Virus neutralisation test Antibodies against NSP NSP ELISA Ø Liquid Phase Blocking ELISA (LPBE) Ø Solid Phase Blocking ELISA (SPCE)

PVM tools : Clinical and virological surveillance Regular field investigationst Laboratory tests

Interpretation of PVM data If low sero-prevalence and/or protection:? Technical gap (e.g. vaccine quality, cool chain, training of staff, etc) Administrative gap (e.g. vaccine delivery) Not all animals were vaccinated Introduction of new animals after vaccination Vaccinated animals have moved and unvaccinated were introduced Investigation Improvement

Improve vaccination program effectiveness Improve vaccine (strain, quality,..) Improve vaccine storage (cold chain) Improve delivery system Improve training Improve awareness

Challenges ü Animal identification ü Awareness and incentives ü Vaccine quality control centers ü Correlation between protection and antibody titers ü Validated PVM screening tools (Calibrated tests, tests with vaccine strain)

Conclusion Ø Vaccination is one of the most important components of FMD control, Ø Ineffective vaccination is a risk and a cost, Ø Several factors my lead to ineffective vaccination and should be controlled, Ø PVM is necessary to ensure the effectiveness of vaccination, Ø PVM program have to be well prepared according to the objective of vaccination and the local situation, Ø Several elements are to be considered to establish an effective PVM, Ø Collaboration between all actors and their involvement is mandatory for success of vaccination/pvm programs, Ø Effectiveness of a control program is the result of a combined effect of vaccination (if used) and additional measures, Ø Guidelines for FMD PVM established by OIE/FAO working group will be soon available.

THANK YOU