Development of Guidelines for Post Vaccination Monitoring

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1 Development of Guidelines for Post Vaccination Monitoring

2 Overview Origins of the PVM Guideline Working groups Aims of the Guideline Structure of the Guideline Progress and next steps

3 Origins of the guideline EuFMD Open Session Recommendation Ref Lab Network working group OIE/FAO endorsed need Rome working group

4 PVM working group Virologists, diagnosticians, epidemiologists, statisticians, field vets Assembled January 2012 FAO- Italy and Botswana Akiko Kamata Ludovic Plee Mok Mokopasetso Pirbright- UK Paul Barnett Simon Gubbins Theodore Knight-Jones BVI- Botswana Gaolathe Thobokwe NAFMDVB- USA Hernando Duque OIE- France Susanne Munstermann Marta Martinez Aviles PANAFTOSA- Brazil Rossana Allende Antonio Mendes IVRI- India B Pattnaik Lanzhou Research Ins- China Xiangtao Liu Friedrich-Loeffler Ins-Germany Bernd Haas Private Industry Danny Goovaerts Philippe Dubourget 4

5 Rome working group Under the umbrella of GF-TADs (FAO and OIE) June 2013 Samia Metwally FAO, Italy Susanne Munstermann OIE, France Kris de Clerq Belgium Tim Doel, United Kingdom Sergio Duffy, Argentina Phaedra Eblé, Netherlands Giancarlo Ferrari, Italy Mary Joy Gordoncillo, Thailand Mokganedi Mokopasetso FAO, Harare Alasdair King, The Netherlands Cornelis van Maanen, the Netherlands David Paton United Kingdom

6 Aims Practical guidance on how to evaluate the effectiveness of FMD vaccination programmes Tailored to needs of countries at different stages of FMD control

7 Categories Countries experiencing FMD with vaccination schemes with the goal to reduce disease burden Countries experiencing FMD with vaccination programmes with the goal to establish freedom from FMD with vaccination Countries recognized by the OIE as FMD-free with vaccination and working towards FMD freedom without vaccination Countries with a recent incursion of FMD and practicing vaccination-to-live after being free of disease.

8 Structure Introduction Purpose Scope Connections to PCP Definitions and glossary Principles of monitoring and evaluation Methodologies Vaccine attributes Vaccine delivery and coverage Vaccine response (population immunity) Vaccination outcomes (incidence of disease and infection)

9 Vaccine attributes Quality and relevance of vaccine information expected from manufacturers assistance from reference laboratories Pilot studies verify quality need for boosters calibration of serology

10 Vaccine coverage Used to monitor immunization performance at local, national and international levels Number of animals vaccinated at the last round of vaccination x 100 Number of animals eligible for vaccination Denominator data National database, livestock census, survey Numerator data Distributed, administered, survey, serology

11 Vaccine immunity Monitor the post vaccination immune response at individual animal level under controlled field conditions level of protection in the population (at regional level) level of protection at herd level (at epi-unit level) Detailed protocols related to control strategy selection and numbers of epi-units and animals sampling and testing (SP / NSP tests) interpretation

12 Vaccine outcomes A monitoring system needs indicators of success of vaccinatio The expected extent of reduction of disease or virus circulation The acceptable incidence of disease, below which a program is considered successful The absence of disease or circulation Relate to PCP stages and OIE freedom status Monitoring needs to be over an extended period Monitoring FMD outbreaks Passive surveillance Active case finding Retrospective outbreak investigation Sentinel animals / epi-units Monitoring FMDV infection Cross-sectional survey Longitudinal monitoring Risk-based surveillance Vaccine effectiveness studies Study design examples

13 Progress and next steps Draft chapters for methodologies written Introduction to be written Chapters to be harmonised Document to be accepted and used by FAO and OIE Integrate PVM guidelines into: Vaccination programmes (PCP) OIE endorsed official control program for FMD Possible future publication

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