FMD vaccination and postvaccination. guidelines. Samia Metwally (FAO) Animal Production and Health Division FAO of the United Nations Rome, Italy

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4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 FMD vaccination and postvaccination monitoring guidelines Samia Metwally (FAO) Animal Production and Health Division FAO of the United Nations Rome, Italy Samia.Metwally@fao.org

Aims Practical guidance on how to evaluate the effectiveness of FMD vaccination programmes Tailored to needs of countries at different stages of FMD control 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 2

The Guidelines What is next? Pocket guide, training sessions, backstopping 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 3

SECTION 2 What tasks should be completed before beginning a vaccination programme? Design Establish clear objectives and targets Decide which animals to vaccinate Decide when to vaccinate and boost Establish a vaccine registration system to evaluate coverage Supplies for vaccination and PVM (syringes, gloves, blood tubes, records) personal protective equipment (PPE) for vaccinating and post vaccination monitoring 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 4

SECTION 2 What tasks should be completed before beginning a vaccination programme? (Cont d) Training Decide who will vaccinate and establish a system of supervision Establish a vaccine monitoring team Establish distribution centres and cold chain Develop standard operating procedures (SOP) for vaccination and farm biosecurity Make diagnostic test kits available and ensure training of laboratory staff Resources Procure sufficient funds for vaccine purchase, vaccination, and monitoring Procure sufficient amounts of vaccine for prophylaxis and emergency 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 5

Chapter 1 What types of FMD vaccines exist? Two types of vaccines classified by type of adjuvant: 1.Aqueous form a) Aluminum hydroxide gel or saponin Commonly used in cattle, sheep, goat, and buffalo Less commonly used in pigs 2. Oil forms a) Single oil emulsion aka water in oil (W/O) vaccines Commonly used in cattle in South America b) Double oil emulsion (DOE) aka water in oil in water (W/O/W) vaccines Commonly used in pigs in Asia 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 6

Chapter 2 1 2 3 4 What are the objectives of the vaccination programme? Reduce clinical Incidence PCP-FMD Stage 2 Vaccination implemented to reduce FMD clinical outbreaks Eliminate FMD virus circulation PCP-FMD Stage 3 Vaccination as part of a control programme, which includes movement control and stamping out Maintain FMD freedom PCP-FMD Stage 4-5 Vaccination implemented to minimise the FMD incursion from outside Regain FMD freedom PCP-FMD Stage 4-5 Vaccination implemented as an emergency measure in order to regain FMD-free status 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 7

Chapter 1 What information should be included in the vaccine tender? Information requested by the tenderer and provided by the manufacturer should include: Vaccine type Species Quantity Route Specify serotypes and strains Vaccine approved for target animals Number of doses and doses per vial Of administration Potency Stability Recommended vaccination schedule Language - Specify PD 50 - Onset and duration of immunity Shelf-life of the vaccine (finished product or batch) Per species and age of vaccination Package inserts and warnings provided in target language Reference sera Adjuvant Request sera for homologous vaccine strains to use as reference standards in serological tests for PVM Type of adjuvant 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 8

Chapter 2 How to determine the vaccine coverage? Vaccine coverage calculations Equation #1 - Vaccination coverage over the entire susceptible population is calculated by: Number of animals vaccinated Number of susceptible animals in population (eligible + ineligible) 100 Equation #2 - Vaccine coverage on only eligible animals after the last round of vaccination is calculated by: Number of animals vaccinated Number of animals eligible for vaccination 100 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 9

Chapter 3 How to assess population immunity? Methodology #1: Estimates proportion of animals vaccinated for the first time. Methodology #2: Estimates the proportion of animals with a detectable level of antibodies in a population (identifies population immunity at the individual animal level) Methodology #3: Monitor immune response at herd level. Estimates the proportion of animals not adequately vaccinated 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 10

SECTION 4 How to investigate outbreaks in vaccinated animals? 1 Introduction of new virus with poor match to vaccine strains Conduct field investigation and laboratory confirmation 2 Vaccine contaminated with live FMD virus Conduct innocuity testing in remaining vaccine batch Report to manufacturer if confirmed 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 11

SECTION 4 How do to investigate outbreaks in vaccinated animals? 3 Failure in vaccination programme in presence of active virus circulation. Possible contributing factors listed below: a) Host factors Age of vaccinates (young animals received one vaccine dose) Health condition (stress, malnutrition, infection) Time of last vaccination b) Vaccine characteristics Low potency Unstable Past recommended shelf life c)vaccine application Vaccination schedule (lapse in interval of vaccinations) Low vaccination coverage Breach in maintaining cold chain d) Serological test used for PVM analysis Low test specificity false positive Misinterpretation of lab results Untrained laboratory staff e) Overwhelming challenge due to lack of other FMD controls 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 12

Breakout Group How will you ensure quality of vaccines used? What are steps and resources needed in planning to evaluate the vaccination programme effectiveness? How will you monitor the effectiveness of your vaccination programmes? 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017 13

Thank you for your attention 4th Middle East FMD Roadmap Meeting Amman, Jordan 15-19 October 2017