Vaccine security Meeting Rome Italy FAO HQ 23-24 January 2020 Pillar I - Improve\1.3 Emerg Vacc\Vaccine Security Meeting\PPTs final

1. What information is needed by FAST
risk managers (Europe)
Sally Gaynor
Emergency Preparedness Expert, EuFMD
Meeting to explore options to improve security of vaccine supply
against Foot-and-Mouth and other similar transboundary diseases,
FAO, Rome 22-23 January 2020
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2. Contents of the presentation
• Information needed on each vaccine
• Information to facilitate planning:
• modelling
• cost-benefit studies
• strategy documents
• resource assessments
• communications with stakeholders
• SPC data
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3. Modelling
Example - EuFMDis
Parameters for vaccination:
• time to onset of immunity
• duration of immunity
• population immunity
• number of vaccine doses available
• prioritisation of animal species
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4. Cost-Benefit
Direct costs:
• vaccine
• vaccine storage and distribution (cold chain)
• vaccination equipment
• special identification for animals vaccinated
• central recording of vaccination
• training and employing staff
• +/- slaughter and disposal of vaccinated animals
• +/- compensation
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5. Cost-benefit
Indirect costs:
• surveillance after vaccination
• control measures on vaccinated animals and their products
• +/- testing of vaccinated animals (vaccination-to-live)
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6. Strategy
• Epidemiological situation (disease present, disease absent)
• Available vaccine strains & category (live, inactivated) + DIVA tests
• Blanket, barrier, ring, targeted (or combination)
• Species, category, zoos
• Timing (immediate, pre-season, when disease introduced/increased risk)
• Duration
• Management of vaccinated animals and their products (to-live, to-kill)
• Compulsory or voluntary
• Stakeholder involvement
• Distribution chain
• Exit strategy
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7. Assessment of resources
• Vaccine (procurement) – number of doses
• Personnel (+/- procurement)
• Facilities, transport, equipment, consumables, laboratory
• Financial
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8. Communication
• Different stakeholders (farmers, vets, industry,
supermarkets, consumers)
• Meetings, TV, radio, website, information packs
• Key messages
• Awareness leaflets
• Q&As
• Communication plan
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9. Information needed on each vaccine
• Trade name
• Manufacturer/licence holder
• Active ingredients (virus strain)
• Category of immunological (live, inactivated)
• Species
• Status in relation to authorisation
• Link to SPC (or equivalent)
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10. Summary of Product Characteristics (SPC) data
1. Name
2. Composition:
• Active component, adjuvant, excipients
3. Pharmaceutical form
4. Clinical particulars
4.1 Target Species
4.2 Indications for use in each species
4.3 Contraindications
4.4 Special warnings for each species
4.5 Special precautions for use
4.6 Adverse reactions (frequency and
seriousness)
4.7 Use during pregnancy, lactation or lay
4.8 Interactions with other VMPs
4.9 Amounts to be administered and
administration route
4.10 Overdose (symptoms, procedures)
4.11 Withdrawal period(s)
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11. Summary of Product Characteristics (SPC) data
5. Immunological propeties
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf-life
6.4 Special precautions for storage
6.5 Nature and composition of immediate packaging
6.6 Special precautions for the disposal of unused product/waste materials
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
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