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

1. Sources of information on the
availability of vaccines against FAST
diseases
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

2. Objectives
• Review the current sources of information on FMD and other
vaccines against FAST diseases to obtain an overview of the
type of information that is available, where the information
can be obtained and what are the restrictions on access.
• Inform decisions by risk managers on contingency planning
and response to disease emergency
• Includes resources both within and outside of Europe
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

3. Sources of information
• European funded projects/organisations
• European Medicines Agency (EMA)
• Heads of Medicines Agencies (HMA) and national agencies
• European Food Safety Authority (EFSA)
• DISCONTOOLS project
• Outside Europe/International organisations
• United States Department of Agriculture (USDA)
• Canadian Food Inspection Agency (CFIA/ACIA)
• OIE
• Non-governmental organizations (CABI, Vetvac.org)
• Universities (Iowa State)
• Vaccine manufacturers
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

4. • In the EU there is currently no single database of VMPs that is complete and
up to date
• EMA publishes information on centrally authorised products but not their
availability (currently 1 FAST disease vaccine - FMD)
• Provides a list of national competent authorities several of which have
published lists of licensed VMPs
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020
European Medicine Agency

5. Heads of Medicines Agencies
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020
• Veterinary Mutual Recognition Information Product Index
(VMRI)
• Contains information only on mutually recognised nationally
authorised products
• Has one FAST vaccine in database (FMD)
http://mri.cts-mrp.eu/veterinary/
• Product name
• MA holder
• Potency
• Species

6. EMA – New Veterinary Regulation
• In the EU there is currently no single
database of VMPs that is complete and up
to date
• From 2022, under new veterinary
regulations, the EMA will introduce a Union
Database of VMP
• All MS must submit and update information
on all licensed VMPs on their territory
• Clear legal obligation on manufacturers and
agencies
• Need to indicate product availability and
withdrawals/shortages
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020
https://www.ema.europa.eu/en/veterinary
-regulatory/overview/implementation-new-
veterinary-medicines-regulation

7. European Food Safety Authority
(EFSA)
• Gives scientific opinions on
different diseases including
aspects of vaccination
• Occasional specific
opinions on FAST vaccines
or helpful reviews
• e.g. Scientific Opinion on
sheep and goat pox
summarises evidence
related to vaccine
performance
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

8. United States Department of
Agriculture (USDA)
• Animal and Plant Health
Inspection Service (APHIS)
• Center for Veterinary Biologics
(CVB)
• Online list of licensed products
with published summaries of
safety and efficacy
• Only for products since 2007
(older products voluntary)
• No FAST diseases included
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020
Example of product summary – IBR, 2011

9. Canadian Food Inspection Agency
(CFIA)
• Database on Veterinary Biologics Licenses in Canada
• Emergency Preparedness section has list of vaccines
including AI, FMD and RVF with basic information
available
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020
https://www.inspection.gc.ca/active/netapp/veterinarybio-bioveterinaire/vetbioe.aspx#table-heading

10. World Organisation for Animal Health
(OIE)
• OIE Disease Cards contain some general information about
available vaccines which are periodically updated
• Has recommended standards for vaccines in the ”Manual of
Diagnostic Tests and Vaccines” published annually
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020
e.g. Rift Valley Fever

11. World Organisation for Animal Health
(OIE)
• Vaccine banks
• “OIE Vaccine Banks facilitate the procurement of high-quality
vaccines, manufactured in accordance with OIE standards, for the
benefit and use of OIE Member Countries”
• “At present (2018), the following three OIE Vaccine Banks are
operational:
• FMD Antigen/Vaccine Bank (prioritising Asia) established in 2011;
• Rabies Vaccine Bank (prioritising Asia and Africa) established in 2012;
• PPR Vaccine Bank (prioritising Africa) established in 2013.”
• Established for transboundary diseases with an existing global
strategy if vaccines are a key component of this and there are
available donor funds.
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

12. World Organisation for Animal Health
(OIE)
• Vaccine banks
• OIE don’t publish a list of eligible vaccines/manufacturers or
prequalified products
• Tenders every four years which specifies the requirements of the
vaccines (including the strains)
• European Union has its own vaccine bank for member states
• FMD
• Other diseases
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

13. Centre for Agriculture and
Bioscience International (CABI)
• Non-governmental organisation
• Invasive Species Compendium has detailed information
about vaccines which is regularly updated
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

14. • Free to use, searchable database of
commercially available livestock
vaccines found globally
• Created in partnership with GALVmed
and Inocul8
• Vaccine producers upload product
information voluntarily
• Website inactive (though references on
GALVmed website still present)
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

15. The Center for Food Security & Public
Health, Iowa State University
• Has animal disease information and technical factsheets
including aspects of protection from diseases
• Previously had a compendium of veterinary vaccines for
TADs which had a list of all vaccine manufacturers and links
to products
• “…no long available due to lack of funding”
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

16. • Originally an EU FP 7 project, now funded by organisations
from various European countries (Austria, Greece Italy, The
Netherlands, Spain, Switzerland, UK)
• Aim to provide a mechanism for focusing and prioritising
research leading to new and improved vaccines,
pharmaceuticals and diagnostic tests
• Open access database identifying research gaps
• Ran from 2008-2013 but restarted in 2014 following
stakeholder requests to continue. Still active today
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

17. • Can generate reports for different diseases (including FAST)
• Up to date and referenced information on vaccines including
availability:
• Commercial vaccines availability (globally)
• Commercial vaccines authorised in Europe
• Marker vaccines available worldwide
• Marker vaccines authorised in Europe
• Effectiveness of vaccines/main shortcomings of current vaccines
• Commercial potential for vaccines in Europe
• Commercial feasibility (e.g. manufacturing)
• Opportunity for barrier protection
• Opportunity for new developments
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

18. • Example of report:
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020

19. Vaccine manufacturers
EuFMD Vaccine Security Meeting, 22nd-23rd January 2020
FAST disease Type of
vaccine
Serotypes Adjuvants Potency
measure
Efficacy*
data
DIVA status Estimated
number of
manufacture
rs (globally)
Licenced in
EU
FMD Killed (or
peptide in
China)
Normally to
lineage level
(not always).
Sometimes
strains
Aqueous or
oil
Antigen dose 3 or ≥PD50 NSP
purification
>60 (Mozzer,
2012)
Yes
PPR Live
attenuated
Strain usually
given.
Lineage not
necessarily
stated
None (all are
live
attenuated)
TCID50 None
typically
provided
None
available
>20 (Diallo,
2015)
No
RVF Live
attenuated
or killed (BEI
or formalin)
Killed,
Smithburn,
Clone 13,
MP-12
Aqueous
(aluminium
hydroxide)
TCID50 None
typically
provided
None
available
2 -
Smithburn
1 - MP-12
1 - Clone 13
3 – killed
No
LSD & SGP Live
attenuated
or killed
Strain usually
given (LSDV,
SPV or GPV)
Most are live
attenuated
TCID50 None
typically
provided
None
available
3 for LSDV
(FAO, 2017)
1 killed LSD
1 killed SGP
No
Summary of typical information provided by manufacturers for FAST diseases available globally

20. Summary and conclusions
• No single source of information exists on licensing and availability of
vaccines against FAST diseases
• Previous attempts to collate and curate information have been partially
successful but have not been sustained
• Risk managers need to be aware of multiple sources of information on
which to base their decisions
• Manufacturers remain the ultimate source of information on vaccines
and their availability
ExCom94

21. Points for discussion
• Are there other sources of information not referenced here?
• Is there value in collating, curating and making available information on
vaccines against FAST diseases?
• Do issues arise in terms of commercial or other aspects of confidentiality
of data and how can they be overcome?
• Who would pay to ensure information was accurate and up-to-date?
• How might manufacturers and licensing authorities be incentivised to
supply data to a voluntary database?
• Could a sustainable model be developed?
ExCom94