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

1. Vaccine Security for FAST diseases
The ‘’HOLD-FAST”” Strategy and Workprogramme (2020-23)

2. The EuFMD – an FAO Art.XIV body
39 member countries – supports > 80
Co-ordinated actions with FAO, EC and OIE

3. ANIMAL HEALTH
SECURITY THROUGH
BETTER PREPAREDNESS AND
REDUCED RISK FROM FMD AND
SIMILAR TADS
(‘’HOLD-FAST””)
The 4 year
EuFMD Strategic Plan
Approved by the 43rd General Session, EuFMD, April 2019
2019

4. EuFMD Strategic Plan - Our THREE GOALS (“Pillars”)

5. Significant new elements in the Strategy – and 4 year
programme
Europe-wide TADS
modelling capacity serving
MS and the region as a
whole (EuFMDis+)
Laboratory proficiency and
capacity for FAST diseases
established across the
Balkan countries supported
by a diagnostic bank
Integrated FAST disease
early warning system in the
REMESA/neighbourhood
region
be in place by end of 2020.
Vaccine security platform:
Addresses a gap affecting
contingency planning

6. GLOBAL VACCINE SECURITY -
OS18

7. Vaccine security –the concept
"Food security exists when all people, at all times, have physical,
social and economic access to sufficient, safe and nutritious food
which meets their dietary needs and food preferences for an
active and healthy life. Household food security is the
application of this concept to the family level, with individuals
within households as the focus of concern (FAO, 2003) "
Vaccine Security
…..people, at all times have physical, social and economic access
to sufficient, safe and effective vaccines to meet their needs and
of the livestock in their care……

8. OS18
Why can’t risk managers – and livestock
owners - access FMD vaccines when they
need them?
MD

9. OS18
Why is it so hard to obtain vaccines?
Money is often NOT the problem. There are
other barriers
And
FMD
VACCINES

10. What is the extent of
vaccination gap? in
large ruminants in non-
free countries?
~ 90%
Vaccination coverage is
currently 13% at best
(much less in SS Africa)
Assuming:
 900 million LR (excludes China)
 Bi-annual vaccination (=1.8
billion doses needed)
 All vaccine is used for cattle/LR
(unlikely – some pigs/SR)
 Based on C Miller, OS18 paper
X 900
million
Currently
–not even one leg to stand
upon = insecurity!

11. Vaccine supply challenges
 Inaccessible and/or non-quantified market
 Lack of sales forecasts
 Complex supply models: sudden surges
 Long term and heavy capital investment required
 Difficulty & costly to produce quality FMD vaccine
 Constant R&D investment in emerging strains
 Complex and costly studies for registration
Few global manufacturers
Shortage of quality FMD vaccine

12. Key Recommendations of OS18
1. Improving vaccine availability
2. Engagement with manufacturers
3. Development of a PPP network to:
 Create an enabling environment for
investment
 Support R&D for innovative
technologies and partnerships
 Ensuring inclusion of all stakeholders
in the value chain
4. Understand the barriers such as registration
and legislation
5. Support manufacturers tackling five major
challenges: bio-secure facilities; expensive
process; constant R&D; registration;
6. Support activities for monitoring of circulating
viruses & vaccine matching
7. Pursue right to access effective vaccine for
livestock keepers in endemic settings

13. GLOBAL VACCINE SECURITY – OUR PARTICIPANTS
VIEWS
OS18

14. OS18: Overwhelming support for action

15. Almost all believed that barriers to vaccine
access must be addressed

16. Strong support for work to quantify future
growth in demand for vaccines (92%)

17. What did we do after?
OS18
 New Strategy agreed
(April 2019)– with
vaccine security a
horizontal component
 Workplans agreed
(September 2019)
 Funding agreed – 4
years, EU DG-SANTE

18. TWO Vaccine Security Components:
Component 1.3 : Vaccination in emergency response plans for FAST diseases
Objective:
Increased preparedness for use of vaccination in emergency response plans for FAST diseases through an increased
understanding of the constraints to use vaccination and through the establishment of new systems to increase FMD vaccine
security.
Component 3.4 : Improved security in FMD vaccine supply
The overarching objective :
Improved security in FMD vaccine supply: support the Public Private Sector Platform (PPSP) to identify and promote solutions to
improve security in access to effective vaccines.

19. Component 1.3 : Vaccination in emergency response plans for
FAST diseases Sub-Activities
The expected result of the component will be achieved through a program of sub-activities:
1.1.3.1. Scoping work to understand the approach to emergency vaccination in MS
1.1.3.2. Regular reporting and guidance to Member States
1.3.2. Establishment of a public and private sector platform (PPSP) for FAST disease vaccination:
1.3.2.1. PPSP regular meetings (2 per annum)
1.3.2.2. Development of guidance papers and studies (3 in 24 months)
1.3.3. New systems to improve FMD vaccine quality and availability:
1.3.3.1. Pre-qualified supplier system for the immediate procurement of vaccines meeting pre-agreed quality
criteria for use in MS; (by Month 18)
1.3.3.2. Assured emergency Supply OPtions (AESOP) for FMD vaccines
– (detailed system by Month 18, System established by the third year of phase V)

20. Initial Actions – Component 1.3
1. Recruitment of Technical Leader
Dr David Mackay
2. Planning for the 1st PPP –VSP meeting : scheduled 22-23rd January 2020, Rome
Meeting between public (medicines regulators, emergency managers, key reference centres) and
vaccine producers, to identify potential solutions to issues affecting availability of FAST vaccines for
emergency use. Sharing of new initiatives (including pre-qualification, AESOP) - and commissioning
studies/guidance for next meetings.

21. OS18
Assured Emergency Supply OPtions (AESOP)
- addressing need to increase reserves for FMD emergencies
EuFMD Feasability study -2017/18
But: Needs first a
prequalification
step to select
quality suppliers

22. Component 3.4 : Improved security in FMD vaccine supply
The biggest issue…for the smallest component…
through a program of sub-activities:
3.4.1. Advance the understanding of technical and policy constraints and solutions for improved
vaccine access and supply in countries in PCP Stage 1 to 3 (→ Report on current unmet demand and future
growth presented at 44 General Session (April 2021)
3.4.1.1. Understand the barriers and drivers for adoption and factors influencing the supply
3.4.2. Development of guidance and advice to the PPSP (→ Three guidance papers and/or studies to be
available by Sept 2021)
3.4.2.1. Regular co-ordination with the PPSP
3.4.2.2. Produce technical and policy study reports and guidance papers

23. Summary
1. There is a real opportunity in the next 4 years to work together on complex issues
2. We have serious concern for our vaccine supply arrangements - for the range of
FAST diseases
3. For FMD, a pre-qualification system could open opportunities for greater inter-
regional /mutual acceptance of FMD vaccines (emergency and preventive use)
4. Desire to explore the feasibility of the PQ system as a mechanism agreed between
FAO and OIE
5. Critical need to increase access to vaccines in endemic regions - and understand
barriers to supply
6. Working with the private sector vaccine producers is essential - we bring a desire
to listen, learn and work in synergy.