Disease control authorities seeking to purchase FMD vaccines are frequently faced with the situation that there are no vaccines with marketing authorisations issued by the regulatory authority in their own country. In these situations, authorities may choose to use vaccines for which it is difficult to obtain assurance on the standards that have been applied for manufacture, testing and the granting of any marketing authorisation that might exist (also termed registration or licensing). An important function of EuFMD is to promote vaccine security for member nations in terms of helping to assure the supply of vaccines of suitable quality when needed. As part of the work plan 2019-2023 EuFMD is putting in place a system for prequalification of FMD vaccines with the objective of promoting the use of vaccines that comply with minimum international standards. Increased uptake of vaccines that have been prequalified should also improve predictability of demand, thereby promoting investment by manufacturers and benefitting vaccine security for member nations. A system of prequalification is an important prerequisite for putting in place Assured Emergency Supply Options (AESOPs) for FMD, representing an alternative, or supplement, to conventional FMD vaccine banks.

1. EuFMD
OS22 Establishing a system for
prequalification of vaccines against
foot-and-mouth disease
David Mackay, Martin Ilott,
European Commission for the Control of FMD, Rome

2. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Rationale for prequalification
• The use of vaccines of high quality promotes effective disease control;
• Few FAST vaccines have full marketing authorizations (also termed licence or registration);
• The small size and unpredictable nature of the market makes it difficult for manufacturers to obtain and maintain
a marketing authorization;
• Competent authorities therefore seek information on vaccines produced and approved in other countries;
• Often difficult to verify the quality and properties of such vaccines;
• Measures that promote the selection and use of vaccines of high quality promote vaccine security by increasing
the market for high quality vaccines;
• An assurance of quality is an essential precondition for EuFMD/FAO to move from the current system of ad hoc
procurement of vaccines when required to establishing a system for long-term supply arrangements with
manufacturers (Assured Emergency Supply Options).

3. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Vision
• The vision for PQv is to improve vaccine security for FAST diseases by promoting the use of vaccines shown to
comply with internationally agreed minimum standards.
Goals
• Establish a system to independently review and make public information on the key characteristics of FAST
vaccines and on the extent to which they meet minimum international standards.
• Prequalify vaccines against foot-and-mouth disease (FMD) in the first instance with the possibility of extending
to other FAST diseases at later stages of development.

4. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22 4
PQv listing
Risk
managers
select PQv
vaccines
Increased
use of PQv
vaccines
Improved
market for
PQv vaccine
Increased
sales and
predictability
of demand
Evidence of
compliance
with WOAH
minimum
standards
Improving
Vaccine
Security

5. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Benefits of prequalification
• Create a publicly available source of independently verified information on FAST vaccines;
• Reduce time and resource required for procurement procedures;
• Inform decisions on approval for use of FAST vaccine by National Regulatory Authorities (NRA);
• Provide access to specialist expertise in evaluation of FAST vaccines and foster capability development in less
developed and/or experienced regulatory authorities;
• Promote the use of vaccines complying with at least WOAH minimum standards;
• Act as the prequalification stage for access to procurement procedures for long term supply arrangements
(AESOPs);
• Foster the exchange of sera, viruses and methodology between manufacturers and reference laboratories to
allow independent analyses for quality control and antigenic matching.

6. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Approach to prequalification
● Follows the same principles as WHO prequalification scheme but adapted to take account of the extensive
differences between the human and veterinary sectors;
● PQv evaluates the extent to which there is evidence that vaccines against FMD comply with at least minimum
internationally accepted standards, as defined in the relevant general and specific chapters of the Manual of
Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (the ‘WOAH
Terrestrial Manual’);
● PQv relies on a combination of existing regulatory approvals issued by national regulatory authorities together
with information provided by applicants in the Prequalification Evidence File (PEF);
● PQv therefore provides ‘qualification assurance’ for risk managers but does not attempt to duplicate or replace
the need for national regulatory approvals;
● Extensive consultation is required with a wide range of stakeholders to ensure that PQv fits within the existing
competence and responsibilities of other organizations operating at national and international level.

7. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22

8. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Phased approach to implementation
Stage 1
• 2020-2023
• Mandate from General Session of the EUFMD
• Assurance based on documentary review
• Information resource for risk managers in member nations of EuFMD
• Voluntary submission of applications from manufacturers
• Operated as a project by EuFMD
Stage 2
• 2023-2025
• Mandate sought to link PQv to EuFMD procurement procedures, particularly in relation to long term supply agreements
(AESOPs)
• Made available as a service to other organizations
• Assurance extended to include independent QC testing of vaccines
• Operational system established based on sustainable business model
Stage 3
• 2025 on
• Assurance extended to include compliance with GMP
• Final operational model in place for long term sustainability based on cost recovery
• Option to extend scheme to include vaccines against other FAST diseases and other veterinary medicines
Stage 2: Established operational system
Stage 3: Sustainable long-term operation
Stage 1: Proof of concept

9. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22 9
Risk-based approach
● The data requirements for PQv are laid out in the Technical guidance
● All manufacturers will submit a ‘Prequalification Evidence File’ to support a PQv application.
● PQv, at Stage 1, is a risk-based approach with the data requirements focusing on the critical elements of FMD vaccine
manufacture and testing rather than requiring a full date package of quality, safety, efficacy and post-authorization
data.
● A risk-based approach is designed to minimise the administrative burden for manufacturers whilst assembling a PEF
with all the critical information to enable the evaluation teams to assure FMD vaccines to WOAH standards.
● PQv applications will be evaluated by independent expert evaluation teams experienced in the regulation of veterinary
vaccines and the standards for manufacture and testing.
● The Standing Committee on Prequalification (SCPQv) is the decision making body for the content of the PQv listing

10. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Risk-based Approach
● Validation of the inactivation kinetics: Inactivation test method and iinactivation control/residual live
virus/innocuity test.
● Virus seed: Details of the tests performed on the MSV and WSV; Identity, titration, absence of bacteria and fungi,
absence of mycoplasmas, absence of extraneous agents.
● 146S content: as an in-process control test to quantify antigen input of the vaccine. Validation reports.
● Batch potency: Validation reports for the potency test for each vaccine strain.
● Identity test on each batch: Validation reports for the identity of each vaccine strain/serotype in the final product.
● Purity test (Non-structural proteins, NSPs): details of the test for the absence of NSPs as approved in national or
regional authorization.
● Batch consistency: Results for 3 consecutive batches to demonstrate consistency of production.
● Stability: The stability of the final vaccine should be demonstrated by supplying the data for at least 3 batches.
10
Pharmaceutical quality

11. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22 11
Risk-based Approach
● Safety: A summary of the critical laboratory safety studies should be included in the PEF, providing sufficient evidence
to demonstrate compliance with the minimum standards of the WOAH Terrestrial Manual.
● Efficacy: The laboratory studies to establish the efficacy of each vaccine strain including onset and duration of
immunity.
Safety and efficacy
● Provide information on the quantity of finished product distributed domestically and exported in the previous 3 years.
Production & Distribution
● Provide information on post-authorization regulatory actions; inspections, rejected lots, and any recalls.
Update on regulatory actions

12. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22
Key milestones achieved to date
 Strategic approach defined and documented following extensive consultation
 Governance and advisory structures in place – Technical Advisory Group and Steering Committee (PQvTAG and
SCPQv)
 Dedicated PQv Team - established within EuFMD Secretariat
 Technical guideline – public consultation closed
 Administrative guideline – public consultation closed
 Extensive consultation with stakeholders – Multistakeholder platform (MSP) established and well attended
Information Day in September with several expressions of interest to submit applications
 Letters of agreement with organisations to provide expert services - being finalized
 Individual expert services – call issued
 IT solution and internal SOPs for managing applications - under development
Stage 1 implementation on schedule to receive first applications from January 2023

13. #OS22
Conclusion
Presenter name
Short title for presentation
Presenter name
Short title for presentation

14. #OS22
Digitalization and innovation applied to the prevention and control of
foot-and-mouth and similar transboundary animal diseases (FAST) OS22 14
● Assuring the quality of vaccines is the
essential first step in promoting vaccine
security
● Prequalification relies on the principle of
‘qualification assurance’ with respect to
the standards for FMD vaccines in the
WOAH Terrestrial Manual
● Implementation will follow a phased
approach starting with desk review of
existing marketing authorisations (also
termed licences or registrations)
supplemented by documentary evidence
provided by manufacturers on
experience from use of the vaccine since
regulatory approval
David Mackay
Prequalification of FMD Vaccines

15. Thank you !..
https://www.fao.org/eufmd/en/
David.mackay@fao.org