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

1. Establishing a pre-qualification system for
vaccines against FAST diseases
David Mackay
FAO Technical Lead – Vaccine Security
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
• Background
• Objectives
• Key principles
• Outline of PQ procedure
• Implementation
• Next steps
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3. Background
– Vaccination is a key element for control of Foot-and-Mouth
Disease And Similar Transboundary diseases (FAST)
– Assured availability of high-quality vaccines (vaccine security)
forms a key component of disease preparedness and response
(Component 1.3 of EuFMD Work programme)
– To date, the need for vaccines has been met through case-by-
case calls for tender
– a Pre-Qualification (PQ) system for vaccines should enable a
shift to more secure procurement arrangements with suppliers:
e.g. Long-Term Agreements, including “Assured Emergency
Supply Options (AESOP)”
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4. Objectives of a PQ system
– Improve security of vaccine supply against FAST diseases
– Ensure that vaccines supplied to FAO are
• of an appropriate quality
• fit-for-purpose for the use proposed by the applicant e.g. endemic
(disease prevention) or emergency (epizootic control) programmes
– To reduce risks of sourcing vaccines of inadequate quality,
safety and efficacy
– To reduce timescale required for procurement
– To ensure a standardised, transparent, rapid & objective
evaluation process for suppliers of FMD/FAST vaccines to FAO
– To reduce complexity & ensure predictability for suppliers and
assist their vaccine production planning
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5. What is pre-qualification ?
Pre-qualification involves
– Review of a summary of all available information on the quality,
properties and manufacture of a vaccine in line with published guidance
on content and format
– Additional evaluation of declared fitness-for-purpose for one or disease
control proposed purpose (disease prevention or emergency control)
– Establishes eligibility and reduces time needed for tender procedure in
emergency situations
– Generally applied to vaccines involving established technologies that are
already approved for use by one or more national regulatory authorities
– Innovative products with no history of safe use require special, in-depth
consideration
– Routine pre-qualification procedure not intended for urgent, emergency
evaluation in crisis situations
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6. Key principles – 1: Overview
– EuFMD will lead the technical work to develop the PQ system
– Subject to feasibility, FAO will operate the PQ system with FMD
vaccines as pilot
– Evaluation process will involve independent experts appointed
through a procedure coordinated by EuFMD/FAO
– Vaccines will be evaluated with respect to quality, safety,
efficacy, suitability for proposed use and ability to manufacture
and supply to appropriate standards
– Evaluation of suitability for use in particular disease situations
(e.g. relevance of strains) will be evaluated as part of future
tender procedures and not during PQ
– A final decision will be made based on a recommendation by a PQ
Panel appointed by FAO (Panel to be discussed later)
– FAO will establish and publish a list of vaccines that have
successfully been pre-qualified (PQ approved)
– Cost recovery : for sustainability of the PQ system it is anticipated
that a system of fees and charges will be necessary
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7. Key principles – 2: compliance with OIE and
national authorisation/registration/licensing
processes
– The standards for acceptability will be those set out in the
relevant general and specific chapters of OIE Manual of
Diagnostic Tests and Vaccines for Terrestrial Animals (‘OIE
standards’)
– The process of PQ will be simplified for products that have
already been approved by a national competent authority
(providing these NCAs themselves meet criteria for competence
in authorisation of veterinary immunological vaccines)
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8. Key principles – 3: coherence with best practices
established for the WHO –PQ system
– A phased approach will be adopted, focussing initially on
establishing a list of PQ vaccines against FMD and progressively
expanding to establish lists for other diseases
– The procedure aims to be consistent with principles used in the
establishment of the Vaccine Banks operated by the International
Office for Animal Health (OIE).
– The procedure takes into account the principles and operation of
the WHO ‘Procedure for assessing the acceptability, in principle,
of vaccines for purchase by United Nations agencies’1, adapted as
required for the veterinary context
– Cooperation with EMA in the context of Article 138 of Regulation
(EC) 2019/6 is foreseen from the coming into force of this
legislation in 2022
1 https://www.who.int/immunization_standards/vaccine_quality/TRS_978_61st_report_Annex_6_PQ_vaccine_procedure.pdf
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9. Key principles – 4: cooperation with National
Regulatory Authorities (NRA)
– Vaccines will generally be authorised or otherwise approved
(Licensed or Registered) for use by a National Regulatory Authority
or an application for authorisation/use will have been made
– This NRA will be expected to have regulatory oversight of the
product and its manufacture (or to cooperate with another NRA
that does)
– FAO will cooperate with these NRAs throughout the process of PQ
– The extent of cooperation and involvement will depend on the
functionality of the NRA
– The process of PQ will be simplified and accelerated where
products have been authorised and are controlled by an NRA
considered as functional by FAO
– FAO may consider alternative arrangements for product
supervision where oversight of the product by a functional NRA at
the site of manufacture/batch release cannot be established
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10. Eligibility criteria for applying for PQ evaluation
Manufacturers may submit a request to apply for PQ
evaluation for a specific vaccine provided the following criteria
are met
– the vaccine meets the essential criteria for a particular disease
control purpose:
• disease prevention and/or emergency use (epidemic control)
– for the relevant disease control purpose for which PQ is sought
• the manufacturer is able to provide appropriate documentation on the quality,
safety, and efficacy of the vaccine in line with the requirements of the PQ
procedure
• the vaccine is produced in compliance with appropriate standards of quality
assurance and quality control, the production facilities comply with the
appropriate standard of Good Manufacturing Practice (GMP) and the
manufacturer has the capacity and capability to meet the requirements of a
future tender
• the vaccine is either already authorised or otherwise permitted to be used by
an NRA or an application for authorisation has been submitted (exemptions
from this requirement may apply in exceptional situations)
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11. Outline of PQ Procedure – Step 1: Validation
Prepare application
and Product Summary
File (PSF)
Validation by FAO for
eligibility and
completeness
FAO appoints
evaluation team and
Lead National
Regulatory Authority
(NRA)
Submission requires
revision
Manufacturer
FAO
Independent Experts
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12. Outline of PQ Procedure – Step 2: Evaluation
Evaluate
application for
suitability for
disease control
purpose against
defined essential
criteria
Evaluate
application for
Quality, Safety,
Efficacy including
history of use
Evaluate
documentation
and decide on
need for site
visit(s) for GMP
inspection and
audit of ability to
supply to FAO
requirements
Request
additional
data
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13. Outline of PQ Procedure – Step 3: Visit of
sites(s) manufacture
Arrange visit of
the sites(s) of
manufacture
according to
requirements
determined from
evaluation of PSF
Inspection
and/or audit of
site(s) of
manufacture and
batch release
Site of
manufacture
compliant with
GMP and
manufacturer
able to meet FAO
essential supply
requirements
Corrective action
by manufacturer
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14. Outline of PQ Procedure – Step 4: Decision on
need for product testing
Decision on need for
product testing based
on outcome of PSF
evaluation and GMP
inspection/audit
Yes
Independent
testing by
Reference
Laboratory
Testing demonstrates
production of a
vaccine that meets
specifications and
fulfils programmatic
requirments
Pass
Application
rejected
FAIL
No Testing Required (default)
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15. Outline of PQ Procedure – Step 5: Decision on
Pre-Qualification
Report prepared by
Lead NRA based on
- Evaluation of PSF
- Outcome of audits
- Results of product
testing
Recommendation by PQ
Panel to FAO based on
review of report
Pass
FAO adds product to list
of PQ vaccines for
defined purpose(s)
Additional
information
required from
Evaluation Team
or Manufacturer Fail
FAO informs manufacturer
of reasons for failure of PQ
procedure
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16. Maintenance of PQ status
– How long with products remain on the PQ list?
– Proposals
• Obligations are placed on manufacturers of vaccines included on the PQ
list
• FAO will periodically review the PQ list and seek the views of the PQ Panel
for re-revaluation or removal of products based on risk assessment/review
– using agreed criteria (e.g. reports of quality issues, adverse events, significant
changes to the product or changes in the benefit risk assessment)
– Review of relevant post-vaccination monitoring (PVM) studies (with PQ vaccine
procured by FAO)
• Products will remain on the PQ list until a decision is made by FAO to
remove them, based on a recommendation from the PQ Panel
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17. Maintenance of PQ status
The following obligations apply to manufacturers of vaccines on the
PQ list
– Ensure that the product remains authorised in the countries indicated in
the PQ dossier or inform FAO of any changes
– Ensure that approved sites remain in compliance with GMP and cooperate
with periodic re-inspection, in cooperation with FAO and supervisory NRA
(if relevant)
– Cooperate with FAO and the supervisory NRA (if relevant) in the conduct
of Post Vaccination Monitoring (PVM) studies for FAO-supplied vaccines and
for general pharmacovigilance
– Report any information that might alter the benefit risk assessment for the
product such as quality defects, recalls, important pharmacovigilance
issues or batch release deviations such as out-of-specification results
– Inform FAO of major variations made to the authorisation that are
included in a list of such changes that will be published as part of the PQ
procedure
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18. Implementation
A phased implementation is envisaged
– Agreement on key principles and outline of procedure
– Identification and resolution of key issues
– Documentation of the procedure, guidance and interim cooperation
agreements
– Establishment of elements required for operation (secretariat, experts,
panel)
– Open call for volunteer applicants for PQ
– Validate applications
– Evaluation (e.g. 90-180 days)
– PQ Panel review : initial applications
– PQ System Review
• Recommended revisions
• FAO response on recommendations
• Implementation plan for definitive PQ procedure
Timescale to be determined following first meeting
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19. FAO’s Procurement of FAST Vaccines
 FAO’s procurement volume: 22 M$ over the past 5 years;
 A PQ system would positively impact FAO’s procurement of vaccines
by:
. supporting the supply of quality vaccines;
. reducing procurement processing time and hence supply lead time;
. giving more visibility to the market and raising interest of
stakeholders inclusive of donors (ref. sustainability of the PQ
system);
. facilitating the establishment of Long-Term Agreements for supply
in emergency situations and for progressive control programmes;
 Ultimately, it could also support the procurement of FAST vaccines
by other UN agencies or public entities;
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20. Next steps
• Discuss outline proposal and identify key issues
• Establish working group(s) to develop proposal
• Initiate discussion with interested parties that will be
involved in operating, or applying to, the PQ procedure
to establish support and engagement with the
initiative
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21. Background Slides
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22. How does PQ differ from a tender procedure?
A specific tender tender involves
– One-off evaluation of compliance with specific
requirements published in tender document
– Evaluates use in a single, defined set of circumstances
which may involve routine or emergency use
– Includes evaluation of both manufacturing quality and
vaccine properties in relation to proposed use
– Usually carried out in a short timeframe in response to a
specific situation
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23. Areas evaluated at PQ vs. Tender
Pre Qualification
• Review of Q, S, E
• Authorisation status
• Quality standards applied to manufacture
(GMP)
• Evidence of quality and consistency of
production of final product (manufacturer
and independent data e.g. OMCL)
• Fitness of vaccine for stated disease
control purpose (e.g. routine use;
emergency use; vaccine bank) vs. Target
Product Profile (TPP)
• Capacity and capability of manufacturer to
produce and deliver vaccine in amounts
and through supply chains appropriate for
FAO tenders
Tender
• TPP vs intended use*
• Appropriateness of
vaccine to particular
disease control
programme/
epidemiological situation
• Choice of strains
• Quantity
• Vial size
• Cost
ExCom94
• PQ opens the possibility of framework contracts/restricted tenders to those
manufacturers with products matching a particular TPP

24. How does PQ differ from marketing
authorisation/licensing?
Marketing Authorisation/licensing involves
– In depth assessment of quality, safety and efficacy to determine
• Quality and consistency of final product
• Compliance with GMP and other quality standards
• Safety for the target animal, users, consumers and the environment
• Efficacy in line with claims made and relevant guidelines
– Routine procedure based on published national and international
standards
– Allows access to national market in line with terms of
authorisation
– Same level of assessment for innovative products/technologies and
products based on established technologies
– Emergency/provisional authorisation procedures for use in
exceptional situations with reduced data requirements
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25. Key issues – list to be developed
– How does the PQ deal with fitness for specific national or
regional vaccination purposes; Should programmatic suitability
be examined as part of PQ or as part of tender procedure??
– How does the system address the specific issue of emergency
vaccine supply?
– How should ‘an FMD vaccine’ be defined for the purpose of
inclusion on the PQ procedure
– How should previous evaluation by regulatory authorities be
taken into account in the PQ system?
– What role should the NRA in the country where the product is
authorised play in the initial PQ evaluation and maintenance of
PQ status?
– What if the NRA of the country of manufacture (or batch
release, if different) is different from the NRA of authorisation?
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26. Key issues – list to be developed
– What if the product is not authorised by a functional NRA?
– What if the product is innovative?
– What should be evaluated as part of the PQ procedure? Should
data on previous use be included?
– What formats for submission of the PSF should be accepted?
– What role should product testing play in the PQ procedure
– What should be the timescale for PQ evaluation?
– Should programmatic suitability be examined as part of PQ or
as part of tender procedure
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