2. 2
Prequalification can be useful
BUT needs to be practical and workable
• Overly burdensome requirements could add barriers
• Lessons may be learnt from the human side
• Who will set requirements?
• Who will make the assessment of suitability?
• Mechanism to remove or replace vaccines when better vaccines
become available?
• Will there be prequalification of new technology vaccines?
Prequalification - Administrative
3. 3
Requirements:
• need to ensure high quality vaccines are used
• need to be non-region specific in approach
• need to fit different climatic and infrastructure requirements
• flexibility where vaccine options are limited
Prequalification - Requirements
PROPOSAL: Create a joint (Public/Private) WG to develop a pre-
qualification scheme, including clear guidelines to define
requirements.
4. 4
Disease Control Strategies 1
Strategies need to be holistic:
• Well-led cooperation between all stakeholders is essential
• Implementation needs to be coordinated and sustainable, including
livestock movements/identification, and conditions to achieve
vaccination coverage
• Sporadic/reactive vaccination campaigns will not control disease
• Assurance that adequate storage facilities are in place in-country
(including ensuring the cold chain) to adequately stock the vaccines.
5. 5
Disease Control Strategies 2
Improvements in surveillance
• better reporting of outbreaks at animal owner level upwards
• improved sampling, typing and sharing of information about
circulating field strains
• How to ensure vaccines for emerging or niche diseases are made
available?
PROPOSAL: FAO, OIE and other involved organisations to improve
and coordinate surveillance.
6. 6
Competition for access to facilities is a real challenge: Therefore:
• accurate forecasts are critical for industry for planning purposes
• common data models and data protocols
• common understanding of capacity/demand to ensure enough volumes of
FAST disease vaccines
• info-sharing about countries expected requirements
• mechanism to share risk - production and uptake
Forecasting capacity.
7. 7
Nagoya Protocol
Complex picture with differing national interpretations of the
protocol.
• When does R&D start? (there is no definition of R&D in the protocol)
How do we avoid negotiations on PIC and MAT unnecessarily
delaying vaccine production:
• In an emergency situation
• Updating existing vaccines to new strains
PROPOSAL: Work to remove pathogens from the scope of Nagoya
Protocol