Process for approving FAO-OIE rinderpest holding facilities and research proposals
1. Maintaining Global Freedom from Rinderpest International Meeting • 20-22 January 2016 • Rome, Italy
Process for approving FAO-OIE RinderpestProcess for approving FAO-OIE Rinderpest
Holding Facilities and Research ProposalsHolding Facilities and Research Proposals
Samia Metwally
Animal health officer (Virology)Animal health officer (Virology)
Animal Production and Health DivisionAnimal Production and Health Division
FAO, Rome ItalyFAO, Rome Italy
2. Maintaining Global Freedom from Rinderpest International Meeting • 20-22 January 2016 • Rome, Italy
FAO-OIE Rinderpest Holding Facilities
Categories
• A) Rinderpest Holding Facility for storing rinderpest virus
containing material, excluding vaccine stocks;
• B) Rinderpest Vaccine Holding Facility for storing only
manufactured vaccines, vaccine stocks and material solely
for their production.
3. Maintaining Global Freedom from Rinderpest International Meeting • 20-22 January 2016 • Rome, Italy
Rinderpest virus-containing material (RVCM)
Risk rank
• High Risk
– field and wild isolates stored in any form stored in frozen status, or in
lyophilized status
• Potential Risk
– vaccine stocks stored in good conditions which were produced where
wild strains were manipulated- cross-contamination
• Not potential risk
– vaccine virus (with documented history to be safe)
– field sera and samples with RP history that have been immersed in
fixative and preserved over decades
4. Maintaining Global Freedom from Rinderpest International Meeting • 20-22 January 2016 • Rome, Italy
FAO-OIE Holding Facility
Category A: mandate, (RVCM-excluding vaccine)
• hold and accept RVCM from FAO and OIE Member Countries
• retain an up-to-date inventory of RVCM and provide an annual report
• provide advice or training on the destruction, safe shipment of RPV-
containing material, and/or decontamination of facilities
• participate in scientific meetings in its capacity as FAO-OIE RHF
• establish and maintain a network with other rinderpest holding facilities
• seek approval from FAO and the OIE before manipulating RVCM
• Cooperate with FAO and OIE when decide to carry out an audit or site
5. Maintaining Global Freedom from Rinderpest International Meeting • 20-22 January 2016 • Rome, Italy
FAO-OIE Holding Facility
Mandate (Category B- vaccine)
• retain an up-to-date inventory of vaccine stocks for the region
• validate or destroy stocks of expired vaccines
• regularly test the quality of the vaccines in accordance with the OIE
guidelines
• contribute, when requested by FAO and the OIE, to the global rinderpest
vaccine bank and preparedness strategy
• accept vaccine virus seeds or stocks from FAO and OIE Member Countries
for safe storage and/or for destruction
6. Maintaining Global Freedom from Rinderpest International Meeting • 20-22 January 2016 • Rome, Italy
Process for Approval of FAO-OIE Holding
Facilities
7. Maintaining Global Freedom from Rinderpest International Meeting • 20-22 January 2016 • Rome, Italy
Site Inspections of Holding Facilities
9. Maintaining Global Freedom from Rinderpest International Meeting • 20-22 January 2016 • Rome, Italy
Approval of Rinderpest Research
Objectives of the research proposal should meet one or more of the following criteria:
•Protect or improve food security
•Sustain effective and efficient global freedom from rinderpest
•Provide significant scientific benefits for public health or animal health
Review of research proposals should account for the following factors:
•Scientific and technical merits of the proposal and methodology are valid and feasible
•Whether the use of RVCM is essential for the research
•Has significance to the post eradication era
•Adequate biosecurity and biosafety measures in place
•Appropriate animal welfare standards
•Potential for malign use of the research outputs has been considered
•Principal investigators’ knowledge, capabilities, related experience, past performance and
qualifications
10. Maintaining Global Freedom from Rinderpest International Meeting • 20-22 January 2016 • Rome, Italy
Rinderpest Research Projects Approved
1. “Testing the potential for protecting cattle against rinderpest virus
using attenuated peste des petits ruminants virus vaccines”. The
Pirbright Laboratory. Completed
2. “Development and Deployment of non-infectious diagnostic test”.
Foreign Animal Disease Diagnostic Laboratory (FADDL) , Plum Island,
USA.
3. Maintaining diagnostic capability for rinderpest virus”. The
Pirbright Laboratory.
4. “Sequence and destroy: full genome sequencing of rinderpest virus
isolates prior to their destruction”. (i) FADDL, (ii) The Pirbright
Laboratory, (iii)CIRAD-BIOS.
11. Thank you for your attention
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Спасибо за внимание
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Merci de votre attention