OIE Regional Workshop on Risk Analysis for Veterinary Vaccines (Tokyo, Japan, 1-3 March 2011)
The Regional Workshop on Risk Analysis for Veterinary Vaccines "Practical Application, including vaccines related to new and emerging technologies" in collaboration with the National Veterinary Assay Laboratory (NVAL) and the National Institute for Animal Health (NIAH), was held in Tokyo, Japan from 1 to 3 March 2011. This workshop was considered partly as a follow-up of the one held in 2009 in Kuala Lumpur, where participants felt the need for further work toward better understanding and application of risk analysis to support vaccine quality and secure effective vaccination in the Region.
The main objectives of this Workshop were (1) to review the risk analysis methodologies currently applied to veterinary vaccines (including new and emerging technologies), (2) to develop an understanding of how to apply such methodologies and of what is missing in the current vaccines policies in the Region, (3) to raise awareness of the recent discussions at OIE ad hoc Group on vaccines in relation to new and emerging technologies and the OIE's work in relation to vaccines, (4) to inform participants of OIE initiatives concerning a vaccine bank, and (5) to inform participants of the roles and functions of the relevant OIE Collaborating Centres in the Region.
The Workshop was partially sponsored by the International Service of USDA-APHIS.
As indicated in the programme attached, one full day and two half days were for lectures, group discussions and presentation of their results, and one half day was for laboratory visits at NVAL and NIAH, which are jointly designated as an OIE Collaborating Centre for Diagnosis and Control of Animal Diseases and Related Veterinary Product Assessment in Asia.
Out of sixteen member countries/regions invited, fifteen sent participants. Participants understood the follow-up nature of this workshop and came with knowledge of risk analysis for vaccines, which was reinforced by the first presentation's review of the previous workshop, and the subsequent presentations on risk analysis by invited experts, in particular presentations on case examples of application of risk analysis methodologies, attracted much attention.
There had been some concern that many members in the Region might not yet be interested in vaccines produced by using new technologies. However, such topic, which was presented from two perspectives, one from OIE ad hoc Group discussion and the other from NIAH research development, was treated by participants as inspiring.
NVAL made a short but useful presentation summarising all the country papers submitted by members in advance. This provided a basis for the following group discussion, where many ideas for recommendation were produced. Participants were divided into three groups based on their preferred topic: 1) Factors for rapid supply of veterinary vaccines against emerging and re-emerging disease outbreaks; 2) How to improve test capability in the Region; and 3) How to respond rapidly and adequately to Adverse Events (AE) of veterinary vaccines. As the discussion was very active, many participants pointed out the shortage of time (one half day).
The session for specific topics related to vaccines comprised three presentations outside the area of risk analysis: 1) VICH framework and activities; 2) FMD outbreak in Japan from the view of using vaccines; and 3) OIE Vaccine bank in the Region. These helped participants discuss the importance of quality of vaccines and good vaccine policy for effective disease control, information sharing and eventual harmonisation of technical requirements for vaccine registration, and cooperation among members in emergency situations, including the use of regional vaccine banks.Presentations
| (1) | Background and objective of Workshop Dr Sayuri IWAKI (OIE RRAP) |
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| (2) | Risk analysis model currently used Dr Richard HILL (USDA APHIS) |
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| (3) | Report on Regional Activities in ASEAN Mr Asfri W. RANGKUTI (ASEAN) |
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| (4) | Risk Analysis for veterinary vaccines in Japan - Outline of Risk Analysis for veterinary vaccines in Japan - Documents Necessary for Risk Assessment of biological products Dr Shigeyuki NAKAMURA (NVAL) & Dr Koji OISHI |
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| (5) | Risk Analysis for veterinary vaccines in USA Dr Richard HILL (USDA APHIS) |
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| (6) | Recent Discussion at OIE ad hoc Group on Vaccines in relation to New and Emerging Technologies Dr Donna HUTCHINGS (OIE ad hoc Group) |
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| (7) | Additional asssessment required for recombinant vaccine under Pharmaceutical Affairs Law and Cartagena Protocol in Japan Dr Hideo SEKIGUCHI (MAFF Japan) |
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| (8) | Development of veterinary biologics using emerging technology Dr Shigeki INUMARU (NIAH) |
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| (9) | Activities and future plan of NVAL and NIAH as the OIE Collaborating Centre Dr Kenich SAKAMOTO (NIAH) & Dr Masato SAKAI (NVAL) |
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(10) | VICH Global Outreach activity Dr Hirotaka MAKIE (MAFF Japan) |
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(11) | Diagnosis and Control of FMD outbreak in Japan 2010 - from the view of using vaccine Dr Kenichi SAKAMOTO (NIAH) |
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(12) | OIE Vaccine Bank for the region Dr Tomoko ISHIBASHI (OIE RRAP) |
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