Vaccine strategic reserve for East Asia: what we have and what we need
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Transcript of Vaccine strategic reserve for East Asia: what we have and what we need
Vaccine strategic reserve for East Asia; what we have and what we need
Taro KokuhoNational Institute of Animal Health, NARO, Japan
Maintaining Global Freedom from Rinderpest, FAO, Rome, Italy
20-22/Jan/2016
改めて学ぶワクチン学― 牛疫撲滅の歴史を例にして―
動物衛生研究所 動物疾病対策センター 製造科 国保 健浩
平成27年度ウイルス講習会
平成27年10月13日
Brief introduction of National Institute of Animal Health
Fact
Headquarters & Main Research Center (Tsukuba)RPHF; category B
Exotic Disease Research Facility (Tokyo)RPHF; category A
South Branch for Tropical Disease Research
North Branch for Dairy Sciences
- Member institute of agricultural research organization, NARO- Only one institute for animal health research in Japan (established in 1904)- R&D, education & training, diagnosis as national/international reference, natural resource bank, biologics manufacturing- 175 research staff & 60 administration personnel
Food Hygiene
Public Health Sector Livestock hygiene center: 166
Vets: 2,084
16 Veterinary
Schools
Disease Control and Biologics
Administration
Research & Education
Veterinary officers of local government (47 prefectures)
GOJ
Ministry of Public Health Labor and Welfare
(MHLW)
Ministry of Education, Culture, Sports, Science (and Technology
(MEXT)
MAFF
Agriculture Sector
Agriculture, Forestry and
Fisheries Research Council
Slaughterhouse: 112Vets: 2,003 Commercial farms
- Audit- Inspection- Surveillance- Consultation
Clinicaldoctors
NIAHTechnical advice
Education and training
NARO
Food Safety and Consumer Affairs
Bureau
NIAH in Animal Hygiene Management of Japan
改めて学ぶワクチン学― 牛疫撲滅の歴史を例にして―
動物衛生研究所 動物疾病対策センター 製造科 国保 健浩
平成27年度ウイルス講習会
平成27年10月13日
Short history of rinderpest in Japan
改めて学ぶワクチン学― 牛疫撲滅の歴史を例にして―
平成27年度ウイルス講習会
平成27年10月13日
The initial outbreak of rinderpest in Japan was recorded in 1636.
The outbreak continuously happened and increased with the import of live cattle from the continent.
The first preventive measure for reinderpest was implemented in 1878.
平成27年10月13日
Dr. Kakizaki developed world’s 1st inactivated rinderpest vaccine in 1917.
平成27年10月13日
The production of anti-rinderpest antisera had been started in 1897. The new production factory was build in Fusan, Korea in 1910.
The last clinical case in Japan was reported in 1920.
平成27年10月13日
Ako branch of the National Institute of Animal Health was settled in 1952. The current vaccine strain, LA-AKO, was established from L strain at Ako branch in 1957.
Dr. Nakamura established rabbit attenuated live vaccine, L (or Nakamura III) strain, from the pathogenic field strain, Fusan (B), in 1938.
- L strain is still pathogenic to highly susceptible cattle breeds, such as Japanese black, Korean yellow.
Then, he established chick embryo attenuated lapinized live vaccine, LA strain, in 1940.
- Those cattle were immunized with L strain vaccine in combination with anti-RP antiserum.
改めて学ぶワクチン学― 牛疫撲滅の歴史を例にして―
動物衛生研究所 動物疾病対策センター 製造科 国保 健浩
平成27年度ウイルス講習会
平成27年10月13日
Production of LA-AKO vaccine for rinderpest in NIAH
Regulation for veterinary vaccine manufacturing
GMP division GQP division
Factory A CB
Materials
Sales division
User
GVP division
NationalAssay
Laboratory
Validation/evaluation
Approval/certificationFollow-up/recall
distribution
Materials Materials
- RP vaccine is stored for emergent use only.
GMP facility of NIAH for vaccine manufacturing
- Currently, 12 biological products are produced by 20 staff at this facility.
改めて学ぶワクチン学― 牛疫撲滅の歴史を例にして―
動物衛生研究所 動物疾病対策センター 製造科 国保 健浩
平成27年度ウイルス講習会
平成27年10月13日
Biological property of LA-AKO vaccine
平成27年10月13日Pedigree of RP vaccine of Japan
- Passage history of the currently used seed of LA-AKO; 456 and 29 passages in chick embryo and in rabbit, respectively
- No clinical sign other than hyperthermia is observed even inhighly sensitive breeds such as Japanese black, Korean yellow.- Biomarkers facilitate easy differentiation of LA-AKO from other field strains.
Takamatsu, Terui, Kokuho. Genome A (2015)
- Over all similarity of LA-AKO with its parental strain, Nakamura III, and most widely used vaccine strain, RBOK, is 97% and 88% at nucleotide level, respectively.
Phylogenic tree of RP strains
- Several SNPs may exist in viral genome of LA-AKO used for RP vaccine production.
改めて学ぶワクチン学― 牛疫撲滅の歴史を例にして―
平成27年度ウイルス講習会
Possibility for extended storage of LA-AKO strain vaccine
改めて学ぶワクチン学
動物衛生研究所 動物疾病対策センター 製造科 国保 健浩
平成27年度ウイルス講習会
平成27年10月13日
Conclusion
- LA-AKO strain is a safe vaccine strain, especially for highly susceptible Asian cattle breeds.- Our vaccine may be active after long term storage at an appropriate temperature.- We are currently producing 100,000 doses of RP vaccine every two years under the control of national laws and regulations.
- We need to discuss possible vaccination strategy and strategic storage and global distribution of RP vaccines for unpredictable outbreak.
We have submitted a revised version of OIE terrestrial manual (Chapter 2.1.15, section C. REQUIREMENTS FOR VACCINES) for discussion in the general meeting 2016.
Thank you
Merci
有り
難う
ござ
いま
した
Gracias謝謝
The Eradication of Riderpest from Africa, AU-IBAR (2011)
80 年代の牛疫による壊滅的被害
強毒牛疫株(釜山株)による感染実験
Vero cells, LA-AKO inoculated
Day1 Day2