Session 5 Minimum Standards on Rabies Vaccine and Vaccine Bank

Transcription

1 Session 5 Minimum Standards on Rabies Vaccine and Vaccine Bank Dr Yooni Oh Regional Representation for Asia and the Pacific Follow up workshop on relevant international standards for dog rabies Bangkok, Thailand, May 2016

2 THE OIE STANDARDS CODES MANUALS Terrestrial Aquatic Terrestrial Aquatic Standards to improve health and animal welfare, and veterinary public health World Organisation for Animal Health Protecting animals, Preserving our future 2

3 THE OIE STANDARDS CODES Health Terrestrial Standards for trade Aquatic in animals and animal products, surveillance and control of animal diseases, food safety, animal welfare, etc. MANUALS Biological TerrestrialStandards for Aquatic diagnostic tests and vaccines Standards to improve health and animal welfare, and veterinary public health World Organisation for Animal Health Protecting animals, Preserving our future 3

4 THE OIE STANDARDS When the Code requires a test that needs to be carried out for international movement or other designated purpose, the Manual should provide a recommended laboratory method. World Organisation for Animal Health Protecting animals, Preserving our future 4

5 OIE Terrestrial Manual Terrestrial Manual structure Divided into 4 parts, presented in 2 volumes: Volume I Volume II Part I Part 2 Part 3 10 introductory chapters 113 Chapters on specific diseases General Guidelines Part 4 OIE Reference Experts and disease index World Organisation for Animal Health Protecting animals, Preserving our future 5

6 Standards on Rabies Vaccines

7 Ch Outline Summary Section A. Introduction (aetiology) Section B. Diagnostic techniques Identification of the agent Serological test Section C. Requirement for vaccines For injectable use (minimum requirements) For oral use (minimum requirements) World Organisation for Animal Health Protecting animals, Preserving our future 7

8 C. Requirements for Vaccines General background RABV; causative agent of the classical rabies & responsible for the vast majority of all human rabies cases all lyssaviruses can cause indistinguishable fatal encephalitis both in humans and other mammals Licensed vaccine available Parenteral for domestic animals Oral vaccines for wild animals Rabies vaccines produced in egg or cell culture nerve-tissue vaccine prepared in animals should be discontinued in animals Phylogroup; serological neutralisation within phylogroups, but very limited cross-neutralisation between phylogroups World Organisation for Animal Health Protecting animals, Preserving our future 8

9 World Organisation for Animal Health Protecting animals, Preserving our future 9

10 RABV for challenge or vaccine manufacturing Pasteur strain Street Alabama Dufferin Flury strain Other strain 1882 France from a rabid cow infected by a dog Passages in rabbits and mice then passages in cells at different levels: - Pasteur virus (PV- 12) - Kissling (CVS-11) - CVS challenge virus strain (CVS- 27) - Pitman-Moore (PM) - RV USA from a dog Primary cells of hamsters & pigs (10 passages) = ERA virus BHK 21 cell line passages: - SAD Vnukovo (USSR Russia) - SAD Vnukovo-32 - SAD Bern (Switzerland) - SAD-B19 - SAG2 - ERA USA from Miss Flury transmitted by a dog 136 passages in 1- day-old chicks 40/50 passages in embryonated eggs: low egg passage (LEP) 220/227 passages in embryonated eggs: high egg passage (HEP) CTN: China from a dog (1956) World Organisation for Animal Health Protecting animals, Preserving our future 10

11 C. Requirements for Vaccines Background Production Authorisation/ Licensing/ Registration Rabies vax for injectable use Domestic animals and wildlife Recombinant, modified live and inactivated virus vaccines Apply according to manufacturer s prescription Monitor vaccination coverage in the population Rabies vax for oral use Wild animals. Domestic?? Mainly administered as baits Efficacy and safety (target & non-target species) Modified live virus or recombinant vaccines Monitoring the impact in the field? World Organisation for Animal Health Protecting animals, Preserving our future 11

12 Vaccine Bank

13 OIE Rabies Vaccine Bank for dog vax Vaccine banks can help to guarantee: High-quality vaccines complying with international standards Financial mechanisms allowing direct purchase by countries or donor funds (multi-donor trust fund) Cost reduction per vaccine unit (Economies of scale) Reduction of administrative delays and costs associated with local registration and the purchase of biologicals/ local procurement/import procedures Support for multi-party vaccination campaigns Country incentive to engage in dog vaccination EU-HPED Programme (finished Dec 2014) The Vaccine Bank mechanism still exists and continues to operate (funds now provided by countries or other donors) World Organisation for Animal Health Protecting animals, Preserving our future 13

14 UPDATES ON PROGRESS RABIES VACCINE BANK >4 million doses of rabies vaccines delivered as of December 2015 Bangladesh (200,000 doses; 2013) Afghanistan (200,000 doses; 2014) Nepal (200,000 doses; 2013) Bhutan (100,000 doses; 2013/2014) Vietnam (872,000 doses; 2012/2013/2014) Laos (290,400 doses; 2012/2013/2014) Singapore (5,000 doses; 2014) Cambodia (50,000 doses; 2015 ) Sri Lanka (300,400 doses; 2013) Indonesia (300,000 doses; 2013/2016) Myanmar (400,000 doses; 2013/2015) Philippines (1.12M doses; 2013/2014/2015)

15 Yooni OH 12, rue de Prony, Paris, France - oie@oie.int