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Volume 26, Number 12—December 2020
Online Report

Role of Oral Rabies Vaccines in the Elimination of Dog-Mediated Human Rabies Deaths

Ryan M. WallaceComments to Author , Florence Cliquet, Christine Fehlner-Gardiner, Anthony R. Fooks, Claude T. Sabeta, Alvaro Aguilar Setién, Changchun Tu, Vlad Vuta, Boris Yakobson, Dong-Kun Yang, Gideon Brückner, Conrad M. Freuling, Lea Knopf, Artem Metlin, Patricia Pozzetti, Pebi Purwo Suseno, Sean V. Shadomy, Gregorio Torres, Marco Antonio Natal Vigilato, Bernadette Abela-Ridder, and Thomas Müller
Author affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (R.M. Wallace, S.V. Shadomy); Agency for Food, Environmental, and Occupational Health and Safety, Malzéville, France (F. Cliquet); Canadian Food Inspection Agency, Ottawa, Ontario, Canada (C. Fehlner-Gardiner); Animal and Plant Health Agency, Weybridge, UK (A.R. Fooks); Onderstepoort Veterinary Institute, Pretoria, South Africa (C.T. Sabeta); Unidad de Investigación Médica en Inmunología, Coordinación de Investigación en Salud, Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico (A.A. Setién); Academy of Agricultural Sciences, Changchun, China (C. Tu); Institute for Diagnosis and Animal Health, Faculty of Veterinary Medicine, Bucharest, Romania (V. Vuta); Kimron Veterinary Institute, Beit Dagan, Israel (B. Yakobson); Animal and Plant Quarantine Agency, Gimcheong-si, South Korea (D.-K. Yang); World Organisation for Animal Health, Paris, France (G. Brückner, P. Pozzetti, G. Torres); Friedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany (C.M. Freuling, T. Müller); World Health Organization, Geneva, Switzerland (L. Knopf, B. Abela-Ridder); Federal Centre for Animal Health, Vladimir, Russia (A. Metlin); Ministry of Agriculture, Jakarta, Indonesia (P. Purwo Suseno); Food and Agriculture Organization of the United Nations, Rome, Italy (S.V. Shadomy); Pan American Health Organization, Rio de Janeiro, Brazil (M.A.N. Vigilato)

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Table 5

Summary of recommendations to promote the safe and effective use of oral rabies vaccine in dogs*

Short-term activities (activities to be accomplished by 2021)
Global health agencies should provide guidance on conducting hand-out vaccination programs for dogs
Global health agencies should provide guidance to policy makers on how to interpret complex safety evaluation studies
Policy makers should be encouraged to evaluate the animal and human health impacts (beneficial and harmful) from use of ORV 
as a complement to injectable vaccines in dog vaccination programs
International organizations, such as United Against Rabies, should acknowledge the need, role, and acceptability of ORV to further
promote safe and cost-effective ORV of dogs
Vaccination programs should be designed using fit-for-purpose methodology, where appropriate methods (or mixed methods) 
and vaccine constructs are chosen based on characteristics of the dog population and capacities of the vaccination staff
International organizations should advocate for the use of tools that assess the role of ORV in mixed-method vaccination 
campaigns to increase awareness of the benefits of ORV
Medium-term activities (activities to be accomplished by 2023)
OIE should continue its efforts to promote the concept of vaccine regulatory convergence to OIE member countries.
Although OIE and WHO do recognize the need for use of animal vaccines off-label, a prospective approach to validating oral rabies
vaccines, like the WHO vaccine pre-qualification process, should be developed to provide more confidence in the use of oral rabies
vaccines, both in field-trials and integration into mass parenteral vaccination programs
Prequalification should be a future requirement for any oral rabies vaccine to be used for dogs in projects funded or supervised 
by the United Against Rabies initiative, thereby creating an incentive for manufacturers to invest into this area.
Benchmark immunogenicity studies and field trials should be conducted in several countries representative of regions where 
dog-mediated rabies is endemic as they are considered crucial to demonstrate the fitness for purpose of oral rabies vaccination 
as a supplementary tool.
OIE and PAHO should offer these vaccines through their vaccine bank (OIE) and Revolving Fund (PAHO)
Long-term activities (activities to be accomplished by 2025)
Although licensure can be a long, arduous, and expensive process, manufacturers should continue to seek central licensure 
for use of their products in dogs.
OIE and WHO should consider developing a global regulatory science agenda for oral rabies vaccines, similar to what is 
recommended for human vaccines

*OIE, World Organisation for Animal Health; ORV, oral rabies vaccination; WHO, World Health Organization; PAHO, Pan American Health Organization.

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Page created: October 15, 2020
Page updated: November 19, 2020
Page reviewed: November 19, 2020
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