Reference : Regulatory issues surrounding the temporary authorisation of animal vaccination in em...
Scientific journals : Article
Life sciences : Veterinary medicine & animal health
Regulatory issues surrounding the temporary authorisation of animal vaccination in emergency situations: the example of bluetongue in Europe
[fr] Questions réglementaires liées à l’autorisation temporaire de vacciner les animaux en situation d’urgence : l’exemple de la fièvre catarrhale du mouton en Europe
Saegerman, Claude mailto [Université de Liège - ULiège > Département des maladies infectieuses et parasitaires > Epidémiologie et analyse des risques appl. aux sc. vétér. >]
Hubaux, M. [> >]
Urbain, B. [> >]
Lengele, L. [> >]
Berkvens, D. [> >]
Revue Scientifique et Technique (International Office of Epizootics)
Office International des Epizooties
Animal vaccination. Part. 2: scientific, economic, regulatory and socio-ethical aspects. Chapter 4: Regulatory aspects
Yes (verified by ORBi)
[en] vaccine ; vaccination ; temporary authorisation ; regulatory issues ; emerging disease ; animal health
[en] A marketing authorisation for a veterinary vaccine is granted after the quality, safety and efficacy of the product have been assessed in accordance with legal standards. The assessment includes complete characterisation and identification of seed material and ingredients, laboratory and host animal safety and efficacy studies, stability studies, and post-licensing monitoring of field performance. This assessment may not be possible during the emergence of a new animal disease, but several mechanisms exist to allow for the availability of products in an emergency animal health situation, e.g. autogenous biologics, conditional licences, experimental and emergency use authorisations, the importation of products in use elsewhere in the world and pre-approved vaccine banks. Using the emergence of bluetongue in northern Europe as an example, the regulatory issues regarding the temporary authorisation of animal vaccination are described. Several conditions must be fulfilled before a temporary authorisation can be granted, e.g. inactivated vaccines should be used in order to exclude reversion to virulence and reassortment between vaccine viruses and/or field strains of the bluetongue virus; decision-making must be supported by scientific evidence and risk analysis; there must be a complete census of the susceptible animals that were vaccinated; vaccination protocols must be adhered to and there must be a scheme allowing for registration, delivery and follow-up of vaccination, and monitoring, analysis and, possibly, adjustment of field use of the vaccination. This temporary authorisation must be replaced by a full authorisation as quickly as possible.

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