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

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

Face Transplant: Extrapolation to Children and Teenagers

International audienceIf there is without any contest a place for face transplant in adults despite the real status of the first 35 realised ones, it is not so obvious that face transplant could be so clearly extrapoled to children. The question is not surgical. It is related to the pathologies themselves for which transplant could be suitable. Moreover the procurement of face transplant will be more difficult because of immunologic criteria but also age and photo type. Specificity of the newborn malformative face is usually not only a question of tissue defect. It is reasonably not an indication for VCA. It should be added that nothing is known about the future of transplantation in terms of duration but also morbidities due to immunosuppression. Indications critera are rather negative. To raise the question of VCA for children has a double benefit. The first is to point out that surgical innovation oftenly arise from a non-imaginable or non-imagined clinical situation. The second is the question of VCA in newborn regarding the tolerance

The Place of Extensive Surgery in Locoregional Recurrence and Limited Metastatic Disease of Breast Cancer: Preliminary Results

The aims of this study were first to clearly define two different entities: locoregional recurrences and limited metastatic disease and secondly to evaluate the place of extensive surgery in these two types of recurrence. Material and Methods. Twenty-four patients were followed from June 2004 until May 2014. All patients underwent surgery but for 1 patient this surgery was stopped because the tumour was unresectable. Results. The median interval between surgery for the primary tumour and the locoregional recurrence or metastatic evolution was 129 months. Eight patients had pure nodal recurrences, 4 had nodal and muscular recurrences, 5 had muscular + skin recurrences, and 8 had metastatic evolution. Currently, all patients are still alive but 2 have liver metastases. Disease free survival was measured at 2 years and extrapolated at 5 years and was 92% at these two time points. No difference was observed for young or older women; limited metastatic evolution and locoregional recurrence exhibited the same disease free survival. Conclusion. Extensive surgery has a place in locoregional and limited metastatic breast cancer recurrences but this option must absolutely be integrated in the multidisciplinary strategy of therapeutic options and needs to be planned with a curative intent

Monitoring des animaux vivants : exemple d’un échantillonnage pour la détection des PCBs et des dioxines chez les bovins de boucherie en Belgique

peer reviewedIn February 1999, a poisoning episode broke out in several industrial poultry farms in Belgium. The source of this contamination was found to be a stock of recycled fat that had been delivered by a firm to several compound feed producers, between 19 and 31 January 1999. A very good correlation was observed between dioxins (PCDFs and PCDDs) and PCBs. Consequently a contamination mainly by PCBs was hypothesized. This finding made it possible to detect contaminated animals and animal products by dosage of the PCBs, more specifically by the 7 congeners with numbers 28, 52, 101, 118, 138, 153 and 180. The advantages of the dosage of PCBs compared to dioxins were its rapid test protocol and the fact that a larger number of laboratories could participate. In the cattle sector, 409 herds (0,81 p. cent) were submitted to the risk of feed contamination. The methodology used to detect a PCBs/dioxins contamination in the Belgian cattle population that was not submitted to the risk, is presented. This population is directly or indirectly destined for human consumption. It consisted in the systematic sampling of all calve fattening stations and all lots of exported bovines, and in the random sampling of slaughter cattle. This methodology is compared to the approach described in directive 96/23/CE.La contamination par les polychlorobiphényls PCBs/dioxines de la chaîne alimentaire en Belgique s'est révélée en février 1999 dans des élevages industriels de volailles. Fin avril 1999, suite à l'enquête alimentaire, il s'est avéré que la source de contamination était un stock de graisses recyclées ayant été livrées par une firme à plusieurs fabricants d'aliments composés pour animaux, entre le 15 et le 31 janvier 1999. Une relation étroite a été mise en évidence entre les quantités de dioxines (PCDFs et PCDDs) et celles des PCBs, étayant ainsi l'hypothèse d'une contamination principale par les PCBs. Cette constatation a permis de baser le dépistage des animaux et des produits animaux susceptibles d'avoir été contaminés sur le dosage des 7 congénères PCBs numéros 28, 52, 101, 118, 138, 153 et 180. Ce dosage offrait l'avantage d'être rapide et réalisable par un plus grand nombre de laboratoires contrairement à celui des dioxines. En ce qui concerne le secteur des bovins, 409 troupeaux ont été soumis au risque alimentaire (0,81 p. cent du total des troupeaux belges). Ces troupeaux ont été placés sous saisie conservatoire et la levée de celle-ci a été effectuée soit sur base des résultats d'enquêtes épidémiologiques et alimentaires, soit sur base des résultats d'analyses PCBs/dioxines effectuées sur un échantillonnage représentatif des troupeaux bovins concernés ou soit sur base de la mise à mort et l’incinération de tous les bovins des 6 troupeaux pour lesquels des résultats d’analyses PCBs/dioxines étaient supérieurs aux normes fixées (PCBs : ≤ 100 ng/g MG dans le lait, ≤ 200 ng/g MG dans les graisses corporelles ; dioxines ≤ 5 pg TEQ/g MG) [Anonyme, 1999]. L'approche méthodologique qui a été utilisée pour détecter une contamination par les PCBs/dioxines au sein de la population des bovins belges non soumise au risque alimentaire est présentée. Cette approche est basée sur l'échantillonnage systématique de toutes les stations d'engraissement de veaux, l'échantillonnage systématique des lots de bovins destinés à l'exportation et l'échantillonnage aléatoire des bovins abattus en Belgique durant une semaine. Cette approche est comparée à celle préconisée par la directive 96/23/CE du Conseil