Regulatory issues surrounding the temporary authorisation of animal vaccination in emergency situations: the example of bluetongue in Europe

Abstract

SummaryA 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.

Global health

“…In addition, on the basis of the same segment, two topotypes were identified enabling the allocation of the strain of a serotype to an Eastern or Western region of origin. This high genetic diversity can be explained by point mutations ('genetic drift') and by the exchange of entire segments between different serotypes ('genetic shift') (Saegerman et al, 2007). For BTV, segment exchange was detected in a Holstein bull 20 years ago (Stott et al, 1987).…”

“…BT is not transmissible to humans. The virus is transmitted by gnats of the genus Culicoides that consists of 1,260 species of which around 30 are competent vectors of diverse orbiviruses (Saegerman et al, 2007 and. Purse et al (2005) referred to 1,400 Culicoides species of which <1 % had been infected by BTV-vectors -with the addition that so far only few species had been examined in this context.…”

Bluetongue control strategy, including recourse to vaccine: a critical review

“…The spread of BTV-16 in Italy has been used as an indication of reversion to virulence of a MLV vaccine [5,60]. While it is true that the BTV-16 strain used in the vaccine and the virus isolated in the field appear to be the same virus [5,59], the phenomenon does not appear to be due to reversion to virulence of the vaccine strain, but rather to an insufficient attenuation process of the virus used in manufacturing the vaccine [1,26].…”

La fièvre du Nil occidental et la fièvre catarrhale ovine, deux viroses en progression inattendue

“…Plusieurs publications prévoyaient cet événement (Gloster et al 2007). (Saegerman et al 2007). La vaccination de masse, réalisée sur plusieurs années consécutives contre les différents sérotypes en cause, est la seule solution à court terme pour réduire l'impact gravissime de la maladie sur l'élevage européen.…”