Saegerman C, Hubaux M, Urbain B, Lengelé L, Berkvens D
Department of Infectious and Parasitic Diseases, Epidemiology and Risk Analysis Applied to Veterinary Sciences, Faculty of Veterinary Medicine, University of Liège, Boulevard de Colonster, 20, B42, B-4000 Liège, Belgium.
Rev Sci Tech. 2007 Aug;26(2):395-413. doi: 10.20506/rst.26.2.1747.
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.
兽用疫苗的上市许可在产品的质量、安全性和有效性按照法定标准评估后授予。评估包括种子材料和成分的全面特性鉴定、实验室和宿主动物安全性及有效性研究、稳定性研究以及上市后现场性能监测。在新动物疾病出现期间，这种评估可能无法进行，但存在多种机制可在紧急动物健康状况下确保产品可用，例如自体生物制品、有条件许可、试验性和紧急使用授权、进口世界其他地方正在使用的产品以及预先批准的疫苗库。以北欧蓝舌病的出现为例，描述了动物疫苗临时授权的监管问题。在授予临时授权之前必须满足若干条件，例如应使用灭活疫苗以排除毒力返强以及疫苗病毒和/或蓝舌病病毒野毒株之间的重配；决策必须有科学证据和风险分析支持；必须对接种疫苗的易感动物进行全面普查；必须遵守接种方案，并且必须有一个允许对接种进行登记、交付和随访以及对现场接种使用进行监测、分析并可能进行调整的计划。这种临时授权必须尽快被全面授权取代。
