Mackay D K J
European Medicines Agency (EMEA), 7 Westferry Circus, London E14 4HB.
Rev Sci Tech. 2007 Aug;26(2):421-8.
Antigenically variable viruses are responsible for some of the most contagious and economically important diseases that affect domestic livestock. The serious consequences of such diseases in terms of economic loss, and human and animal health, were clearly demonstrated by recent epizootics of foot and mouth disease, and outbreaks of avian influenza and bluetongue in the European Union (EU). For such diseases, government authorities need to be able to respond, if appropriate, by making use of vaccines that are suited to the epidemiological situation. The current EU regulatory framework is not well adapted for approval and maintenance of vaccines where the antigens included have to be chosen to reflect the epidemiological need. An extensive revision of the technical requirements for authorisation of veterinary medicinal products within the EU is currently underway. Additionally, a major revision of the regulations that control how such authorisations are kept up-to-date is about to start. This provides an ideal opportunity to introduce into EU legislation the concept of the 'multistrain dossier' whereby a potentially large number of approved strains may be included within a marketing authorisation and the final vaccines may be blended to include strains according to need. In addition, new strains may be added onto the marketing authorisation by means of a rapid regulatory procedure should new antigenic variants actually or potentially threaten the EU.
抗原可变的病毒是导致一些影响家畜的最具传染性和经济重要性疾病的原因。口蹄疫近期的流行以及欧盟禽流感和蓝舌病的爆发，清楚地表明了此类疾病在经济损失以及人类和动物健康方面的严重后果。对于此类疾病，政府当局需要能够在适当情况下通过使用适合流行病学情况的疫苗做出应对。当前的欧盟监管框架不太适合批准和维持其中必须选择抗原以反映流行病学需求的疫苗。目前正在对欧盟内兽药授权的技术要求进行广泛修订。此外，控制此类授权如何保持最新状态的法规的重大修订即将开始。这提供了一个理想的机会，将“多毒株档案”的概念引入欧盟立法，据此，一份上市许可中可能包含大量已批准的毒株，最终疫苗可根据需要混合包含不同毒株。此外，如果新的抗原变体实际或潜在地威胁到欧盟，可通过快速监管程序将新毒株添加到上市许可中。
