Veterinary Autogenous Vaccines for Poultry in Europe-Many Ways to Crack an Egg.

Tarik Sulejmanovic, Jana Schnug, Hans-Christian Philipp
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Abstract

In the past decade, European animal farming has increasingly used autogenous vaccines for the prevention of nonnotifiable diseases. In Europe, these vaccines are exclusively inactivated bacterial and viral vaccines, with a set of specific regulations that differentiate them from conventional vaccines. The highest number of applications most likely occurs in poultry, as these animal species are farmed in the highest numbers compared with other types of food-producing animals. In 2019, autogenous vaccines came within the scope of harmonized European regulation for the first time, although many important aspects are still missing and need to be further developed. Consequently, several important legal provisions remain in national legislations and can vary tremendously between different member states of the European Union. The inclusion of autogenous vaccines in the management of certain diseases of poultry is justified by the nonavailability of licensed vaccines and the evolution and diversity of antigens in the field that are not covered by licensed vaccines. In addition, these vaccines aid in reducing the use of antibiotics. The methods for isolating and typing pathogenic isolates to obtain relevant antigens are pathogen specific and require a careful approach based on clinical evidence. Manufacturing processes are optimized according to regulatory standards, and they represent the most critical factor influencing the quality of autogenous vaccines and their placement on the market. This review presents the important requirements for manufacturing autogenous vaccines for poultry in addition to the relevant regulatory considerations. The results from a survey of several European Union member states regarding specific provisions within their national legislations are also presented.

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欧洲家禽兽用自体疫苗--破解鸡蛋的多种方法。
在过去十年中,欧洲动物养殖业越来越多地使用自体疫苗来预防非传染性疾病。在欧洲,这些疫苗完全是灭活的细菌和病毒疫苗,有一套区别于传统疫苗的特殊规定。应用数量最多的可能是家禽,因为与其他类型的食用动物相比,这些动物物种的养殖数量最多。2019 年,自体疫苗首次被纳入欧洲统一法规的范围,但仍有许多重要方面尚待完善。因此,一些重要的法律规定仍停留在国家立法中,在欧盟不同成员国之间可能存在巨大差异。将自体疫苗纳入某些家禽疾病的管理是有道理的,因为目前还没有获得许可的疫苗,而且该领域的抗原不断演变,种类繁多,而许可疫苗并未涵盖这些抗原。此外,这些疫苗还有助于减少抗生素的使用。分离和分型病原体分离物以获得相关抗原的方法是针对特定病原体的,需要根据临床证据采取谨慎的方法。生产工艺根据监管标准进行优化,是影响自体疫苗质量及其上市的最关键因素。本综述介绍了生产禽用自体疫苗的重要要求以及相关的监管考虑因素。此外,还介绍了对几个欧盟成员国就其国家立法中的具体规定进行调查的结果。
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