Veterinary vaccines need to be authorized by relevant authorities before they can be used in the field. This paper briefly describes the development and authorization process of vaccines. It also highlights important regulatory trends, challenges and opportunities from the veterinary vaccine industry standpoint in EU, US, Asia and Latin America, with a specific focus on avian vaccines' relevant topics.
A retrospective analysis encompassing 18 yr (1999-2016) of broiler chicken health surveys from broiler production complexes throughout the United States was conducted to identify trends and areas of opportunity. The analysis used necropsy data from 19,577 broiler chickens considered to be "healthy" or "clinically normal" by visual assessment. The very low incidence of dehydrated (0.01%) or undersized (0.02%) broilers is evidence that the objective of examining "healthy" birds was achieved. The results of the correlation analysis were what was expected for "healthy" broilers, with these birds having positive correlations with skin color and size of the bursa of Fabricius. The average age of broilers included in this analysis ranged from 26.2 days in 2008 to 33.7 days in 2013. The percentage of "normal" broilers (those without visible lesions or abnormalities) varied from 5.63% in 2012 to 28.33% in 1999. The results of this study identified four areas of opportunity for improving poultry health: 1) coccidiosis, 2) oral lesions and gizzard erosions, 3) retained yolks, and 4) pododermatitis.
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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