New technological progress and increased demands for fish as a source of
animal protein are driving significant growth of aquaculture production.
Intensification of production increases the severity and frequency of
infectious disease outbreaks, and so requires significant effort to prevent
and control disease. Because of the global crisis of bacterial resistance to
antibiotics, the use of antibiotics in aquaculture is increasingly subjected
to strict control and regulatory measures, leading to potential misuse. The
lack of availability of approved veterinary medical products for use in
aquaculture, combined with the risk of drug resistance development and
antibiotic residues in fish flesh or water, support the development of
preventive actions, including vaccines. However, the diversity of species
and aquaculture production methods, including epidemiological units and
their links, results in economic challenges for commercial vaccine
development and authorization. As a possible response to the increasing
demand for less antibiotic use in fish farms, and to the expenses associated
with novel veterinary product development, there is a need for increased use
of safe and effective autogenous vaccines in aquaculture. Regulatory
processes for autogenous vaccine production, approval and application should
recognize the specificities of epidemiological units and their links in
aquatic animal production facilities. The joint efforts of regulatory
authorities, producers, and veterinary services to follow veterinary
biosecurity principles, including risk analysis, surveillance, and
selection/prioritization of pathogens, are essential to provide maximum
safety and efficacy of autogenous vaccines as disease prevention and control
tools within larger areas, such as compartments and zones, and allow for
reductions in antibiotic use.