Fish vaccines: The regulatory process and requirements from the laboratory bench to a final commercial product, including field trials

Abstract

Vaccines are recognised as important tools for the prevention and control of diseases in fish. The regulatory requirements for registering veterinary vaccines have grown considerably over the last 50 years; nevertheless, they have contributed to a steady increase in the availability of vaccines of high quality with good safety profiles and proven efficacy against many diseases. In the EU, there are stringent requirements for vaccine manufacturers to comply with good manufacturing practice (GMP); consequently, the cost of vaccine production is high. Compared with vaccines for other animal species, the market for fish vaccines is limited in size; however, the cost in meeting the regulatory requirements is similar and the cost of development is equally expensive. Fortunately vaccines for use in small markets may take advantage of the Minor Use Minor Species Limited Market (MUMS) and limited market process for which the regulatory requirements are reduced where a successful application can be made for inclusion in the MUMS listings. Also, the field of animal ethics is constantly changing, leading to some reductions in the regulatory requirements for animal studies performed to generate safety, quality and efficacy data. The pharmaceutical industry needs to keep abreast of such changes and amend product development plans accordingly to remain competitive in the market.