ABSTRACT
Guidelines for evaluating the efficacy and safety of live anticoccidial vaccines, and obtaining approval for their use in chickens and turkeys

H. D. Chapman1, B. Roberts2, M.W. Shirley3 and R. B. Williams4

1 Department of Poultry Science, University of Arkansas, Fayetteville, AR 72701, USA, 2 Great Missenden, Buckinghamshire, UK, 3 Institute for Animal Health, Compton Laboratory, Compton, Newbury, Berkshire, RG20 7NN, UK, 4 Coxitec Consulting, Hertfordshire, UK. Corresponding author: dchapman@uark.edu

Guidelines have recently been published in Avian Pathology that are intended as an aid in the design, implementation and interpretation of laboratory, floor-pen and field studies for the assessment of the efficacy and safety of live anticoccidial vaccines for immunisation of chickens and turkeys against Eimeria species. In addition to efficacy and safety requirements, manufacture, quality control, and licensing considerations are discussed. The guidelines do not address sub-unit vaccines, but many of the principles described will be relevant to such vaccines if they are developed in the future. Guidelines are available in some countries for avian vaccines of bacterial or viral origin, but specific standards for anticoccidial vaccines in poultry have not, as far as we know, been produced. Information is provided on general requirements of registration authorities (based upon regulations applicable in the European Union and the USA) for obtaining marketing authorisations for vaccines. These guidelines may assist poultry specialists in providing specific information for administrators involved in the decision-making process leading to registration of new vaccines, and are intended to facilitate the worldwide adoption of consistent, standard procedures.

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