Comparing Inspection Standards of Newcastle Disease Inactivated Vaccine

SR Yeh*, BY Chen, CT Lin, IT Ko, CC Chung, SH Lee

Animal Drugs Inspection Branch, Animal Health Research Institute, Council of Agriculture, Executive Yuan

Abstract

We outlined the inspection methods of ND inactivated vaccine in Taiwan and compared these methods with those performed in Japan, United States, European Union, Association of Southeast Asian Nations and China. For general tests, such as sterility test, preservative content test and safety test, most countries displayed similar protocols and standards. However, potency test protocols varied. In general, vaccine efficacy tests can be broken down into three parts: the challenge test, a serum Hemagglutination inhibition test (HI test) and a 50% protective dose (PD50) test. Criteria for acceptable results regarding vaccine test performance are not entirely consistent from one country to the next, though results generated in vaccine trials carried out in 2014 indicate that the ND inactivated vaccine met our national standards when ND Sato strain was used as the challenge; this strain is standard for vaccine trials worldwide. In Taiwan, all imported ND vaccines irrespective of origin are tested using internal (domestic) protocols and performance standards.

Keywords: Newcastle disease, vaccine, inspection standards