Reflections on national reference materials of preventive human vaccines / 中国生物制品学杂志

ABSTRACT

@#The national standards for biological products include three types of reference materials,vaccines,biotherapeutics,and diagnostics,among which the national standards for vaccines play a crucial role in the production,issuance,and supervision inspection of vaccines. In recent years,the vaccine industry in China has developed rapidly,and especially,the application of new technology platforms such as mRNA in vaccines has highlighted the urgency of further improving the level of national standards for vaccines in China. Referring to WHO(World Health Organization)development requirements for reference materials of vaccines and taking Chinese national standard for SARS-CoV-2 neutralizing antibody as example,this paper summarized the thinking on national standards for vaccines in China,and presented the priority principles of establishing national standards for vaccines which are not traceable to WHO international standard(IS),in view to provide ideas for the further improvement of development and application of national standards for vaccines in China.