Stöhr Klaus, Bucher Doris, Colgate Tony, Wood John
Novartis Vaccines and Diagnostics, Cambridge, MA, USA.
Methods Mol Biol. 2012;865:147-62. doi: 10.1007/978-1-61779-621-0_9.
As outlined in other chapters, the influenza virus, existing laboratory diagnostic abilities, and disease epidemiology have several peculiarities that impact on the timing and processes for the annual production of influenza vaccines. The chapter provides an overview on the key biological and other factors that influence vaccine production. They are the reason for an "annual circle race" beginning with global influenza surveillance during the influenza season in a given year to the eventual supply of vaccines 12 months later in time before the next seasonal outbreak and so on. As influenza vaccines are needed for the Northern and Southern Hemisphere outbreaks in fall and spring, respectively, global surveillance and vaccine production has become a year round business. Its highlights are the WHO recommendations on vaccine strains in February and September and the eventual delivery of vaccine doses in time before the coming influenza season. In between continues vaccine strain and epidemiological surveillance, preparation of new high growth reassortments, vaccine seed strain preparation and development of standardizing reagents, vaccine bulk production, fill-finishing and vaccine release, and in some regions, clinical trials for regulatory approval.
如其他章节所述，流感病毒、现有的实验室诊断能力以及疾病流行病学具有若干特性，这些特性会影响流感疫苗年度生产的时间安排和流程。本章概述了影响疫苗生产的关键生物学因素和其他因素。这些因素导致了一场“年度循环赛跑”，从特定年份流感季节的全球流感监测开始，到12个月后在下一个季节性疫情爆发前及时供应疫苗，如此循环往复。由于北半球和南半球分别在秋季和春季爆发流感时都需要流感疫苗，全球监测和疫苗生产已成为一项全年性的工作。其重点是世卫组织在2月和9月关于疫苗毒株的建议，以及在即将到来的流感季节之前及时交付疫苗剂量。在此期间，持续进行疫苗毒株和流行病学监测、制备新的高生长重组体、制备疫苗种子毒株和开发标准化试剂、批量生产疫苗、灌封和疫苗放行，在一些地区还包括为获得监管批准而进行的临床试验。
