Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA.
Expert Rev Vaccines. 2012 Oct;11(10):1235-47. doi: 10.1586/erv.12.99. Epub 2012 Nov 21.
Currently, 13-valent pneumococcal conjugate vaccine (PCV); and ten-valent PCV vaccine are marketed. Neither vaccine obtained regulatory approval based on efficacy trials, but instead were approved based on a surrogate end point: immunogenicity data measuring effective antibody levels. Therefore, direct measures of efficacy were unavailable at the time economic analyses were conducted. The authors systematically reviewed cost-effectiveness studies of ten-valent PCV and 13-valent PCV from the literature to analyze the methodologies and compare the assumptions made about vaccine effectiveness. The following three inputs were found the most variant across analyses: efficacy against acute otitis media; inclusion of indirect effects; and cross protection. These assumptions are discussed with regard to the validity of supporting data and implications on decision-making.
目前，市场上有 13 价肺炎球菌结合疫苗（PCV）和 10 价 PCV 疫苗。这两种疫苗都不是基于疗效试验获得监管批准的，而是基于替代终点获得批准：免疫原性数据测量有效抗体水平。因此，在进行经济分析时，没有直接的疗效衡量标准。作者系统地回顾了文献中关于 10 价 PCV 和 13 价 PCV 的成本效益研究，以分析方法并比较疫苗有效性的假设。在分析中发现，以下三个输入变量变化最大：对急性中耳炎的疗效；间接效应的纳入；以及交叉保护。这些假设与支持数据的有效性和对决策的影响进行了讨论。
