Pfizer Vaccines, Collegeville, PA, USA.
Pfizer Vaccines, Collegeville, PA, USA.
Vaccine. 2019 Aug 14;37(35):4853-4857. doi: 10.1016/j.vaccine.2019.07.040. Epub 2019 Jul 18.
We review a previously published randomized clinical trial of 23-valent pneumococcal polysaccharide vaccine (PPSV23) that has been used extensively globally to support PPSV23 use among adults. We argue that serious issues with internal and external validity exist that affect the usefulness of these data when evaluating pneumococcal vaccines for the general adult population. As one example of internal data inconsistency, the values reported for the percent of all pneumonia cases due to pneumococcus and the vaccine efficacy (VE) for all cause pneumonia are mutually inconsistent, even based on unrealistically high values for PPSV23 VE against vaccine serotypes and the proportion of pneumococcal pneumonias due to vaccine serotypes.
我们回顾了一项先前发表的 23 价肺炎球菌多糖疫苗（PPSV23）的随机临床试验，该疫苗已在全球范围内广泛使用，以支持成人使用 PPSV23。我们认为，内部和外部有效性存在严重问题，影响了这些数据在评估普通成年人群的肺炎球菌疫苗时的有用性。作为内部数据不一致的一个例子，报告的所有肺炎病例中因肺炎球菌引起的百分比和针对所有病因肺炎的疫苗效力（VE）相互不一致，即使基于针对疫苗血清型的 PPSV23 VE 和因疫苗血清型引起的肺炎球菌肺炎的比例的不切实际的高值。
