Merck & Co., Inc., Kenilworth, NJ, USA.
Merck & Co., Inc., Kenilworth, NJ, USA.
Vaccine. 2021 Jan 22;39(4):641-643. doi: 10.1016/j.vaccine.2020.12.033. Epub 2020 Dec 23.
The recent article by Gessner et al. discussed several concerns regarding the design and results of the clinical trial by Maruyama et al. in 2010 on the vaccine efficacy (VE) of 23-valent pneumococcal polysaccharide vaccine. First, Gessner et al. questioned the integrity of the study randomization and blinding. Maruyama et al. have indicated that study participants were individually randomized and blinding was maintained throughout the study. Second, Gessner et al. questioned the internal validity of the trial results. Gessner et al. applied the reported VE against pneumococcal pneumonia and assumptions to estimate how much all-cause pneumonia could be prevented resulting in a "VE" estimate of 19.5%. This estimate does not truly qualify as a VE estimate, but as vaccine effectiveness estimate from a hypothetical cohort. The randomized, placebo-controlled trial conducted by Maruyama et al. met the methodological standards for a randomized control trial and its results are unquestionably valid.
最近，Gessner 等人发表的一篇文章讨论了 2010 年 Maruyama 等人进行的 23 价肺炎球菌多糖疫苗疫苗效力（VE）临床试验的设计和结果的几个问题。首先，Gessner 等人质疑研究随机分组和盲法的完整性。Maruyama 等人表示，研究参与者被单独随机分组，并且在整个研究过程中保持盲法。其次，Gessner 等人质疑试验结果的内部有效性。Gessner 等人应用报告的针对肺炎球菌肺炎的 VE 和假设来估计可以预防多少例所有原因肺炎，从而得出“VE”估计值为 19.5%。这个估计值实际上并不能真正作为 VE 估计值，而是作为来自假设队列的疫苗有效性估计值。Maruyama 等人进行的随机、安慰剂对照试验符合随机对照试验的方法学标准，其结果无疑是有效的。
