Rethinking results from the Japanese 23-valent pneumococcal polysaccharide vaccine randomized clinical trial

Vaccine. 2019 Aug 14;37(35):4853-4857. doi: 10.1016/j.vaccine.2019.07.040. Epub 2019 Jul 18.

Abstract

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.

Keywords: Japan; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine; Pneumococcus; Randomized clinical trial; Vaccine; Vaccine efficacy; Validity.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged, 80 and over
  • Antibodies, Bacterial / blood
  • Bias
  • Data Interpretation, Statistical
  • Double-Blind Method
  • Humans
  • Japan
  • Meta-Analysis as Topic
  • Pneumococcal Vaccines / administration & dosage*
  • Pneumococcal Vaccines / adverse effects
  • Pneumonia, Pneumococcal / mortality
  • Pneumonia, Pneumococcal / prevention & control*
  • Randomized Controlled Trials as Topic*
  • Serogroup
  • Streptococcus pneumoniae
  • Vaccine Potency*

Substances

  • 23-valent pneumococcal capsular polysaccharide vaccine
  • Antibodies, Bacterial
  • Pneumococcal Vaccines