Evaluating clinical effectiveness of 13-valent pneumococcal conjugate vaccination against pneumonia among middle-aged and older adults in Catalonia: results from the EPIVAC cohort study

Abstract

BackgroundBenefits using the 13-valent pneumococcal conjugate vaccine (PCV13) in adults are controversial. This study investigated clinical effectiveness of PCV13 vaccination in preventing hospitalisation from pneumonia among middle-aged and older adults.MethodsPopulation-based cohort study involving 2,025,730 individuals ≥50 years in Catalonia, Spain, who were prospectively followed from 01/01/2015 to 31/12/2015. Primary outcomes were hospitalisation for pneumococcal or all-cause pneumonia and death from any cause. Cox regression models were used to evaluate the association between PCV13 vaccination and the risk of each outcome, adjusting for age, sex and major comorbidities/underlying risk conditions.ResultsCohort members were observed for a total of 1,990,701 person-years, of which 6912 person-years were PCV13 vaccinated. Overall, crude incidence rates (per 100,000 person-years) were 82.8 (95% confidence interval [CI]: 77.7–88.1) for pneumococcal pneumonia, 637.9 (95% CI: 599.0–678.7) for all-cause pneumonia and 2367.2 (95% CI: 2222.8–2518.7) for all-cause death. After multivariable adjustments we found that the PCV13 vaccination did not alter significantly the risk of pneumococcal pneumonia (multivariable-adjusted hazard ratio [mHR]: 1.17; 95% CI: 0.75–1.83; p = 0.493) and all-cause death (mHR: 1.07; 95% CI: 0.97–1.18; p = 0.190), although it remained significantly associated with an increased risk of all-cause pneumonia (mHR: 1.69; 95% CI: 1.48–1.94; p < 0.001). In stratified analyses focused on middle-aged or elderly persons and immunocompromised or immunocompetent subjects, PCV13 vaccination did not appear effective either.ConclusionOur data does not support clinical benefits of PCV13 vaccination against pneumonia among adults in Catalonia. It must be closely monitored in future studies involving more vaccinated person-time at-observation.

A Systematic Review of Studies Published between 2016 and 2019 on the Effectiveness and Efficacy of Pneumococcal Vaccination on Pneumonia and Invasive Pneumococcal Disease in an Elderly Population

“…The vaccinated cohort was significantly sicker and older, with 34% having an immunocompromising condition and 27% were 80 years or older. The follow-up period was only one year, and the vaccination rate was only 0.2% [16].…”

“…Cohort members were observed for almost 2,000,000 person-years. However, only about 7000 of these were in PCV13-vaccinated persons [16].…”

“…Nine studies reported on PCV13 VE [11][12][13][14][15][16][17][18][19] (Table 1). Five of these were post-hoc analyses based on CAPITA data [11][12][13][14][15].…”

“…Five of these were post-hoc analyses based on CAPITA data [11][12][13][14][15]. Besides the post-hoc studies, we identified two cohort studies, one from Spain [16] and one from Germany [17], and two studies using test-negative design (TND), one from the US [18] and one from Italy [19]. The Spanish cohort study used routine data collected in 2015 to identify all-cause pneumonia and pneumococcal pneumonia cases.…”

“…The last post hoc study analyzed the VE of time since vaccination and did not find evidence of waning over the study period [15]. The remaining studies reported VE on the following outcomes: all-cause pneumonia [16,17], pneumococcal pneumonia [16], pneumococcal-CAP [19] and VT-CAP [18,19] (Table 1). None of the observational studies reported on IPD.…”