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.
Highlights
Benefits using the 13-valent pneumococcal conjugate vaccine (PCV13) in adults are controversial
13-valent protein-polysaccharide conjugate vaccine (PCV13) vaccination did not alter significantly the risk of pneumococcal pneumonia or all-cause death, but it remained significantly associated with an increased risk of all-cause pneumonia among vaccinated subjects
After multivariable adjustments we found that PCV13 vaccination did not alter significantly the risk of hospitalisation for pneumococcal pneumonia and/or all-cause death, but it remained significantly associated with an increased risk of hospitalisation for all-cause pneumonia considering the total study cohort
Summary
Benefits using the 13-valent pneumococcal conjugate vaccine (PCV13) in adults are controversial. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC, Atlanta, Ga, USA) recommends PCV13 vaccination (sequentially with the PPsV23) for those persons aged 19–64 years who have high-risk conditions (mainly anatomical or functional asplenia and immunocompromising conditions) and all persons 65 years or older (with or without risk conditions) [4, 5] These recommendations are based on immunogenicity studies (which showed that PCV13 induced an immune response as good as or better than that induced by PPsV23 for common serotypes) [6, 7] and the results of the CAPITA study (a randomised-controlled trial [RCT] comparing PCV13 vs placebo among elderly individuals in the Netherlands) [8] which reported a PCV13 efficacy of 46% against vaccine-type invasive pneumococcal infections. The PCV13 is recommended and publicly funded for some high-risk individuals (basically immunocompromised patients), [14] being prescribed by some clinicians for adults with other risk conditions (chronic pulmonary or respiratory disease, heart disease, liver disease, diabetes mellitus, etc) it is not publicly funded in these patients and, PCV13 coverage remains low [12]
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