Abstract
ABSTRACT Seven-valent pneumococcal conjugate vaccine (PCV7) was introduced to Sweden in 2009 and replaced by pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) or 13-valent PCV (PCV13) from late 2009. A retrospective cohort study assessed the impact of PCVs on otitis media/acute otitis media (OM) in children aged ≤5 years (NCT02742753) living in Skåne (PCV7 then PHiD-CV) or Västra Götalandsregionen (PCV7 then PCV13) between 2005 and 2013 using linked regional and national databases. Time-series analyses described differences between pre-PCV and post-PCV eras. Adjusted age-period-cohort (APC) predictive models estimated vaccine effectiveness and OM incidence ratios between PCV cohorts. Time-to-first OM diagnosis was estimated in ≤2 year-olds by survival analysis using a Cox proportional hazards model. Descriptive interrupted time-series analyses showed OM incidence in ≤2 year-olds declined by 42% (Skåne) and 25% (Västra Götalandsregionen) after PHiD-CV/PCV13, respectively, versus pre-PCV, but baseline OM incidence and duration of PCV7 use differed between regions. In adjusted APC models, OM incidence decreased after PHiD-CV by 9.9% (95% confidence interval [CI]: 4.4; 15.1, p < .001) and PCV13 by 2.3% (95%CI: −3.2; 7.6, p = .401) compared with pre-PCV. Both PHiD-CV and PCV13 decreased the risk of first OM diagnosis: hazard ratio (95%CI) for PHiD-CV relative to pre-PCV 0.67 (0.65; 0.69); 0.87 (0.85; 0.89) for PCV13 relative to pre-PCV; p < .001 for both comparisons. Within the limitations of this study conducted in two large Swedish regions, descriptive time-series analyses showed that OM incidence rates declined following the introduction of PHiD-CV and PCV13; however, this reduction only reached statistical significance for PHiD-CV in the adjusted APC models.
Highlights
Otitis media/acute otitis media (OM) is one of the most com mon diseases among children worldwide, and the incidence is highest between 1 and 4 years of age.[1]
A more recent review of clinical trials and observational studies using higher valency pneumococcal conjugate vaccines (PCVs), noted that there is evidence that these PCVs may have a greater impact on OM incidence and on antibiotic use than PCV7, estimates of that impact vary widely due to underlying differences between studies in epidemiology, study methodology, and local OM clinical man agement guidelines and practices.[14]
Higher incidence rates of OM were associated with male sex, a previous diagnosis of OM, and winter season, while lower rates were associated with increasing age from the second birthday onwards (≤5 year population, Table S9)
Summary
Otitis media/acute otitis media (OM) is one of the most com mon diseases among children worldwide, and the incidence is highest between 1 and 4 years of age.[1]. PCVs have greatly reduced the global burden of invasive pneumococcal disease due to vaccine serotypes, pneumococcal pneumonia, and all-cause pneumonia in children.[10,11] The vac cine impact on OM has been more difficult to establish. PCV13 contains capsular polysaccharides of 13 serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F conjugated to CRM197 protein.[16] Because eight of the 10 serotypes in the PHiD-CV formulation are conjugated to NTHi protein D, it has been hypothesized that PHiD-CV may protect against NTHi, and could potentially have a greater impact on the incidence of OM com pared to other PCVs.[17]
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