Abstract
Few studies have reported the effect of 10-valent pneumococcal conjugate vaccine (PCV10) on otitis media (OM) in infants. In particular, no population-based study in upper-middle income countries is available. In 2010, Brazil introduced PCV10 into its routine National Immunization Program using a 3+1 schedule. We measured the impact of PCV10 on all-cause OM in children. An interrupted time-series analysis was conducted in Goiânia/Brazil considering monthly rates (per 100,000) of all-cause OM outpatient visits in children aged 2–23 months. We used case-based data from the Outpatient Visits Information System of the Unified Health System coded for ICD-10 diagnosis for the period of August/2008 to July/2015. As a comparator, we used rates of outpatient visits due to all-other causes. The relative reduction of all-cause OM and all-other causes of outpatient visits were calculated as the difference between the predicted and observed cumulative rates of the PCV10 post-vaccination period. We then subtracted the relative reduction of all-other causes of outpatient visits from all-cause OM to obtain the impact of PCV10 on OM. In total, 6,401 OM outpatient visits were recorded in 4,793 children aged 2–23 months. Of these, 922 (19.2%) children had more than one OM episode. A significant reduction in all-cause OM visits was observed (50.7%; 95%CI: 42.2–59.2%; p = 0.013), while the reduction in visits due to all-other causes was 7.7% (95% CI 0.8–14.7%; p<0.001). The impact of PCV10 on all-cause OM was thus estimated at 43.0% (95%CI 41.4–44.5). This is the first study to show significant PCV10 impact on OM outpatient visits in infants in a developing country. Our findings corroborate the available evidence from developed countries.
Highlights
Considering the availability of an information system, which allows the use of population based primary care outpatient visits within SUS in a large metropolis in Brazil, we conducted an interrupted time-series analysis to evaluate the impact of PCV10 on rates of outpatient visits for all-cause Otitis media (OM) in children, from the SUS perspective, in Brazil
We only considered outpatient visits occurring in primary care, and not emergency room visit, as these were only incorporated into the Outpatient Visit Information System (OVIS) in 2010
6,401 outpatient visits due to OM in children aged 2 to 23 months were recorded in OVIS in Goiania from August 2008 to July 2015
Summary
Otitis media (OM) is one of the main reasons for seeking healthcare services and receiving an antibiotic prescription during childhood in both developed and developing countries [1, 2]. Results of efficacy randomized trials of 7-valent PCV pneumococcal conjugate vaccine (PCV7) to prevent all-cause AOM showed modest beneficial effects in healthy infants and no benefit for preventing further episodes in high-risk infants [12, 13]. No population-based study has reported the impact of PCV10 on otitis in an upper-middle income country. Considering the availability of an information system, which allows the use of population based primary care outpatient visits within SUS in a large metropolis in Brazil, we conducted an interrupted time-series analysis to evaluate the impact of PCV10 on rates of outpatient visits for all-cause OM in children, from the SUS perspective, in Brazil
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