Articles The direct effect of pneumococcal conjugate vaccines on invasive pneumococcal disease in children in the Latin American and Caribbean region (SIREVA 2006-17): a multicentre, retrospective observational study

Background Streptococcus pneumoniae isolated from patients with invasive pneumococcal disease has been subjected to laboratory-based surveillance in Latin American and Caribbean countries since 1993. Invasive pneumococcal diseases remain a major cause of death and disability worldwide, particularly in children. We therefore aimed to assess the direct effect of pneumococcal conjugate vaccines (PCVs) on the distribution of pneumococcal serotypes causing invasive pneumococcal disease in children younger than 5 years before and after PCV introduction. Methods We did a multicentre, retrospective observational study in eight countries that had introduced PCV (ie, PCV countries) in the Latin American and Caribbean region: Argentina, Brazil, Chile, Colombia, Dominican Republic, Mexico, Paraguay, and Uruguay. Cuba and Venezuela were also included as non-PCV countries. Isolate data for Streptococcus pneumoniae were obtained between 2006 and 2017 from children younger than 5 years with an invasive pneumococcal disease from local laboratories or hospitals. Species' confirmation and capsular serotyping were done by the respective national reference laboratories. Databases from the Sistema Regional de Vacttnas (SIREVA) participating countries were managed and cleaned in a unified database using Microsoft Excel 2016 and the program R (version 3.6.1). Analysis involved percentage change in vaccine serotypes between pre-PCV and post-PCV periods and the annual reporting rate of invasive pneumococcal diseases per 100 000 children younger than 5 years, which was used as a population reference to calculate percentage vaccine type reduction. Findings Between 2006 and 2017, 12 269 isolates of invasive pneumococcal disease were collected from children younger than 5 years in the ten Latin American and Caribbean countries. The ten serotypes included in ten-valent pneumococcal conjugate vaccine (PCV10) decreased significantly (p<0.0001) after any PCV introduction, except for the Dominican Republic. The percentage change for the ten vaccine serotypes in PCV10 countries was -91.6% in Brazil (530 172.9%] of 727 before, 27 16.1%] of 441 after); -85.0% in Chile (613 [72.6%] of 844 before, 44 [10.9%] of 404] after); -84.7% in Colombia (231 [63.1%1 of 366 before, 34 [9.7%] of 352 after); and -73.8% in Paraguay (127 [77.0%] of 165 before, 22 [20.2%] of 109 after). In the 13-valent pneumococcal conjugate vaccine (PCV13) countries, the percentage change for the 13 vaccine serotypes was -59.6% in Argentina (853 [85.0%] of 1003 before, 149 [34.3%] of 434 after); -16.5% in the Dominican Republic (95 [80.5%] of 118 before, 39 [67.2%] of 58 after); -43.7% in Mexico (202 [73.2%] of 276 before, 63 [41.2%] of 153 after); and -45.9% in Uruguay (138 [80.7%] of 171 before, 38 [43 - 7%] of 87 after). Annual reporting rates showed a reduction from -82.5% (6.21 before vs 1.09 after per 100 000, 95% CI -61.6 to -92.0) to -94- 7% (1.15 vs 0.06 per 100 000, -89.7 to -97.3) for PCV10 countries, and -58.8% (2.98 vs 1.23 per 100 000, -21.4 to -78.4) to -82.9% (7.80 vs 1. 33 per 100 000, - 76.9 to -87.4) for PCV13 countries. An increase in the amount of non-vaccine types was observed in the eight countries after PCV introduction together with an increase in their percentage in relation to total invasive strains in the post-PCV period. Interpretation SIREVA laboratory surveillance was able to confirm the effect of PCV vaccine on serotypes causing invasive pneumococcal disease in the eight PCV countries. Improved monitoring of the effect and trends in vaccine type as well as in non-vaccine type isolates is needed, as this information will be relevant for future decisions associated with new PCVs. Copyright (C) 2020 Elsevier Ltd. All rights reserved.