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Int J Pediatr Otorhinolaryngol. 2019 Apr;119:96-102. doi: 10.1016/j.ijporl.2019.01.023. Epub 2019 Jan 19.

National impact of 13-valent pneumococcal conjugate vaccine on ambulatory care visits for otitis media in children under 5 years in the United States.

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Epidemiology, Worldwide Safety and Regulatory, Pfizer Inc, New York, NY, USA. Electronic address:
Epidemiology, Worldwide Safety and Regulatory, Pfizer Inc, New York, NY, USA.
Statistical Research and Consultation Center, Pfizer Inc, New York, NY, USA.
Biostatistician Consultant, Pittsboro, NC, USA.
Vaccine Clinical Research and Development, Pfizer Inc, Collegeville, PA, USA.



The 7- and 13-valent pneumococcal conjugate vaccines (PCV7 and PCV13) were approved in the US in 2000 and 2010, respectively, for active immunization against invasive disease caused by all vaccine serotypes and otitis media (OM) caused by 7 serotypes common to both vaccines, starting at ∼6 weeks of age. This study assessed the impact of PCV13 on OM by evaluating changes in US ambulatory care visit rates between the period before PCV7 (1997-1999), during PCV7 (2001-2009), and after the introduction of PCV13 (2011-2013) among US children <5 years old.


This ecological study used US National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey data. Trend analyses using weighted least-squares regression and mean visit rates were calculated for OM and two control endpoints not likely to be related to either vaccine (skin rash and trauma).


Among children <5 and < 2 years old, the observed reduction in OM visit rates was 22% (95%CI: 12%-32%) and 24% (95%CI: 13%-35%) when comparing PCV13 to PCV7 periods, and 41% (95%CI: 30%-52%) and 48% (95%CI: 37%-59%) when comparing PCV13 to pre-PCV7 periods. Visit rates for skin rash and trauma remained stable.


Significant reductions in US ambulatory care visit rates for OM were observed among children aged <5 years after introduction of PCV13 compared to the periods before and during PCV7; reductions were greatest among children <2 years old. The reductions beyond the PCV7 period support the effectiveness of the vaccine's 6 additional serotypes in preventing OM.


NAMCS; NHAMCS; Otitis media; PCV13; S. pneumoniae

[Indexed for MEDLINE]

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