Zhou Xiaofeng, de Luise Cynthia, Gaffney Michael, Burt Catharine W, Scott Daniel A, Gatto Nicolle, Center Kimberly J
Epidemiology, Worldwide Safety and Regulatory, Pfizer Inc, New York, NY, USA.
Epidemiology, Worldwide Safety and Regulatory, Pfizer Inc, New York, NY, USA.
Int J Pediatr Otorhinolaryngol. 2019 Apr;119:96-102. doi: 10.1016/j.ijporl.2019.01.023. Epub 2019 Jan 19.
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.
7价和13价肺炎球菌结合疫苗(PCV7和PCV13)分别于2000年和2010年在美国获批,用于对所有疫苗血清型引起的侵袭性疾病以及两种疫苗共有的7种血清型引起的中耳炎(OM)进行主动免疫,起始接种年龄约为6周龄。本研究通过评估美国5岁以下儿童在PCV7之前(1997 - 1999年)、PCV7期间(2001 - 2009年)以及PCV13引入后(2011 - 2013年)门诊就诊率的变化,来评估PCV13对中耳炎的影响。
这项生态学研究使用了美国国家门诊医疗调查和国家医院门诊医疗调查数据。采用加权最小二乘法回归进行趋势分析,并计算中耳炎以及两个不太可能与任何一种疫苗相关的对照终点(皮疹和创伤)的平均就诊率。
在5岁及以下和2岁及以下儿童中,将PCV13时期与PCV7时期相比,观察到的中耳炎就诊率降低分别为22%(95%置信区间:12% - 32%)和24%(95%置信区间:13% - 35%);将PCV13时期与PCV7之前时期相比,降低分别为41%(95%置信区间:30% - 52%)和48%(95%置信区间:37% - 59%)。皮疹和创伤的就诊率保持稳定。
与PCV7之前和期间相比,PCV13引入后美国5岁以下儿童中耳炎门诊就诊率显著降低;2岁以下儿童降低幅度最大。PCV7时期之后的降低幅度支持了该疫苗新增的6种血清型在预防中耳炎方面的有效性。