Pelton Stephen I, Klein Jerome O
Department of Pediatrics, Boston University School of Medicine, and Maxwell Finland Laboratory for Infectious Diseases, Boston Medical Center, Boston, Massachusetts 02118, USA.
Pediatrics. 2002 Oct;110(4):805-14. doi: 10.1542/peds.110.4.805.
Seven-valent pneumococcal conjugate vaccine (PCV7) was licensed in February 2000. In June 2000, the Advisory Committee on Immunization Practices and the American Academy of Pediatrics recommended the universal administration of pneumococcal conjugate vaccine for all children 23 months of age and younger and for children 24 to 59 months of age who are at high risk for serious pneumococcal disease. Since then, >23 million doses have been administered in the United States. Postlicensure surveillance of invasive pneumococcal disease (IPD) in the United States from the Active Bacterial Core Surveillance program at the Centers for Disease Control and Prevention and the Northern California Kaiser Permanente Vaccine Study Center has reported a decline in IPD and in pneumococcal disease incidence as a result of vaccine serotypes, respectively. During this period, issues critical to the long-term success of PCV7 have become more relevant: Will PCV7 be as effective in groups of children who are at high risk for IPD as in healthy children? Will nonvaccine types replace vaccine serotypes in the nasopharynx and in disease? Why are the results of the clinical trials different for IPD and for acute otitis media? How many doses of PCV7 and what concentrations of antibody are necessary for protection? Will universal administration of PCV7 to children younger than 2 years reduce antimicrobial drug resistance and alter prescribing patterns of physicians for febrile infants? Have there been unanticipated adverse events or benefits observed? The purpose of this report is to review the current data available to address these questions and to identify gaps that will require additional knowledge to determine the ultimate value of pneumococcal conjugate vaccines in reducing the burden of pneumococcal disease in infants and children.
七价肺炎球菌结合疫苗（PCV7）于2000年2月获得许可。2000年6月，免疫实践咨询委员会和美国儿科学会建议，对所有23个月及以下的儿童以及24至59个月有严重肺炎球菌疾病高风险的儿童普遍接种肺炎球菌结合疫苗。从那时起，美国已接种超过2300万剂。美国疾病控制与预防中心的主动细菌核心监测项目以及北加利福尼亚凯撒永久疫苗研究中心对侵袭性肺炎球菌疾病（IPD）进行的上市后监测报告称，IPD以及由疫苗血清型导致的肺炎球菌疾病发病率均有所下降。在此期间，对PCV7长期成功至关重要的问题变得更加突出：PCV7对IPD高风险儿童群体是否会像对健康儿童一样有效？非疫苗血清型会在鼻咽部和疾病中取代疫苗血清型吗？为什么IPD和急性中耳炎的临床试验结果不同？需要多少剂量的PCV7以及何种抗体浓度才能提供保护？对2岁以下儿童普遍接种PCV7会降低抗菌药物耐药性并改变医生对发热婴儿的处方模式吗？是否观察到了意外的不良事件或益处？本报告的目的是回顾现有数据以解决这些问题，并确定需要更多知识来确定肺炎球菌结合疫苗在减轻婴幼儿肺炎球菌疾病负担方面最终价值的差距。
