Prescrire Int. 2006 Dec;15(86):227-33.
(1) In France, before widespread infant immunisation with the 7-valent pneumococcal conjugate vaccine, there were about 13 deaths a year and about 145 cases of pneumococcal meningitis, often with serious sequelae. The peak incidence of pneumococcal meningitis occurs at approximately 5 months of age. (2) About 65% of the pneumococcal serotypes that cause meningitis in French children are covered by the 7-valent vaccine. (3) Several trials have yielded similar results: vaccination during infancy reduces the risk of invasive pneumococcal infection due to serotypes covered by the vaccine by 80% to 90%, leading to a relative reduction of 60% to 70% in the risk of invasive pneumococcal infections due to all serotypes. (4) In the United States, since the introduction of routine vaccination for all infants under 2 years of age, infant mortality due to invasive pneumococcal infections has fallen, with roughly one death prevented per 200 000 infants. Infant vaccination also appears to reduce the circulation of vaccine serotypes among unvaccinated subjects, especially those over 50 years of age. There is some evidence of replacement by non-vaccine serotypes, but the magnitude of occurrence is small. (5) The efficacy of the 7-valent pneumococcal conjugate vaccine in the prevention of acute otitis media in infants has been tested in several clinical trials: it is minimal to non-existent. (6) The adverse effects of the 7-valent pneumococcal conjugate vaccine are similar to those of other commonly used vaccines, and include fever, rash, urticaria, reactions at the injection site, and agitation. Serious allergic reactions have occurred: at least one spontaneous report of one serious allergic reaction per 500 000 vaccinated children. (7) There is consensus on the vaccination schedule: 3 intramuscular injections given at least 4 weeks apart, plus a booster at 12-15 months, if vaccination is started at 2 months of age. (8) In France, routine vaccination would prevent about a dozen deaths, several dozen cases of meningitis, and a few hundred hospital admissions per year, at a cost of at least one serious allergic reaction. (9) The risk-benefit balance is very favourable in infants who are at a high risk of invasive pneumococcal infection. It is also positive in other infants, and should therefore be routinely offered from the age of 2 months. Epidemiological monitoring must continue.
(1)在法国,在7价肺炎球菌结合疫苗广泛用于婴儿免疫之前,每年约有13例死亡和约145例肺炎球菌性脑膜炎病例,且常伴有严重后遗症。肺炎球菌性脑膜炎的发病高峰约在5个月大时出现。(2)在法国儿童中引起脑膜炎的肺炎球菌血清型约65%可被7价疫苗覆盖。(3)多项试验得出了类似结果:婴儿期接种疫苗可使疫苗所覆盖血清型导致的侵袭性肺炎球菌感染风险降低80%至90%,从而使所有血清型导致的侵袭性肺炎球菌感染风险相对降低60%至70%。(4)在美国,自从对所有2岁以下婴儿实施常规疫苗接种以来,侵袭性肺炎球菌感染导致的婴儿死亡率有所下降,每20万名婴儿中约有1例死亡得以避免。婴儿接种疫苗似乎还减少了未接种疫苗者(尤其是50岁以上者)中疫苗血清型的传播。有证据表明存在非疫苗血清型的替代现象,但发生程度较小。(5)7价肺炎球菌结合疫苗在预防婴儿急性中耳炎方面的疗效已在多项临床试验中得到检验:疗效微乎其微或不存在。(6)7价肺炎球菌结合疫苗的不良反应与其他常用疫苗相似,包括发热、皮疹、荨麻疹、注射部位反应和烦躁不安。曾发生过严重过敏反应:每50万名接种疫苗的儿童中至少有1例严重过敏反应的自发报告。(7)对于疫苗接种程序已达成共识:如果在2个月大时开始接种,需进行3次肌肉注射,每次间隔至少4周,外加在12至15个月时进行一次加强注射。(8)在法国,常规疫苗接种每年可预防约十几例死亡、几十例脑膜炎以及几百例住院病例,代价是至少发生1例严重过敏反应。(9)对于侵袭性肺炎球菌感染高危婴儿,风险效益比非常有利。对其他婴儿也是积极的,因此应从2个月大时开始常规接种。必须继续进行流行病学监测。