ST LOUIS (MD Consult) - On February 24, 2010, Pfizer and the US Food and Drug Administration announced the approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]), an immunization indicated for the prevention of invasive disease caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in children aged 6 weeks through 5 years. Invasive pneumococcal disease includes meningitis, bacteremic pneumonia, empyema, sepsis, and bacteremia.

Prevnar 13 is also indicated for the prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No efficacy data are available for ear infections caused by the 1, 3, 5, 6A, 7F, and 19A serotypes.

Prevnar 13 includes the 7 S pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) included in the previously approved vaccine Prevnar (pneumococcal 7-valent conjugate vaccine [diphtheria CRM197 protein]) plus 6 additional serotypes.

The recommendations for administration of Prevnar 13 state that the vaccine should be given as a 4-dose series at ages 2, 4, 6, and 12 to 15 months. Children who have received one or more doses of Prevnar may complete the 4-dose immunization series with Prevnar 13. Children aged 15 months through 5 years who have received 4 doses of Prevnar may receive 1 dose of Prevnar 13 to elicit immune responses to the additional serotypes. The immune responses induced by this Prevnar 13 transition schedule may result in lower antibody concentrations for the additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared with antibody concentrations achieved after the administration of 4 doses of Prevnar 13 (given at 2, 4, 6, and 12 to 15 months). The clinical relevance of these lower antibody responses is not known.

The safety of Prevnar 13 was evaluated in a study of 5,084 infants and young children. The reactions of these participants were compared with reactions observed in 2,760 infants and children who received Prevnar, the control vaccine. Common adverse effects reported after administration of Prevnar 13 were pain, redness, and swelling at the injection site, irritability, decreased appetite, and fever. These reactions were similar to those observed with Prevnar.

Vaccine effectiveness was assessed in a randomized multicenter immunogenicity study conducted in the United States. Using several immunologic measures, investigators compared antibody responses elicited by administration with Prevnar 13 to those elicited by vaccination with Prevnar. Administration of Prevnar 13 was shown to induce antibodies comparable to those induced by and shown to be protective after the administration of Prevnar.

Prevnar 13 should not be administered to any child with a history of experiencing a severe allergic reaction to any component of Prevnar 13, Prevnar, or any diphtheria-toxoid–containing vaccine. The vaccine may not offer adequate protection for all vaccinees (eg, children who are immunocompromised). Protection against ear infections is expected to be less than that for invasive disease. A temporary pause of breathing after vaccination has been observed in some infants who were born prematurely.

Immunization with Prevnar does not substitute for routine diphtheria immunization.

The vaccine is available in single-dose, prefilled syringes.

圣路易斯(MD Consult)——2010年2月24日，辉瑞公司宣布，美国食品药品管理局(FDA)已批准Prevnar 13 [肺炎球菌13价结合疫苗(白喉CRM197蛋白)]用于接种年龄为6周~5岁的儿童，以帮助预防由13种肺炎链球菌血清型(1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F和23F)引起的侵袭性疾病。侵袭性肺炎球菌疾病包括脑膜炎、菌血性肺炎、脓胸、脓毒症和菌血症。

 

Prevnar 13还适用于预防由肺炎链球菌血清型4、6B、9V、14、18C、19F和23F引起的中耳炎。尚缺乏有关该疫苗预防1、3、5、6A、7F和19A血清型所致耳部感染的疗效数据。

 

Prevnar 13含有此前获批的Prevnar 疫苗 [肺炎球菌7价结合疫苗白喉(CRM197蛋白)]所含有的7种肺炎链球菌血清型(4、6B、9V、14、18C、19F和23F)和另外6种血清型。

 

建议在2、4、6及12~15月龄时，连续接种4剂Prevnar 13。已接种≥1剂Prevnar的儿童可完成4剂Prevnar 13免疫程序。已接种4剂Prevar的年龄为15个月~5岁的儿童可接种1剂Prevnar 13，以诱导产生针对其他血清型的免疫应答。与接种4剂Prevnar 13 (在月龄为2、4、6和12~15个月时接种)后获得的抗体应答水平相比，上述Prevnar 13过渡方案诱导产生的针对其他血清型(1、3、5、6A、7F和19A)的抗体应答水平较低，其临床意义尚不清楚。

 

一项纳入5,084名婴幼儿的研究对Prevnar 13的安全性进行了评价。对照组为接种Prevnar的2,760名婴儿和儿童。对两组的接种反应进行比较。接种Prevnar 13后常见的不良反应包括接种部位疼痛、泛红和肿胀、以及易激、食欲减退和发热。这些反应与接种Prevnar后所观察到的类似。

 

美国一项随机多中心免疫原性研究对疫苗有效性进行了评价。研究者采用几项免疫学指标，对接种Prevnar 13和Prevnar后诱导的抗体应答进行了比较。接种Prevnar 13后诱导的抗体与接种Prevnar后诱导的抗体具有可比性，并具有保护作用。

 

Prevnar 13不应用于对Prevnar 13、Prevnar或任何含白喉类毒素疫苗的任何成分严重过敏的儿童。该疫苗不能为所有接种者(如免疫低下的儿童)提供充分保护，并且其对耳部感染的预防作用次于对侵袭性疾病的预防作用。观察到一些早产婴儿在接种后出现呼吸暂停。

 

Prevnar接种不能代替常规白喉疫苗接种。

 

该疫苗为单剂量预填充式注射器包装。