Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Atlanta GA 30333, USA.
MMWR Recomm Rep. 2010 Dec 10;59(RR-11):1-18.
On February 24, 2010, a 13-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals Inc., marketed by Pfizer Inc.]) was licensed by the Food and Drug Administration (FDA) for prevention of invasive pneumococcal disease (IPD) caused among infants and young children by the 13 pneumococcal serotypes covered by the vaccine and for prevention of otitis media caused by serotypes also covered by the 7-valent pneumococcal conjugate vaccine formulation (PCV7 [Prevnar, Wyeth]). PCV13 contains the seven serotypes included in PCV7 (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and six additional serotypes (serotypes 1, 3, 5, 6A, 7F, and 19A). PCV13 is approved for use among children aged 6 weeks-71 months and supersedes PCV7, which was licensed by FDA in 2000. This report summarizes recommendations approved by the Advisory Committee on Immunization Practices (ACIP) on February 24, 2010, for the use of PCV13 to prevent pneumococcal disease in infants and young children aged <6 years. Recommendations include 1) routine vaccination of all children aged 2-59 months, 2) vaccination of children aged 60-71 months with underlying medical conditions, and 3) vaccination of children who received ≥1 dose of PCV7 previously (CDC. Licensure of a 13-valent pneumococcal conjugate vaccine [PCV13] and recommendations for use among children-Advisory Committee on Immunization Practices [ACIP], 2010. MMWR 2010;59:258-61). Recommendations also are provided for targeted use of the 23-valent pneumococcal polysaccharide vaccine (PPSV23, formerly PPV23) in children aged 2-18 years with underlying medical conditions that increase their risk for contracting pneumococcal disease or experiencing complications of pneumococcal disease if infected. The ACIP recommendation for routine vaccination with PCV13 and the immunization schedules for children aged ≤59 months who have not received any previous PCV7 or PCV13 doses are the same as those published previously for PCV7 (CDC. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2000;49[No. RR-9]; CDC. Updated recommendation from the Advisory Committee on Immunization Practices [ACIP] for use of 7-valent pneumococcal conjugate vaccine [PCV7] in children aged 24-59 months who are not completely vaccinated. MMWR 2008;57:343-4), with PCV13 replacing PCV7 for all doses. For routine immunization of infants, PCV13 is recommended as a 4-dose series at ages 2, 4, 6, and 12-15 months. Infants and children who have received ≥1 dose of PCV7 should complete the immunization series with PCV13. A single supplemental dose of PCV13 is recommended for all children aged 14-59 months who have received 4 doses of PCV7 or another age-appropriate, complete PCV7 schedule. For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through age 71 months. Children aged 2-18 years with underlying medical conditions also should receive PPSV23 after completing all recommended doses of PCV13.
2010 年 2 月 24 日,食品药品监督管理局(FDA)批准了一种 13 价肺炎球菌多糖蛋白结合疫苗(PCV13[沛儿 13,惠氏制药公司,辉瑞公司销售]),用于预防由疫苗涵盖的 13 种肺炎球菌血清型引起的侵袭性肺炎球菌病(IPD)和由 7 价肺炎球菌结合疫苗制剂(PCV7[沛儿,惠氏])涵盖的血清型引起的中耳炎。PCV13 包含 PCV7 中包含的七种血清型(血清型 4、6B、9V、14、18C、19F 和 23F)和另外六种血清型(血清型 1、3、5、6A、7F 和 19A)。PCV13 适用于 6 周-71 个月龄的儿童,替代了 2000 年 FDA 批准的 PCV7。本报告总结了免疫实践咨询委员会(ACIP)于 2010 年 2 月 24 日批准的关于使用 PCV13 预防 6 岁以下儿童肺炎球菌病的建议。建议包括 1)所有 2-59 月龄儿童常规接种疫苗,2)对有潜在医疗条件的 60-71 月龄儿童接种疫苗,以及 3)以前接种过≥1 剂 PCV7 的儿童接种疫苗(CDC。批准一种 13 价肺炎球菌结合疫苗[PCV13]和建议在儿童中使用[ACIP],2010 年。MMWR 2010;59:258-61)。对于有潜在医疗条件的 2-18 岁儿童,也建议有针对性地使用 23 价肺炎球菌多糖疫苗(PPSV23,以前称为 PPV23),以增加他们感染肺炎球菌病或感染后发生肺炎球菌病并发症的风险。ACIP 关于 PCV13 常规接种的建议和未接受过任何以前的 PCV7 或 PCV13 剂量的≤59 月龄儿童的免疫接种计划与之前为 PCV7 发布的计划相同(CDC。预防婴幼儿肺炎球菌病:免疫实践咨询委员会[ACIP]的建议。MMWR 2000;49[No. RR-9];CDC。更新的建议来自免疫实践咨询委员会[ACIP],建议 24-59 月龄未完全接种疫苗的儿童使用 7 价肺炎球菌结合疫苗[PCV7]。MMWR 2008;57:343-4),所有剂量均用 PCV13 替代 PCV7。对于婴儿的常规免疫,建议在 2、4、6 和 12-15 月龄时进行 4 剂 PCV13 系列接种。已接受≥1 剂 PCV7 的婴儿和儿童应使用 PCV13 完成免疫系列。建议所有已接受 4 剂 PCV7 或其他年龄适宜的、完整的 PCV7 接种计划的 14-59 月龄儿童接种一剂 PCV13 补充剂。对于有潜在医疗条件的儿童,建议在 71 月龄前补充一剂 PCV13。有潜在医疗条件的 2-18 岁儿童在完成所有推荐剂量的 PCV13 后,还应接种 PPSV23。