2010 年,免疫实践咨询委员会(ACIP)批准了 13 价肺炎球菌结合疫苗(PCV13)并提出了其在儿童中的使用建议。
Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children - Advisory Committee on Immunization Practices (ACIP), 2010.
出版信息
MMWR Morb Mortal Wkly Rep. 2010 Mar 12;59(9):258-61.
On February 24, 2010, a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.]) was licensed by the Food and Drug Administration (FDA) for prevention of invasive pneumococcal disease (IPD) caused by the 13 pneumococcal serotypes covered by the vaccine and for prevention of otitis media caused by serotypes in the 7-valent pneumococcal conjugate vaccine formulation (PCV7 [Prevnar, Wyeth]). PCV13 is approved for use among children aged 6 weeks-71 months and succeeds PCV7, which was licensed by FDA in 2000. The Pneumococcal Vaccines Work Group of the Advisory Committee on Immunization Practices (ACIP) reviewed available data on the immunogenicity, safety, and cost-effectiveness of PCV13, and on estimates of the vaccine-preventable pneumococcal disease burden. The working group then presented policy options for consideration of the full ACIP. This report summarizes recommendations approved by ACIP on February 24, 2010, for 1) routine vaccination of all children aged 2-59 months with PCV13, 2) vaccination with PCV13 of children aged 60-71 months with underlying medical conditions that increase their risk for pneumococcal disease or complications, and 3) PCV13 vaccination of children who previously received 1 or more doses of PCV7. CDC guidance for vaccination providers regarding transition from PCV7 to the PCV13 immunization program also is included.
2010 年 2 月 24 日,食品和药物管理局(FDA)批准了一种 13 价肺炎球菌结合疫苗(PCV13 [沛儿 13,辉瑞公司惠氏制药子公司]),用于预防疫苗涵盖的 13 种肺炎球菌血清型引起的侵袭性肺炎球菌病(IPD),以及预防 7 价肺炎球菌结合疫苗(PCV7 [沛儿,惠氏])制剂中血清型引起的中耳炎。PCV13 适用于 6 周至 71 个月龄的儿童,并取代了 2000 年 FDA 批准使用的 PCV7。免疫实践咨询委员会(ACIP)肺炎球菌疫苗工作组审查了 PCV13 的免疫原性、安全性和成本效益的现有数据,以及疫苗可预防的肺炎球菌疾病负担的估计。工作组随后提出了供 ACIP 全体成员审议的政策选择。本报告总结了 2010 年 2 月 24 日 ACIP 批准的建议,包括:1)所有 2-59 月龄儿童常规接种 PCV13;2)对存在增加患肺炎球菌疾病或并发症风险的基础疾病的 60-71 月龄儿童接种 PCV13;3)对以前接种过 1 剂或多剂 PCV7 的儿童接种 PCV13。本报告还包括了关于从 PCV7 向 PCV13 免疫规划过渡的疫苗接种提供者的 CDC 指南。