MMWR Morb Mortal Wkly Rep. 2012 Jun 1;61(21):394-5.
In 2010, 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) and recommended by the Advisory Committee on Immunization Practices (ACIP) for children aged 6 weeks through 71 months for the prevention of invasive pneumococcal disease (IPD) caused by the 13 pneumococcal serotypes included in the vaccine. PCV13 currently is recommended as a 4-dose series for children starting at age 2 months. On December 30, 2011, FDA approved PCV13 for prevention of pneumonia and invasive disease caused by PCV13 serotypes among adults aged 50 years and older. This report summarizes data on the immunogenicity and safety of PCV13 in adults and outlines key additional evidence requested by ACIP to formulate recommendations for its use.
2010 年，食品和药物管理局（FDA）批准了 13 价肺炎球菌结合疫苗（PCV13[沛儿 13，辉瑞制药有限公司的子公司惠氏制药有限公司]），免疫接种咨询委员会（ACIP）建议将其用于 6 周龄至 71 月龄的儿童，以预防疫苗中包含的 13 种肺炎球菌血清型引起的侵袭性肺炎球菌病（IPD）。PCV13 目前建议用于 2 月龄开始的儿童进行 4 剂系列接种。2011 年 12 月 30 日，FDA 批准 PCV13 用于预防 50 岁及以上成年人由 PCV13 血清型引起的肺炎和侵袭性疾病。本报告总结了 PCV13 在成年人中的免疫原性和安全性数据，并概述了 ACIP 要求提供的额外关键证据，以制定其使用建议。
