MMWR Morb Mortal Wkly Rep. 2010 Mar 12;59(9):273.
On February 19, 2010, the Food and Drug Administration (FDA) licensed a quadrivalent meningococcal conjugate vaccine, MenACWY-CRM (Menveo, Novartis Vaccines and Diagnostics). MenACWY-CRM is licensed as a single dose for use among persons aged 11-55 years. The Advisory Committee on Immunization Practices (ACIP) reviewed data from prelicensure clinical trials on the safety and immunogenicity of MenACWY-CRM. This report summarizes the approved indications for MenACWY-CRM and provides guidance from ACIP for its use. The following guidance for use of MenACWY-CRM is consistent with licensed indications and ACIP recommendations for meningococcal conjugate vaccines.
2010 年 2 月 19 日，食品和药物管理局（FDA）批准了一种四价脑膜炎球菌结合疫苗，MenACWY-CRM（Menveo，诺华疫苗和诊断公司）。MenACWY-CRM 被批准为 11-55 岁人群使用的单剂量疫苗。免疫实践咨询委员会（ACIP）审查了 MenACWY-CRM 的上市前临床试验的安全性和免疫原性数据。本报告总结了 MenACWY-CRM 的批准适应症，并提供了 ACIP 使用该疫苗的指导。以下使用 MenACWY-CRM 的指南与脑膜炎球菌结合疫苗的许可适应症和 ACIP 建议一致。
