MMWR Morb Mortal Wkly Rep. 2021 Jan 1;69(5152):1653-1656. doi: 10.15585/mmwr.mm695152e1.
On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 μg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework, using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
2020 年 12 月 18 日,美国食品和药物管理局(FDA)发布了 Moderna COVID-19(mRNA-1273)疫苗(ModernaTX,Inc;马萨诸塞州剑桥)的紧急使用授权(EUA),这是一种包裹在脂质纳米颗粒中的、经核苷修饰的 mRNA 疫苗,编码导致 2019 年冠状病毒病(COVID-19)的 SARS-CoV-2 病毒的稳定融合前刺突糖蛋白(1)。这是美国根据 EUA 批准的第二种用于预防 COVID-19 的 COVID-19 疫苗(2)。接种 Moderna COVID-19 疫苗由 2 剂(每剂 100μg,0.5mL)肌内注射组成,间隔 1 个月(4 周)(3)。2020 年 12 月 19 日,免疫实践咨询委员会(ACIP)发布了一项临时建议*,用于 18 岁及以上人群接种 Moderna COVID-19 疫苗以预防 COVID-19。为指导其对疫苗的审议,ACIP 采用了证据到建议(EtR)框架,使用了推荐评估、制定和评估(GRADE)方法。包括 Moderna COVID-19 疫苗在内的所有根据 EUA 授权的 COVID-19 疫苗的使用,都应结合 ACIP 关于分配 COVID-19 疫苗初始供应的临时建议来实施(3)。根据 EUA 使用 Moderna COVID-19 疫苗的 ACIP 建议是临时的,将根据更多信息进行更新。