MMWR Morb Mortal Wkly Rep. 2021 May 21;70(20):749-752. doi: 10.15585/mmwr.mm7020e1.
The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 μg, 0.3 mL each) administered 3 weeks apart. On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine (Pfizer, Inc; Philadelphia, Pennsylvania) in persons aged ≥16 years (1); on December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the vaccine in the same age group (2). As of May 12, 2021, approximately 141.6 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥16 years.* On May 10, 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years (1). On May 12, 2021, ACIP issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework, using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥12 years under an EUA is interim and will be updated as additional information becomes available.
辉瑞-BioNTech COVID-19(BNT162b2)疫苗是一种脂质纳米颗粒制剂,含有修饰核苷的 mRNA,编码导致 COVID-19 的 SARS-CoV-2 病毒的融合前刺突糖蛋白。辉瑞-BioNTech COVID-19 疫苗的接种包括 2 剂肌肉内注射(每次 30 μg,每 0.3 mL),间隔 3 周。2020 年 12 月 11 日,美国食品和药物管理局(FDA)发布了辉瑞-BioNTech COVID-19 疫苗(辉瑞公司;宾夕法尼亚州费城)的紧急使用授权(EUA),用于年龄≥16 岁的人群(1);2020 年 12 月 12 日,免疫实践咨询委员会(ACIP)发布了在相同年龄组中使用该疫苗的临时建议(2)。截至 2021 年 5 月 12 日,约有 1.416 亿剂辉瑞-BioNTech COVID-19 疫苗接种给≥16 岁的人群。*2021 年 5 月 10 日,FDA 将辉瑞-BioNTech COVID-19 疫苗的 EUA 扩大到包括 12-15 岁的青少年(1)。2021 年 5 月 12 日,ACIP 发布了在 12-15 岁青少年中使用辉瑞-BioNTech COVID-19 疫苗预防 COVID-19 的临时建议。为了指导其关于疫苗的审议,ACIP 使用了证据推荐(EtR)框架,使用了分级评估、制定与评价(GRADE)方法。ACIP 对 EUA 下≥12 岁人群使用辉瑞-BioNTech COVID-19 疫苗的建议是临时的,将根据获得的更多信息进行更新。