MMWR Morb Mortal Wkly Rep. 2021 Sep 24;70(38):1344-1348. doi: 10.15585/mmwr.mm7038e2.
The Pfizer-BioNTech COVID-19 vaccine (BNT162b2) is a lipid nanoparticle-formulated, nucleoside 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. In December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) as well as an interim recommendation for use among persons aged ≥16 years by the Advisory Committee on Immunization Practices (ACIP) (1). In May 2021, the EUA and interim ACIP recommendations for Pfizer-BioNTech COVID-19 vaccine were extended to adolescents aged 12-15 years (2). During December 14, 2020-September 1, 2021, approximately 211 million doses of Pfizer-BioNTech COVID-19 vaccine were administered in the United States.* On August 23, 2021, FDA approved a Biologics License Application for use of the Pfizer-BioNTech COVID-19 vaccine, Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (3). The ACIP COVID-19 Vaccines Work Group's conclusions regarding the evidence for the Pfizer-BioNTech COVID-19 vaccine were presented to ACIP at a public meeting on August 30, 2021. To guide its deliberations regarding the Pfizer-BioNTech COVID-19 vaccine, ACIP used the Evidence to Recommendation (EtR) Framework, and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. In addition to initial clinical trial data, ACIP considered new information gathered in the 8 months since issuance of the interim recommendation for Pfizer-BioNTech COVID-19 vaccine, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. The additional information increased certainty that benefits from prevention of asymptomatic infection, COVID-19, and associated hospitalization and death outweighs vaccine-associated risks. On August 30, 2021, ACIP issued a recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19.
辉瑞-生物科技的 COVID-19 疫苗（BNT162b2）是一种脂质纳米颗粒制剂的，基于核苷的 mRNA 疫苗，编码 SARS-CoV-2 的前融合刺突糖蛋白，SARS-CoV-2 是导致 COVID-19 的病毒。辉瑞-生物科技的 COVID-19 疫苗接种由 2 剂肌内注射组成（每剂 30 μg，0.3 mL），间隔 3 周。2020 年 12 月，美国食品和药物管理局（FDA）授予该疫苗紧急使用授权（EUA），免疫实践咨询委员会（ACIP）也临时推荐在年龄≥16 岁的人群中使用该疫苗（1）。2021 年 5 月，辉瑞-生物科技 COVID-19 疫苗的 EUA 和临时 ACIP 建议扩大到 12-15 岁的青少年（2）。在 2020 年 12 月 14 日至 2021 年 9 月 1 日期间，美国已接种了约 2.11 亿剂辉瑞-生物科技的 COVID-19 疫苗。*2021 年 8 月 23 日，FDA 批准了 Pfizer，Inc. 生产的 Comirnaty（辉瑞公司）用于年龄≥16 岁人群的 Pfizer-BioNTech COVID-19 疫苗的生物制品许可申请（3）。ACIP COVID-19 疫苗工作组于 2021 年 8 月 30 日在一次公开会议上向 ACIP 提交了关于辉瑞-生物科技 COVID-19 疫苗证据的结论。为了指导其对辉瑞-生物科技 COVID-19 疫苗的审议，ACIP 使用了证据到推荐（EtR）框架，并采用了评估、制定和评估（GRADE）方法。除了最初的临床试验数据外，ACIP 还考虑了自发布辉瑞-生物科技 COVID-19 疫苗临时建议以来的 8 个月中收集的新信息，包括临床试验中的随访时间延长、真实世界疫苗有效性研究和疫苗上市后安全性监测。这些额外的信息增加了对预防无症状感染、COVID-19、相关住院和死亡的益处大于疫苗相关风险的确定性。2021 年 8 月 30 日，ACIP 发布了一项建议，即 16 岁及以上人群使用辉瑞-生物科技的 COVID-19 疫苗预防 COVID-19。
