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BNT162b2 COVID-19疫苗在6个月随访期间的结果

BNT162b2 Covid-19 Vaccine over 6 Months of Follow-up

2021年11月4日

朗读者：Dr. Stephen Morrissey, NEJM常务执行主编

BNT162b2 mRNA COVID-19于2020年末在美国获得使用授权时，当时只有2个月的临床试验数据。我们需要更长期的安全性和效力数据。短视频中总结了新的研究发现。

02:03

BNT162b2 mRNA COVID-19疫苗截至6个月的安全性和效力

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months

摘 要

背景

BNT162b2是使用脂质纳米颗粒制成的核苷修饰RNA疫苗，编码膜锚定，融合前稳定构象的SARS-CoV-2全长刺突蛋白。BNT162b2可以非常有效地预防COVID-19，目前已在全世界获得批准、附条件批准或紧急使用授权。最初获得授权时，接种疫苗2个月之后的数据尚未出来。

Background

BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable.

方法

在一项正在进行中，旨在评估疫苗效力的安慰剂对照、观察者设盲的多国、关键试验中，我们将44,165例≥16岁参与者和2264例12~15岁参与者随机分组，两组分别间隔21天接种两剂30 μg BNT162b2或安慰剂。试验终点是疫苗对实验室确诊的COVID-19的预防效力和安全性，两项终点的评估工作均持续至接种疫苗后6个月。

Methods

In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination.

结果

BNT162b2仍然安全，并且具有可接受的不良事件特性。少数参与者发生导致其退出试验的不良事件。在无既往SARS-CoV-2感染证据的可评估参与者中，截至6个月随访时，疫苗对COVID-19的预防效力为91.3%（95%置信区间[CI]，89.0~93.2）。疫苗效力逐渐减弱。在无既往SARS-CoV-2感染证据的参与者中，在各国以及在各种年龄、性别、人种或族群及COVID-19危险因素的人群中，疫苗效力为86%~100%。疫苗对重症疾病的预防效力为96.7%（95% CI，80.3~99.9）。在以SARS-CoV-2高关注变异株B.1.351（或beta变异株）为主的南非，观察到的疫苗效力为100%（95% CI，53.5~100）。

Result

BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed.

结论

截至6个月随访期时，虽然疫苗效力逐渐减弱，但BNT162b2安全性仍然良好，并且仍然可以非常有效地预防COVID-19。（由BioNTech和辉瑞资助；在ClinicalTrials.gov注册号为NCT04368728。）

Conclusions

Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

Stephen J. Thomas, Edson D. Moreira, Jr., et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. DOI: 10.1056/NEJMoa2110345