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BNT162b2 COVID-19疫苗的安全性和有效性

Safety and Efficacy of the BNT162b2 Covid-19 Vaccine

2020年12月31日

朗读者：Dr. Stephen Morrissey, NEJM执行主编

WHO于2020年3月11日宣布COVID-19构成全球大流行以来，全球已有数千万人患病。我们亟需安全、有效的疫苗。短视频中总结了新的研究发现。

BNT162b2 COVID-19 mRNA疫苗的安全性和有效性

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

摘 要

背景

SARS-CoV-2感染及其所致疾病COVID-19已在此次的全球大流行中累及数千万人。我们迫切需要安全有效的疫苗。

Background

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently.

方法

在一项仍在进行的多国、安慰剂对照、观察者设盲的关键有效性试验中，我们以1:1比例将≥16岁的参与者随机分组，两组分别间隔21天接种两剂安慰剂或BNT162b2候选疫苗（每剂30 μg）。BNT162b2是一种脂质纳米颗粒制成、核苷修饰RNA疫苗，能够编码融合前稳定、膜锚定的SARS-CoV-2全长棘突蛋白。主要终点是疫苗预防COVID-19（需经实验室证实）的有效性和安全性。

Methods

In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety.

结果

共计43,548例参与者被随机分组，其中43,448例接受了注射：21,720例注射了BNT162b2，21,728例注射了安慰剂。BNT162b2组8例参与者和安慰剂组162例参与者发生了接种第二剂至少7日后发病的COVID-19；BNT162b2预防COVID-19的有效率为95%（95%可信区间[credible interval]，90.3~97.6）。在根据年龄、性别、人种、族群、基线体质指数和是否患合并症定义的各亚组中，我们均观察到了相似的疫苗有效率（一般为90%~100%）。在接种第一剂后发生的10例重症COVID-19中，9例发生于安慰剂组，1例发生于BNT162b2组。BNT162b2的安全性特征包括短期的轻度至中度注射部位疼痛、疲劳和头痛。疫苗组和安慰剂组的严重不良事件发生率均较低且相似。

Result

A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.

结论

16岁及以上人群接种两剂BNT162b2后在预防COVID-19方面达到了95%的有效率。中位2个月期间的安全性与其他病毒疫苗相似。（由BioNTech和辉瑞资助；在ClinicalTrials.gov注册号为NCT04368728。）

Conclusions

A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

Fernando P. Polack, Stephen J. Thomas, Nicholas Kitchin, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. DOI:10.1056/NEJMoa2034577