13 January 2021
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (IF: NEJM, 70.670)
BACKGROUND 背景
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.
严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)感染及其引发的2019冠状病毒疾病(Covid-19)在全球范围内大流行,已使数千万人深受其害。人们迫切需要安全有效的疫苗。
METHODS 措施
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 fulllength spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety.
在一项正在进行的跨国、安慰剂对照、观察者盲法、关键疗效试验中,我们以1:1的比例随机分配了16岁或16岁以上的人,间隔21天接受两剂安慰剂或BNT162b2候选疫苗(每剂30微克)。BNT162b2是一种脂质纳米颗粒制剂,经核苷修饰的RNA疫苗,编码融合前稳定的膜锚定SARS-CoV-2全长刺突蛋白。主要终点是实验室确认的Covid-19疫苗的有效性和安全性。
RESULTS 结果
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.
共有43548名参与者接受随机分组,其中43448人接受了注射:21720人接受BNT162b2治疗,21728人接受安慰剂治疗。在第二次接受BNT162b2治疗的受试者中,有8例在第二次给药后至少7天出现了Covid-19,而在接受安慰剂治疗的受试者中有162例;BNT162b2预防Covid-19的有效率为95%(95%可信区间为90.3~97.6)。在按年龄、性别、种族、族群、基线体重指数和共存条件定义的亚组中,观察到类似的疫苗效力(通常为90%至100%)。在10例首次给药后发病的严重Covid-19病例中,9例发生在安慰剂受试者,1例发生在BNT162b2受试者。BNT162b2的安全性特征是短期、注射部位轻度至中度疼痛、疲劳和头痛。严重不良事件的发生率较低,疫苗组和安慰剂组相似。
CONCLUSIONS 结论
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.
BNT162b2的两剂方案可为16岁或以上的人群提供针对Covid-19的95%保护。平均2个月的安全性与其他病毒疫苗相似。