Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
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BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
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发表时间：
2020-12-31
期刊：
影响因子：
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通讯作者：
C4591001 Clinical Trial Group
中科院分区：
文献类型：
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作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
严重急性呼吸系统综合征冠状病毒2型（SARS-CoV-2）感染和由此导致的2019冠状病毒病（Covid-19）在全球范围内大流行，已使数千万人受到影响。迫切需要安全有效的疫苗。在一项正在进行的多国、安慰剂对照、双盲、关键有效性试验中，我们将16岁或以上的受试者以1：1的比例随机分配接受两剂安慰剂或BNT 162 b2候选疫苗（每剂30 μg），间隔21天。BNT 162 b2是一种脂质纳米颗粒配制的核苷修饰的RNA疫苗，编码融合前稳定的膜锚定SARS-CoV-2全长刺突蛋白。主要终点是疫苗对实验室确认的Covid-19的有效性和安全性。共有43，548名参与者接受了随机分组，其中43，448人接受了注射：21，720人接受了BNT 162 b2注射，21，728人接受了安慰剂注射。在分配接受BNT 162 b2的参与者中，有8例Covid-19在第二次给药后至少7天发病，在分配接受安慰剂的参与者中有162例; BNT 162 b2在预防Covid-19方面的有效性为95%（95%可信区间，90.3至97.6）。在按年龄、性别、人种、种族、基线体重指数和是否存在共存疾病定义的亚组中观察到相似的疫苗有效性（通常为90 - 100%）。在首次给药后发病的10例重度Covid-19病例中，9例发生在安慰剂接受者中，1例发生在BNT 162 b2接受者中。BNT 162 b2的安全性特征为注射部位的短期轻度至中度疼痛、疲劳和头痛。严重不良事件的发生率很低，疫苗组和安慰剂组相似。BNT 162 b2的两剂方案使16岁或以上的人对COVID-19的保护率达到95%。中位2个月的安全性与其他病毒疫苗相似。（由BioNTech和Pfizer资助; ClinicalTrials.gov编号，NCT 04368728。）
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. 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. 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. 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.)