BNT162b2 mRNA 新冠病毒疫苗的安全性和有效性。
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
机构信息
From Fundacion INFANT (F.P.P.) and iTrials-Hospital Militar Central (G.P.M.), Buenos Aires; State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.V.K., D.C., P.R.D., K.U.J., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., P.L.) and Worldwide Safety, Safety Surveillance and Risk Management (S.M.), Pfizer, Collegeville, PA; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Global Product Development, Pfizer, Peapack, NJ (S.R.); Cincinnati Children's Hospital, Cincinnati (R.W.F.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); BioNTech, Mainz (ÖT., U.Ş.), and Medizentrum Essen Borbeck, Essen (A.S.) - both in Germany; Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); Hacettepe University, Ankara, Turkey (S.Ü.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
出版信息
N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.
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.
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.
RESULTS
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.
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.).
背景
严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）感染和由此产生的 2019 年冠状病毒病（Covid-19）在全球大流行中使数千万人患病。迫切需要安全有效的疫苗。
方法
在一项正在进行的多国、安慰剂对照、观察者盲法、主要疗效试验中，我们将 16 岁及以上的人群以 1:1 的比例随机分配，接受两剂、间隔 21 天的安慰剂或 BNT162b2 候选疫苗（每剂 30μg）。BNT162b2 是一种脂质纳米颗粒制剂、核苷修饰 RNA 疫苗，编码预融合稳定、膜锚定的 SARS-CoV-2 全长刺突蛋白。主要终点是疫苗对实验室确诊的 Covid-19 的疗效和安全性。
结果
共有 43548 名参与者接受了随机分组，其中 43448 名接受了注射：21720 名接受了 BNT162b2，21728 名接受了安慰剂。在接受 BNT162b2 治疗的参与者中，有 8 例 Covid-19 病例在第二剂后至少 7 天发病，在接受安慰剂治疗的参与者中，有 162 例；BNT162b2 预防 Covid-19 的有效率为 95%（95%置信区间，90.3 至 97.6）。在按年龄、性别、种族、民族、基线体重指数和并存疾病划分的亚组中，观察到相似的疫苗疗效（通常为 90%至 100%）。在第一剂后发病的 10 例严重 Covid-19 病例中，9 例发生在安慰剂组，1 例发生在 BNT162b2 组。BNT162b2 的安全性特征为注射部位短期、轻度至中度疼痛、疲劳和头痛。严重不良事件的发生率较低，且在疫苗组和安慰剂组相似。
结论
两剂 BNT162b2 方案可使 16 岁及以上人群对 Covid-19 的保护率达到 95%。中位时间为 2 个月的安全性与其他病毒疫苗相似。（由 BioNTech 和辉瑞公司资助；ClinicalTrials.gov 编号，NCT04368728）。
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