辉瑞-BioNTech 信使核糖核酸新冠病毒疫苗 6 个月的安全性和有效性
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.
机构信息
From the 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., S.B., W.V.K., D.C., Q.Y., P.L., P.R.D., W.C.G., K.U.J.) - both in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Bahia (E.D.M.), and iTrials-Hospital Militar Central (G.P.M.) and Fundacion INFANT, Buenos Aires (F.P.P.) - all in Brazil; Centro Paulista de Investigação Clinica, São Paulo (C.Z.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); Vaccine Research and Development (J.L.P., X.X.) and Worldwide Safety, Safety Surveillance, and Risk Management (D.B.T., S.M.), Pfizer, Collegeville, PA; 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 (Ö.T., 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., S.M.).
出版信息
N Engl J Med. 2021 Nov 4;385(19):1761-1773. doi: 10.1056/NEJMoa2110345. Epub 2021 Sep 15.
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.
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.
RESULTS
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.
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.).
背景
BNT162b2 是一种脂质纳米颗粒配方、核苷修饰的 RNA 疫苗，编码一种预融合稳定的、膜锚定的严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）全长刺突蛋白。BNT162b2 对 2019 年冠状病毒病（Covid-19）非常有效，目前在全球范围内获得批准、有条件批准或授权紧急使用。在最初获得授权时，尚无接种疫苗后 2 个月以上的数据。
方法
在一项正在进行的、安慰剂对照、观察者设盲、多中心、关键疗效试验中，我们将 44165 名 16 岁及以上和 2264 名 12 至 15 岁的参与者随机分配，接受两剂 30μg 的 BNT162b2 或安慰剂，间隔 21 天。试验终点是疫苗对实验室确诊的 Covid-19 的疗效和安全性，这两者均在接种后 6 个月内进行评估。
结果
BNT162b2 继续安全，具有可接受的不良事件谱。少数参与者因不良事件而退出试验。在没有 SARS-CoV-2 既往感染证据且可评估的参与者中，接种疫苗后 6 个月的疫苗对 Covid-19 的疗效为 91.3%（95%置信区间[CI]，89.0 至 93.2）。疫苗疗效逐渐下降。在没有 SARS-CoV-2 既往感染证据的参与者中，疫苗在各国和不同年龄、性别、种族或族裔以及有 Covid-19 风险因素的人群中的疗效为 86%至 100%。疫苗对重症疾病的疗效为 96.7%（95%CI，80.3 至 99.9）。在南非，主要流行的 SARS-CoV-2 变体关注的 B.1.351（或 beta），观察到疫苗效力为 100%（95%CI，53.5 至 100）。
结论
在接种后 6 个月的随访中，尽管疫苗效力逐渐下降，但 BNT162b2 具有良好的安全性，对预防 Covid-19 非常有效。（由 BioNTech 和辉瑞资助；ClinicalTrials.gov 编号，NCT04368728）。
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