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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. ​

文献信息 ​

DOI10.1056/NEJMoa2034577
PMID33301246
期刊The New England journal of medicine
影响因子78.5
JCR 分区Q1
发表年份2020
被引次数8401
关键词BNT162b2疫苗, Covid-19, 疫苗有效性, 安全性, SARS-CoV-2
文献类型Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial
ISSN0028-4793
页码2603-2615
期号383(27)
作者Fernando P Polack, Stephen J Thomas, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L Perez, Gonzalo Pérez Marc, Edson D Moreira, Cristiano Zerbini, Ruth Bailey, Kena A Swanson, Satrajit Roychoudhury, Kenneth Koury, Ping Li, Warren V Kalina, David Cooper, Robert W Frenck, Laura L Hammitt, Özlem Türeci, Haylene Nell, Axel Schaefer, Serhat Ünal, Dina B Tresnan, Susan Mather, Philip R Dormitzer, Uğur Şahin, Kathrin U Jansen, William C Gruber

一句话小结 ​

本研究评估了BNT162b2疫苗对16岁及以上人群预防Covid-19的有效性和安全性，结果显示该疫苗提供了95%的保护率，且安全性良好，主要不良反应为轻至中度的注射部位疼痛和疲劳。这一发现为应对全球疫情提供了重要的疫苗选择，具有显著的公共卫生意义。

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BNT162b2疫苗 · Covid-19 · 疫苗有效性 · 安全性 · SARS-CoV-2

摘要 ​

背景
严重急性呼吸综合症冠状病毒2型（SARS-CoV-2）感染及由此引发的2019冠状病毒病（Covid-19）在全球范围内造成了数千万人的影响，急需安全有效的疫苗。

方法
在一项正在进行的多国、安慰剂对照、观察者盲法的关键性有效性试验中，我们以1:1的比例随机分配16岁及以上的参与者，接受两剂疫苗（间隔21天）的注射，分别为安慰剂或BNT162b2疫苗候选剂（每剂30微克）。BNT162b2是一种脂质纳米颗粒制剂，经过核苷酸修饰的RNA疫苗，编码一种预融合稳定、膜锚定的SARS-CoV-2全长刺突蛋白。主要终点为疫苗对实验室确诊的Covid-19的有效性及安全性。

结果
共有43,548名参与者接受随机分配，其中43,448人接受了注射：21,720人接种BNT162b2，21,728人接种安慰剂。在接种BNT162b2的参与者中，有8例Covid-19病例发生在第二剂接种后至少7天，而在接种安慰剂的参与者中有162例；BNT162b2对预防Covid-19的有效性为95%（95%可信区间为90.3至97.6）。在按年龄、性别、种族、民族、基线体重指数及合并症状定义的亚组中观察到类似的疫苗有效性（一般为90%至100%）。在接种第一剂后发生的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的安全性特征为短期的轻至中度注射部位疼痛、疲劳和头痛。严重不良事件的发生率较低，并且在疫苗组和安慰剂组中相似。

结论
BNT162b2的两剂方案在16岁及以上的人群中提供了95%的Covid-19保护。中位随访2个月的安全性与其他病毒疫苗相似。（本研究由BioNTech和Pfizer资助；临床试验登记号，NCT04368728。）

英文摘要 ​

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.).

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主要研究问题 ​

  1. BNT162b2疫苗在不同年龄段的有效性差异如何？
  2. 在疫苗接种后，短期内有哪些常见的副作用需要注意？
  3. BNT162b2疫苗的长期安全性研究目前有哪些进展？
  4. 除了BNT162b2，还有哪些新型疫苗正在研发以对抗Covid-19？
  5. 如何评估BNT162b2疫苗在不同种族和民族群体中的效果差异？

核心洞察 ​

研究背景和目的 ​

新冠疫情的爆发促使全球范围内对疫苗的研发进行快速响应。BNT162b2 mRNA疫苗是由Pfizer和BioNTech联合开发的针对COVID-19的疫苗。本研究旨在评估该疫苗的安全性和有效性，以为其在公众中的使用提供科学依据。

主要方法/材料/实验设计 ​

本研究采用随机、双盲、安慰剂对照的临床试验设计，主要包括以下步骤：

Mermaid diagram
  • 参与者招募：选择合适的志愿者，确保样本的多样性。
  • 随机分组：将参与者随机分为接种疫苗组和安慰剂组。
  • 接种程序：疫苗组接种BNT162b2，安慰剂组接种无活性成分的安慰剂。
  • 观察和记录：对参与者的健康状况进行监测，记录任何不良反应。
  • 免疫反应评估：通过血液检测评估抗体水平。
  • 数据分析：对收集的数据进行统计分析，以确定疫苗的有效性和安全性。

关键结果和发现 ​

  • 安全性：大多数参与者在接种后出现轻微至中度的不良反应，如注射部位疼痛、疲劳、头痛等，严重不良反应发生率较低。
  • 有效性：疫苗在临床试验中显示出高达95%的有效性，能够显著降低感染COVID-19的风险。
  • 免疫反应：接种后产生了强烈的中和抗体反应，且在接种后几个月内抗体水平保持在有效范围内。

主要结论/意义/创新性 ​

本研究证实了BNT162b2 mRNA疫苗在预防COVID-19方面的高效性和良好的安全性。这一成果为疫苗的广泛使用提供了重要的科学依据，标志着mRNA疫苗技术在公共卫生领域的重大突破，可能改变未来疫苗研发的方向。

研究局限性和未来方向 ​

  • 局限性：研究样本主要集中在特定人群，可能无法完全代表更广泛的群体。此外，长期效果和安全性仍需进一步观察。
  • 未来方向：建议开展长期随访研究，以监测疫苗的持久免疫效果及潜在的罕见不良反应。同时，探索不同人群（如老年人、免疫抑制患者）的疫苗反应，以优化接种策略。
部分内容
研究背景和目的评估BNT162b2 mRNA疫苗的安全性和有效性，为疫苗的公众使用提供依据
主要方法随机、双盲、安慰剂对照的临床试验，招募参与者、随机分组、接种、观察和数据分析
关键结果高达95%的有效性，轻微至中度不良反应，良好的免疫反应
主要结论BNT162b2疫苗安全有效，为mRNA疫苗技术的应用提供了重要证据
研究局限性样本代表性不足，长期效果需进一步观察
未来方向长期随访研究，探索不同人群的疫苗反应

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引用本文的文献 ​

  1. Single-component, self-assembling, protein nanoparticles presenting the receptor binding domain and stabilized spike as SARS-CoV-2 vaccine candidates. - Linling He;Xiaohe Lin;Ying Wang;Ciril Abraham;Cindy Sou;Timothy Ngo;Yi Zhang;Ian A Wilson;Jiang Zhu - bioRxiv : the preprint server for biology (2021)
  2. The impact of vaccination on COVID-19 outbreaks in the United States. - Seyed M Moghadas;Thomas N Vilches;Kevin Zhang;Chad R Wells;Affan Shoukat;Burton H Singer;Lauren Ancel Meyers;Kathleen M Neuzil;Joanne M Langley;Meagan C Fitzpatrick;Alison P Galvani - medRxiv : the preprint server for health sciences (2021)
  3. Optimal symptom combinations to aid COVID-19 case identification: analysis from a community-based, prospective, observational cohort. - M Antonelli;J Capdevila;A Chaudhari;J Granerod;L S Canas;M S Graham;K Klaser;M Modat;E Molteni;B Murray;C H Sudre;R Davies;A May;L H Nguyen;D A Drew;A Joshi;A T Chan;J P Cramer;T Spector;J Wolf;S Ourselin;C J Steves;A E Loeliger - medRxiv : the preprint server for health sciences (2021)
  4. Arab nations first to approve Chinese COVID vaccine - despite lack of public data. - David Cyranoski - Nature (2020)
  5. Multifaceted strategies for the control of COVID-19 outbreaks in long-term care facilities in Ontario, Canada. - Thomas N Vilches;Shokoofeh Nourbakhsh;Kevin Zhang;Lyndon Juden-Kelly;Lauren E Cipriano;Joanne M Langley;Pratha Sah;Alison P Galvani;Seyed M Moghadas - medRxiv : the preprint server for health sciences (2021)
  6. Assessing Durability of Vaccine Effect Following Blinded Crossover in COVID-19 Vaccine Efficacy Trials. - Dean Follmann;Jonathan Fintzi;Michael P Fay;Holly E Janes;Lindsey Baden;Hana El Sahly;Thomas R Fleming;Devan V Mehrotra;Lindsay N Carpp;Michal Juraska;David Benkeser;Deborah Donnell;Youyi Fong;Shu Han;Ian Hirsch;Ying Huang;Yunda Huang;Ollivier Hyrien;Alex Luedtke;Marco Carone;Martha Nason;An Vandebosch;Honghong Zhou;Iksung Cho;Erin Gabriel;James G Kublin;Myron S Cohen;Lawrence Corey;Peter B Gilbert;Kathleen M Neuzil - medRxiv : the preprint server for health sciences (2020)
  7. A guide to vaccinology: from basic principles to new developments. - Andrew J Pollard;Else M Bijker - Nature reviews. Immunology (2021)
  8. Real-world data suggest antibody positivity to SARS-CoV-2 is associated with a decreased risk of future infection. - Raymond A Harvey;Jeremy A Rassen;Carly A Kabelac;Wendy Turenne;Sandy Leonard;Reyna Klesh;William A Meyer;Harvey W Kaufman;Steve Anderson;Oren Cohen;Valentina I Petkov;Kathy A Cronin;Alison L Van Dyke;Douglas R Lowy;Norman E Sharpless;Lynne T Penberthy - medRxiv : the preprint server for health sciences (2020)
  9. Priority COVID-19 Vaccination for Patients with Cancer while Vaccine Supply Is Limited. - Antoni Ribas;Rajarshi Sengupta;Trevan Locke;Sayyed Kaleem Zaidi;Katie M Campbell;John M Carethers;Elizabeth M Jaffee;E John Wherry;Jean-Charles Soria;Gypsyamber D'Souza; - Cancer discovery (2021)
  10. COVID-19 vaccines and women's security. - Sophie Harman;Asha Herten-Crabb;Rosemary Morgan;Julia Smith;Clare Wenham - Lancet (London, England) (2021)

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