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BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. ​

文献信息 ​

DOI10.1056/NEJMoa2101765
PMID33626250
期刊The New England journal of medicine
影响因子78.5
JCR 分区Q1
发表年份2021
被引次数1441
关键词BNT162b2 mRNA疫苗, 新冠病毒感染, 疫苗有效性, 大规模接种, 健康结果
文献类型Journal Article, Research Support, Non-U.S. Gov't
ISSN0028-4793
页码1412-1423
期号384(15)
作者Noa Dagan, Noam Barda, Eldad Kepten, Oren Miron, Shay Perchik, Mark A Katz, Miguel A Hernán, Marc Lipsitch, Ben Reis, Ran D Balicer

一句话小结 ​

本研究利用以色列最大的医疗保健组织的数据，评估了BNT162b2 mRNA疫苗在非控制环境中的有效性，结果显示首次接种后的有效性为46%-74%，第二次接种后提升至87%-94%。这一发现表明疫苗在实际应用中对多种与Covid-19相关的疾病结果具有显著保护作用，为公共卫生政策提供了重要依据。

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BNT162b2 mRNA疫苗 · 新冠病毒感染 · 疫苗有效性 · 大规模接种 · 健康结果

摘要 ​

背景
随着全球范围内针对2019冠状病毒病（Covid-19）的大规模疫苗接种活动的启动，需要在非控制环境中对不同人群的疫苗有效性进行评估。本研究利用以色列最大的医疗保健组织的数据来评估BNT162b2 mRNA疫苗的有效性。

方法
在2020年12月20日至2021年2月1日期间，所有新接种疫苗的人士根据人口统计学和临床特征与未接种对照组以1:1的比例进行匹配。研究结果包括经确认的严重急性呼吸综合症冠状病毒2型（SARS-CoV-2）感染、症状性Covid-19、与Covid-19相关的住院、重症以及死亡。我们使用Kaplan-Meier估计法将每个结果的疫苗有效性估算为1减去风险比。

结果
每个研究组均包括596,618人。在首次接种后第14至20天以及在第二次接种后7天或以上，研究结果的疫苗有效性估计如下：对于确诊感染，首次接种后为46%（95%置信区间[CI]，40至51），第二次接种后为92%（95% CI，88至95）；对于症状性Covid-19，首次接种后为57%（95% CI，50至63），第二次接种后为94%（95% CI，87至98）；对于住院，首次接种后为74%（95% CI，56至86），第二次接种后为87%（95% CI，55至100）；对于重症，首次接种后为62%（95% CI，39至80），第二次接种后为92%（95% CI，75至100）。在首次接种后第14至20天，估计Covid-19死亡的预防有效性为72%（95% CI，19至100）。在特定亚人群中，针对确诊感染和症状性Covid-19的有效性在不同年龄组中是一致的，但在存在多种共存疾病的人群中有效性可能略低。

结论
本研究在全国范围内的大规模疫苗接种环境中表明，BNT162b2 mRNA疫苗对多种与Covid-19相关的结果有效，这一发现与随机试验的结果一致。

英文摘要 ​

BACKGROUND As mass vaccination campaigns against coronavirus disease 2019 (Covid-19) commence worldwide, vaccine effectiveness needs to be assessed for a range of outcomes across diverse populations in a noncontrolled setting. In this study, data from Israel's largest health care organization were used to evaluate the effectiveness of the BNT162b2 mRNA vaccine.

METHODS All persons who were newly vaccinated during the period from December 20, 2020, to February 1, 2021, were matched to unvaccinated controls in a 1:1 ratio according to demographic and clinical characteristics. Study outcomes included documented infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic Covid-19, Covid-19-related hospitalization, severe illness, and death. We estimated vaccine effectiveness for each outcome as one minus the risk ratio, using the Kaplan-Meier estimator.

RESULTS Each study group included 596,618 persons. Estimated vaccine effectiveness for the study outcomes at days 14 through 20 after the first dose and at 7 or more days after the second dose was as follows: for documented infection, 46% (95% confidence interval [CI], 40 to 51) and 92% (95% CI, 88 to 95); for symptomatic Covid-19, 57% (95% CI, 50 to 63) and 94% (95% CI, 87 to 98); for hospitalization, 74% (95% CI, 56 to 86) and 87% (95% CI, 55 to 100); and for severe disease, 62% (95% CI, 39 to 80) and 92% (95% CI, 75 to 100), respectively. Estimated effectiveness in preventing death from Covid-19 was 72% (95% CI, 19 to 100) for days 14 through 20 after the first dose. Estimated effectiveness in specific subpopulations assessed for documented infection and symptomatic Covid-19 was consistent across age groups, with potentially slightly lower effectiveness in persons with multiple coexisting conditions.

CONCLUSIONS This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19-related outcomes, a finding consistent with that of the randomized trial.

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主要研究问题 ​

  1. BNT162b2 mRNA疫苗在不同年龄组中的有效性是否存在显著差异？
  2. 该研究中使用的匹配控制组在临床特征上有哪些关键因素？
  3. 在以色列的大规模疫苗接种中，疫苗对具有多种共病的患者的效果如何？
  4. 如何评估BNT162b2疫苗在不同种族和社会经济背景人群中的有效性？
  5. 研究结果对未来疫苗接种策略和公共卫生政策有何影响？

核心洞察 ​

研究背景和目的 ​

本研究旨在评估BNT162b2 mRNA新冠疫苗在全国范围内大规模接种背景下的有效性。随着新冠疫情的全球蔓延，疫苗的研发和接种成为控制疫情的关键措施，因此了解其在实际应用中的效果至关重要。

主要方法/材料/实验设计 ​

研究采用了回顾性队列研究设计，数据来源于以色列的全国疫苗接种计划。研究涉及以下主要步骤：

Mermaid diagram
  1. 数据收集：通过国家卫生系统获取疫苗接种记录和病例数据。
  2. 选择研究对象：确定符合条件的接种者与未接种者。
  3. 分组：将参与者分为接种组和对照组，确保组间可比性。
  4. 效果评估：分析接种后新冠病毒感染、住院及重症病例的发生率。
  5. 统计分析：使用适当的统计方法（如Cox回归模型）进行数据分析。

关键结果和发现 ​

  • 疫苗有效性：BNT162b2疫苗在接种后显示出高效的保护作用，感染率显著低于对照组。
  • 住院率：接种者的住院率和重症病例发生率均显著低于未接种者，表明疫苗对重症病例有良好的预防效果。
  • 持续时间：疫苗的保护效应在接种后数月内保持稳定，但在接种后6个月后逐渐减弱。

主要结论/意义/创新性 ​

本研究证实了BNT162b2 mRNA疫苗在大规模接种背景下的有效性，支持了疫苗在公共卫生中的应用。研究结果为政策制定者提供了科学依据，强调了持续监测疫苗效力和接种策略的重要性。

研究局限性和未来方向 ​

  • 局限性：本研究为观察性研究，可能存在选择偏倚和混杂因素的影响；此外，数据的长期追踪仍需加强。
  • 未来方向：建议进行长期的随机对照试验，评估不同人群中的疫苗效力，并探索加强针的效果。同时，研究疫苗对变异株的保护作用也将是未来的重点。

参考文献 ​

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引用本文的文献 ​

  1. 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)
  2. Evaluation of COVID-19 vaccination strategies with a delayed second dose. - Seyed M Moghadas;Thomas N Vilches;Kevin Zhang;Shokoofeh Nourbakhsh;Pratha Sah;Meagan C Fitzpatrick;Alison P Galvani - medRxiv : the preprint server for health sciences (2021)
  3. Interpreting vaccine efficacy trial results for infection and transmission. - Marc Lipsitch;Rebecca Kahn - medRxiv : the preprint server for health sciences (2021)
  4. Signals of hope: gauging the impact of a rapid national vaccination campaign. - Smadar Shilo;Hagai Rossman;Eran Segal - Nature reviews. Immunology (2021)
  5. COVID-19 vaccines for low- and middle-income countries. - Edward M Choi - Transactions of the Royal Society of Tropical Medicine and Hygiene (2021)
  6. Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine Among Residents of Two Skilled Nursing Facilities Experiencing COVID-19 Outbreaks - Connecticut, December 2020-February 2021. - Amadea Britton;Kara M Jacobs Slifka;Chris Edens;Srinivas Acharya Nanduri;Stephen M Bart;Nong Shang;Adora Harizaj;Jillian Armstrong;Kerui Xu;Hanna Y Ehrlich;Elizabeth Soda;Gordana Derado;Jennifer R Verani;Stephanie J Schrag;John A Jernigan;Vivian H Leung;Sunil Parikh - MMWR. Morbidity and mortality weekly report (2021)
  7. Blunting COVID-19's negative impact: Lessons from Israel's vaccination campaign. - Panagiotis Tsigaris;Jaime A Teixeira da Silva - Travel medicine and infectious disease (2021)
  8. COVID-19 vaccine decisions: considering the choices and opportunities. - Peter J Hotez;Tasmiah Nuzhath;Timothy Callaghan;Brian Colwell - Microbes and infection (2021)
  9. SARS-CoV-2 Infection after Vaccination in Health Care Workers in California. - Jocelyn Keehner;Lucy E Horton;Michael A Pfeffer;Christopher A Longhurst;Robert T Schooley;Judith S Currier;Shira R Abeles;Francesca J Torriani - The New England journal of medicine (2021)
  10. The plasmablast response to SARS-CoV-2 mRNA vaccination is dominated by non-neutralizing antibodies and targets both the NTD and the RBD. - Fatima Amanat;Mahima Thapa;Tinting Lei;Shaza M Sayed Ahmed;Daniel C Adelsberg;Juan Manuel Carreno;Shirin Strohmeier;Aaron J Schmitz;Sarah Zafar;Julian Q Zhou;Willemijn Rijnink;Hala Alshammary;Nicholas Borcherding;Ana Gonzalez Reiche;Komal Srivastava;Emilia Mia Sordillo;Harm van Bakel; ;Jackson S Turner;Goran Bajic;Viviana Simon;Ali H Ellebedy;Florian Krammer - medRxiv : the preprint server for health sciences (2021)

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