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BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting.
Literature Information
| DOI | 10.1056/NEJMoa2101765 |
|---|---|
| PMID | 33626250 |
| Journal | The New England journal of medicine |
| Impact Factor | 78.5 |
| JCR Quartile | Q1 |
| Publication Year | 2021 |
| Times Cited | 1441 |
| Keywords | BNT162b2 vaccine, COVID-19, vaccine effectiveness, mass vaccination, Israel |
| Literature Type | Journal Article, Research Support, Non-U.S. Gov't |
| ISSN | 0028-4793 |
| Pages | 1412-1423 |
| Issue | 384(15) |
| Authors | Noa Dagan, Noam Barda, Eldad Kepten, Oren Miron, Shay Perchik, Mark A Katz, Miguel A Hernán, Marc Lipsitch, Ben Reis, Ran D Balicer |
TL;DR
This study evaluates the effectiveness of the BNT162b2 mRNA vaccine against COVID-19 using data from Israel's largest healthcare organization, revealing that the vaccine demonstrated significant effectiveness in preventing documented infections (46% after the first dose and 92% after the second), symptomatic disease (57% and 94%), hospitalization (74% and 87%), severe illness (62% and 92%), and death (72% after the first dose). These findings underscore the vaccine's effectiveness across diverse populations, reinforcing results from previous randomized trials and highlighting its critical role in public health during the pandemic.
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BNT162b2 vaccine · COVID-19 · vaccine effectiveness · mass vaccination · Israel
Abstract
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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Primary Questions Addressed
- What are the long-term effects of the BNT162b2 mRNA vaccine on various populations?
- How does the effectiveness of the BNT162b2 vaccine compare to other Covid-19 vaccines in mass vaccination settings?
- What factors might influence the variation in vaccine effectiveness among different demographic groups?
- How do the results of this study inform future vaccination strategies and policies in different countries?
- What additional research is needed to understand the vaccine's effectiveness in individuals with multiple coexisting conditions?
Key Findings
Research Background and Objective
The document is a disclosure form based on the ICMJE (International Committee of Medical Journal Editors) guidelines for authors submitting manuscripts. Its purpose is to ensure transparency regarding any potential conflicts of interest that may influence the interpretation of the research findings. This is particularly relevant in the context of biomedical research, where financial relationships with commercial entities can impact perceptions of research integrity.
Main Methods/Materials/Experimental Design
The form is divided into six sections, which authors must complete individually:
- Identifying Information: Basic author details and manuscript title.
- The Work Under Consideration for Publication: Authors indicate whether they or their institution received third-party funding for the research.
- Relevant Financial Activities Outside the Submitted Work: Disclosure of any financial relationships with biomedical entities that could influence the work.
- Intellectual Property: Information on any patents or copyrights related to the work.
- Relationships Not Covered Above: Any additional relationships that could be perceived as influencing the work.
- Disclosure Statement: A summary statement based on the provided disclosures.
The form emphasizes that each author is responsible for the accuracy and completeness of their disclosures.
Key Results and Findings
- Authors must disclose all financial relationships with entities relevant to their research, regardless of the amount of compensation.
- Financial relationships include grants, personal fees, and non-financial support from entities like pharmaceutical companies.
- The form encourages transparency, suggesting that disclosing potential conflicts is better than omitting them.
Main Conclusions/Significance/Innovation
The ICMJE disclosure form aims to enhance the credibility of biomedical research by promoting transparency regarding conflicts of interest. This is crucial for maintaining trust in published research, particularly in areas like vaccine effectiveness, where public health implications are significant.
Research Limitations and Future Directions
- The effectiveness of the disclosure process relies on authors' honesty and the enforcement of disclosure requirements by journals.
- Future efforts could focus on standardizing how disclosures are presented in published articles, enhancing clarity for readers.
- Further studies may be needed to assess the impact of disclosed conflicts on public perception and trust in scientific research.
Summary Table of Author Disclosures
| Author Name | Conflicts Disclosed | Financial Relationships Outside Work | Patents/Copyrights |
|---|---|---|---|
| Ran Balicer | Grants from Pfizer | Yes | No |
| Noam Barda | Grants from Pfizer | Yes | No |
| Noa Dagan | Grants from Pfizer | Yes | No |
| Miguel Hernan | Grants from NIH, personal fees | Yes | No |
| Mark Katz | Grants from Pfizer | Yes | No |
| Eldad Kepten | Grants from Pfizer | Yes | No |
| Marc Lipsitch | Grants from multiple entities | Yes | No |
| Oren Miron | Grants from Pfizer | Yes | No |
| Shay Perchik | Grants from Pfizer | Yes | No |
| Ben Reis | No disclosures | No | No |
This structured summary encapsulates the essential aspects of the ICMJE disclosure form, highlighting its significance in ensuring ethical standards in biomedical research.
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Literatures Citing This Work
- 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)
- 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)
- Interpreting vaccine efficacy trial results for infection and transmission. - Marc Lipsitch;Rebecca Kahn - medRxiv : the preprint server for health sciences (2021)
- Signals of hope: gauging the impact of a rapid national vaccination campaign. - Smadar Shilo;Hagai Rossman;Eran Segal - Nature reviews. Immunology (2021)
- COVID-19 vaccines for low- and middle-income countries. - Edward M Choi - Transactions of the Royal Society of Tropical Medicine and Hygiene (2021)
- 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)
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- 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)
... (1431 more literatures)
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