Curated Papers > Highly Cited Authoritative Literature on "mRNA Vaccines"

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

Literature Information

DOI	10.1056/NEJMoa2034577
PMID	33301246
Journal	The New England journal of medicine
Impact Factor	78.5
JCR Quartile	Q1
Publication Year	2020
Times Cited	8401
Keywords	BNT162b2 vaccine, Covid-19, vaccine efficacy, safety, SARS-CoV-2
Literature Type	Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial
ISSN	0028-4793
Pages	2603-2615
Issue	383(27)
Authors	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

TL;DR

This study evaluates the efficacy and safety of the BNT162b2 mRNA vaccine against Covid-19 in a large multinational trial involving over 43,000 participants, finding that it provides 95% protection against the disease with a safety profile comparable to other viral vaccines. These results underscore the critical role of BNT162b2 in combating the Covid-19 pandemic.

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BNT162b2 vaccine · Covid-19 · vaccine efficacy · safety · SARS-CoV-2

Abstract

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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Primary Questions Addressed

1. What are the long-term safety profiles of the BNT162b2 vaccine compared to other Covid-19 vaccines?
2. How does the efficacy of the BNT162b2 vaccine vary among different demographic groups beyond those studied in the trial?
3. What mechanisms contribute to the observed 95% efficacy of the BNT162b2 vaccine against Covid-19?
4. Are there any specific populations that may not respond as well to the BNT162b2 vaccine, and what factors influence this?
5. How does the BNT162b2 vaccine's safety profile compare to traditional inactivated virus vaccines used for other diseases?

Key Findings

Research Background and Purpose

The study focuses on the safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine, developed by Pfizer-BioNTech. With the global outbreak of Covid-19, there was an urgent need for effective vaccines to control the pandemic. The primary aim of this research was to evaluate the vaccine's performance in preventing Covid-19 infection and to assess its safety profile in a diverse population.

Main Methods/Materials/Experimental Design

The study employed a randomized, double-blind, placebo-controlled trial design involving participants aged 16 years and older.

Key Components of the Study Design

• Participants: Diverse population including various age groups and underlying health conditions.
• Intervention: Administration of the BNT162b2 mRNA vaccine.
• Control: Placebo group receiving saline solution.
• Endpoints: Primary endpoint was the efficacy in preventing symptomatic Covid-19; secondary endpoints included safety assessments and the occurrence of severe adverse events.

Experimental Flowchart

Key Results and Findings

• Efficacy: The vaccine demonstrated an efficacy of approximately 95% in preventing symptomatic Covid-19 infection.
• Safety: The safety profile was favorable, with most adverse events being mild to moderate, including pain at the injection site, fatigue, and headache.
• Demographics: The vaccine was effective across different demographic groups, including age, sex, and racial/ethnic backgrounds.

Main Conclusions/Significance/Innovation

The study concluded that the BNT162b2 mRNA vaccine is highly effective in preventing Covid-19 and has a manageable safety profile. This research significantly contributes to the understanding of mRNA vaccine technology and its application in pandemic response, paving the way for future vaccine developments.

Research Limitations and Future Directions

• Limitations: The study had a limited follow-up period post-vaccination, and the long-term safety and efficacy data were not fully established at the time of publication.
• Future Directions: Ongoing monitoring of vaccine effectiveness in real-world settings, assessment of long-term safety, and studies on variant responses are recommended. Additionally, further research is needed to explore booster doses and vaccine adaptations for emerging variants.

Aspect	Summary
Study Design	Randomized, double-blind, placebo-controlled trial
Population	Adults aged 16 and older, diverse demographic
Primary Endpoint	Efficacy in preventing symptomatic Covid-19
Secondary Endpoints	Safety assessments and occurrence of severe adverse events
Key Findings	95% efficacy, favorable safety profile, effective across demographics
Future Research	Long-term safety and efficacy studies, real-world effectiveness, booster dose assessments

References

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Literatures Citing This Work

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)

... (8391 more literatures)

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