Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

被引：10664

作者：

Polack, Fernando P. ^{[1
]}

Thomas, Stephen J. ^{[3
]}

Kitchin, Nicholas ^{[5
]}

Absalon, Judith ^{[4
]}

Gurtman, Alejandra ^{[4
]}

Lockhart, Stephen ^{[5
]}

Perez, John L. ^{[6
]}

Perez Marc, Gonzalo ^{[2
]}

Moreira, Edson D. ^{[8
,9
]}

Zerbini, Cristiano ^{[10
]}

Bailey, Ruth ^{[5
]}

Swanson, Kena A. ^{[4
]}

Roychoudhury, Satrajit ^{[11
]}

Koury, Kenneth ^{[4
]}

Li, Ping ^{[6
]}

Kalina, Warren V. ^{[4
]}

Cooper, David ^{[4
]}

Frenck, Robert W., Jr. ^{[12
]}

Hammitt, Laura L. ^{[13
]}

Tureci, Ozlem ^{[14
]}

Nell, Haylene ^{[16
]}

Schaefer, Axel ^{[15
]}

Unal, Serhat ^{[17
]}

Tresnan, Dina B. ^{[18
]}

Mather, Susan ^{[7
]}

Dormitzer, Philip R. ^{[4
]}

Sahin, Ugur ^{[14
]}

Jansen, Kathrin U. ^{[4
]}

Gruber, William C. ^{[4
]}

机构：

[1] Fdn INFANT, Buenos Aires, DF, Argentina

[2] ITrials Hosp Mil Cent, Buenos Aires, DF, Argentina

[3] SUNY Upstate Med Univ, Syracuse, NY 13210 USA

[4] Pfizer, Vaccine Res & Dev, Pearl River, NY USA

[5] Pfizer, Vaccine Res & Dev, Hurley, England

[6] Pfizer, Vaccine Res & Dev, Collegeville, PA USA

[7] Pfizer, Worldwide Safety Safety Surveillance & Risk Manag, Collegeville, PA USA

[8] Assoc Obras Sociais Irma Dulce, Salvador, BA, Brazil

[9] Fundacao Oswaldo Cruz, Salvador, BA, Brazil

[10] Ctr Paulista Invest Clin, Sao Paulo, Brazil

[11] Pfizer, Global Product Dev, Peapack, NJ USA

[12] Cincinnati Childrens Hosp, Cincinnati, OH USA

[13] Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USA

[14] BioNTech, Mainz, Germany

[15] Medizentrum Essen Borbeck, Essen, Germany

[16] Karl Bremer Hosp, Tiervlei Trial Ctr, Cape Town, South Africa

[17] Hacettepe Univ, Ankara, Turkey

[18] Pfizer, Worldwide Safety Safety Surveillance & Risk Manag, Groton, CT USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2020年 / 383卷 / 27期

关键词：

D O I：

10.1056/NEJMoa2034577

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

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 mu g 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.)

引用

页码：2603 / 2615

页数：13

共 12 条

[1]

Centers for Disease Control and Prevention, COVID 19 INF PAG

[2] Comparative Immunogenicity of Several Enhanced Influenza Vaccine Options for Older Adults: A Randomized, Controlled Trial [J].

Cowling, Benjamin J. ;

Perera, Ranawaka A. P. M. ;

Valkenburg, Sophie A. ;

Leung, Nancy H. L. ;

Iuliano, A. Danielle ;

Tam, Yat Hung ;

Wong, Jennifer H. F. ;

Fang, Vicky J. ;

Li, Athena P. Y. ;

So, Hau Chi ;

Ip, Dennis K. M. ;

Azziz-Baumgartner, Eduardo ;

Fry, Alicia M. ;

Levine, Min Z. ;

Gangappa, Shivaprakash ;

Sambhara, Suryaprakash ;

Barr, Ian G. ;

Skowronski, Danuta M. ;

Peiris, J. S. Malik ;

Thompson, Mark G. .

CLINICAL INFECTIOUS DISEASES, 2020, 71 (07) :1704-1714

[3]

Food and Drug Administration, 2020, GUID IND EM US AUTH

[4]

Food and Drug Administration, 2019, SHRINGR ZOST VACC RE

[5] Prospects for a safe COVID-19 vaccine [J].

Haynes, Barton F. ;

Corey, Lawrence ;

Fernandes, Prabhavathi ;

Gilbert, Peter B. ;

Hotez, Peter J. ;

Rao, Srinivas ;

Santos, Michael R. ;

Schuitemaker, Hanneke ;

Watson, Michael ;

Arvin, Ann .

SCIENCE TRANSLATIONAL MEDICINE, 2020, 12 (568)

[6]

Johns Hopkins University Coronavirus Resource Center, 2020, COVID 19 DASHB CENT

[7] Incorporation of Pseudouridine Into mRNA Yields Superior Nonimmunogenic Vector With Increased Translational Capacity and Biological Stability [J].

Kariko, Katalin ;

Muramatsu, Hiromi ;

Welsh, Frank A. ;

Ludwig, Janos ;

Kato, Hiroki ;

Akira, Shizuo ;

Weissman, Drew .

MOLECULAR THERAPY, 2008, 16 (11) :1833-1840

[8] The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application [J].

Lauer, Stephen A. ;

Grantz, Kyra H. ;

Bi, Qifang ;

Jones, Forrest K. ;

Zheng, Qulu ;

Meredith, Hannah R. ;

Azman, Andrew S. ;

Reich, Nicholas G. ;

Lessler, Justin .

ANNALS OF INTERNAL MEDICINE, 2020, 172 (09) :577-+

[9] Expression kinetics of nucleoside-modified mRNA delivered in lipid nanoparticles to mice by various routes [J].

Pardi, Norbert ;

Tuyishime, Steven ;

Muramatsu, Hiromi ;

Kariko, Katalin ;

Mui, Barbara L. ;

Tam, Ying K. ;

Madden, Thomas D. ;

Hope, Michael J. ;

Weissman, Drew .

JOURNAL OF CONTROLLED RELEASE, 2015, 217 :345-351

[10]

Sahin U, 2020, BNT162B2 INDUCES SAR, DOI [10.1101/2020.12.09.20245175v1, DOI 10.1101/2020.12.09.20245175V1]

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