Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
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 Jr, 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, C4591001 Clinical Trial Group, Judith Aberg, Marylyn Addo, Sıla Akhan, Timothy Albertson, Mohamed Al-Ibrahim, Sedat Altın, Corey Anderson, Charles Andrews, Samir Arora, Ismail Balik, Elizabeth Barnett, George Bauer, Sybille Baumann-Noss, Mezgebe Berhe, Paul Bradley, Donald Brandon, Daniel Brune, Abram Burgher, Bain Butcher, David Butuk, Kevin Cannon, Jose Cardona, Rachael Cavelli, Fadi Chalhoub, Shane Christensen, Tom Christensen, Laurence Chu, Steven Cox, Gretchen Crook, Matthew Davis, Rajesh Davit, Douglas Denham, Michael Dever, Curtis Donskey, Matthew Doust, Michael Dunn, John Earl, Frank Eder, Andreas Eich, David Ensz, Brandon Essink, Robert Falcone, Ann Falsey, Cecil Farrington, Robert Finberg, Daniel Finn, David Fitz-Patrick, Stephen Fortmann, Leon Fouche, Veronica Fragoso, Robert Frenck, David Fried, Gregory Fuller, Suzanne Fussell, Julia Garcia-Diaz, Andrew Gentry, Richard Glover, Carla Greenbaum, Stephen Grubb, Laura Hammitt, Charles Harper, Wayne Harper, Aaron Hartman, Robert Heller, Ernest Hendrix, Darrell Herrington, Timothy Jennings, Oğuz Karabay, Steven Kaster, Steven Katzman, Jeffrey Kingsley, Nicola Klein, Tracy Klein, Mark Koch, Iftahar Köksal, Michael Koren, Mark Kutner, Marcus Lee, Mark Leibowitz, Michael Levin, Romina Libster, Michael Lillestol, Christopher Lucasti, Matthias Luttermann, Mary Beth Earl Manning, Martin Martin, Paul Matherne, James McMurray, Ali Mert, Randle Middleton, Essack Mitha, Emily Morawski, Edson Moreira, Mark Mulligan, Alexander Murray, Murtaza Mussaji, Dany Musungaie, Haylene Nell, Larry Odekirk, Onyema Ogbuagu, Kristopher Paolino, Suchet Patel, James Peterson, Paul Pickrell, Fernando Polack, Donald Poretz, George Raad, William Randall, Bruce Rankin, Steven Reynolds, Robert Riesenberg, Hector Rodriguez, Jeffrey Rosen, John Rubino, Richard Rupp, Salma Saiger, Robert Salata, Jamshid Saleh, Axel Schaefer, Martin Schear, Armin Schultz, Howard Schwartz, Nathan Segall, William Seger, Shelly Senders, Stephan Sharp, Sylvia Shoffner, Serap Simsek Yavuz, Teresa Sligh, William Smith, Helen Stacey, Michael Stephens, Harry Studdard, Fehmi Tabak, Kawsar Talaat, Stephen Thomas, William Towner, Van Tran, Serhat Ünal, Lisa Usdan, John Vanchiere, Susann Varano, Edward Tyler L Wadsworth, Walsh Walsh, Emmanuel Walter, Diego Wappner, Rick Whiles, Hayes Williams, Jonathan Wilson, Peter Winkle, Patricia Winokur, Thomas Wolf, Joseph Yozviak, Cristiano Zerbini, 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 Jr, 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, C4591001 Clinical Trial Group, Judith Aberg, Marylyn Addo, Sıla Akhan, Timothy Albertson, Mohamed Al-Ibrahim, Sedat Altın, Corey Anderson, Charles Andrews, Samir Arora, Ismail Balik, Elizabeth Barnett, George Bauer, Sybille Baumann-Noss, Mezgebe Berhe, Paul Bradley, Donald Brandon, Daniel Brune, Abram Burgher, Bain Butcher, David Butuk, Kevin Cannon, Jose Cardona, Rachael Cavelli, Fadi Chalhoub, Shane Christensen, Tom Christensen, Laurence Chu, Steven Cox, Gretchen Crook, Matthew Davis, Rajesh Davit, Douglas Denham, Michael Dever, Curtis Donskey, Matthew Doust, Michael Dunn, John Earl, Frank Eder, Andreas Eich, David Ensz, Brandon Essink, Robert Falcone, Ann Falsey, Cecil Farrington, Robert Finberg, Daniel Finn, David Fitz-Patrick, Stephen Fortmann, Leon Fouche, Veronica Fragoso, Robert Frenck, David Fried, Gregory Fuller, Suzanne Fussell, Julia Garcia-Diaz, Andrew Gentry, Richard Glover, Carla Greenbaum, Stephen Grubb, Laura Hammitt, Charles Harper, Wayne Harper, Aaron Hartman, Robert Heller, Ernest Hendrix, Darrell Herrington, Timothy Jennings, Oğuz Karabay, Steven Kaster, Steven Katzman, Jeffrey Kingsley, Nicola Klein, Tracy Klein, Mark Koch, Iftahar Köksal, Michael Koren, Mark Kutner, Marcus Lee, Mark Leibowitz, Michael Levin, Romina Libster, Michael Lillestol, Christopher Lucasti, Matthias Luttermann, Mary Beth Earl Manning, Martin Martin, Paul Matherne, James McMurray, Ali Mert, Randle Middleton, Essack Mitha, Emily Morawski, Edson Moreira, Mark Mulligan, Alexander Murray, Murtaza Mussaji, Dany Musungaie, Haylene Nell, Larry Odekirk, Onyema Ogbuagu, Kristopher Paolino, Suchet Patel, James Peterson, Paul Pickrell, Fernando Polack, Donald Poretz, George Raad, William Randall, Bruce Rankin, Steven Reynolds, Robert Riesenberg, Hector Rodriguez, Jeffrey Rosen, John Rubino, Richard Rupp, Salma Saiger, Robert Salata, Jamshid Saleh, Axel Schaefer, Martin Schear, Armin Schultz, Howard Schwartz, Nathan Segall, William Seger, Shelly Senders, Stephan Sharp, Sylvia Shoffner, Serap Simsek Yavuz, Teresa Sligh, William Smith, Helen Stacey, Michael Stephens, Harry Studdard, Fehmi Tabak, Kawsar Talaat, Stephen Thomas, William Towner, Van Tran, Serhat Ünal, Lisa Usdan, John Vanchiere, Susann Varano, Edward Tyler L Wadsworth, Walsh Walsh, Emmanuel Walter, Diego Wappner, Rick Whiles, Hayes Williams, Jonathan Wilson, Peter Winkle, Patricia Winokur, Thomas Wolf, Joseph Yozviak, Cristiano Zerbini
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.).
Copyright © 2020 Massachusetts Medical Society.
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Source: PubMed