Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months
Stephen J Thomas, Edson D Moreira Jr, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L Perez, Gonzalo Pérez Marc, Fernando P Polack, Cristiano Zerbini, Ruth Bailey, Kena A Swanson, Xia Xu, Satrajit Roychoudhury, Kenneth Koury, Salim Bouguermouh, Warren V Kalina, David Cooper, Robert W Frenck Jr, Laura L Hammitt, Özlem Türeci, Haylene Nell, Axel Schaefer, Serhat Ünal, Qi Yang, Paul Liberator, Dina B Tresnan, Susan Mather, Philip R Dormitzer, Uğur Şahin, William C Gruber, Kathrin U Jansen, 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 Manning, Earl Martin, Paul Matherne, James McMurray, Ali Mert, Randle Middleton, Essack Mitha, Emily Morawski, Edson Moreira, 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, L Tyler Wadsworth, Edward Walsh, Emmanuel Walter, Diego Wappner, Rick Whiles, Hayes Williams, Jonathan Wilson, Peter Winkle, Patricia Winokur, Thomas Wolf, Joseph Yozviak, Cristiano Zerbini, Stephen J Thomas, Edson D Moreira Jr, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, John L Perez, Gonzalo Pérez Marc, Fernando P Polack, Cristiano Zerbini, Ruth Bailey, Kena A Swanson, Xia Xu, Satrajit Roychoudhury, Kenneth Koury, Salim Bouguermouh, Warren V Kalina, David Cooper, Robert W Frenck Jr, Laura L Hammitt, Özlem Türeci, Haylene Nell, Axel Schaefer, Serhat Ünal, Qi Yang, Paul Liberator, Dina B Tresnan, Susan Mather, Philip R Dormitzer, Uğur Şahin, William C Gruber, Kathrin U Jansen, 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 Manning, Earl Martin, Paul Matherne, James McMurray, Ali Mert, Randle Middleton, Essack Mitha, Emily Morawski, Edson Moreira, 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, L Tyler Wadsworth, Edward Walsh, Emmanuel Walter, Diego Wappner, Rick Whiles, Hayes Williams, Jonathan Wilson, Peter Winkle, Patricia Winokur, Thomas Wolf, Joseph Yozviak, Cristiano Zerbini
Abstract
Background: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable.
Methods: In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination.
Results: BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed.
Conclusions: Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).
Copyright © 2021 Massachusetts Medical Society.
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Source: PubMed