Safety and efficacy of the BNT162B2 mRNA covid-19 vaccine through 6 months

Jonathan Zenilman; Robert Belshe; Kathryn Edwards; Stephen Self; Lawrence Stanberry; Tricia Newell; Sheena Hunt; Philippa Jack; Greg Adams; Negar Ali-Abadi; Mohanish Anand; Fred Angulo; Ayman Ayoub; Melissa Bishop-Murphy; Mark Boaz; Christopher Bowen; Donna Boyce; Sarah Burden; Andrea Cawein; Patrick Caubel; Darren Cowen; Kimberly Ann Cristall; Michael Cruz; Daniel Curcio; Gabriela Dávila; Carmel Devlin; Gokhan Duman; Niesha Foster; Maja Gacic; Juleen Gayed; Ahmed Hassan; Luis Jodar; Stephen Kay; William Lam; Esther Ladipo; Joaquina Maria Lazaro; Marie Pierre Hellio Le Graverand-Gastineau; Kwok Lee; Zhenghui Li; Jacqueline Lowenberg; Hua Ma; Rod MacKenzie; Robert Ma-Roko; Jason McKinley; Tracey Mellelieu; Neda Aghajani Memar; Farheen Muzaffar; Brendan O'Neill; Jason Painter; Elizabeth Paulukonis; Allison Pfeffer; Katie Puig; Kimberly Rarrick; Balaji Prabu Raja; Christine Rainey; Kellie Lynn Richardson; Elizabeth Rogers; Melinda Rottas; Charulata Sabharwal; Uzma Sarwar; Vilas Satishchandran; Harpreet Seehra; Judy Sewards; Huiqing Si; Helen Smith; David Swerdlow; James Trammel; Elisa Harkins Tull; Sarah Tweedy; Erica Weaver; John Wegner; Jenah West; Christopher Webber; David C. Whritenour; Fae Wooding; Emily Worobetz; Nita Zalavadia; Liping Zhang; Corinna Rosenbaum; Christian Miculka; Andreas Kuhn; Ferdia Bates; Paul Strecker; Ruben Rizzi; Martin Bexon; Eleni Lagkadinou; Alexandra Kemmer-Brück; Dietmar Katinger; Andreas Wagner; Stephen J. Thomas; Edson D. Moreira; 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; 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

doi:10.1056/NEJMoa2110345

Safety and efficacy of the BNT162B2 mRNA covid-19 vaccine through 6 months

Jonathan Zenilman
, Robert Belshe
, Kathryn Edwards
, Stephen Self
, Lawrence Stanberry
, Tricia Newell
, Sheena Hunt
, Philippa Jack
, Greg Adams
, Negar Ali-Abadi
, Mohanish Anand
, Fred Angulo
, Ayman Ayoub
, Melissa Bishop-Murphy
, Mark Boaz
, Christopher Bowen
, Donna Boyce
, Sarah Burden
, Andrea Cawein
, Patrick Caubel

Darren Cowen, Kimberly Ann Cristall, Michael Cruz, Daniel Curcio, Gabriela Dávila, Carmel Devlin, Gokhan Duman, Niesha Foster, Maja Gacic, Juleen Gayed, Ahmed Hassan, Luis Jodar, Stephen Kay, William Lam, Esther Ladipo, Joaquina Maria Lazaro, Marie Pierre Hellio Le Graverand-Gastineau, Kwok Lee, Zhenghui Li, Jacqueline Lowenberg, Hua Ma, Rod MacKenzie, Robert Ma-Roko, Jason McKinley, Tracey Mellelieu, Neda Aghajani Memar, Farheen Muzaffar, Brendan O'Neill, Jason Painter, Elizabeth Paulukonis, Allison Pfeffer, Katie Puig, Kimberly Rarrick, Balaji Prabu Raja, Christine Rainey, Kellie Lynn Richardson, Elizabeth Rogers, Melinda Rottas, Charulata Sabharwal, Uzma Sarwar, Vilas Satishchandran, Harpreet Seehra, Judy Sewards, Huiqing Si, Helen Smith, David Swerdlow, James Trammel, Elisa Harkins Tull, Sarah Tweedy, Erica Weaver, John Wegner, Jenah West, Christopher Webber, David C. Whritenour, Fae Wooding, Emily Worobetz, Nita Zalavadia, Liping Zhang, Corinna Rosenbaum, Christian Miculka, Andreas Kuhn, Ferdia Bates, Paul Strecker, Ruben Rizzi, Martin Bexon, Eleni Lagkadinou, Alexandra Kemmer-Brück, Dietmar Katinger, Andreas Wagner, Stephen J. Thomas, Edson D. Moreira, 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, 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

Microbiology & Immunology

Upstate Medical University

ICON
Polymun
Fundação Oswaldo Cruz
Pfizer
iTrials-Hospital Militar Central
Fundacion INFANT
Centro Paulista de Investigação Clinica
Cincinnati Children's Hospital
Johns Hopkins University
BioNTech Ag
Karl Bremer Hospital
Medizentrum Essen Borbeck
Hacettepe University

Research output: Contribution to journal › Article › peer-review

1156 Scopus citations

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 SARSCoV-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.

Original language	English
Pages (from-to)	1761-1773
Number of pages	13
Journal	New England Journal of Medicine
Volume	385
Issue number	19
DOIs	https://doi.org/10.1056/NEJMoa2110345
State	Published - Nov 4 2021

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10.1056/NEJMoa2110345

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Zenilman, J., Belshe, R., Edwards, K., Self, S., Stanberry, L., Newell, T., Hunt, S., Jack, P., Adams, G., Ali-Abadi, N., Anand, M., Angulo, F., Ayoub, A., Bishop-Murphy, M., Boaz, M., Bowen, C., Boyce, D., Burden, S., Cawein, A., ... Jansen, K. U. (2021). Safety and efficacy of the BNT162B2 mRNA covid-19 vaccine through 6 months. New England Journal of Medicine, 385(19), 1761-1773. https://doi.org/10.1056/NEJMoa2110345

@article{c850ca973cd8401987adafff38202b2d,

title = "Safety and efficacy of the BNT162B2 mRNA covid-19 vaccine through 6 months",

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 SARSCoV-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.",

author = "Jonathan Zenilman and Robert Belshe and Kathryn Edwards and Stephen Self and Lawrence Stanberry and Tricia Newell and Sheena Hunt and Philippa Jack and Greg Adams and Negar Ali-Abadi and Mohanish Anand and Fred Angulo and Ayman Ayoub and Melissa Bishop-Murphy and Mark Boaz and Christopher Bowen and Donna Boyce and Sarah Burden and Andrea Cawein and Patrick Caubel and Darren Cowen and Cristall, \{Kimberly Ann\} and Michael Cruz and Daniel Curcio and Gabriela D{\'a}vila and Carmel Devlin and Gokhan Duman and Niesha Foster and Maja Gacic and Juleen Gayed and Ahmed Hassan and Luis Jodar and Stephen Kay and William Lam and Esther Ladipo and Lazaro, \{Joaquina Maria\} and \{Le Graverand-Gastineau\}, \{Marie Pierre Hellio\} and Kwok Lee and Zhenghui Li and Jacqueline Lowenberg and Hua Ma and Rod MacKenzie and Robert Ma-Roko and Jason McKinley and Tracey Mellelieu and Memar, \{Neda Aghajani\} and Farheen Muzaffar and Brendan O'Neill and Jason Painter and Elizabeth Paulukonis and Allison Pfeffer and Katie Puig and Kimberly Rarrick and Raja, \{Balaji Prabu\} and Christine Rainey and Richardson, \{Kellie Lynn\} and Elizabeth Rogers and Melinda Rottas and Charulata Sabharwal and Uzma Sarwar and Vilas Satishchandran and Harpreet Seehra and Judy Sewards and Huiqing Si and Helen Smith and David Swerdlow and James Trammel and Tull, \{Elisa Harkins\} and Sarah Tweedy and Erica Weaver and John Wegner and Jenah West and Christopher Webber and Whritenour, \{David C.\} and Fae Wooding and Emily Worobetz and Nita Zalavadia and Liping Zhang and Corinna Rosenbaum and Christian Miculka and Andreas Kuhn and Ferdia Bates and Paul Strecker and Ruben Rizzi and Martin Bexon and Eleni Lagkadinou and Alexandra Kemmer-Br{\"u}ck and Dietmar Katinger and Andreas Wagner and Thomas, \{Stephen J.\} and Moreira, \{Edson D.\} and Nicholas Kitchin and Judith Absalon and Alejandra Gurtman and Stephen Lockhart and Perez, \{John L.\} and Marc, \{Gonzalo P{\'e}rez\} and Polack, \{Fernando P.\} and Cristiano Zerbini and Ruth Bailey and Swanson, \{Kena A.\} and Xia Xu and Satrajit Roychoudhury and Kenneth Koury and Salim Bouguermouh and Kalina, \{Warren V.\} and David Cooper and Frenck, \{Robert W.\} and Hammitt, \{Laura L.\} and {\"O}zlem T{\"u}reci and Haylene Nell and Axel Schaefer and Serhat {\"U}nal and Qi Yang and Paul Liberator and Tresnan, \{Dina B.\} and Susan Mather and Dormitzer, \{Philip R.\} and Uğur {\c S}ahin and Gruber, \{William C.\} and Jansen, \{Kathrin U.\}",

note = "Publisher Copyright: {\textcopyright} 2021 Massachusetts Medical Society.",

year = "2021",

month = nov,

day = "4",

doi = "10.1056/NEJMoa2110345",

language = "English",

volume = "385",

pages = "1761--1773",

journal = "New England Journal of Medicine",

issn = "0028-4793",

number = "19",

}

Zenilman, J, Belshe, R, Edwards, K, Self, S, Stanberry, L, Newell, T, Hunt, S, Jack, P, Adams, G, Ali-Abadi, N, Anand, M, Angulo, F, Ayoub, A, Bishop-Murphy, M, Boaz, M, Bowen, C, Boyce, D, Burden, S, Cawein, A, Caubel, P, Cowen, D, Cristall, KA, Cruz, M, Curcio, D, Dávila, G, Devlin, C, Duman, G, Foster, N, Gacic, M, Gayed, J, Hassan, A, Jodar, L, Kay, S, Lam, W, Ladipo, E, Lazaro, JM, Le Graverand-Gastineau, MPH, Lee, K, Li, Z, Lowenberg, J, Ma, H, MacKenzie, R, Ma-Roko, R, McKinley, J, Mellelieu, T, Memar, NA, Muzaffar, F, O'Neill, B, Painter, J, Paulukonis, E, Pfeffer, A, Puig, K, Rarrick, K, Raja, BP, Rainey, C, Richardson, KL, Rogers, E, Rottas, M, Sabharwal, C, Sarwar, U, Satishchandran, V, Seehra, H, Sewards, J, Si, H, Smith, H, Swerdlow, D, Trammel, J, Tull, EH, Tweedy, S, Weaver, E, Wegner, J, West, J, Webber, C, Whritenour, DC, Wooding, F, Worobetz, E, Zalavadia, N, Zhang, L, Rosenbaum, C, Miculka, C, Kuhn, A, Bates, F, Strecker, P, Rizzi, R, Bexon, M, Lagkadinou, E, Kemmer-Brück, A, Katinger, D, Wagner, A, Thomas, SJ, Moreira, ED, Kitchin, N, Absalon, J, Gurtman, A, Lockhart, S, Perez, JL, Marc, GP, Polack, FP, Zerbini, C, Bailey, R, Swanson, KA, Xu, X, Roychoudhury, S, Koury, K, Bouguermouh, S, Kalina, WV, Cooper, D, Frenck, RW, Hammitt, LL, Türeci, Ö, Nell, H, Schaefer, A, Ünal, S, Yang, Q, Liberator, P, Tresnan, DB, Mather, S, Dormitzer, PR, Şahin, U, Gruber, WC & Jansen, KU 2021, 'Safety and efficacy of the BNT162B2 mRNA covid-19 vaccine through 6 months', New England Journal of Medicine, vol. 385, no. 19, pp. 1761-1773. https://doi.org/10.1056/NEJMoa2110345

TY - JOUR

T1 - Safety and efficacy of the BNT162B2 mRNA covid-19 vaccine through 6 months

AU - Zenilman, Jonathan

AU - Belshe, Robert

AU - Edwards, Kathryn

AU - Self, Stephen

AU - Stanberry, Lawrence

AU - Newell, Tricia

AU - Hunt, Sheena

AU - Jack, Philippa

AU - Adams, Greg

AU - Ali-Abadi, Negar

AU - Anand, Mohanish

AU - Angulo, Fred

AU - Ayoub, Ayman

AU - Bishop-Murphy, Melissa

AU - Boaz, Mark

AU - Bowen, Christopher

AU - Boyce, Donna

AU - Burden, Sarah

AU - Cawein, Andrea

AU - Caubel, Patrick

AU - Cowen, Darren

AU - Cristall, Kimberly Ann

AU - Cruz, Michael

AU - Curcio, Daniel

AU - Dávila, Gabriela

AU - Devlin, Carmel

AU - Duman, Gokhan

AU - Foster, Niesha

AU - Gacic, Maja

AU - Gayed, Juleen

AU - Hassan, Ahmed

AU - Jodar, Luis

AU - Kay, Stephen

AU - Lam, William

AU - Ladipo, Esther

AU - Lazaro, Joaquina Maria

AU - Le Graverand-Gastineau, Marie Pierre Hellio

AU - Lee, Kwok

AU - Li, Zhenghui

AU - Lowenberg, Jacqueline

AU - Ma, Hua

AU - MacKenzie, Rod

AU - Ma-Roko, Robert

AU - McKinley, Jason

AU - Mellelieu, Tracey

AU - Memar, Neda Aghajani

AU - Muzaffar, Farheen

AU - O'Neill, Brendan

AU - Painter, Jason

AU - Paulukonis, Elizabeth

AU - Pfeffer, Allison

AU - Puig, Katie

AU - Rarrick, Kimberly

AU - Raja, Balaji Prabu

AU - Rainey, Christine

AU - Richardson, Kellie Lynn

AU - Rogers, Elizabeth

AU - Rottas, Melinda

AU - Sabharwal, Charulata

AU - Sarwar, Uzma

AU - Satishchandran, Vilas

AU - Seehra, Harpreet

AU - Sewards, Judy

AU - Si, Huiqing

AU - Smith, Helen

AU - Swerdlow, David

AU - Trammel, James

AU - Tull, Elisa Harkins

AU - Tweedy, Sarah

AU - Weaver, Erica

AU - Wegner, John

AU - West, Jenah

AU - Webber, Christopher

AU - Whritenour, David C.

AU - Wooding, Fae

AU - Worobetz, Emily

AU - Zalavadia, Nita

AU - Zhang, Liping

AU - Rosenbaum, Corinna

AU - Miculka, Christian

AU - Kuhn, Andreas

AU - Bates, Ferdia

AU - Strecker, Paul

AU - Rizzi, Ruben

AU - Bexon, Martin

AU - Lagkadinou, Eleni

AU - Kemmer-Brück, Alexandra

AU - Katinger, Dietmar

AU - Wagner, Andreas

AU - Thomas, Stephen J.

AU - Moreira, Edson D.

AU - Kitchin, Nicholas

AU - Absalon, Judith

AU - Gurtman, Alejandra

AU - Lockhart, Stephen

AU - Perez, John L.

AU - Marc, Gonzalo Pérez

AU - Polack, Fernando P.

AU - Zerbini, Cristiano

AU - Bailey, Ruth

AU - Swanson, Kena A.

AU - Xu, Xia

AU - Roychoudhury, Satrajit

AU - Koury, Kenneth

AU - Bouguermouh, Salim

AU - Kalina, Warren V.

AU - Cooper, David

AU - Frenck, Robert W.

AU - Hammitt, Laura L.

AU - Türeci, Özlem

AU - Nell, Haylene

AU - Schaefer, Axel

AU - Ünal, Serhat

AU - Yang, Qi

AU - Liberator, Paul

AU - Tresnan, Dina B.

AU - Mather, Susan

AU - Dormitzer, Philip R.

AU - Şahin, Uğur

AU - Gruber, William C.

AU - Jansen, Kathrin U.

PY - 2021/11/4

Y1 - 2021/11/4

N2 - 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 SARSCoV-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.

AB - 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 SARSCoV-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.

UR - https://www.scopus.com/pages/publications/85119180697

U2 - 10.1056/NEJMoa2110345

DO - 10.1056/NEJMoa2110345

M3 - Article

C2 - 34525277

SN - 0028-4793

VL - 385

SP - 1761

EP - 1773

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 19

ER -

Safety and efficacy of the BNT162B2 mRNA covid-19 vaccine through 6 months

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