Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.
Emmanuel B. Walter,Kawsar R. Talaat,Charu Sabharwal,Alejandra Gurtman,Stephen Lockhart,Grant Paulsen,Elizabeth D. Barnett,Flor M. Munoz,Yvonne Maldonado,Barbara A. Pahud,Joseph B. Domachowske,Eric A. F. Simões,Uzma N. Sarwar,Nicholas Kitchin,Luke Cunliffe,Pablo Rojo,Ernest Kuchar,Mika Rämet,Iona Munjal,John L. Perez,Robert W. Frenck,Eleni Lagkadinou,Kena A. Swanson,Hua Ma,Xia Xu,Kenneth Koury,Susan Mather,Todd Belanger,David K. C. Cooper,Özlem Türeci,Philip R. Dormitzer,Ugur Sahin,Kathrin U. Jansen,William C. Gruber +33 more
TLDR
A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age.Abstract:
Background Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age. Methods A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed. Results During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3). Conclusions A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).read more
Citations
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Three exposures to the spike protein of SARS-CoV-2 by either infection or vaccination elicit superior neutralizing immunity to all variants of concern
Paul R. Wratil,Marcel Stern,Alina Priller,Annika Willmann,Giovanni Almanzar,E Vogel,Martin Feuerherd,Cho-Chin Cheng,Sarah Yazici,Catharina Christa,Samuel Jeske,Gaia Lupoli,Tim Vogt,Manuel Albanese,Ernesto Mejías-Pérez,Stefan Bauernfried,N. Graf,Hrvoje Mijočević,Martin Vu,Kathrin Tinnefeld,Jochen M. Wettengel,Dieter Hoffmann,Maximilian Muenchhoff,C. Daechert,Helga Mairhofer,Stefan Krebs,Volker Fingerle,Alexander Graf,Philipp Steininger,Helmut Blum,Veit Hornung,Bernhard Liebl,Klaus Überla,Martina Prelog,Percy A. Knolle,Oliver T. Keppler,Ulrike Protzer +36 more
TL;DR: In this paper , neutralizing antibody dynamics in a longitudinal cohort of coronavirus disease 2019 convalescent and infection-naive individuals vaccinated with mRNA BNT162b2 were quantified and neutralization capacity in serum.
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Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5–17 Years — VISION Network, 10 States, April 2021–January 2022
Nicola P. Klein,Melissa S. Stockwell,Maria Demarco,Manjusha Gaglani,Anupam B. Kharbanda,Stephanie A. Irving,S. Rao,Shaun J. Grannis,Kristin Dascomb,Kempapura Murthy,Elizabeth Rowley,Alexandra F. Dalton,Malini B. DeSilva,Brian E. Dixon,Karthik Natarajan,Edward Stenehjem,Allison L. Naleway,Ned Lewis,Toan C. Ong,Palak Patel,D. Konatham,Peter J. Embi,Sara E. Reese,Jungmi Han,Nancy Grisel,Kristin Goddard,Michelle A. Barron,M. Dickerson,I-Chia Liao,William F. Fadel,Duck-Hye Yang,Julie Arndorfer,Bruce Fireman,E. Griggs,Nimish Valvi,C. Hallowell,Ousseny Zerbo,Sue Reynolds,Jill M. Ferdinands,Mehiret Wondimu,Jeremiah Williams,Catherine H Bozio,Ruth Link-Gelles,Eduardo Azziz-Baumgartner,Stephanie J. Schrag,Mark Thompson,Jennifer R. Verani +46 more
TL;DR: VE against laboratory-confirmed COVID-19-associated hospitalization among children aged 5-11 years was 74% 14-67 days after dose 2, with wide CIs that included zero, and in adolescents aged 16-17 years, VE during the Omicron predominant period increased to 81% ≥7 days after a third booster dose.
Journal ArticleDOI
BNT162b2 Protection against the Omicron Variant in Children and Adolescents
TL;DR: In this paper , a case-control, test-negative design was used to assess vaccine effectiveness against laboratory-confirmed Covid-19 leading to hospitalization and against critical Covid19 (i.e., leading to receipt of life support or to death).
Journal ArticleDOI
Effectiveness of 2-Dose BNT162b2 (Pfizer BioNTech) mRNA Vaccine in Preventing SARS-CoV-2 Infection Among Children Aged 5–11 Years and Adolescents Aged 12–15 Years — PROTECT Cohort, July 2021–February 2022
Ashley Fowlkes,Sarang K Yoon,Karen Lutrick,Lisa A. Gwynn,Joy S. Burns,L. Grant,Andrew N. Phillips,Katherine Ellingson,Maria V. Ferraris,Lindsay B LeClair,Clare Mathenge,Young Yoo,Matthew S. Thiese,Lynn B. Gerald,Natasha Schaefer Solle,Zuha Jeddy,Leah Odame-Bamfo,Josephine Y.W. Mak,Kurt T. Hegmann,Joe K. Gerald,Jezahel S Ochoa,M. Berry,Spencer Rose,Julie Mayo Lamberte,Purnima Madhivanan,Felipe A Pubillones,Ramona P Rai,Kayan Dunnigan,John T. Jones,Karl Krupp,Laura Edwards,Edward J. Bedrick,Brian Sokol,Ashley A. Lowe,Hilary McLeland-Wieser,Krystal S. Jovel,Deanna E. Fleary,Sana Khan,Brandon Poe,James Hollister,Joanna Lopez,Patrick Rivers,Shawn C. Beitel,Harmony L. Tyner,Allison L. Naleway,Lauren E.W. Olsho,Alberto J. Caban-Martinez,Jefferey L. Burgess,Mark Thompson,Manjusha Gaglani +49 more
TL;DR: The BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine was recommended by CDC's Advisory Committee on Immunization Practices for persons aged 12-15 years (referred to as adolescents in this report) on May 12, 2021, and for children aged 5-11 years on November 2, 2021 and real-world data on vaccine effectiveness (VE) in these age groups are needed.
Journal ArticleDOI
Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARS-CoV-2 Infection in Children and Adolescents During Omicron Predominance.
Katherine E. Fleming-Dutra,Amadea Britton,Nong Shang,Gordana Derado,Ruth Link-Gelles,Emma Accorsi,Zachary R Smith,Joseph D. Miller,Jennifer R. Verani,Stephanie J. Schrag +9 more
TL;DR: Among children and adolescents, estimated VE for 2 doses of BNT162b2 against symptomatic infection was modest and decreased rapidly, and among adolescents, the estimated effectiveness increased after a booster dose.
References
More filters
Journal ArticleDOI
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 Kalina,David A. Cooper,Robert W. Frenck,Laura L. Hammitt,Özlem Türeci,Haylene Nell,Axel Schaefer,Serhat Ünal,Dina B. Tresnan,Susan Mather,Philip R. Dormitzer,Ugur Sahin,Kathrin U. Jansen,William C. Gruber +28 more
TL;DR: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older and safety over a median of 2 months was similar to that of other viral vaccines.
Journal ArticleDOI
Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates.
Edward E. Walsh,Robert W. Frenck,Ann R. Falsey,Ann R. Falsey,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,Kathleen M. Neuzil,Mark J. Mulligan,Ruth Bailey,Kena A. Swanson,Ping Li,Kenneth Koury,Warren Kalina,David A. Cooper,Camila R. Fontes-Garfias,Pei Yong Shi,Özlem Türeci,Tompkins Kristin Rachael,Kirsten E. Lyke,Vanessa Raabe,Philip R. Dormitzer,Kathrin U. Jansen,Ugur Sahin,William C. Gruber +25 more
TL;DR: The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults support the selection of BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation.
Journal ArticleDOI
Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents.
Robert W. Frenck,Nicola P. Klein,Nicholas Kitchin,Alejandra Gurtman,Judith Absalon,Stephen Lockhart,John L. Perez,Emmanuel B. Walter,Shelly Senders,Ruth Bailey,Kena A. Swanson,Hua Ma,Xia Xu,Kenneth Koury,Warren Kalina,David K. C. Cooper,Timothy Jennings,Donald M Brandon,Stephen J. Thomas,Özlem Türeci,Dina B. Tresnan,Susan Mather,Philip R. Dormitzer,Ugur Sahin,Kathrin U. Jansen,William C. Gruber +25 more
TL;DR: The vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of.
Journal ArticleDOI
Learning loss due to school closures during the COVID-19 pandemic.
TL;DR: This paper evaluated the effect of school closures on primary school performance using exceptionally rich data from The Netherlands (n ≈ 350,000) using the fact that national examinations took place before and after lockdown and compare progress during this period to the same period in the 3 previous years.
Journal ArticleDOI
BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans.
Ugur Sahin,Alexander Muik,Isabel Vogler,Evelyna Derhovanessian,Lena M. Kranz,Mathias Vormehr,Jasmin Quandt,Nicole Bidmon,Alexander Ulges,Alina Baum,Kristen E. Pascal,Daniel Maurus,Sebastian Brachtendorf,Verena Lörks,Julian Sikorski,Peter Koch,Rolf Hilker,Dirk Becker,Ann Kathrin Eller,Jan Grützner,Manuel Tonigold,Carsten Boesler,Corinna Rosenbaum,Ludwig Heesen,Marie Cristine Kühnle,Asaf Poran,Jesse Z. Dong,Ulrich Luxemburger,Alexandra Kemmer-Brück,David J. Langer,Martin Bexon,Stefanie Bolte,Tania Palanche,Armin Schultz,Sybille Baumann,Azita J. Mahiny,Gábor Boros,Jonas Reinholz,Gábor Szabó,Katalin Karikó,Pei Yong Shi,Camila R. Fontes-Garfias,John L. Perez,Mark Cutler,David A. Cooper,Christos A. Kyratsous,Philip R. Dormitzer,Kathrin U. Jansen,Özlem Türeci +48 more
TL;DR: BNT162b2, a lipid nanoparticle (LNP) formulated nucleoside-modified messenger RNA (mRNA) that encodes the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike glycoprotein (S) stabilized in the prefusion conformation, has demonstrated 95% efficacy in preventing coronavalirus disease-19 (COVID-19)1 as mentioned in this paper.
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