Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

C4591007 Clinical Trial Group; Emmanuel B Walter; Kawsar R Talaat; Charu Sabharwal; Alejandra Gurtman; Stephen Lockhart; Grant C Paulsen; Elizabeth D Barnett; Flor M Muñoz; 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 J Belanger; David Cooper; Özlem Türeci; Philip R Dormitzer; Uğur Şahin; Kathrin U Jansen; William C Gruber

doi:10.1056/NEJMoa2116298

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

C4591007 Clinical Trial Group, Emmanuel B Walter, Kawsar R Talaat, Charu Sabharwal, Alejandra Gurtman, Stephen Lockhart, Grant C Paulsen, Elizabeth D Barnett, Flor M Muñoz, 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 MunjalJohn L Perez, Robert W Frenck, Eleni Lagkadinou, Kena A Swanson, Hua Ma, Xia Xu, Kenneth Koury, Susan Mather, Todd J Belanger, David Cooper, Özlem Türeci, Philip R Dormitzer, Uğur Şahin, Kathrin U Jansen, William C Gruber

Clinical Medicine

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

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.).

Original language	English
Pages (from-to)	35-46
Number of pages	12
Journal	NEW ENGLAND JOURNAL OF MEDICINE
Volume	386
Issue number	1
Early online date	9 Nov 2021
DOIs	https://doi.org/10.1056/NEJMoa2116298
Publication status	Published - 6 Jan 2022
Publication type	A1 Journal article-refereed

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Publication forum level 3

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1056/NEJMoa2116298

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C4591007 Clinical Trial Group, Walter, E. B., Talaat, K. R., Sabharwal, C., Gurtman, A., Lockhart, S., Paulsen, G. C., Barnett, E. D., Muñoz, F. M., Maldonado, Y., Pahud, B. A., Domachowske, J. B., Simões, E. A. F., Sarwar, U. N., Kitchin, N., Cunliffe, L., Rojo, P., Kuchar, E., Rämet, M., ... Gruber, W. C. (2022). Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. NEW ENGLAND JOURNAL OF MEDICINE, 386(1), 35-46. https://doi.org/10.1056/NEJMoa2116298

@article{2239a15ba1b34c8b86249c73d793dd23,

title = "Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 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.).",

author = "{C4591007 Clinical Trial Group} and Walter, {Emmanuel B} and Talaat, {Kawsar R} and Charu Sabharwal and Alejandra Gurtman and Stephen Lockhart and Paulsen, {Grant C} and Barnett, {Elizabeth D} and Mu{\~n}oz, {Flor M} and Yvonne Maldonado and Pahud, {Barbara A} and Domachowske, {Joseph B} and Sim{\~o}es, {Eric A F} and Sarwar, {Uzma N} and Nicholas Kitchin and Luke Cunliffe and Pablo Rojo and Ernest Kuchar and Mika R{\"a}met and Iona Munjal and Perez, {John L} and Frenck, {Robert W} and Eleni Lagkadinou and Swanson, {Kena A} and Hua Ma and Xia Xu and Kenneth Koury and Susan Mather and Belanger, {Todd J} and David Cooper and {\"O}zlem T{\"u}reci and Dormitzer, {Philip R} and Uğur {\c S}ahin and Jansen, {Kathrin U} and Gruber, {William C}",

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

year = "2022",

month = jan,

day = "6",

doi = "10.1056/NEJMoa2116298",

language = "English",

volume = "386",

pages = "35--46",

journal = "NEW ENGLAND JOURNAL OF MEDICINE",

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C4591007 Clinical Trial Group, Walter, EB, Talaat, KR, Sabharwal, C, Gurtman, A, Lockhart, S, Paulsen, GC, Barnett, ED, Muñoz, FM, Maldonado, Y, Pahud, BA, Domachowske, JB, Simões, EAF, Sarwar, UN, Kitchin, N, Cunliffe, L, Rojo, P, Kuchar, E, Rämet, M, Munjal, I, Perez, JL, Frenck, RW, Lagkadinou, E, Swanson, KA, Ma, H, Xu, X, Koury, K, Mather, S, Belanger, TJ, Cooper, D, Türeci, Ö, Dormitzer, PR, Şahin, U, Jansen, KU & Gruber, WC 2022, 'Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age', NEW ENGLAND JOURNAL OF MEDICINE, vol. 386, no. 1, pp. 35-46. https://doi.org/10.1056/NEJMoa2116298

TY - JOUR

T1 - Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

AU - C4591007 Clinical Trial Group

AU - Walter, Emmanuel B

AU - Talaat, Kawsar R

AU - Sabharwal, Charu

AU - Gurtman, Alejandra

AU - Lockhart, Stephen

AU - Paulsen, Grant C

AU - Barnett, Elizabeth D

AU - Muñoz, Flor M

AU - Maldonado, Yvonne

AU - Pahud, Barbara A

AU - Domachowske, Joseph B

AU - Simões, Eric A F

AU - Sarwar, Uzma N

AU - Kitchin, Nicholas

AU - Cunliffe, Luke

AU - Rojo, Pablo

AU - Kuchar, Ernest

AU - Rämet, Mika

AU - Munjal, Iona

AU - Perez, John L

AU - Frenck, Robert W

AU - Lagkadinou, Eleni

AU - Swanson, Kena A

AU - Ma, Hua

AU - Xu, Xia

AU - Koury, Kenneth

AU - Mather, Susan

AU - Belanger, Todd J

AU - Cooper, David

AU - Türeci, Özlem

AU - Dormitzer, Philip R

AU - Şahin, Uğur

AU - Jansen, Kathrin U

AU - Gruber, William C

PY - 2022/1/6

Y1 - 2022/1/6

N2 - 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.).

AB - 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.).

U2 - 10.1056/NEJMoa2116298

DO - 10.1056/NEJMoa2116298

M3 - Article

C2 - 34752019

VL - 386

SP - 35

EP - 46

JO - NEW ENGLAND JOURNAL OF MEDICINE

JF - NEW ENGLAND JOURNAL OF MEDICINE

SN - 0028-4793

IS - 1

ER -

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

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