Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12-18 Years - United States, July-December 2021

Overcoming COVID-19 Investigators

doi:10.15585/MMWR.MM7102E1

Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12-18 Years - United States, July-December 2021

Overcoming COVID-19 Investigators

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

105 Scopus citations

Abstract

Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5), § and real-world studies in persons aged 12-18 years demonstrated high vaccine effectiveness (VE) against severe COVID-19 (6). Recent evidence suggests that COVID-19 vaccination is associated with lower MIS-C incidence among adolescents (7); however, VE of the 2-dose Pfizer-BioNTech regimen against MIS-C has not been evaluated. The effectiveness of 2 doses of Pfizer-BioNTech vaccine received ≥28 days before hospital admission in preventing MIS-C was assessed using a test-negative case-control design ¶ among hospitalized patients aged 12-18 years at 24 pediatric hospitals in 20 states** during July 1-December 9, 2021, the period when most MIS-C patients could be temporally linked to SARS-CoV-2 B.1.617.2 (Delta) variant predominance. Patients with MIS-C (case-patients) and two groups of hospitalized controls matched to case-patients were evaluated: test-negative controls had at least one COVID-19-like symptom and negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or antigen-based assay results, and syndrome-negative controls were hospitalized patients without COVID-19-like illness. Among 102 MIS-C case-patients and 181 hospitalized controls, estimated effectiveness of 2 doses of Pfizer-BioNTech vaccine against MIS-C was 91% (95% CI = 78%-97%). All 38 MIS-C patients requiring life support were unvaccinated. Receipt of 2 doses of the Pfizer-BioNTech vaccine is associated with a high level of protection against MIS-C in persons aged 12-18 years, highlighting the importance of vaccination among all eligible children.

Original language	English (US)
Pages (from-to)	52-58
Number of pages	7
Journal	Morbidity and Mortality Weekly Report
Volume	71
Issue number	2
DOIs	https://doi.org/10.15585/MMWR.MM7102E1
State	Published - Jan 14 2022

Bibliographical note

Funding Information:
All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Jennifer E. Schuster reports institutional support from Merck for an RSV research study, unrelated to the current work. Adrienne G. Randolph reports institutional support from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), royalties from UpToDate as the Pediatric Critical Care Section Editor, and participation on a data safety monitoring board (DSMB) for a National Institute of Child Health and Human Development-funded study. Pia S. Pannaraj reports institutional support from AstraZeneca and Pfizer, consulting fees from Sanofi-Pasteur and Seqirus, payment from law firms for expert testimony, participation on a Division of Microbiology and Infectious Diseases DSMB, and an unpaid leadership role in the California Immunization Coalition. Ryan A. Nofziger reports institutional support from NIH for participation in a multicenter influenza study. Satoshi Kamidani reports institutional support from NIH and Pfizer. Charlotte V. Hobbs reports consulting fees from Dynamed and honoraria from Biofire/ Biomerieux. Natasha B. Halasa reports grants from Sanofi and Quidel and an educational grant from Genentech. Natalie Z. Cvijanovich reports a speaker’s registration discount at the Society of Critical Care Medicine meeting. Samina S. Bhumbra reports receipt of an NIH, NIAID training grant during September 1, 2019–August 31, 2020. No other potential conflicts of interest were disclosed.

Keywords

Adolescent
BNT162 Vaccine/therapeutic use
COVID-19/complications
Case-Control Studies
Child
Female
Hospitalization/statistics & numerical data
Humans
Male
Patient Acuity
SARS-CoV-2/immunology
Systemic Inflammatory Response Syndrome/drug therapy
United States/epidemiology
Vaccine Efficacy

PubMed: MeSH publication types

Journal Article

UN SDGs

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

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10.15585/MMWR.MM7102E1

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@article{28ff07311bf84034bc986eefc97928a7,

title = "Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12-18 Years - United States, July-December 2021",

abstract = "Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5), § and real-world studies in persons aged 12-18 years demonstrated high vaccine effectiveness (VE) against severe COVID-19 (6). Recent evidence suggests that COVID-19 vaccination is associated with lower MIS-C incidence among adolescents (7); however, VE of the 2-dose Pfizer-BioNTech regimen against MIS-C has not been evaluated. The effectiveness of 2 doses of Pfizer-BioNTech vaccine received ≥28 days before hospital admission in preventing MIS-C was assessed using a test-negative case-control design ¶ among hospitalized patients aged 12-18 years at 24 pediatric hospitals in 20 states** during July 1-December 9, 2021, the period when most MIS-C patients could be temporally linked to SARS-CoV-2 B.1.617.2 (Delta) variant predominance. Patients with MIS-C (case-patients) and two groups of hospitalized controls matched to case-patients were evaluated: test-negative controls had at least one COVID-19-like symptom and negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or antigen-based assay results, and syndrome-negative controls were hospitalized patients without COVID-19-like illness. Among 102 MIS-C case-patients and 181 hospitalized controls, estimated effectiveness of 2 doses of Pfizer-BioNTech vaccine against MIS-C was 91% (95% CI = 78%-97%). All 38 MIS-C patients requiring life support were unvaccinated. Receipt of 2 doses of the Pfizer-BioNTech vaccine is associated with a high level of protection against MIS-C in persons aged 12-18 years, highlighting the importance of vaccination among all eligible children. ",

keywords = "Adolescent, BNT162 Vaccine/therapeutic use, COVID-19/complications, Case-Control Studies, Child, Female, Hospitalization/statistics & numerical data, Humans, Male, Patient Acuity, SARS-CoV-2/immunology, Systemic Inflammatory Response Syndrome/drug therapy, United States/epidemiology, Vaccine Efficacy",

author = "{Overcoming COVID-19 Investigators} and Zambrano, {Laura D.} and Newhams, {Margaret M.} and Olson, {Samantha M.} and Halasa, {Natasha B.} and Price, {Ashley M.} and Boom, {Julie A.} and Sahni, {Leila C.} and Satoshi Kamidani and Tarquinio, {Keiko M.} and Maddux, {Aline B.} and Heidemann, {Sabrina M.} and Bhumbra, {Samina S.} and Bline, {Katherine E.} and Nofziger, {Ryan A.} and Hobbs, {Charlotte V.} and Bradford, {Tamara T.} and Cvijanovich, {Natalie Z.} and Katherine Irby and MacK, {Elizabeth H.} and Cullimore, {Melissa L.} and Pannaraj, {Pia S.} and Michele Kong and Walker, {Tracie C.} and Gertz, {Shira J.} and Michelson, {Kelly N.} and Cameron, {Melissa A.} and Kathleen Chiotos and Mia Maamari and Schuster, {Jennifer E.} and Orzel, {Amber O.} and Patel, {Manish M.} and Campbell, {Angela P.} and Randolph, {Adrienne G.} and Meghan Murdock and Gaspers, {Mary Glas} and Typpo, {Katri V.} and Kelley, {Connor P.} and Sanders, {Ronald C.} and Masson Yates and Chelsea Smith and Katheryn Crane and Geraldina Lionetti and Juliana Murcia-Montoya and Zinter, {Matt S.} and Denise Villarreal-Chico and Skura, {Adam L.} and Harvey Peralta and Lockwood, {Justin M.} and Hume, {Janet R.} and Goertzen, {Lexie A.}",

note = "Funding Information: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Jennifer E. Schuster reports institutional support from Merck for an RSV research study, unrelated to the current work. Adrienne G. Randolph reports institutional support from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), royalties from UpToDate as the Pediatric Critical Care Section Editor, and participation on a data safety monitoring board (DSMB) for a National Institute of Child Health and Human Development-funded study. Pia S. Pannaraj reports institutional support from AstraZeneca and Pfizer, consulting fees from Sanofi-Pasteur and Seqirus, payment from law firms for expert testimony, participation on a Division of Microbiology and Infectious Diseases DSMB, and an unpaid leadership role in the California Immunization Coalition. Ryan A. Nofziger reports institutional support from NIH for participation in a multicenter influenza study. Satoshi Kamidani reports institutional support from NIH and Pfizer. Charlotte V. Hobbs reports consulting fees from Dynamed and honoraria from Biofire/ Biomerieux. Natasha B. Halasa reports grants from Sanofi and Quidel and an educational grant from Genentech. Natalie Z. Cvijanovich reports a speaker{\textquoteright}s registration discount at the Society of Critical Care Medicine meeting. Samina S. Bhumbra reports receipt of an NIH, NIAID training grant during September 1, 2019–August 31, 2020. No other potential conflicts of interest were disclosed.",

year = "2022",

month = jan,

day = "14",

doi = "10.15585/MMWR.MM7102E1",

language = "English (US)",

volume = "71",

pages = "52--58",

journal = "Morbidity and Mortality Weekly Report",

issn = "0149-2195",

publisher = "Department of Health and Human Services",

number = "2",

}

TY - JOUR

T1 - Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12-18 Years - United States, July-December 2021

AU - Overcoming COVID-19 Investigators

AU - Zambrano, Laura D.

AU - Newhams, Margaret M.

AU - Olson, Samantha M.

AU - Halasa, Natasha B.

AU - Price, Ashley M.

AU - Boom, Julie A.

AU - Sahni, Leila C.

AU - Kamidani, Satoshi

AU - Tarquinio, Keiko M.

AU - Maddux, Aline B.

AU - Heidemann, Sabrina M.

AU - Bhumbra, Samina S.

AU - Bline, Katherine E.

AU - Nofziger, Ryan A.

AU - Hobbs, Charlotte V.

AU - Bradford, Tamara T.

AU - Cvijanovich, Natalie Z.

AU - Irby, Katherine

AU - MacK, Elizabeth H.

AU - Cullimore, Melissa L.

AU - Pannaraj, Pia S.

AU - Kong, Michele

AU - Walker, Tracie C.

AU - Gertz, Shira J.

AU - Michelson, Kelly N.

AU - Cameron, Melissa A.

AU - Chiotos, Kathleen

AU - Maamari, Mia

AU - Schuster, Jennifer E.

AU - Orzel, Amber O.

AU - Patel, Manish M.

AU - Campbell, Angela P.

AU - Randolph, Adrienne G.

AU - Murdock, Meghan

AU - Gaspers, Mary Glas

AU - Typpo, Katri V.

AU - Kelley, Connor P.

AU - Sanders, Ronald C.

AU - Yates, Masson

AU - Smith, Chelsea

AU - Crane, Katheryn

AU - Lionetti, Geraldina

AU - Murcia-Montoya, Juliana

AU - Zinter, Matt S.

AU - Villarreal-Chico, Denise

AU - Skura, Adam L.

AU - Peralta, Harvey

AU - Lockwood, Justin M.

AU - Hume, Janet R.

AU - Goertzen, Lexie A.

N1 - Funding Information: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Jennifer E. Schuster reports institutional support from Merck for an RSV research study, unrelated to the current work. Adrienne G. Randolph reports institutional support from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), royalties from UpToDate as the Pediatric Critical Care Section Editor, and participation on a data safety monitoring board (DSMB) for a National Institute of Child Health and Human Development-funded study. Pia S. Pannaraj reports institutional support from AstraZeneca and Pfizer, consulting fees from Sanofi-Pasteur and Seqirus, payment from law firms for expert testimony, participation on a Division of Microbiology and Infectious Diseases DSMB, and an unpaid leadership role in the California Immunization Coalition. Ryan A. Nofziger reports institutional support from NIH for participation in a multicenter influenza study. Satoshi Kamidani reports institutional support from NIH and Pfizer. Charlotte V. Hobbs reports consulting fees from Dynamed and honoraria from Biofire/ Biomerieux. Natasha B. Halasa reports grants from Sanofi and Quidel and an educational grant from Genentech. Natalie Z. Cvijanovich reports a speaker’s registration discount at the Society of Critical Care Medicine meeting. Samina S. Bhumbra reports receipt of an NIH, NIAID training grant during September 1, 2019–August 31, 2020. No other potential conflicts of interest were disclosed.

PY - 2022/1/14

Y1 - 2022/1/14

N2 - Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5), § and real-world studies in persons aged 12-18 years demonstrated high vaccine effectiveness (VE) against severe COVID-19 (6). Recent evidence suggests that COVID-19 vaccination is associated with lower MIS-C incidence among adolescents (7); however, VE of the 2-dose Pfizer-BioNTech regimen against MIS-C has not been evaluated. The effectiveness of 2 doses of Pfizer-BioNTech vaccine received ≥28 days before hospital admission in preventing MIS-C was assessed using a test-negative case-control design ¶ among hospitalized patients aged 12-18 years at 24 pediatric hospitals in 20 states** during July 1-December 9, 2021, the period when most MIS-C patients could be temporally linked to SARS-CoV-2 B.1.617.2 (Delta) variant predominance. Patients with MIS-C (case-patients) and two groups of hospitalized controls matched to case-patients were evaluated: test-negative controls had at least one COVID-19-like symptom and negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or antigen-based assay results, and syndrome-negative controls were hospitalized patients without COVID-19-like illness. Among 102 MIS-C case-patients and 181 hospitalized controls, estimated effectiveness of 2 doses of Pfizer-BioNTech vaccine against MIS-C was 91% (95% CI = 78%-97%). All 38 MIS-C patients requiring life support were unvaccinated. Receipt of 2 doses of the Pfizer-BioNTech vaccine is associated with a high level of protection against MIS-C in persons aged 12-18 years, highlighting the importance of vaccination among all eligible children.

AB - Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5), § and real-world studies in persons aged 12-18 years demonstrated high vaccine effectiveness (VE) against severe COVID-19 (6). Recent evidence suggests that COVID-19 vaccination is associated with lower MIS-C incidence among adolescents (7); however, VE of the 2-dose Pfizer-BioNTech regimen against MIS-C has not been evaluated. The effectiveness of 2 doses of Pfizer-BioNTech vaccine received ≥28 days before hospital admission in preventing MIS-C was assessed using a test-negative case-control design ¶ among hospitalized patients aged 12-18 years at 24 pediatric hospitals in 20 states** during July 1-December 9, 2021, the period when most MIS-C patients could be temporally linked to SARS-CoV-2 B.1.617.2 (Delta) variant predominance. Patients with MIS-C (case-patients) and two groups of hospitalized controls matched to case-patients were evaluated: test-negative controls had at least one COVID-19-like symptom and negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or antigen-based assay results, and syndrome-negative controls were hospitalized patients without COVID-19-like illness. Among 102 MIS-C case-patients and 181 hospitalized controls, estimated effectiveness of 2 doses of Pfizer-BioNTech vaccine against MIS-C was 91% (95% CI = 78%-97%). All 38 MIS-C patients requiring life support were unvaccinated. Receipt of 2 doses of the Pfizer-BioNTech vaccine is associated with a high level of protection against MIS-C in persons aged 12-18 years, highlighting the importance of vaccination among all eligible children.

KW - Adolescent

KW - BNT162 Vaccine/therapeutic use

KW - COVID-19/complications

KW - Case-Control Studies

KW - Child

KW - Female

KW - Hospitalization/statistics & numerical data

KW - Humans

KW - Male

KW - Patient Acuity

KW - SARS-CoV-2/immunology

KW - Systemic Inflammatory Response Syndrome/drug therapy

KW - United States/epidemiology

KW - Vaccine Efficacy

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U2 - 10.15585/MMWR.MM7102E1

DO - 10.15585/MMWR.MM7102E1

M3 - Article

C2 - 35025852

AN - SCOPUS:85123461626

SN - 0149-2195

VL - 71

SP - 52

EP - 58

JO - Morbidity and Mortality Weekly Report

JF - Morbidity and Mortality Weekly Report

IS - 2

ER -

Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12-18 Years - United States, July-December 2021

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

UN SDGs

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