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Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination

BACKGROUND: Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse po...

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Autores principales: Goddard, Kristin, Lewis, Ned, Fireman, Bruce, Weintraub, Eric, Shimabukuro, Tom, Zerbo, Ousseny, Boyce, Thomas G., Oster, Matthew E., Hanson, Kayla E., Donahue, James G., Ross, Pat, Naleway, Allison, Nelson, Jennifer C., Lewin, Bruno, Glanz, Jason M., Williams, Joshua T.B., Kharbanda, Elyse O., Katherine Yih, W., Klein, Nicola P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Authors. Published by Elsevier Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9273527/
https://www.ncbi.nlm.nih.gov/pubmed/35902278
http://dx.doi.org/10.1016/j.vaccine.2022.07.007
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author Goddard, Kristin
Lewis, Ned
Fireman, Bruce
Weintraub, Eric
Shimabukuro, Tom
Zerbo, Ousseny
Boyce, Thomas G.
Oster, Matthew E.
Hanson, Kayla E.
Donahue, James G.
Ross, Pat
Naleway, Allison
Nelson, Jennifer C.
Lewin, Bruno
Glanz, Jason M.
Williams, Joshua T.B.
Kharbanda, Elyse O.
Katherine Yih, W.
Klein, Nicola P.
author_facet Goddard, Kristin
Lewis, Ned
Fireman, Bruce
Weintraub, Eric
Shimabukuro, Tom
Zerbo, Ousseny
Boyce, Thomas G.
Oster, Matthew E.
Hanson, Kayla E.
Donahue, James G.
Ross, Pat
Naleway, Allison
Nelson, Jennifer C.
Lewin, Bruno
Glanz, Jason M.
Williams, Joshua T.B.
Kharbanda, Elyse O.
Katherine Yih, W.
Klein, Nicola P.
author_sort Goddard, Kristin
collection PubMed
description BACKGROUND: Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse population. METHODS: Members 18–39 years of age at eight integrated healthcare-delivery systems were monitored using data updated weekly and supplemented with medical record review of myocarditis and pericarditis cases. Incidence of myocarditis and pericarditis events that occurred among vaccine recipients 0 to 7 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by conditional Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Head-to-head comparison directly assessed risk following mRNA-1273 versus BNT162b2 during 0–7 days post-vaccination. RESULTS: From December 14, 2020 – January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for ≤1 day; none required intensive care. During days 0–7 after dose 2 of BNT162b2, the incidence was 14.3 (CI: 6.5–34.9) times higher than the comparison interval, amounting to 22.4 excess cases per million doses; after mRNA-1273 the incidence was 18.8 (CI: 6.7–64.9) times higher than the comparison interval, amounting to 31.2 excess cases per million doses. In head-to-head comparisons 0–7 days after either dose, risk was moderately higher after mRNA-1273 than after BNT162b2 (RR: 1.61, CI 1.02–2.54). CONCLUSIONS: Both vaccines were associated with increased risk of myocarditis and pericarditis in 18–39-year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2.
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spelling pubmed-92735272022-07-12 Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination Goddard, Kristin Lewis, Ned Fireman, Bruce Weintraub, Eric Shimabukuro, Tom Zerbo, Ousseny Boyce, Thomas G. Oster, Matthew E. Hanson, Kayla E. Donahue, James G. Ross, Pat Naleway, Allison Nelson, Jennifer C. Lewin, Bruno Glanz, Jason M. Williams, Joshua T.B. Kharbanda, Elyse O. Katherine Yih, W. Klein, Nicola P. Vaccine Article BACKGROUND: Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse population. METHODS: Members 18–39 years of age at eight integrated healthcare-delivery systems were monitored using data updated weekly and supplemented with medical record review of myocarditis and pericarditis cases. Incidence of myocarditis and pericarditis events that occurred among vaccine recipients 0 to 7 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by conditional Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Head-to-head comparison directly assessed risk following mRNA-1273 versus BNT162b2 during 0–7 days post-vaccination. RESULTS: From December 14, 2020 – January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for ≤1 day; none required intensive care. During days 0–7 after dose 2 of BNT162b2, the incidence was 14.3 (CI: 6.5–34.9) times higher than the comparison interval, amounting to 22.4 excess cases per million doses; after mRNA-1273 the incidence was 18.8 (CI: 6.7–64.9) times higher than the comparison interval, amounting to 31.2 excess cases per million doses. In head-to-head comparisons 0–7 days after either dose, risk was moderately higher after mRNA-1273 than after BNT162b2 (RR: 1.61, CI 1.02–2.54). CONCLUSIONS: Both vaccines were associated with increased risk of myocarditis and pericarditis in 18–39-year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2. The Authors. Published by Elsevier Ltd. 2022-08-19 2022-07-12 /pmc/articles/PMC9273527/ /pubmed/35902278 http://dx.doi.org/10.1016/j.vaccine.2022.07.007 Text en © 2022 The Authors Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Goddard, Kristin
Lewis, Ned
Fireman, Bruce
Weintraub, Eric
Shimabukuro, Tom
Zerbo, Ousseny
Boyce, Thomas G.
Oster, Matthew E.
Hanson, Kayla E.
Donahue, James G.
Ross, Pat
Naleway, Allison
Nelson, Jennifer C.
Lewin, Bruno
Glanz, Jason M.
Williams, Joshua T.B.
Kharbanda, Elyse O.
Katherine Yih, W.
Klein, Nicola P.
Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination
title Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination
title_full Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination
title_fullStr Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination
title_full_unstemmed Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination
title_short Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination
title_sort risk of myocarditis and pericarditis following bnt162b2 and mrna-1273 covid-19 vaccination
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9273527/
https://www.ncbi.nlm.nih.gov/pubmed/35902278
http://dx.doi.org/10.1016/j.vaccine.2022.07.007
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