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Risk of Myocarditis and Pericarditis Following BNT162b2 and mRNA-1273 COVID-19 Vaccination

24 Pages Posted: 16 Mar 2022

See all articles by Kristin Goddard

Kristin Goddard

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center

Edwin Lewis

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center

Bruce Fireman

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center

Eric Weintraub

Government of the United States of America - Immunization Safety Office

Tom T. Shimabukuro

Government of the United States of America - Immunization Safety Office

Ousseny Zerbo

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center

Thomas G. Boyce

Marshfield Clinic Research Institute

Matthew E. Oster

Government of the United States of America - Immunization Safety Office

Kayla E. Hanson

Marshfield Clinic Research Institute

James G. Donahue

Marshfield Clinic Research Institute

Pat Ross

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center

Allison L. Naleway

Kaiser Permanente Northwest - Center for Health Research

Jennifer C. Nelson

Kaiser Permanente Washington Health Research Institute

Bruno Lewin

Kaiser Permanente - Department of Research & Evaluation

Jason M. Glanz

Kaiser Permanente Colorado - Institute for Health Research

Joshua T.B. Williams

Denver Health and Hospital Authority - Ambulatory Care Services

Elyse O. Kharbanda

HealthPartners Institute

W. Katherine Yih

Harvard Pilgrim Health Care

Nicola P. Klein

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center

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Multiple version iconThere are 2 versions of this paper

Abstract

Background: Accumulating evidence indicates that mRNA COVID-19 vaccination is associated with increased risk of myocarditis and possibly pericarditis, especially in young males. It is not yet clear if risk differs between mRNA-1273 (Moderna) versus BNT162b2 (Pfizer-BioNTech).

Methods: Myocarditis and pericarditis cases in patients 18–39-years-old were characterized by medical record review at 8 participating Vaccine Safety Datalink sites. We updated previous risk estimates of myocarditis and pericarditis during days 0–7 (risk interval) versus days 22–42 (comparison interval) post-vaccination and conducted direct comparisons of risk for mRNA-1273 versus BNT162b2 during 0–7 days post-vaccination. Rate ratios (RRs) were estimated by conditional Poisson regression.

Findings: 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).

Interpretation: Both mRNA COVID-19 vaccines were associated with increased risk of myocarditis and pericarditis in 18-39-year-olds. Overall risk estimates were modestly higher after mRNA-1273 than after BNT162b2.

Funding Information: This study was supported by the Centers for Disease Control and Prevention (CDC), contract number Contract #200-2012-53581-0011.

Declaration of Interests: NPK reports research support from Pfizer for COVID-19 vaccine clinical trials and Pfizer, Merck & Co., GlaxoSmithKline, Sanofi Pasteur, and Protein Science (now Sanofi Pasteur) for unrelated studies.

ALN reports research support from Pfizer and Vir Biotechnology for unrelated studies.

WKY reports research support from Pfizer for protocol development in the 17 past.

JGD report research support from Janssen for an unrelated study. None of the other coauthors have disclosures to report.

Ethics Approval Statement: This activity was approved by the Institutional Review Boards of all participating organizations with a waiver of informed consent and was conducted consistent with appliable federal law and CDC policy.

Keywords: VACCINES, myocarditis, vaccine safety, COVID-19, SARS-CoV_2

Suggested Citation

Goddard, Kristin and Lewis, Edwin and Fireman, Bruce and Weintraub, Eric and Shimabukuro, Tom T. and Zerbo, Ousseny and Boyce, Thomas G. and Oster, Matthew E. and Hanson, Kayla E. and Donahue, James G. and Ross, Pat and Naleway, Allison L. and Nelson, Jennifer C. and Lewin, Bruno and Glanz, Jason M. and Williams, Joshua T.B. and Kharbanda, Elyse O. and Yih, W. Katherine and Klein, Nicola P., Risk of Myocarditis and Pericarditis Following BNT162b2 and mRNA-1273 COVID-19 Vaccination. Available at SSRN: https://ssrn.com/abstract=4059218 or http://dx.doi.org/10.2139/ssrn.4059218

Kristin Goddard

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center ( email )

Oakland, CA
United States

Edwin Lewis

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center ( email )

Oakland, CA
United States

Bruce Fireman

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center ( email )

Oakland, CA
United States

Eric Weintraub

Government of the United States of America - Immunization Safety Office ( email )

Atlanta, GA
United States

Tom T. Shimabukuro

Government of the United States of America - Immunization Safety Office ( email )

Atlanta, GA
United States

Ousseny Zerbo

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center ( email )

Oakland, CA
United States

Thomas G. Boyce

Marshfield Clinic Research Institute ( email )

Marshfield, WI
United States

Matthew E. Oster

Government of the United States of America - Immunization Safety Office ( email )

Atlanta, GA
United States

Kayla E. Hanson

Marshfield Clinic Research Institute ( email )

Marshfield, WI
United States

James G. Donahue

Marshfield Clinic Research Institute ( email )

Marshfield, WI
United States

Pat Ross

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center ( email )

Oakland, CA
United States

Allison L. Naleway

Kaiser Permanente Northwest - Center for Health Research ( email )

Portland, OR
United States

Jennifer C. Nelson

Kaiser Permanente Washington Health Research Institute ( email )

1730 Minor Ave
Seattle, WA 98195
United States

Bruno Lewin

Kaiser Permanente - Department of Research & Evaluation ( email )

Pasadena, CA
United States

Jason M. Glanz

Kaiser Permanente Colorado - Institute for Health Research ( email )

Denver, CO
United States

Joshua T.B. Williams

Denver Health and Hospital Authority - Ambulatory Care Services ( email )

Denver, CO
United States

Elyse O. Kharbanda

HealthPartners Institute ( email )

Minneapolis, MN
United States

W. Katherine Yih

Harvard Pilgrim Health Care ( email )

93 Worcester Street
Wellesley, 02481
United States

Nicola P. Klein (Contact Author)

Kaiser Permanente Northern California - Kaiser Permanente Vaccine Study Center ( email )

Oakland, CA
United States

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