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Oral Presentation

Vaccines

Session: Evaluating the Vaccines Against the Nasty Bugs: Safety First Round II

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

Sunday, August 28, 2022

1:45 PM – 2:00 PM CEST

Location: C1M1

Publication Number: 272

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).

Objectives: To determine whether risk of myocarditis and pericarditis after vaccination among people ages 18-39 years differs by mRNA vaccine product.

Methods: As part of ongoing real-time COVID-19 vaccine safety monitoring within the Vaccine Safety Datalink, myocarditis and pericarditis cases in patients 18—39-years-old were identified and characterized by medical record review. 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.

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 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.

Presenting Author(s)

Nicola Klein

Kaiser Permanente
Oakland, California, United States

Slides

Co-Author(s)

KG

Kristin Goddard

Kaiser Permanente Northern California, Vaccine Study Center, CA, United States
EL

Edwin Lewis

Kaiser Permanente Northern California, Vaccine Study Center, CA, United States
BF

Bruce Fireman

Kaiser Permanente Northern California, Vaccine Study Center, California, United States
Ousseny Zerbo

Kaiser Permanente Northern California Division of Research
Oakland, California, United States
TB

Thomas Boyce

Marshfield Clinic Research Institute, Marshfield, Wisconsin, United States
KH

Kayla Hansen

Center for Clinical Epidemiology & Population Health, Marshfield Clinic Research Institute, Marshfield, Wisconsin, Wisconsin, United States
JD

James Donahue

Center for Clinical Epidemiology & Population Health, Marshfield Clinic Research Institute, Marshfield, Wisconsin, WI, United States
PR

Pat Ross

Kaiser Permanente Northern California, Vaccine Study Center, California, United States
AN

Allison Naleway

Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, Oregon, United States
JN

Jennifer Nelson

Kaiser Permanente Washington Health Research Institute, United States
BL

Bruno Lewin

Research and Evaluation, Kaiser Permanente Southern California, California, United States
JG

Jason Glanz

Institute for Health Research, Kaiser Permanente Colorado, Colorado, United States
JW

Joshua Williams

Denver Health Medical Center, United States
EK

Elyse Kharbanda

HealthPartners Institute, MN, United States
KY

Katherine Yih, MPH, PhD

Epidemiologist
Harvard Pilgrim Health Care Institute
Department of Population Medicine, Harvard Medical School
Boston, Massachusetts, United States