Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination |
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| Affiliation: | 1. Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, CA, United States;2. Marshfield Clinic Research Institute, Marshfield, WI, United States;3. Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States;4. Children’s Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, United States;5. Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States;6. Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States;7. Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States;8. Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, United States;9. Ambulatory Care Services, Denver Health & Hospital Authority, Denver, CO, United States;10. HealthPartners Institute, Minneapolis, MN, United States;11. Harvard Pilgrim Health Care Institute, Boston, MA, United States |
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| Abstract: | BackgroundEvidence 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.MethodsMembers 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.ResultsFrom 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).ConclusionsBoth 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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| Keywords: | Myocarditis Pericarditis COVID-19 SARS-CoV2 Vaccine safety Relative vaccine safety Vaccine Safety Datalink Rapid cycle analysis Messenger ribonucleic acid (mRNA) vaccines |
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