Epidemiology |
- Epidemiological studies have reported an increased risk of myo/pericarditis after mRNA COVID-19 vaccination.1–14
- The estimated incidence* of BNT162b2 vaccine-related myo/pericarditis, per 100,000 persons, was observed to be:
- Myocarditis:
- Risk difference (per 100,000 persons):
- Between 1st and 2nd doses- 1.76 cases in ages ≥ 16 years, with the largest observed risk difference of 13.73 cases among males ages 16–19 years, 21 days post-vaccination.6
- Between vaccinated and unvaccinated persons- 2.7 events, in age ≥ 16 years, 42 days post-vaccination.1
- Cases (per 100,000 persons):
- 2.13 cases in vaccinated persons aged ≥ 16 years, with the highest observed rates of 10.69 cases in ages 16–29 years.11
- Pericarditis:
- Risk difference (per 100,000 persons):
- Between vaccinated and unvaccinated persons- 0.98 events, in age ≥ 16 years (42 days post-vaccination).1
- Myo/pericarditis:
- Cases (per 100,000 persons), highest observed rates:
- 35.9 and 6.5 cases in males ages 12–17 (21 days post 2nd dose) and 5–11 years (unspecified dose), respectively.12
- 5.4 cases in females ages 12–17, 21 days post 2nd dose. No cases were reported in females ages 5–11 years.12
- The estimated incidence of SARS-CoV-2-related myo/pericarditis, per 100,000 persons, was observed to be:
- Myo/pericarditis:
- Risk difference (per 100,000 persons):
- Between vaccinated and unvaccinated persons- 11 events, in age ≥ 16 years, 42 days after SARS-CoV-2 infection.1
- Cases (per 100,000 persons), highest observed rates:
- 65 and 17.6 cases in males ages 12–17 years and 5–11 years, respectively, with risk window of 21 days.12
- 35.7 and 10.8 cases in females ages 12–17 years and 5–11 years, respectively, with risk window of 21 days.12
- The estimated number of excess events of myo/pericarditis attributable to BNT162b2 vaccine, per 100,000 doses administered14 or per 100,000 vaccinees13, were observed to be:
- 1.39 and 0.31 excess events in males and females, respectively, with the highest observed rate of 8.3 excess events in male 16–24 years, 28 days post 2nd dose.13
- 1.9 excess events in males ages 12–17 years and 4.7 excess events in participants ages 18–24 years, 7 days post 2nd dose.14
- Association of myo/pericarditis with COVID-19 viral infection has been reported and at higher rates than after mRNA COVID-19 vaccination.1,12
- The myo/pericarditis reporting rate is very rare.3,7,10
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(1) Barda; (2) Gargano; (3) Husby; (4) Klein; (5) Mevorach, NEJM 2022: (6) Mevorach, NEJM 2021; (7) Oster; (8) Patone; (9) Rosenblum; (10) Simone; (11) Witberg; (12) Block; (13) Karlstad; (14) Le Vu
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Risk Factors |
- The risk of COVID-19 vaccine-related myo/pericarditis appears to be higher in certain subpopulations:
- In male adolescents 12–17 years of age (60–82% of cases) and young adults < 39 years.1–3,5–8,10–13
- After the 2nd dose of mRNA vaccine and within the first 7 days of vaccination.3–7,10
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(1) Barda; (2) Gargano; (3) Husby; (4) Klein (5) Mevorach, NEJM 2022; (6) Mevorach, NEJM 2021; (7) Oster; (8) Patone; (10) Simone; (11) Witberg; (13) Karlstad; (14) Le Vu
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Clinical course, severity, and complications |
- The majority of observed cases were mild (76–95%) and recovered (87%).2,5–7,12
- Disease severity, duration, and complications appear to be decreased in mRNA vaccine-related myo/pericarditis when compared to classic viral or SARS-CoV-2-related myo/pericarditis.12
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(2) Gargano; (5) Mevorach, JAMA 2021; (6) Mevorach, NEJM 2022; (7) Oster; (12) Block
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Current recommendations |
- CDC continues to recommend COVID-19 vaccination for everyone 6 months of age and older given the risk of COVID-19 illness and related, possibly severe complications, such as long-term health problems, hospitalization, and even death.16
- An 8-week interval between the 1st and 2nd doses of BNT162b2 may be optimal for some individuals ages 6 months–64 years, especially for males ages 12–39 years, as it may reduce the small risk of vaccine-related myocarditis.16,17
- A shorter interval of 3 weeks between the 1st and 2nd doses remains the recommended interval for those who are moderately or severely immunocompromised; adults ages ≥ 65 years; and when there is increased concern about COVID-19 community levels or an individual’s higher risk of severe disease. 16,17
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(15) Clinical Considerations: Myocarditis and Pericarditis after receipt of mRNA COVID-19 Vaccines | CDC; (16) Use of COVID-19 Vaccines in the United States, Interim Clinical Considerations I CDC; (17) Interim COVID-19 Immunization Schedule for 6 months of age and older I CDC
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