Key result
BNT162b2 vaccination was associated with significantly higher odds of carditis (adjusted OR 3.57) compared to no vaccination, whereas no such association was observed for the CoronaVac vaccine.
Why the study?
Case reports of carditis after BNT162b2 vaccination were accruing worldwide, prompting an evaluation of the association between BNT162b2 or CoronaVac vaccination and carditis.
Does vaccination with BNT162b2 or CoronaVac increase the risk of incident carditis in persons aged 12 years or older?
Case-Control (n=1,693)
Does vaccination with BNT162b2 or CoronaVac increase the risk of incident carditis in persons aged 12 years or older?
Odds Ratio: 3.57 (95% CI 1.93–6.6)
BNT162b2 mRNA vaccination is associated with a significantly increased risk of carditis, particularly myocarditis in young males after the second dose, whereas the inactivated virus vaccine CoronaVac shows no such association.
May warrant carditis surveillance after BNT162b2 in young males; leaves open causality and vaccine-specific risk-benefit tradeoffs.
BACKGROUND: Case reports of carditis after BNT162b2 vaccination are accruing worldwide. OBJECTIVE: To examine the association of BNT162b2 and CoronaVac (Sinovac) vaccination with carditis. DESIGN: Case-control study with hospital control participants. SETTING: Territory-wide, public health care database with linkage to population-based vaccination records in Hong Kong. PATIENTS: Inpatients aged 12 years or older first diagnosed with carditis were selected as case patients. All other hospitalized patients without carditis were treated as control participants. Ten control participants were randomly matched with each case patient by age, sex, and admission date. INTERVENTION: Vaccination with BNT162b2 or CoronaVac. MEASUREMENTS: Incident diagnosis of carditis based on the International Classification of Diseases, Ninth Revision, and elevated troponin levels. RESULTS: A total of 160 case patients and 1533 control participants were included. Incidence of carditis per 100 000 doses of CoronaVac and BNT162b2 administered was estimated to be 0.31 (95% CI, 0.13 to 0.66) and 0.57 (CI, 0.36 to 0.90), respectively. Multivariable analyses showed that recipients of the BNT162b2 vaccine had higher odds of carditis (adjusted odds ratio [OR], 3.57 [CI, 1.93 to 6.60]) than unvaccinated persons. Stratified by sex, the OR was 4.68 (CI, 2.25 to 9.71) for males and 2.22 (CI, 0.57 to 8.69) for females receiving the BNT162b2 vaccine. The ORs for adults and adolescents receiving the BNT162b2 vaccine were 2.41 (CI, 1.18 to 4.90) and 13.79 (CI, 2.86 to 110.38), respectively. Subanalysis showed an OR of 9.29 (CI, 3.94 to 21.91) for myocarditis and 1.06 (CI, 0.35 to 3.22) for pericarditis associated with BNT162b2. The risk was mainly seen after the second dose of BNT162b2 rather than the first. No association between CoronaVac and carditis with a magnitude similar to that for BNT162b2 was seen. LIMITATION: Limited sample size, absence of electrocardiography and other clinical investigative data, and unrecorded overseas vaccination exposure. CONCLUSION: Despite a low absolute risk, there is an increased risk for carditis associated with BNT162b2 vaccination. This elevated risk should be weighed against the benefits of vaccination. PRIMARY FUNDING SOURCE: Health and Medical Research Fund.
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A 2022 study conducted a case-control in Carditis (myocarditis or pericarditis) (n=1,693). BNT162b2 vaccination vs. Unvaccinated persons was evaluated on Incident diagnosis of carditis (OR 3.57, 95% CI 1.93 to 6.60). BNT162b2 vaccination was associated with significantly higher odds of carditis (adjusted OR 3.57) compared to no vaccination, whereas no such association was observed for the CoronaVac vaccine.
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