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Carditis After COVID-19 Vaccination With a Messenger RNA Vaccine and an Inactivated Virus Vaccine : A Case-Control
Francisco Tsz Tsun Lai1, Xue Li2, Kuan Peng3
1Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, and Laboratory of Data Discovery for Health (D24H), Hong Kong Science Park, Hong Kong Science and Technology Park, Hong Kong Special Administrative Region, China (F.T.T., E.W.Y.).
Insights
The BNT162b2 vaccine is associated with an increased risk of carditis, particularly in males and adolescents, with the highest risk observed after the second dose. This finding highlights the need to balance vaccination benefits against potential risks.
Area of Science:
- Cardiology
- Vaccinology
- Public Health
Background:
- Reports of carditis following BNT162b2 vaccination are increasing globally.
- Understanding the association between COVID-19 vaccines and carditis is crucial for public health strategies.
Purpose of the Study:
- To investigate the link between BNT162b2 (Pfizer-BioNTech) and CoronaVac (Sinovac) vaccinations and the incidence of carditis.
- To quantify the risk of carditis associated with each vaccine type.
Main Methods:
- A territory-wide case-control study was conducted using Hong Kong's public healthcare database.
- Inpatients diagnosed with carditis (cases) were matched with hospitalized individuals without carditis (controls) by age, sex, and admission date.
- Vaccination records were linked to identify BNT162b2 and CoronaVac recipients.
Main Results:
- The incidence of carditis was higher following BNT162b2 vaccination (0.57 per 100,000 doses) compared to CoronaVac (0.31 per 100,000 doses).
- BNT162b2 recipients had significantly higher odds of carditis (adjusted OR, 3.57) compared to unvaccinated individuals.
- The elevated risk was more pronounced in males (OR, 4.68) and adolescents (OR, 13.79), primarily after the second vaccine dose. Myocarditis showed a stronger association (OR, 9.29) than pericarditis (OR, 1.06).
Conclusions:
- BNT162b2 vaccination is associated with an increased risk of carditis, although the absolute risk remains low.
- The findings necessitate careful consideration of the elevated carditis risk alongside the established benefits of BNT162b2 vaccination.
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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