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Comparative safety profile of bivalent and original COVID-19 mRNA vaccines regarding myocarditis/pericarditis: A
Congqin Chen1, Chunmei Chen2, Longxing Cao3
1Department of Pharmacy, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen 361000, China.
Objectives:
Bivalent COVID-19 mRNA vaccines, which contain two different components, were authorized to provide protection against both the original strain of SARS-CoV-2 and the Omicron variant as a measure to address the COVID-19 pandemic. Concerns regarding the risk of myocarditis/pericarditis associated with bivalent vaccination have been raised due to the observed superior neutralizing antibody responses. This study aimed to investigate the risk of myocarditis/pericarditis following bivalent COVID-19 mRNA vaccination compared to monovalent vaccination.
Methods:
The CDC COVID Data Tracker and the Vaccines Adverse Event Reporting System (VAERS) were analyzed between December 13, 2020 to March 8, 2023. Reporting rates were determined by dividing the number of myocarditis/pericarditis cases by the total number of vaccine doses administered. Disproportionality patterns regarding myocarditis/pericarditis were evaluated for various COVID-19 mRNA vaccinations using reporting odds ratios (RORs).
Results:
The reporting rate for myocarditis/pericarditis following original monovalent COVID-19 mRNA vaccination was 6.91 (95 % confidence interval [95 %CI] 6.71-7.12) per million doses, while the reporting rate for bivalent vaccination was significantly lower (1.24, 95%CI 0.96-1.58). Disproportionality analysis revealed a higher reporting of myocarditis/pericarditis following original vaccination with a ROR of 2.21 (95 %CI 2.00-2.43), while bivalent COVID-19 mRNA vaccination was associated with fewer reports of myocarditis/pericarditis (ROR 0.57, 95 %CI 0.45-0.72). Sub-analyses based on symptoms, sex, age and manufacturer further supported these findings.
Conclusion:
This population-based study provides evidence that bivalent COVID-19 mRNA vaccination is not associated with risk of myocarditis/pericarditis. These findings provide important insights into the safety profile of bivalent COVID-19 mRNA vaccines and support their continued use as updated boosters.
Insights
Bivalent COVID-19 mRNA vaccines show a lower risk of myocarditis/pericarditis compared to original monovalent vaccines. These updated boosters are safe and support continued use for pandemic protection.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Bivalent COVID-19 mRNA vaccines were developed to target SARS-CoV-2 original strain and Omicron variant.
- Concerns exist regarding potential myocarditis/pericarditis risk with bivalent vaccines due to enhanced immune responses.
Purpose of the Study:
- To compare the risk of myocarditis/pericarditis following bivalent COVID-19 mRNA vaccination versus original monovalent vaccination.
Main Methods:
- Analysis of CDC COVID Data Tracker and VAERS from December 2020 to March 2023.
- Calculation of myocarditis/pericarditis reporting rates per million vaccine doses.
- Evaluation of disproportionality using reporting odds ratios (RORs).
Main Results:
- Bivalent vaccination had a significantly lower reporting rate (1.24/million) than monovalent vaccination (6.91/million).
- Disproportionality analysis showed lower reporting odds for myocarditis/pericarditis with bivalent vaccines (ROR 0.57) compared to monovalent (ROR 2.21).
- Sub-analyses by symptoms, demographics, and manufacturer corroborated these safety findings.
Conclusions:
- Bivalent COVID-19 mRNA vaccination is not associated with an increased risk of myocarditis/pericarditis.
- Findings support the continued use of bivalent COVID-19 mRNA vaccines as updated boosters.
- The safety profile of bivalent vaccines is favorable for ongoing pandemic management.
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