Booster Dose of COVID-19 MRNA Vaccine Does Not Increase Risks of Myocarditis and Pericarditis Compared with Primary Vaccination: New Insights from the Vaccine Adverse Event Reporting System

Overview

Journal Front Immunol

Specialty Allergy & Immunology

Date 2022 Sep 29

PMID 36172346

Authors

Congqin Chen

Fang Fu

Lingqing Ding

Jie Fang

Jie Xiao

Affiliations

Soon will be listed here.

Abstract

Background: Despite the likely association between coronavirus 2019 (COVID-19) mRNA vaccines and cases of myocarditis/pericarditis, the benefit-risk assessment by the Centers for Disease Control (CDC) still showed a favorable balance for the primary series of COVID-19 mRNA vaccinations. Since August 2021, a full-scale booster vaccination in certain recipients has been recommended. Great concerns about whether the COVID-19 mRNA booster vaccination could increase the risks of myocarditis/pericarditis have been raised since then. The present study aimed to compare the incidence rates and risks of myocarditis/pericarditis between booster and primary vaccination programs.

Methods: The CDC COVID Data Tracker and the Vaccines Adverse Event Reporting System (VAERS) were queried between December 11, 2020 and March 15, 2022. Incidence rates were calculated by cases of myocarditis/pericarditis divided by the number of vaccinated people or the total doses of COVID-19 mRNA vaccines. Disproportionality patterns for myocarditis/pericarditis of different COVID-19 mRNA vaccinations were accessed based on the reporting odds and proportional reporting ratios (ROR and PRR, respectively).

Results: A total of 2,588 reports of myocarditis/pericarditis were identified after administration of primary-series COVID-19 mRNA vaccination and 269 after the booster dose program during the study period. The incidence of myocarditis/pericarditis following booster COVID-19 mRNA vaccination was lower than that of primary series. The results showed significantly high reporting of myocarditis/pericarditis following the administration of primary COVID-19 mRNA vaccination, whereas the disproportional level was lower in the booster-dose vaccination.

Conclusion: This study found that the booster dose of COVID-19 mRNA vaccination when compared with primary series course did not lead to an increase in the risks of myocarditis/pericarditis.

Citing Articles

Fatal Myocarditis following COVID-19 mRNA Immunization: A Case Report and Differential Diagnosis Review.

Barros de Sousa P, Silva E, Garcia Campos M, Lages J, Correa R, Silva G Vaccines (Basel). 2024; 12(2).

PMID: 38400177 PMC: 10891853. DOI: 10.3390/vaccines12020194.

Myocarditis and pericarditis in individuals exposed to the Ad26.COV2.S, BNT162b2 mRNA, or mRNA-1273 SARS-CoV-2 vaccines.

Pareek M, Sessa P, Polverino P, Sessa F, Kragholm K, Sessa M Front Cardiovasc Med. 2023; 10:1210007.

PMID: 38075965 PMC: 10704142. DOI: 10.3389/fcvm.2023.1210007.

Real-world evidence of autoimmune hepatitis following COVID-19 vaccination: A population-based pharmacovigilance analysis.

Chen C, Xie D, Xiao J Front Pharmacol. 2023; 14:1100617.

PMID: 37124218 PMC: 10133579. DOI: 10.3389/fphar.2023.1100617.

Myocarditis/pericarditis following vaccination with BNT162b2, CoronaVac, and ChAdOx1 among adolescent and adult in Malaysia.

Ab Rahman N, Lim M, Lee F, Anak Jam E, Peariasamy K, Sivasampu S Vaccine X. 2023; 14:100303.

PMID: 37091730 PMC: 10104785. DOI: 10.1016/j.jvacx.2023.100303.

Adverse Reactions after BNT162b2 Messenger RNA Vaccination for Coronavirus Disease 2019 in Healthcare Workers Compared with Influenza Vaccination.

Kim A, Kim S, Song J, Hwang S, Nam E, Kwon K Vaccines (Basel). 2023; 11(2).

PMID: 36851243 PMC: 9958848. DOI: 10.3390/vaccines11020363.

References

Larson K, Ammirati E, Adler E, Cooper Jr L, Hong K, Saponara G . Myocarditis After BNT162b2 and mRNA-1273 Vaccination. Circulation. 2021; 144(6):506-508. PMC: 8340725. DOI: 10.1161/CIRCULATIONAHA.121.055913. View

Gargano J, Wallace M, Hadler S, Langley G, Su J, Oster M . Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices - United States, June 2021. MMWR Morb Mortal Wkly Rep. 2021; 70(27):977-982. PMC: 8312754. DOI: 10.15585/mmwr.mm7027e2. View

Rothman K, Lanes S, Sacks S . The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf. 2004; 13(8):519-23. DOI: 10.1002/pds.1001. View

Li M, Yuan J, Lv G, Brown J, Jiang X, Lu Z . Myocarditis and Pericarditis following COVID-19 Vaccination: Inequalities in Age and Vaccine Types. J Pers Med. 2021; 11(11). PMC: 8624452. DOI: 10.3390/jpm11111106. View

Fairweather D, Cooper Jr L, Blauwet L . Sex and gender differences in myocarditis and dilated cardiomyopathy. Curr Probl Cardiol. 2012; 38(1):7-46. PMC: 4136454. DOI: 10.1016/j.cpcardiol.2012.07.003. View

Shiyovich A, Witberg G, Aviv Y, Kornowski R, Hamdan A . A Case Series of Myocarditis Following Third (Booster) Dose of COVID-19 Vaccination: Magnetic Resonance Imaging Study. Front Cardiovasc Med. 2022; 9:839090. PMC: 8930918. DOI: 10.3389/fcvm.2022.839090. View

Giron-Gonzalez J, Moral F, Elvira J, Garcia-Gil D, Guerrero F, Gavilan I . Consistent production of a higher TH1:TH2 cytokine ratio by stimulated T cells in men compared with women. Eur J Endocrinol. 2000; 143(1):31-6. DOI: 10.1530/eje.0.1430031. View

Mbaeyi S, Oliver S, Collins J, Godfrey M, Goswami N, Hadler S . The Advisory Committee on Immunization Practices' Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines - United States, 2021. MMWR Morb Mortal Wkly Rep. 2021; 70(44):1545-1552. PMC: 8568093. DOI: 10.15585/mmwr.mm7044e2. View

Sessa M, Kragholm K, Hviid A, Andersen M . Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines. Expert Opin Drug Saf. 2021; 20(11):1451-1453. PMC: 8330010. DOI: 10.1080/14740338.2021.1955101. View

10.

Bonaldo G, Vaccheri A, DAnnibali O, Motola D . Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017. Br J Clin Pharmacol. 2018; 85(3):634-643. PMC: 6379209. DOI: 10.1111/bcp.13841. View

11.

Gubernot D, Jazwa A, Niu M, Baumblatt J, Gee J, Moro P . U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines. Vaccine. 2021; 39(28):3666-3677. PMC: 8118666. DOI: 10.1016/j.vaccine.2021.05.016. View

12.

Ammirati E, Cavalotti C, Milazzo A, Pedrotti P, Soriano F, Schroeder J . Temporal Relation Between Second Dose BNT162b2 mRNA Covid-19 Vaccine and Cardiac involvement in a Patient with Previous SARS-COV-2 Infection. Int J Cardiol Heart Vasc. 2021; :100778. PMC: 8020086. DOI: 10.1016/j.ijcha.2021.100778. View

13.

Aviram G, Viskin D, Topilsky Y, Sadon S, Shalmon T, Taieb P . Myocarditis Associated With COVID-19 Booster Vaccination. Circ Cardiovasc Imaging. 2022; 15(2):e013771. PMC: 8845415. DOI: 10.1161/CIRCIMAGING.121.013771. View

14.

Das B, Moskowitz W, Taylor M, Palmer A . Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination: What Do We Know So Far?. Children (Basel). 2021; 8(7). PMC: 8305058. DOI: 10.3390/children8070607. View

15.

Mouchet J, Begaud B . Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database. Drug Saf. 2018; 41(8):767-774. DOI: 10.1007/s40264-018-0652-4. View

16.

Polack F, Thomas S, Kitchin N, Absalon J, Gurtman A, Lockhart S . Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020; 383(27):2603-2615. PMC: 7745181. DOI: 10.1056/NEJMoa2034577. View

17.

Hajjo R, Sabbah D, Bardaweel S, Tropsha A . Shedding the Light on Post-Vaccine Myocarditis and Pericarditis in COVID-19 and Non-COVID-19 Vaccine Recipients. Vaccines (Basel). 2021; 9(10). PMC: 8541143. DOI: 10.3390/vaccines9101186. View

18.

Kariko K, Buckstein M, Ni H, Weissman D . Suppression of RNA recognition by Toll-like receptors: the impact of nucleoside modification and the evolutionary origin of RNA. Immunity. 2005; 23(2):165-75. DOI: 10.1016/j.immuni.2005.06.008. View

19.

Kyaw H, Shajahan S, Gulati A, Synn S, Khurana S, Nazar N . COVID-19 mRNA Vaccine-Associated Myocarditis. Cureus. 2022; 14(1):e21009. PMC: 8820479. DOI: 10.7759/cureus.21009. View

20.

Taher F, Eysa A, Fahmy D, Shalaby A, Mahmoud A, El-Melegy M . COVID-19 and myocarditis: a brief review. Front Biosci (Landmark Ed). 2022; 27(2):73. DOI: 10.31083/j.fbl2702073. View