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Myocarditis and pericarditis risk with mRNA COVID-19 vaccination compared to unvaccinated individuals: A retrospective cohort study in a Spanish Tertiary Hospital - 04/02/24

Doi : 10.1016/j.biopha.2024.116181 
Mikel Urroz Elizalde a, , 1 , Francisco Javier Guijarro Eguinoa a, Arturo Gómez López de las Huertas a, María Jiménez-González b, c, Elena Ramírez a, , 2
a Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, Faculty of Medicine, Universidad Autónoma de Madrid, 28046 Madrid, Spain 
b Clinical Trial Unit, La Paz University Hospital-IdiPAZ, Spain 
c Infectious Disease Unit, La Paz University Hospital-IdiPAZ, Spain 

Corresponding authors.

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Abstract

Objective

This study compared the incidence of pericarditis and myocarditis in patients exposed to mRNA COVID-19 vaccines to the incidence in those who were not vaccinated, considering the incidence of these conditions resulting from COVID-19 infection.

Methods

This was a retrospective cohort study of individuals assigned to health area of La Paz University Hospital in Spain. The exposure factor was vaccination with mRNA COVID-19 vaccines between December 27th, 2020 and January 9th, 2022 with a minimum follow-up of one month. The outcome was the incidence of pericarditis or myocarditis in these individuals.

Results

The incidence of pericarditis and myocarditis in the total population exposed to at least one dose of mRNA COVID-19 vaccines was 5/100,000 (CI95%:3 to 8 per 100,000), compared to 70/100,000 (CI95%: 66 to 92 per 100,000) in those who were not vaccinated. In the adolescent population (aged 12–17), the incidence was 10/100,000 in vaccinated population (CI95%: 5 to 45 per 100,000) compared to 20/100,000 in unvaccinated (CI95%: 6 to 79 per 100,000). The incidence of pericarditis or myocarditis in patients with COVID-19 infection was 200/100,000 people (CI95%: 114 to 306 per 100,000). The most common cause of pericarditis and myocarditis in the cohort was idiopathic/infectious (74 cases). Cases of myocarditis attributed to COVID-19 infection were more severe and had higher mortality rates compared to cases with other causes.

Conclusion

The incidence of pericarditis and myocarditis in patients exposed to mRNA COVID-19 vaccines was lower than in those who were not vaccinated, especially in adults.The most common cause of pericarditis and myocarditis was idiopathic/infectious, but the most frequent cause in adolescent patients was mRNA COVID-19 vaccination. Cases of myocarditis due to COVID-19 infection were more severe and had greater mortality.

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Graphical Abstract




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Highlights

The incidence of pericarditis/myocarditis in total and adult population exposed to mRNA COVID-19 vaccine was 5 per 100,000.
Most cases of pericarditis and myocarditis exposed to mRNA COVID-19 vaccines were young men who received 2 doses.
The incidence of pericarditis/myocarditis due to COVID-19 infection was 20 times higher than those due to mRNA vaccines.
The most frequent cause of pericarditis/myocarditis in adolescent patients was mRNA COVID-19 vaccination.

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Keywords : COVID-19 vaccines, Adverse drug reactions, Causality algorithms, Myocarditis, Pericarditis


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© 2024  The Authors. Publié par Elsevier Masson SAS. Tous droits réservés.
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