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Association between SARS-CoV-2 Vaccines and Myoand Pericarditis;a Large Observational Study Using Electronic Healthcare Data from Four European Countries: An International Journal of Medical Toxicology and Drug Experience
Drug Safety ; 45(10):1305-1306, 2022.
Article in English | ProQuest Central | ID: covidwho-2046534
ABSTRACT

Introduction:

Some COVID-19 vaccines (Moderna and Pfizer) have been associated with an elevated risk of myocarditis in younger adults. However, observational studies were unable to stratify by dose and had limited ability to evaluate the effect of adenovirus-based COVID-19 vaccines due to the limited distribution of these in their study populations [1-4].

Objective:

Estimate the incidence rates (IR), rate differences (RD) and incidence rate ratios (IRR) of myocarditis and pericarditis before and after each dose of mRNA (Pfizer and Moderna) and adenovirusplatform (AstraZeneca and Janssen) COVID-19 vaccines.

Methods:

We conducted a population-based cohort design with nested self-controlled risk interval (SCRI) study. Participants were followed from 1st January 2020 to 31st December 2021. Data were derived from healthcare data from five population-based data sources in four European countries Italy, the Netherlands, the United Kingdom (UK), and Spain. The main outcome was first occurrence of myocarditis or pericarditis. RD and IR before COVID-19 disease and after each COVID-19 vaccine dose in those without COVID-19 were calculated. The SCRI calculated IRR with 60-day control period prior to vaccination and 28-day risk windows, with adjustment for seasonality. All analyses were stratified by age (< 30 and > 30 years) and in the cohorts refined age-bands for < 30 were utilised.

Results:

The study cohort comprised 35,365,669 persons with median age between 39-49 years, 57.4% received at least one COVID-19 vaccine dose and 77.6% of these received two. Myocarditis background rates were highest in persons 18-29 years (IR 2.8, 95% CI [1.5-4.1] to 6.4 [3.8-9.0] across UK, the Netherlands and Spain, and for 12-17 years in Italy (IR = 9.9 [5.3-14.4]). Pericarditis rates were higher in persons > 30 years (standardised IR from 11.6 [10.9-12.4] to 29.7 [19.8-22.1] across databases). RD of myocarditis were significantly elevated after Moderna dose 2 in persons between 18-29 years in Italy. Significantly reduced RD of pericarditis in the age group above 30 years was seen for Pfizer, Moderna and AstraZeneca. The SCRI showed significantly higher myocarditis IRR after dose 1 of Pfizer (IRR = 3.3 [1.2-9.4]), and also after dose 2 of Pfizer and Moderna in persons 12-29 years (IRR of 7.8 [2.6-23.5] and 6.1 [1.1-33.5], respectively). No association was observed between COVID-19 vaccination and pericarditis in the SCRI. In a sensitivity analysis, occasional significant association was seen for AstraZeneca dose 2 and myocarditis.

Conclusion:

Myocarditis is rare, but rates were increased significantly after both doses of Pfizer and the second dose of Moderna vaccines in persons below 30 years of age. This was not seen for pericarditis.
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Collection: Databases of international organizations Database: ProQuest Central Type of study: Observational study / Prognostic study Topics: Vaccines Language: English Journal: Drug Safety Year: 2022 Document Type: Article

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Collection: Databases of international organizations Database: ProQuest Central Type of study: Observational study / Prognostic study Topics: Vaccines Language: English Journal: Drug Safety Year: 2022 Document Type: Article