Index Entries

Stéphane Le Vu, Marion Bertrand, Marie-Joelle Jabagi, Jérémie Botton, Jérôme Drouin, Bérangère Baricault, Alain Weill, Rosemary Dray-Spira, and Mahmoud Zureik
June 25, 2022
Nature Communications
French National Agency for the Safety of Medicines and Health Products

¨Abstract

Cases of myocarditis and pericarditis have been reported following the receipt of Covid-19 mRNA vaccines. As vaccination campaigns are still to be extended, we aimed to provide a comprehensive assessment of the association, by vaccine and across sex and age groups. Using nationwide hospital discharge and vaccine data, we analysed all 1612 cases of myocarditis and 1613 cases of pericarditis that occurred in France in the period from May 12, 2021 to October 31, 2021. We perform matched case-control studies and find increased risks of myocarditis and pericarditis during the first week following vaccination, and particularly after the second dose, with adjusted odds ratios of myocarditis of 8.1 (95% confidence interval [CI], 6.7 to 9.9) for the BNT162b2 and 30 (95% CI, 21 to 43) for the mRNA-1273 vaccine. The largest associations are observed for myocarditis following mRNA-1273 vaccination in persons aged 18 to 24 years. Estimates of excess cases attributable to vaccination also reveal a substantial burden of both myocarditis and pericarditis across other age groups and in both males and females...

Introduction

On July 19, 2021 the European Medicines Agency advised that myocarditis and pericarditis be added to the list of adverse effects of both messenger RNA (mRNA) based vaccines (BNT162b2 [Pfizer–BioNTech] and mRNA-1273 [Moderna]) against coronavirus disease 2019 (Covid-19)... Here, we aimed to estimate the age and sex-specific associations between each mRNA Covid-19 vaccine and the risk of myocarditis and pericarditis, using nationwide hospital discharge and vaccine data for France.

Results ...

Risk of myocarditis and pericarditis associated with vaccination: For both vaccines, the risk of myocarditis was increased in the seven days post vaccination (Table 2; in the rest of the text, we will refer to multivariable odds ratios). For the BNT162b2 vaccine, odds ratios were 1.8 (95% confidence interval [CI]: 1.3–2.5) for the first dose and 8.1 (95% CI, 6.7–9.9) for the second. The association was stronger for the mRNA-1273 vaccine with odds-ratios of 3.0 (95% CI, 1.4–6.2) for the first dose and 30 (95% CI, 21–43) for the second. The risk of pericarditis was increased in the seven days following the second dose of both vaccines, with odds ratios of 2.9 (95% CI, 2.3–3.8) for the BNT162b2 vaccine and 5.5 (95% CI, 3.3–9.0) for the mRNA-1273 vaccine. 

Discussion

... [T]his study provides strong evidence of an increased risk of myocarditis and of pericarditis in the week following vaccination against Covid-19 with mRNA vaccines in both males and females, in particular after the second dose of the mRNA-1273 vaccine."

document
adverse events,COVID-19,heart disorders,mRNA,vaccines