JAMA: "MRNA vaccines were associated with increased risk of MYOCARDITIS & PERICARDITIS"

"Conclusions and Relevance Results of this large cohort study indicated that both first and second doses of mRNA vaccines were associated with increased risk of myocarditis and pericarditis."
SOURCE:
https://jamanetwork.com/journals/jamacardiology/fullarticle/2791253
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Original Investigation
April 20, 2022
SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents

Øystein Karlstad, MScPharm, PhD1;
Petteri Hovi, MD, PhD2;
Anders Husby, MD, PhD3,4; et al
Tommi Härkänen, PhD2;
Randi Marie Selmer, MSc, PhD1;
Nicklas Pihlström, MSc5;
Jørgen Vinsløv Hansen, MSc, PhD3;
Hanna Nohynek, MD, PhD6;
Nina Gunnes, MSc, PhD1,7;
Anders Sundström, BA, PhD8;
Jan Wohlfahrt, MSc, DMSC3;
Tuomo A. Nieminen, MSocSc9;
Maria Grünewald, MSc, PhD5;
Hanne Løvdal Gulseth, MD, PhD1;
Anders Hviid, MSc, DMSC3,10;
Rickard Ljung, MD, PhD, MPH8,11
JAMA Cardiol.
Published online April 20, 2022.
doi:10.1001/jamacardio.2022.0583

Question
Is SARS-CoV-2 messenger RNA (mRNA) vaccination associated with risk of myocarditis?

Findings
In a cohort study of 23.1 million residents across 4 Nordic countries, risk of myocarditis after the first and second doses of SARS-CoV-2 mRNA vaccines was highest in young males aged 16 to 24 years after the second dose. For young males receiving 2 doses of the same vaccine, data were compatible with between 4 and 7 excess events in 28 days per 100 000 vaccines after second-dose BNT162b2, and between 9 and 28 per 100 000 vaccines after second-dose mRNA-1273.

Meaning
The risk of myocarditis in this large cohort study was highest in young males after the second SARS-CoV-2 vaccine dose, and this risk should be balanced against the benefits of protecting against severe COVID-19 disease.

Abstract
Importance
Reports of myocarditis after SARS-CoV-2 messenger RNA (mRNA) vaccination have emerged.

Objective
To evaluate the risks of myocarditis and pericarditis following SARS-CoV-2 vaccination by vaccine product, vaccination dose number, sex, and age.

Design, Setting, and Participants
Four cohort studies were conducted according to a common protocol, and the results were combined using meta-analysis. Participants were 23 122 522 residents aged 12 years or older. They were followed up from December 27, 2020, until incident myocarditis or pericarditis, censoring, or study end (October 5, 2021). Data on SARS-CoV-2 vaccinations, hospital diagnoses of myocarditis or pericarditis, and covariates for the participants were obtained from linked nationwide health registers in Denmark, Finland, Norway, and Sweden.

Exposures
The 28-day risk periods after administration date of the first and second doses of a SARS-CoV-2 vaccine, including BNT162b2, mRNA-1273, and AZD1222 or combinations thereof. A homologous schedule was defined as receiving the same vaccine type for doses 1 and 2.

Main Outcomes and Measures
Incident outcome events were defined as the date of first inpatient hospital admission based on primary or secondary discharge diagnosis for myocarditis or pericarditis from December 27, 2020, onward. Secondary outcome was myocarditis or pericarditis combined from either inpatient or outpatient hospital care. Poisson regression yielded adjusted incidence rate ratios (IRRs) and excess rates with 95% CIs, comparing rates of myocarditis or pericarditis in the 28-day period following vaccination with rates among unvaccinated individuals.

Results
Among 23 122 522 Nordic residents (81% vaccinated by study end; 50.2% female), 1077 incident myocarditis events and 1149 incident pericarditis events were identified. Within the 28-day period, for males and females 12 years or older combined who received a homologous schedule, the second dose was associated with higher risk of myocarditis, with adjusted IRRs of 1.75 (95% CI, 1.43-2.14) for BNT162b2 and 6.57 (95% CI, 4.64-9.28) for mRNA-1273. Among males 16 to 24 years of age, adjusted IRRs were 5.31 (95% CI, 3.68-7.68) for a second dose of BNT162b2 and 13.83 (95% CI, 8.08-23.68) for a second dose of mRNA-1273, and numbers of excess events were 5.55 (95% CI, 3.70-7.39) events per 100 000 vaccinees after the second dose of BNT162b2 and 18.39 (9.05-27.72) events per 100 000 vaccinees after the second dose of mRNA-1273. Estimates for pericarditis were similar.

Conclusions and Relevance
Results of this large cohort study indicated that both first and second doses of mRNA vaccines were associated with increased risk of myocarditis and pericarditis. For individuals receiving 2 doses of the same vaccine, risk of myocarditis was highest among young males (aged 16-24 years) after the second dose. These findings are compatible with between 4 and 7 excess events in 28 days per 100 000 vaccinees after BNT162b2, and between 9 and 28 excess events per 100 000 vaccinees after mRNA-1273. This risk should be balanced against the benefits of protecting against severe COVID-19 disease.

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