Abstract
Vaccines against coronavirus 2019 disease (COVID-19) have shown to be greatly effective in preventing viral spread, serious illness and death from this infectious disease and are therefore critical for the management of the COVID-19 pandemic. However, the listing of myocarditis and pericarditis as possible rare side effects of the messenger RNA (mRNA) vaccines against COVID-19 by regulatory agencies has sparked discussion on the vaccines’ safety. The most important published cohort studies to date demonstrat that myocarditis is a very rare side effect after COVID-19 mRNA vaccination, with an incidence of approximately 1–4 cases per 100,000 vaccinated persons. Young males (16–29 years) appear to be at highest risk, predominantly after receiving the second dose. The disease course is self-limiting in a vast majority of cases: 95% of patients show a rapid resolution of symptoms and normalisation of cardiac biomarkers, electro- and echocardiographic findings within days. Importantly, the available data suggest that the incidence rate of myocarditis in the context of COVID-19 is much greater than the risk of this side effect following vaccination. We conclude that the benefit of vaccination against COVID-19 outweighs the potential risk of myocarditis and pericarditis in both adolescents and adults. Prospective follow-up of patients who have developed these complications after vaccination is required to assess long-term outcomes.
Highlights
In the summer of 2021, six months after the Emergency Use Authorization of the messenger RNA vaccines against coronavirus 2019 disease (COVID-19) from Pfizer-BioNTech and Moderna, the European Medicines Agency (EMA) and the American Food and Drug Administration (FDA) recommended listing myocarditis and pericarditis as new side effects [1, 2]
New data on the occurrence of these side effects has recently appeared [5–10], reigniting the discussion on the safety of COVID-19 vaccines, especially on social media. In this point of view paper, we summarise the findings of the most important peer-reviewed population studies published far on the occurrence of myocarditis and pericarditis after COVID-19 vaccination, to assess whether the benefit of vaccination outweighs the possible risk of these adverse events
Similar findings were reported by the Centers for Disease Control and Prevention (CDC) in the United States, where 0.15% of the patients with COVID-19 were diagnosed with myocarditis during an inpatient or outpatient hospital encounter across more than 900 hospitals [17]
Summary
In the summer of 2021, six months after the Emergency Use Authorization of the messenger RNA (mRNA) vaccines against coronavirus 2019 disease (COVID-19) from Pfizer-BioNTech and Moderna, the European Medicines Agency (EMA) and the American Food and Drug Administration (FDA) recommended listing myocarditis and pericarditis as new side effects [1, 2]. Prior to this recommendation, a number of cases of myocarditis and pericarditis had been reported in the scientific literature, as well as in the Vaccine Adverse Event Reporting System and EudraVigilance databases [1–4].
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