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FDA requires updated warning about rare heart risk with COVID shots
- The Food and Drug Administration expanded warnings on COVID-19 vaccines about a rare heart side effect called myocarditis, particularly in young men.
- The new warning indicates a risk of myocarditis at 8 cases per 1 million people aged 6 months to 64 years who received the 2023-2024 COVID shots.
- The myocarditis risk is most prevalent among males aged 12 to 24, according to the FDA's report.
- FDA officials highlighted that cases of myocarditis are usually mild and resolve quickly, noting they are less severe than myocarditis linked to COVID-19 itself.
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88 Articles
The cellular and molecular cardiac tissue responses in human inflammatory cardiomyopathies after SARS-CoV-2 infection and COVID-19 vaccination
Myocarditis, characterized by inflammatory cell infiltration, can have multiple etiologies, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or, rarely, mRNA-based coronavirus disease 2019 (COVID-19) vaccination. The underlying cellular and molecular mechanisms remain poorly understood. In this study, we performed single-nucleus RNA sequencing on left ventricular endomyocardial biopsies from patients with myocardi…
COVID-19 Vaccine Labels Updated With Expanded Warnings About Risk of Heart Inflammation
Federal regulators on June 25 updated labels for the Pfizer-BioNTech and Moderna COVID-19 vaccines to expand warnings regarding heart inflammation. The updated labels state that myocarditis, inflammation, and a related condition called pericarditis have occurred following receipt of one of the shots “most commonly in males 12 years through 24 years of age.” The Food and Drug Administration said in letters to the vaccine manufacturers earlier thi…
The Food and Drug Administration (FDA) reported Wednesday that it expanded the existing warnings about the two main vaccines against COVID-19 on a rare cardiac side effect observed mainly in young men. Myocarditis, a type of inflammation of the heart that is usually mild, emerged as a complication after the first vaccines were widely available in 2021. Prescription information from both Pfizer and Moderna already warns doctors about the issue. I…
In its update the FDA warns that 8 out of every million people vaccinated could develop myocarditis
MedPage Today
VINnewsFDA Requires Updated Warning About Rare Heart Risk With COVID Shots
(MedPage Today) -- The FDA said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men. Myocarditis, a type of heart inflammation that is usually mild, emerged as...
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