FDA Fact Sheets Have Been Updated to Include Risk of Myocarditis and Pericarditis Following COVID Vaccine

June 29, 2021

Last week, the CDC Advisory Committee on Immunization Practices convened to discuss the uptake in myocarditis and pericarditis cases in young adults following a COVID-19 vaccination. During the advisory meeting, it was stated that there was a “likely association.” FDA Fact Sheets have since been updated to include the risk of developing myocarditis and pericarditis, particularly following a second dose of the mRNA vaccine. 
The CDC Advisory Committee meeting was organized as over 1200 cases of myocarditis have been reported in young persons 30 years and younger. Because 300 million doses have been administered thus far, cases of myocarditis and pericarditis are still considered rare adverse events. 

The majority of cases were presented in males, most often one week after the second dose; chest pain was the most common reported symptom. It was emphasized that heart inflammation and heart function are separate, and that heart inflammation was reduced with prescription medications, over-the-counter medications, or resolved on their own. It should also be noted that close to 1600 young athletes have undergone a cardiac MRI following a SARS-CoV-2 infection. 

It was recommended that those who experience myocarditis following their first dose should wait until symptoms resolve completely before receiving a second dose of the vaccine. Additionally, it was stated that the risk of side effects following an mRNA vaccine do not outweigh their benefits within this age group, as post-Covid conditions often pose a greater risk in children, such as the development of MIS-C. 
4,018 MIS-C cases have been reported as of June 2, 2021, with 60-70% of patients being admitted into the ICU. 12-20-year-olds account for 36% of cases.