From a physcian to the FDA 12/8/2020, excerpt: I am a pediatric specialist caring for children with the multisystem inflammatory syndrome (MIS-C). I am concerned about the possibility that the new vaccines aimed at creating immunity against the SARS-CoV-2 spike protein (including the mRNA vaccines of Moderna and Pfizer) have the potential to cause microvascular injury to the brain, heart, liver, and kidneys in a way that does not currently appear to be assessed in safety trials of these potential drugs. Puntmann et al. (JAMA Cardiol. 2020;5:1265-1273) showed that the prospective study of 100 German patients who were recently recovered from COVID-19 revealed significant cardiac involvement on cardiac MRI scans in 78% of them, an average 2-1/2 months after their recovery from the acute illness. Two-thirds of these patients were never hospitalized, and there was ongoing myocardial inflammation in 60%. The abnormalities occurred independent of preexisting conditions, severity of the initial disease, and overall course of the acute illness. Full text here: https://www.regulations.gov/document/FDA-2020-N-1898-0246