These data are derived from a rushed, non-FDA-approved, ongoing investigational product roll-out, and our conclusions are thus limited by the information at hand. In addition to the 12-15-year-old age group data being very early, it is vital to acknowledge that these reports represent a fraction of the actual total. Thus, due to both the problems of under-reporting and the known lag in report processing, this analysis reveals a strong signal from the VAERS data that the risk of suffering CIRM – especially males is unacceptably high. Again, children are not a high-risk group for COVID-19 respiratory illness, and yet they are the high-risk group for CIRM.
Efficacy of these products needs to be assessed by immunological assays and long-term studies are required, while safety needs to be evaluated by rigorous clinical, laboratory and imaging assessments of severe reported adverse events such as CIRM. Autopsies should be done in cases of cardiovascular-related deaths temporally associated with COVID-19 injectables. It is reasonable to use the precautionary principle in this particular setting since an alarming number of reports are coming from young males between the ages of 12 and 15. Boys of these ages should be carefully monitored for warning signs of myocarditis which many may pass off such as pallor, chest pain, shortness of breath or lethargy, following dose 1 with the aim of seeking prompt evaluation and avoiding dose 2.
Effective multidrug therapy is available for rare case of serious COVID-19 respiratory illness in the forms of antivirals, immunomodulators, and anthrombotics. The combination of a low IFR in children indicating effective and robust immune responses, and the ability to treat with medical therapy, should the need arise, bodes well for clinical outcomes in children.
As part of any risk/benefit analysis which must be completed in the context of experimental products, the points herein must be considered before a decision can be made pertaining to agreeing to 2-dose injections of these experimental COVID-19 products, especially into children and by no means, should parental consent be waived under any circumstances to avoid children volunteering for injections with products that do not have proven safety or efficacy.
Future work may include on-site clinical observations of Troponin, BNP, galectin-3, ST2, IL-6 and D-dimer levels to corroborate temporal effects of onset of myocarditis following injections with particular COVID-19 products. Delineation between COVID-19 respiratory infection with mild ICU-related cardiac injury and true CIRM using these and other clinical diagnostic markers would be incredibly useful for clinicians and should become the standard for differential diagnosis of suspected CIRM. Correcting the inherent limitations of the VAERS dataset must be a priority as part of future studies. Incomplete VAERS dataset field entries describing prior COVID-19 infection and diagnostic tests such as cardiac MRIs in individuals diagnosed with myocarditis, for example, would make this particular study even more potent. However, despite these limitations, and the limitation of using the VAERS dataset for studies like this one, the usable sample sizes have good statistical power. Ultimately, it remains vital to share the results herein to allow true pharmacovigilance to take place.
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