A Prospective Study of the Incidence of Myocarditis/Pericarditis and New Onset Cardiac Symptoms following Smallpox and Influenza Vaccination
Spontaneous Reporting Grossly Underestimates True Incidence
By Peter A. McCullough, MD, MPH
We have been barraged by government agency statements and peer-reviewed publications from academic medical centers asserting that serious complications from COVID-19 vaccination are “rare.” Often, investigators take a number of spontaneously reported events from a data system, and in error, divide that number by the total injections given in a period of time. This is incorrect since not all individuals who took the vaccine were assessed for the outcome and we cannot assume they are OK.
Engler et al from Military Vaccine Agency-Vaccine Healthcare Centers Network (currently Defense Health Agency, Immunization Healthcare Branch), make this point with an analysis of myocarditis after smallpox and trivalent influenza vaccination. Both study cohorts were evaluated during a pre-immunization visit and up to 2 post-vaccine visits (day 5–8 and/or day 9–28). Baseline data including age, race/ethnicity, sex, cardiac risk factors, atopic/medical history, and fitness assessments as measured by physical training abilities, were collected on the day of the SPX or TIV immunization. Clinical data including cardiac symptoms with visual analogue scale rating (0–10) of severity, 12-lead electrocardiograms (ECG), and troponin-T were collected at baseline and at between days 5 and 30.
While there were no myopericarditis events with the influenza vaccine, there were 5 cases with the smallpox shot. Compared to historical rates of spontaneous reporting, there was a fourfold increased incidence of cardiac symptoms when assessed prospectively.
In vaccine safety research, we should not trust any assertions of “rarity” unless it is a prospective cohort study in which all recipients are checked. We should focus on the absolute number of serious adverse events which are the crude data. These numbers cannot be argued with our understanding that they indeed happened, but are likely to be a gross underestimate of reality.
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Engler RJ, Nelson MR, Collins LC Jr, Spooner C, Hemann BA, Gibbs BT, Atwood JE, Howard RS, Chang AS, Cruser DL, Gates DG, Vernalis MN, Lengkeek MS, McClenathan BM, Jaffe AS, Cooper LT, Black S, Carlson C, Wilson C, Davis RL. A prospective study of the incidence of myocarditis/pericarditis and new onset cardiac symptoms following smallpox and influenza vaccination. PLoS One. 2015 Mar 20;10(3):e0118283. doi: 10.1371/journal.pone.0118283. PMID: 25793705; PMCID: PMC4368609.