“When I told Pfizer about it, they refused to believe me for a period of four months. Only after we asked for reports on all of the cases of myocarditis in Israel, which we analyzed and were then able to statistically prove that the incidence of myocarditis doubled in the wake of receiving the vaccination, only then did Pfizer accept the findings.”—Professor Dror Mevorach, Head of the Internal Medicine Department, at Hadassah University Hospital, Israel, and author of this seminal New England Journal of Medicine study on the initial cases of Pfizer covid-19 vaccine-associated myocarditis in young Israeli men.
**
Variola virus (VARV), a member of the Orthopoxvirus family, the causative agent of smallpox, is believed to have emerged around 10,000 BC when people began congregating in small settlements. Across thousands of years, innumerable human beings, regardless of age, sex or vocation, were killed by smallpox, which historically, had a 20–60% fatality rate (persisting at 15-30% in its last endemic century). Survivors were often maimed by the disease. This scourge, and the havoc it wrought, destroyed entire civilizations, and killed some 300 million in the 20th century, alone.
Edward Jenner’s 1796 experimental use of cowpox virus (CPXV)—relatively benign to humans, and delivered to the skin by scarification—was a momentous medical breakthrough. The word ‘vaccine’ was derived (Latin vacca for cow) from Jenner’s method, which provided a mechanism to eliminate naturally occurring smallpox.
Conjoined to the fact that VARV has no nonhuman reservoir, Jenner’s vaccine made smallpox eradication a possibility. Absent a nonhuman reservoir, if person-to-person transmission could be blocked, then smallpox would cease after infecting its last victims. Following some 200 years of intermittent vaccine use, the lethal, or disabling cycle of person-to-person transmission was finally halted. The WHO-sponsored Smallpox Eradication Program, launched in 1959, which involved a sophisticated worldwide monitoring effort, and ring (case and contact targeted) vaccination, eliminated endemic smallpox. The final naturally occurring smallpox case was reported October 26, 1977, and during the spring of 1980, the WHO declared smallpox officially eradicated. Routine smallpox vaccination of U.S. children ended in 1972, and this practice was stopped worldwide by 1982.
Use of Jenner’s vaccine conferred risks. In the beginning, the vaccine was distributed arm-to-arm, spreading other diseases such as tetanus and syphilis. Ultimately, immunization with CPXV became less common and vaccinia virus (VACV) became the vaccine of choice. A 1947 smallpox outbreak in New York City triggered mass vaccination of some ~5-million residents. Combined clinical diagnosis, and autopsy investigation, revealed that there were 43 cases of smallpox vaccine-induced encephalitis, including two fatalities. Another vaccine fatality, in a 34 year-old male, was determined to be caused by “severe acute focal myocarditis, with mononuclear inflammatory foci.”
The elegant 2004 review of Cassimatis et al included a comprehensive survey of European and Australian reports of post-smallpox vaccination myocarditis, following a wave of smallpox vaccinations, which began in the 1950s, through the 1970s. Overall, these investigators found 8 fatal cases in adults, and 2 among children, in addition to 70 non-fatal adult cases, and 7 non-fatal cases in children. Cassimatis et al noted the relative paucity of similar U.S. reports—two fatal adult cases (including the one described earlier, from 1947), and two non-fatal cases. Although it was surmised this disparity resulted from the use of “a different strain of vaccinia in the U.S. (i.e., the New York City Board of Health strain, “Dryvax”), the authors, referring to “the current experiences (i.e., circa December 2002-June 2003) using the New York City Board of Health vaccine strain in the last year,” noted, “we must now question the validity of this assumption and wonder if the difference was actually due to variations in monitoring and reporting.”
What were those “experiences,” to which Cassimatis et al alluded?
The cataclysmic jihad terror attacks in New York City, and Washington, D.C., on September 11, 2001, and the “Lewis Doctrine” U.S. military response, engendered fears of bioterrorism directed at U.S. military populations, in particular. Potential military personnel exposure to smallpox, and exposure of those health care workers who would care for them, prompted a resumption of military service member smallpox vaccination, during December, 2002. By mid-June of 2003, 468,000 had been vaccinated, and The Department of Defense identified more than 50 cases, of “suspected, probable, or confirmed myopericarditis occurring within 30 days of vaccination in these personnel, based upon clinical evaluation of symptoms, ECG, cardiac enzyme assays, echocardiography, and the exclusion of ischemic coronary artery disease.” Through December, 2003, 541,000 military personnel were vaccinated, and a total of 67 myopericarditis cases (66 male/1 female; mean age 26.6 ±5.2 years old) had accrued. One fatality was believed possibly caused by vaccination. Upon autopsy of this case, epicardial inflammation was revealed (with eosinophilic predominance), but histopathological evidence of myocarditis was absent. Active vaccinia infection by culture, or DNA polymerase chain reaction testing, was not present in the fatal case, or three other cases that underwent right ventricular biopsy. Inflammatory changes were observed in all three of the cases biopsied, however. Finally, among ~38,000 civilian Health and Human Services (HHS) volunteers who received smallpox vaccine (from January 24, to October 31, 2003) as part of a bioterrorism preparedness initiative, 21 developed myopericarditis (5 probable; 16 suspected). Thus the military and civilian rates of probable post-smallpox vaccine myopericarditis were comparable (i.e., ~ 13 per 100,000 vaccinees in the HHS program, and 12 per 100,000 vaccinees in the U.S. military program).
Subsequent to the generation of the U.S. military’s retrospective passive surveillance data post-smallpox vaccination, Engler et al performed a unique prospective, active surveillance study (August 2004, through June 2010, with follow-up completed by January, 2011) of healthy service members receiving either smallpox or trivalent influenza vaccine. Each study cohort was assessed at a pre-immunization visit, and up to 2 post-vaccine visits (day 5-8, and/or day 9-28). Key data collected at baseline and follow-up included cardiac symptoms with visual analogue scale rating (0-10) of severity, 12-lead electrocardiograms (ECG), and blood samples for cardiac troponin T (cTnT) assay. Four Caucasian males were diagnosed (see Tables 1 & 2, below, for diagnosis criteria) with probable myocarditis, and one female with suspected pericarditis, among 1081 smallpox vaccinated study participants (956 male/125 female) who completed follow-up. This post-smallpox vaccine myopericarditis incidence rate (463/100,000) was over 200-fold (relative risk= 214, 95% confidence interval 65-558) greater than the pre-smallpox vaccine background Department of Defense Medical Surveillance System incidence rate (2.2/100,000; Table 3). The post-smallpox myopericarditis incidence of 463/100,000 by active surveillance, was also almost 40-fold increased relative to a passive surveillance rate of 12/100,000. Moreover, 31 smallpox vaccine recipients, in the absence of specific cardiac symptoms, evidenced more than 2-fold increases in cTnT (> 99th percentile normal range) from their pre-vaccination baseline during their myocarditis/pericarditis “risk window”, satisfying the a priori case definition for possible subclinical myocarditis. Accordingly, the subclinical myocarditis incidence rate (2868/100,000) was 60-fold the incidence rate of overt clinical myocarditis (Table 7). None of the trivalent influenza vaccine recipients developed clinical myocarditis or pericarditis, or subclinical myocarditis. The authors concluded with a call for long-term outcome surveillance of both clinical and subclinical cases, warning, further,
“Our study identified a rate of myocarditis/pericarditis following smallpox immunization that is significantly higher than previously described, and highlights the challenges of post-licensure vaccine safety surveillance to identify adverse events that are not well understood or previously unrecognized. Applying the incidence described in this study to a smallpox immunization program that has delivered over 2 million doses, largely to young, healthy primary vaccinees, there are potentially thousands of vaccine associated cases, many undiagnosed because of self-medication or lack of provider awareness. In our study, 3 of the 5 clinical cases would not have sought medical care without study interventions including enhanced education and surveillance.”
Near term (32 ± 16-week) follow-up of 64/67 (96%) myopericarditis cases that developed during the December, 2002 to December, 2003 U.S. military smallpox vaccination campaign, and its passive surveillance, indicated “all (64) patients had objective normalization of echocardiography, electrocardiography, laboratory testing, graded exercise testing, and functional status”. I recently received a personal communication (January 30, 2023) from Drs. Jay Montgomery and Renata Engler that a long-term follow-up study of smallpox vaccine-associated myocarditis (n=276 patients), and pericarditis (n=72 patients), among United States service members (putatively entitled, “Myocarditis and Pericarditis Recovery Following Smallpox Vaccine 2002-2016: A Comparative Observational Cohort Study in the Military Health System,”), is in the latter stages (i.e., revisions) of peer review. These imminent data should prove very enlightening.
What was the response to the 5 probable (originally here) non-military (HHS) smallpox-vaccine associated myopericarditis cases identified during January, 24 2003, to October, 31 2003 (and small number of other confirmed smallpox vaccine injuries—inadvertent inoculation [n=9], ocular vaccinia [n=2], and generalized vaccina [n=1]—identified through December 31,2003)?
By April 30, 2003, Congress approved, and then POTUS George W. Bush signed, the Smallpox Emergency Personnel Protection Act of 2003. This act begot the Smallpox Vaccine Injury Compensation Program to provide medical and lost employment income coverage to persons who received a smallpox vaccination voluntarily under the HHS-approved smallpox emergency response plan, and sustained a covered medical injury as a direct result of the vaccination. Phase 1 of this compensation program was the Federal Register August 27, 2003 publication of the program’s Vaccine Injury Table (below). By December 16, 2003, HHS published the administrative policies and procedures regulations for the program in the Federal Register, officially implementing it. Notwithstanding the reality of how inadequate this compensation mechanism has proven to be, which I will address later, at the time of the injury compensation program’s implementation, only 5 probable civilian cases of smallpox vaccine-associated myopericarditis had accrued.
A well-designed observational study of the entire French population, published on June 25, 2022 in Nature, definitively confirmed earlier experimental (here), clinical (here), and epidemiological (here; here; here; here) observations, first suggested during February, 2021: covid-19 mRNA vaccination confers an excess risk for myopericarditis, particularly in men under 30 years of age.
This compelling association—despite being unambiguous from the outset—was not readily accepted by the major covid-19 mRNA vaccine manufacturer, Pfizer. Professor Dror Mevorach, Head of the Internal Medicine Department, at Hadassah University Hospital, Israel, was the first author of a seminal New England Journal of Medicine study on the initial cases of Pfizer covid-19 vaccine-associated myocarditis in young Israeli men. He told one of Israel’s major newspapers, Haaretz, in January, 2022:
“When I told Pfizer about it (by early 2021), they refused to believe me for a period of four months. Only after we asked for reports on all of the cases of myocarditis in Israel, which we analyzed and were then able to statistically prove that the incidence of myocarditis doubled in the wake of receiving the vaccination, only then did Pfizer accept the findings.”
Pediatric Cardiologist Matthew Oster and colleagues analyzed U.S. Centers For Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS) data entered between December 14,2020, and August 31, 2021, on 1991 reports of myocarditis (391 of which also included pericarditis), after receipt of at least 1 dose of an mRNA-based COVID-19 vaccine. Oster et al employed the following operational definitions for myocarditis, pericarditis, and myopericarditis (in their Supplement):
1626 (81.7%) of the 1991 reports of myocarditis fulfilled the CDC’s case definition for probable or confirmed myocarditis. 1195 (73%) of the 1626 reports meeting CDC’s case definition for myocarditis were younger than 30 years of age, while 543 (33%) were younger than 18 years of age, and the median age was 21 years (inter-quartile range, 16-31 years). The peak incidence rates for myopericarditis occurred in young males, after the second dose: 7.1/100,000 for 12–15-year-olds, 10.6/100,000 for 16-17 year olds, and 5.2/100,000 for 18–24-year-olds. As with smallpox vaccine-associated myopericarditis, active surveillance studies (here; here), albeit much less elegantly designed than the report by Engler et al, certainly suggest there is a much higher incidence of at least subclinical myopericarditis (i.e., troponin elevations, or ECG abnormalities) following covid-19 mRNA vaccination, as well.
While acute severe outcomes (i.e., death, cardiogenic shock) with covid-19 mRNA vaccine-associated myopericarditis are uncommon, passive surveillance registry data from the U.S. and Europe through mid-March, 2022 recorded 122 fatalities (=~0.78% of the total 15,702 cases documented). Five of these cases occurred in persons under 18 years old. Moreover, an accompanying systematic published review of the international literature found 0.22% (n=30) of 13, 571 covid vaccine-associated myocarditis or pericarditis events were fatal. At least 15 autopsy-diagnosed (13 likely; 2 possible) fatal cases have now been reported (14 here; another here). There have also been steadily accumulating case reports of acute fulminant covid-19 mRNA vaccine-associated myopericarditis, with cardiogenic shock (here; here; here; here; here; here; here; here; here; here).
Limited cardiac magnetic resonance follow-up imaging studies demonstrate late gadolinium enhancement (LGE)—a finding indicative of myocardial necrosis/scarring (here)—persists 3 to 8-months after acute covid-19 mRNA vaccine-associated myopericarditis (here; here; here; here; here; here; here; here; here), and can be associated with ventricular tachycardia, beyond the acute presentation (here; here; here). Finally, during ~6-months (180 days) of observation after mRNA vaccine myocarditis among 104 predominantly male (mean age ~ 26 years old) Hong Kong residents, there were 3 deaths, and 2 persons developed heart failure (see Supplement, Table e6). These very preliminary data indicate a heart failure incidence after covid-19 mRNA vaccination myocarditis (3.85 per 100 person-years) > 7-fold the background incidence of heart failure in urban Chinese aged 25 to 74 years old (0.53 per 100 person-years), during a recent pre-covid-19 year (i.e., 2017).
The publication of Oster et al confirmed almost 1630 cases of myopericarditis (all meeting CDC’s own diagnosis criteria) following covid-19 mRNA vaccination, within the first 8.5 months after the vaccines were widely and aggressively administered. At present, however, over 2-years after the mRNA vaccines were introduced, HHS still has no specific vaccine injury compensation initiative formally recognizing this established complication. Recall that a mere 5 cases of probable smallpox vaccine-associated myopericarditis had accrued in under a calendar year among civilians, when HHS launched the Smallpox Vaccine Injury Compensation Program (SVICP), December 16, 2003.
While HHS does have a “generic” Countermeasures Injury Compensation Program (CICP), ostensibly applicable to covid-19 vaccine, or any other vaccine injuries, the CICP has long been deemed unsatisfactory, and that remains true at present. Effectively superseded by the CICP, even the compensation track record (2003-2006) of HHS’s “flagship” smallpox vaccine-specific SVICP was at best marginally better, underscoring the ongoing, overall dismal record (here; here) of U.S. vaccine injury compensation.
CICP , presently the only viable option for covid-19 vaccine injury compensation, epitomizes the hollow, uncompensated failure of heart of U.S. “efforts.” Through February 1, 2023, 11,196 Covid-19 vaccine injury claims have been filed. Although 17 claims for covid-19 associated myocarditis/pericarditis are “pending,” (out of >100 filed), none have been compensated thus far. Indeed, CICP has compensated only 30 total claims, since 2010, including a single smallpox vaccine injury myopericarditis claim, awarded $323,035.75.
During two decades (here), continuing till now on a sporadic basis (here; here), irrefragable evidence of smallpox vaccine-associated myopericarditis has accumulated, albeit, mercifully, with a relatively small number of confirmed total cases, given the vaccine’s limited, primarily military use. Covid-19 mRNA vaccine-associated myopericarditis cases, another irrefragably established vaccine-injury, have burgeoned to at least ~4000 U.S. cases (per VAERS search 2/20/23, and applying CDC criteria per Oster et al demonstrating ~80% of VAERS myopericarditis reports are valid). The long-term sequelae of such vaccine-associated myopericarditis remains unknown, although the data pending publication by Dr. Renata Engler et al (“Myocarditis and Pericarditis Recovery Following Smallpox Vaccine 2002-2016: A Comparative Observational Cohort Study in the Military Health System,”) will be illuminating.
Regardless, what is glaringly obvious now, meriting immediate rectification, is the ethically-challenged failure to routinely compensate victims of vaccine-associated myopericarditis, especially after covid-19 mRNA vaccination.
