An analysis of claims made by Steve Kirsch in his Substack_ “Dr-3.pdf -

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An analysis of claims made by Steve Kirsch in his Substack: “Dr. Paul Offit is lying to us about myocarditis rates - For teen boys, vaccines are more likely, not less likely, to kill you or give you myocarditis. Here's the proof.” https://web.archive.org/web/20211102092120/https://stevekirsch.substack.com/p/dr-paul-offit-is-l ying-to-us-about Nov 4, 2021 - Twitter: @CanYouSpellmRNA COVID vaccines are causing increased cases of myocarditis, especially among young males. Estimates vary on the rate, but the evidence is very clear and not in dispute. Myocarditis is a potentially serious condition with a wide range of case severity, ranging from mild symptoms treatable on an outpatient basis to hospitalization/ICU care to death. When considering whether to approve vaccines for use in these populations, the FDA weighs the relative risks and costs of adverse effects against the protective benefits from the disease itself. Parents and individuals ought to make clear, well-informed choices as well. Some have seized on the elevated risks of myocarditis following COVID vaccination to make some extraordinary claims, including Steve Kirsch. Steve Kirsch is a serial tech entrepreneur and billionaire. He is founder of the COVID-19 Early Treatment Fund (CETF), a research venture aimed at early treatments for COVID. In May, all 12 members of CETF’s scientific advisory board resigned, citing his alarming dangerous claims and erratic behavior. For more background on Steve, see here. In a Substack article, Stever argues that “for teen boys, vaccines are more likely, not less likely, to kill you.” Kirch’s argument hinges on the following important premises: - COVID vaccines are causing myocarditis at substantially higher rates than COVID itself among teen boys - Myocarditis is very deadly These premises simply don’t hold up under careful scrutiny. Kirsch cherry-picks the group with highest vaccine-related myocarditis rate (males age 16-17 who received Pfizer vaccine) and compares it against the COVID-related myocarditis rate of a completely different demographic (males & females age 12-17). This is an invalid comparison. When the demographics are properly matched and calculations re-run, the conclusions run counter to Kirsch’s assertion. In addition, there is also some empirical evidence suggesting he may be under-estimating the number of cases of myocarditis resulting from COVID infection. There is little empirical support I found in available research for his argument that myocarditis Page 1 resulting from vaccination is, in fact, anywhere near as deadly as his article implies. Finally, the author doesn’t even attempt to prove his main assertion because he never once introduces any evidence regarding mortality rate from myocarditis following vaccination or COVID. Claim: Rate of myocarditis caused by vaccination is higher than rate of myocarditis caused by COVID in teen boys. Kirsch begins by formulating an estimate of myocarditis caused by COVID in teens. He combines CDC estimates quoted in a NY Times article on infection rate among adolescents age 12-17 (37.4 per 100,000), with another estimate from a different NY Times article on the rate of myocarditis seen in youths with positive COVID cases (2.3%). He extrapolates this out over 6 months to arrive at his estimate of 204 myocarditis cases per million over a 6 month span. Keep in mind that this estimate represents a rate for a combined group of males and females age 12-17. Next, using a CDC-analyst-provided chart of myocarditis rates (see below) based on VAERS data, Kirsch selects the sub-group with highest vaccine-related myocarditis rate, males age 16-17 (shown in red rectangle below) who received the Pfizer vaccine. There are two fairly substantial issues with his approach: 1. A huge flaw is that the groups he’s comparing are not matched on age and sex, rendering his follow-on calculations and conclusions meaningless. 2. We should also note that the rates of myocarditis following the Moderna and J&J vaccines are substantially lower (60% lower and completely absent, respectively) than with Pfizer. So there also limitations on the generalizability of conclusions he might have reached regarding all vaccines, since he only examined the data for one. Page 2 What if we followed Kirsch’s approach to estimate the rate of myocarditis from Pfizer vaccination for an appropriately matched group (male & female 12-17, indicated in purple rectangle above)? We would then have a demographically matched group to compare against the post-COVID-infection myocarditis rates based on the NY Times articles above. If we assume an equal population distribution for kids aged 12-17, we apply a weight of 0.66 to the 12-15 age bracket and 0.33 to the 16-17 age bracket. The result is an age-weighted estimate of the rate across the combined (male & female 12-17) group. 0.66 * (2.6 + 20.9) + 0.33 * (2.5 + 34.0) = 27.5 (per 1,000,000) If we apply Kirsch’s 5x scaling factor to these raw VAERS data, we reach an estimate of 27.5 * 5 = 137.5 myocarditis cases per million in the (male & female 12-17) group receiving Pfizer vaccinations. This 137.5 rate is substantially below the 204 per million myocarditis rate resulting from COVID infection. The apples-to-apples comparison contradicts Kirsch’s conclusion. Further, the argument becomes flimsier if the comparison is made against the Moderna or J&J vaccines (or some blended average) rather than just using the Pfizer vaccine data alone. Is the 137.5 rate estimate for Pfizer vaccine-induced myocarditis an underestimate? Possibly. The FDA itself used higher figures in its recent risk-benefit review of COVID vaccines for use in Page 3 5-11 year olds. In the “base scenario” assumptions, the FDA used patient medical records from OPTUM, a large US health care network, to estimate rates of 179 per million and 196 per million cases of myocarditis caused by vaccines in males 12-15 and males 16-17, respectively. (Note: Although the presentation was prepared to evaluate risk and benefits for 5-11 year olds, the FDA used males 12-15 as its assumed rate for males 5-11; it also showed males 16-17 for comparison). Source: https://www.fda.gov/media/153507/download Another reference point is data from an Israeli study (4) of males 16-19, which estimated 150 myocarditis cases per million vaccinees. Page 4 Each of these rates are still below the 204 per million following COVID infection. Is it possible that the 204 per million rate of myocarditis following COVID infection was an over-estimate by Kirsch? Adolescent case rates have varied dramatically from month to month over the last 6 months. Kirsch used an estimate of 37 per 100k. The observed rate was close during August (37.4 and 40.9 per 100k for 12-15 year olds and 16-17 year olds, respectively) and September (42.1 and 43.86 per 100k for 12-15 year olds and 16-17 year olds, respectively). However, observed case rates were much, much lower during the summer and, more recently, in October. It should be noted that testing can contribute greatly to these fluctuations. The observed data is consistent with the hypothesis that much more intensive testing occurred during back-to-school months, while few kids were much less frequently tested for illness during the summer time. Source: CDC COVID Data Tracker. Nov 4, 2021. Since testing can also contribute greatly to the volatility in observed case rates, it’s worth checking the trend of clinically-significant (hospitalized) COVID infection rate among adolescents. The latest data from COVID-NET, which covers about 10% of the US population, appear to show that the rate of serious COVID related illnesses is on a relatively steady trend. It is worth noting that cumulatively, over the last 6 months, ~55 per 100k youths aged 5-17 were hospitalized with lab-confirmed COVID, which translates to ~550 per million. Page 5 Source: https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html Nonetheless, if COVID cases serious enough to generate myocarditis risks were to drop by significant amounts (25-33%), while the rate of vaccinations remain unchanged, then it would be theoretically possible for the rate of vaccine-caused myocarditis to exceed that of COVID itself. Is it possible that the estimated rate of myocarditis occurring following COVID infection is lower than the NY Times estimate used by Kirsch? For the rates of vaccine-linked myocarditis and COVID-linked myocarditis to be equal using Kirsch’s methodology (both would need to be ~137.5 per million), we would need to assume a substantially lower ~1.5% rate of COVID-linked myocarditis vs. 2.3% in the original estimate. It’s easy to imagine fairly wide confidence intervals for a fairly rare condition in a condition that already has fairly low rates of clinical significance in this age range (12-17). On the other hand, there is some evidence based on patient medical record examination that suggests that Kirsch’s estimate could be too low for COVID-linked myocarditis. A US non-peer-reviewed study (1) examined myocarditis diagnosis within 90 days of confirmed COVID infection using the TriNetX Research Network, an electronic health record aggregator from 48 mostly large U.S. Healthcare Organizations (HCOs) covering ~18% of the US Page 6 population. In a group of (male & female 12-17), they found a 328 per million rate. Incidence of Myocarditis Summary Following vaccination Following COVID infection Israel Study (3) Male 16-29 10.7 per 100k = 107 per million [95% CI: 69-145] Israel Study (4) Male 16-19 15 per 100k = 150 per million Female 16-19 10 per 100k = 100 per million Kirch’s estimates Males & Females 204 per million 12-17 (Using NY Times Data) Male 12-15 (VAERS) 48 * 5 = 240 per million Male 16-17 (VAERS) 77 * 5 = 375 per million Males & Females 0.66 * (2.6 + 20.9) + 12-17 (VAERS) 0.33 * (2.5 + 34.0) = 27.5 * 5 = 137.5 per million Optum (Large US Male & Female 106 per million Health Care Provider Combined 12-15 Medical Records) TriNetX (1) Male 12-15 (TriNetX) 601 [Wilson Score interval: 257 - 1,406] Male 16-17 (TriNetX) 561 [Wilson Score interval: 240 - 1,313] Males & Females 328 12-17 (TriNetX) [Wilson Score interval: 173 - 624] Høeg Male 12-15 (VAERS) 162.2 per million Male 16-17 (VAERS) 94.0 per million Page 7 1. Risk of Myocarditis from COVID-19 Infection in People Under Age 20: A Population-Based Analysis. (Pre-Print). July 2021. Claim: There are no mild cases of myocarditis. Myocarditis can be clinically significant and even fatal. The author heavily implies that myocarditis is deadly in many, if not most, cases. It is highly unusual that Kirsch consulted with Dr. McCollough about the severity of myocarditis, but yet did not ask him more specifically about mortality rates, which is vital to Kirsch’s thesis. It is worth noting that in Dr. McCollough’s most recent research paper on myocarditis, he makes virtually no mention of fatalities resulting from the illness (note: Dr. McCollough’s paper has been temporarily removed by the publisher for unspecified reasons at which we can only speculate). Furthermore, the preponderance of credible evidence I’ve reviewed shows most cases of myocarditis occurring in the time period following vaccination are clinically well-managed, and resolved within a few days (sources 2 and 3 below). FDA analysis shows a median of 1 day hospital stay for myocarditis occurring following a vaccination vs. 6 day median for COVID. (6) Hence they are deemed mild. A large Israel study (4) of a population of 2.5 million vaccinated people 16 years and older saw 54 cases meeting criteria of myocarditis following vaccination. Of these 54 cases, 76% were described as mild, 22% as intermediate. There was 1 case associated with cardiogenic shock and death. Another Israel study (5) looked at data from the Ministry of Health database covering over 9.2 million people. The study found 142 cases of myocarditis among vaccine recipients within 21 days of receiving dose 1, and within 30 days of receiving dose 2. Of these, 129 of the 142, (95%) of the myocarditis cases were judged to be mild. There was 1 death. Sources: 2. Myocarditis Temporally Associated With COVID-19 Vaccination. June 2021. 3. Myocarditis With COVID-19 mRNA Vaccines. July 2021. 4. Myocarditis after Covid-19 Vaccination in a Large Health Care Organization. October 2021. 5. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. October 2021. 6. Benefits-Risks of Pfizer-BioNTech COVID-19 Vaccine for Ages 5 to 11 Years. FDA VRBPAC, October 26, 2021. 7. SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis. (Pre-Print). Sept. 2021. Page 8 Conclusion Kirsch argues that myocarditis is deadly, and myocarditis risks from vaccination are higher than from COVID itself. He claims “Your child is more likely to die from the vaccines than be saved by them”. Extraordinary claims like this require extraordinary evidence. Yet there is not any analysis or discussion of death rates from either vaccination or COVID in his entire piece. None. Kirsch focuses exclusively on rates of myocarditis, which occur at substantially elevated rates after vaccination, particularly so in young males receiving the Pfizer vaccine. What stands out starkly is: 1. Myocarditis incidence following vaccination appears LOWER than the incidence following COVID infection, after properly matching demographics. 2. The death rate from myocarditis following vaccination appears to be extremely low. In short, Kirsch fails to prove his argument. Available evidence reviewed is consistent with the prevailing FDA and CDC perspective that vaccine risks in adolescents, while real, are outweighed by the direct benefits in terms of reduced hospitalizations and suquellae such as COVID-related myocarditis, MIS-C, and long COVID (PASC). Appendix: The Perplexing Case of Ernesto Ramirez Claim: 16 year old Ernesto Ramirez died from COVID vaccination Kirsch brings up the case of Ernesto Ramirez, a 16-year old whose father claims died of myocarditis subsequent to receiving COVID vaccination. While it is possible that COVID vaccination was a cause or contributor in his death, there are some unusual circumstances surrounding this anecdote. 1. No evidence exists in the US VAERS database (which tracks adverse effects from vaccinations) for a single reported death in Texas for a 6-17 year old male since COVID vaccines were introduced. 2. No information has been released about whether Ernesto did or did not have a pre-existing diagnosis of myocarditis prior to vaccination. The absence of a report in VAERS is noteworthy because health care providers are both ethically and legally obligated to report serious adverse events (including hospitalization and death) that could be related to a recent vaccination to the system. It is also noteworthy because patients and their families may also directly file a VAERS report, but they do so under warning Page 9 that filing false reports is a felony. If Ernesto’s death were in fact linked to vaccination, the absence of a VAERS report suggests that every health care provider involved with his vaccination, life-saving efforts, and post-mortem examination have all failed to follow the law; and further that Ernesto’s family also failed to report his death to VAERS. The absence of any offered information about whether Ernesto had a pre-existing condition is also noteworthy. If Ernesto lacked a pre-existing condition, this would surely be mentioned by the father and covered in the reporting of the story. It would add substantial weight to the claim that vaccination were responsible for his son’s death. The absence of such a statement is consistent with Ernesto having pre-existing myocarditis, possibly an advanced case that could have been fatal at any time. We can’t fully eliminate the possibility that Ernesto’s death was triggered by a COVID vaccine. However, Occam’s Razor suggests an alternative explanation which is even more consistent with the observable evidence. Specifically, that Ernesto suffered from severe pre-existing myocarditis and died suddenly and spontaneously. This tragically occurs in a certain number of myocarditis cases. It’s possible that this simply happened to coincide with his vaccination date. VAERS search criteria: Age: 6-17 years, Event Category: Death, Onset Interval: 0 days; 1 day; 2 days; 3 days; 4 days; 5 days; 6 days; 7 days; 8 days; 9 days; 10-14 days; Sex: Male; Unknown, State / Territory: Texas, Vaccine Products: COVID19 VACCINE (COVID19), Group By: Vaccine; Month Vaccinated; Age; Onset Interval; VAERS ID Page 10