By Karina Acevedo Whitehouse Ph.D.
Massari et al. have published a few days ago, in the journal PLoS a study entitled “Post-market active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: A study based on self controlled multi-database case studies”: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9333264/
In this epidemiological study, the authors found that, as has been shown in several other studies, mRNA injections are associated with these cardiac harms, especially in young men. Their study is not trivial.
Between December 2020 and July 2021 they followed 2,861,809 people aged 12 to 39 years who received mRNA inoculations from Pfizer (BNT162b2) or Moderna (mRNA-1273). There were, in total, 2,405,759 people inoculated with BNT162b2 and 456,050 people inoculated with mRNA-1273). Of these, 441 inoculates developed myocarditis/pericarditis (346 BT162b2; 95 mRNA-1273).
In the 21 days after inoculation, the risk was highest after the second dose (1.99; 95% CI: 1.30 to 3.05) of Pfizer. For Moderna the risk was high after the first dose (2.22; 95% CI: 1.00 to 4.91) and even higher for the second (2.63; 95% CI: 1.21 to 5.71). The risk was even higher during the first week post-inoculation, where the first dose of Moderna had a risk incidence of 6.55 (95% CI: 2.73 to 15.72), the second dose of Moderna had a risk incidence of 7.59 (95% CI: 3.26 to 17.65), and the second dose of Pfizer had a risk incidence of 3.39 (95% CI: 2.02 to 5.68).
The number of events for the second dose of Moderna was 5.5 per 100,000 vaccinees. This risk was even higher for males, who had a risk incidence of 12.28 (95% CI: 4.09 to 36.83) seven days after the first dose of Moderna and 11.91 (95% CI: 3.88 to 36.53) seven days after the second dose of Moderna. For 12- to 17-year-olds, the risk was significant and calculated at 5.74 (95% CI: 1.52 to 21.72) after the second dose of Pfizer.
Because there were so few vaccinees in this group, it was not possible to calculate the adverse event rate. For persons aged 18 to 29 years, the risks were higher: first dose of Moderna 7.58 (95% CI: 2.62 to 21.94), second dose of Pfizer 4.02 (95% CI: 1.81 to 8.91) and second dose of Moderna 9.58 (95% CI: 3.32 to 27.58). Here, the number of adverse cardiac events was 3.4 (1.1 to 6.0) and 8.6 (4.4 to 12.6) per 100,000.
Acute myocarditis associated with other vaccines is generally known to be attributed to allergic reactions and hypersensitivity reactions, but “the pathophysiology of myocarditis and pericarditis from mRNA vaccines is not well understood and various mechanisms have been postulated.
Molecular mimicry between the Spike protein and self-antigens [i.e., that resembling the Spike protein to proteins of ours and thereby generating an autoimmune reaction or immunopathology] turns on already dysregulated immune cascades, immune responses to mRNA [i.e., what the Seneff et al. 2022 paper, and what Roxana Bruno and I argue], or dysregulated cytokine expression [could it be that what several of us have been saying for almost two years is true?].
The authors acknowledge that their study has the limitation that the outcome (myocarditis and pericarditis) was not validated by clinical registries, nor did they take into account severity. Their conclusions: mRNA injections are associated in myocarditis and pericarditis in the population under 40 years of age. The greatest risk of these events occurring is associated with the second dose of Pfizer and the two doses of mRNA and the greatest risk exists for men aged 12 to 39 years and for either sex aged 18 to 29 years vaccinated with Moderna.
Implications: Well, there will be those who may think, “Well, 12.28 cases in 100,000 is a good number.” Hmmm…, well before you get your Vegas bets on, let me tell you that a young man is far more likely to develop myocarditis or pericarditis from vaccination with Pfizer or Moderna than he is to hit the lottery (calculated as 1 in 13,983,816; https://en.wikipedia. org/wiki/Lottery_mathematics): On the other hand, I don’t want to be biased by avoiding telling you that the probability that you have myocarditis associated with SARS-CoV-2 infection has been calculated as 450 per million (45 per 100,000), you can see it at: https://pubmed.ncbi.nlm.nih.gov/34341797; so, you might think that “it’s better your expectation with the vaccine than with the virus”. But in reality it is not. Why? Because for one thing, the vaccine doesn’t just impact the heart. That mRNA – we have said it many times – reaches far more organs than the virus can even dream of, and on the other hand, it is ignoring that last study that people under the age of 20 do not usually have symptomatic COVID. Of the few who do have moderate to severe symptoms (which are few, less than 8%), that is where they calculated that 45 per 100,000 probability. On the other hand, those who receive the vaccine, receive the vaccine. There the universe is 100%. I hope I am really explaining myself. So much for the article by Karina Acevedo Whitehouse, Ph.D.
Novavax COVID vaccines should carry heart inflammation warning, says EU
The European Medicines Agency (EMA) today recommended adding a warning for two types of heart inflammation to Novavax’s COVID-19 vaccine, marketed under the brand names Nuvaxovid and Covovax, based on a number of cases reported in those who received the vaccine.
According to a statement , the EMA’s Pharmacovigilance Risk Assessment Committee, responsible for assessing and monitoring the safety of human medicines, concluded that “myocarditis and pericarditis may occur after vaccination with Nuvaxovid.”
“Therefore, the Committee recommends including myocarditis and pericarditis as new side effects in the Nuvaxovid product information, along with a warning to raise awareness among healthcare professionals and individuals receiving this vaccine,” the statement said.
The Pharmacovigilance Risk Assessment Committee also asked the “marketing authorization holder for Nuvaxovid to provide additional data on the risk of side effects.”
According to Reuters , the U.S. Food and Drug Administration (FDA) flagged a risk of cardiac inflammation from the Novavax vaccine in early June.
However, on July 13, the agency granted Novavax’s application for emergency use authorization of the vaccine for adults 18 and older in the U.S . U.S.
Novavax hoped that people who opted out of Pfizer and Moderna’s mRNA vaccines, both of which are associated with a risk of heart inflammation , would prefer its vaccine because it “relies on technology used for decades,” Reuters reported .
The FDA’s “Fact Sheet for Healthcare Providers Administering Vaccines” now includes a warning that “clinical trial data provide evidence of an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following administration of Novavax COVID-19 Vaccine, Adjuvanted.”
The FDA’s “Fact Sheet for Recipients and Caregivers” states that for most people who have had myocarditis or pericarditis after receiving the vaccine, symptoms began within 10 days after vaccination and that vaccine recipients should seek medical attention immediately if they experience chest pain, shortness of breath, feeling of having a racing, pounding or throbbing heart.
Myocarditis is inflammation of the heart muscle that can lead to cardiac arrhythmia and death. According to the National Organization for Rare Disorders , myocarditis can result from infections, but “most commonly, myocarditis is the result of the body’s immune reaction to the initial heart damage.”
Pericarditis is an inflammation of the tissue surrounding the heart that can cause sharp chest pain and other symptoms.
Unlike the Pfizer and Moderna vaccines that use mRNA technology, and the Johnson & Johnson (J&J) vaccine that uses adenovirus vector technology, the Novavax vaccine uses a more traditional vaccine technology.
As The Defender reported in June, that may be one reason the committee recommended the vaccine, hoping that the “reluctant unvaccinated,” suspicious of newer technologies or allergic to components of mRNA vaccines, would be more likely to receive the Novavax vaccine. .
Despite the unanimous vote of the FDA’s vaccine advisory panel, members expressed several concerns about the Novavax vaccine, including heart-related adverse events observed during clinical trials.
FDA documents show multiple cases of myocarditis and pericarditis reported after Novavax vaccine administration:
“Multiple events of myocarditis/pericarditis were reported in temporal relation to the administration of NVX-CoV2373 [the Novavax vaccine used during the trials], similar to myocarditis following COVID-19 mRNA vaccines and raised concern for a causal relationship with NVX-CoV2373.
“Lymphadenopathy events were infrequent, but were reported by a higher proportion of participants in the NVX arm, with the highest rate observed after dose 2 (0.2%).
“The review of the data also identified small imbalances in certain thromboembolic events, including
cardiac and neurovascular events,
heart failure and
“Passive surveillance data during post-licensure use in other countries also indicate a higher than expected rate of myocarditis and pericarditis (primarily pericarditis) associated with the vaccine.”
In a safety database covering data from 40,000 Novavax vaccine recipients, four young men, aged 16 to 28 years, reported myocarditis or pericarditis within 20 days after injection, although one of the four had a viral illness that could have caused the symptoms.
According to the FDA , there were 26,000 people in the Novavax clinical trial. However, only 21,000 of the 26,000 people who received the vaccine during the trial were “followed for at least 2 months.”
It is unknown whether any of the participants developed cardiac inflammation after the 2-month follow-up period, why the other 5,000 clinical trial participants were not followed, or whether those individuals experienced cardiac inflammation.
In briefing papers released June 3, the FDA wrote :
“These events raise concern of a causal association with this vaccine, similar to the association documented with COVID-19 mRNA vaccines.”
The FDA asked Novavax to “flag” myocarditis and pericarditis as an “identified significant risk” in materials accompanying the vaccine. However, Novavax has not yet agreed to do so.
“Based on our interpretation of all clinical data supporting NVX-CoV2373 … we believe there is insufficient evidence to establish a causal relationship,” the company said in a statement.
Novavax asserted that “natural background events” of myocarditis can be expected in any large database and that the “totality of clinical evidence” is “not sufficient to establish an overall causal relationship with the vaccine.”
Novavax on Monday asked the World Health Organization to expand the emergency use list of its vaccine for adolescents aged 12 to 17. Japan, Australia and the EU previously licensed the vaccine for that age group.