A new and more traditional type of Coronavirus Disease 2019 (COVID-19) vaccine that will soon be either approved or rejected by the Food and Drug Administration for an Emergency Use Authorization (EUA) is also causing myocarditis and pericarditis as a side effect, FDA documents show.
The injection targets the original and Delta variants of SARS-CoV-2, the virus that causes COVID-19.
Novavax’s Omicron-specific vaccine is still in preclinical stages, according to the company’s pipeline, a notable fact considering that Omicron composed 95 percent of positive sequences as far back as January and that existing vaccines have extremely limited, or even negative, vaccine efficacy against the variant.
The Administration’s Vaccines and Related Biological Products Advisory Committee is set to hold a public hearing on June 7.
You are now signed up for our newsletter
Check your email to complete sign up
The Committee is the same one that rubber stamped an approval for the children’s aged 5 to 11 injection in November by a score of 17-1.
During the meeting, panelist Eric Rubin showed the public a latent disregard for the risks of adverse reactions on youth when he stated, “We’re never gonna learn about how safe the vaccine is until we start giving it…That’s just the way it goes. That’s how we found out about rare complications of other vaccines…
A sudden crash
On June 3, Novavax’s investors endured an unpleasant morning when stock price took a 30 percent single day tumble after an FDA Briefing Document released in advance of the meeting revealed multiple cases of myocarditis had been documented during testing.
The company had closed June 2 at $55.97 before bottoming at $41.10 the next day.
Novavax has already manifested enormous losses for investors after trading at a high of $331.68 during 2021’s bubble-like market-wide bull run.
MORE ON MYOCARDITIS
- Apple Watch Records Two Days of Arrhythmia Leading Up To Myocarditis Death of 26-Year-Old Following Pfizer Booster
- 21-Year-old Bayern Munchen Canadian Soccer Star Develops Myocarditis After COVID, December Booster Vaccine
- Risk of Heart Inflammation From Moderna Vaccine Greater Than From COVID-19 Under 40, Research Shows
The Document stated clearly, “Multiple events of myocarditis/pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373.”
Data showed a total of 7 myocarditis or pericarditis cases were logged among 5 males and two females. Five of the seven cases were aged between 16 and 31.
Of the 7 cases, only four were concluded to have a temporal relationship to the Novavax injection, with symptoms onsetting between 2 and 8 days after either the second dose or a booster injection.
The most severe appears to have occurred in a 16 year old male who was described as having a “preceding nonspecific viral illness” in addition to taking the ADHD drug methylphenidate.
The boy’s reaction was classified as a “serious event.” He was hospitalized for four days before the case was marked as “recovered/resolved.”
The Document showed his troponin levels peaked at 32,000 ng/L.
A website for the Cleveland Clinic preparing patients to take a troponin test states that the substance is a complex molecule that “exists inside muscle cells and only freely circulates in your bloodstream in tiny amounts.”
“However, damage to certain types of muscle cells can cause more troponin to escape into your blood.”
It adds, “Troponin levels usually increase sharply within three to 12 hours after a heart attack and peak about 24 hours after the heart attack. They will also remain high for several days.”
The website explains that normal troponin levels are in the range of 0 to 0.04 ng/L.
“The medical standard for elevated troponin levels is for them to be higher than 99% of the expected value in a healthy adult…If your results are higher than 99% of the expected value…that indicates heart muscle damage.”
The event is notable in light of the fact that human heart muscle does not heal when damaged, a quandary that has led scientists to explore using a similar gene therapy technology used in the Moderna and Pfizer COVID injections in an attempt to regenerate human hearts.
The technique is reported to have been successful on pigs.
A common spike
However, while many in the anti-vaccine and alt-right community have been quick to blame the injections at-will for the adverse reactions, it is worth noting that heart inflammation has also manifested in unvaccinated individuals who have contracted COVID.
Perhaps the most notable case is that of the NHL’s Josh Archibald, a player for the Edmonton Oilers who was tarred and feathered in the media last October after he developed season-ending and possibly career-ending myocarditis after not only remaining the only player on the team to not accept vaccination, but being a vocal opponent of mandatory injection mandates.
Team doctors attributed his myocarditis to an “an asymptomatic case of COVID-19 that initially went undetected over the summer,” reported CTV news.
The outlet also interviewed a cardiologist who claimed that Archibald—and others—were at “a 10,000 fold greater risk of getting myocarditis from the virus, we think, than from the vaccine.”
The emergence of myocarditis in Novavax patients is notable for the theory that it is the SARS-CoV-2 spike protein itself that is causing the damage, as the injection works completely differently from the Moderna, Pfizer-BioNTech, AstraZeneca, and Johnson & Johnson offerings.
The existing batches utilize a lipid nanoparticle—a man made fat—in addition to either a messenger RNA genetic instruction or a sterilized adenovirus genetically engineered to carry a double stranded DNA instruction to force human cells to grow the SARS-CoV-2 spike protein on their surface with the goal of eliciting an immune response.
Novavax, however, uses a genetically engineered baculovirus to do the same, but in the body of moths.
After the moths grow the SARS-CoV-2 spike on their bodies, they are killed and the spike is harvested, combined with an adjuvant made from an extract from the soapbark tree, and directly injected into the human body.
The FDA’s Briefing Document openly cites science that supports the theory that it’s the spike protein that directly causes damage, “The Spike protein antigen can induce antibodies to SARS-CoV-2 spike glycoproteins that cross-react with myocardial contractile proteins, including myocardial α-myosin heavy chain (Vojdani and Kharrazian, 2020).”
It continues, “It has been postulated that the effect of these antibodies, influenced by hormonal differences, immune–genetic background, age, and sex are potential mechanisms of myocardial injury associated with SARS-CoV-2 infection or COVID-19 vaccination (Heymans and Cooper, 2022).”
In October of 2021, research from Chinese researchers at a Sweden’s Umea University was published in the journal Viruses that discovered the spike protein was amassing in the nucleus of human cells, interfering with a crucial DNA repair mechanism, a factor which may be the cause of severe immune system deficiencies common in those who have been infected by the virus.
The researchers stated, however, that the problem was not limited merely to those who had been infected, but may implicate the vaccinated as well, “Our findings reveal a potential molecular mechanism by which the spike protein might impede adaptive immunity and underscore the potential side effects of full-length spike-based vaccines.”