On December 14th, 2021 Nature Medicine released a study based on a broad population data set analyzed by researchers at Oxford examining the risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination and infection. Interestingly, the literature revealed some eye opening information about myocarditis that will be discussed in this publication. Having said that, today you will learn 3 things:
- First, you will learn a brief history of COVID-19 vaccine rollouts
- Second, you will learn the pertinent details of this study like who experienced myocarditis, length of hospital stay associated with injury, and names of vaccine manufacturers involved
- Third, you will learn what could be done in the USA to reduce the occurrence of vaccine induced myocarditis
📚First, some history
What brought things to this point? In other words, why this study examining adverse events following COVID-19 vaccination? To fully understand, you will need to hear a story first.
Early on amidst the pandemic in mid December of 2020, Pfizer was granted emergency use authorization for their mRNA vaccine against the SARS-CoV-2 virus in the UK. Said differently, Pfizer was afforded the ability by the FDA and WHO to deliver their COVID-19 vaccine to the general public for administration by healthcare professionals. It wasn’t long until many others followed suit: Moderna (April 2021), AstraZeneca (January 2021) etc. By September of 2021 nearly 6.3 billion doses had been administered around the world. As the months went by, adverse events after vaccination began being reported that were not seen in the original clinical trials.
By November 2021, the self reporting system VAERS (Vaccine Adverse Event Reporting System) revealed 1,783 reports of myocarditis and pericarditis from individuals between the ages of 12-30 that received Pfizer and Moderna’s mRNA vaccine. By early July 2021, the EMA (European Medicines Agency) had 283 reports of myocarditis and pericarditis after 177 millions doses of Pfizer were administered, and of course 9 cases of myocarditis and 19 cases of pericarditis linked to Moderna . Simultaneously, Israel inoculated 5 million people with Pfizer (BNT162b2), and by May of 2021 275 cases of myocarditis were reported.
So let’s examine the question again, why all of a sudden the interest in COVID-19 vaccine side effects? The answer, because initial vaccine clinical trials conducted by Pfizer, Moderna, and AstraZeneca revealed ⚠️NO CASES OF MYOCARDITIS OR PERICARDITIS⚠️. Conversely, when Pfizer, Moderna, and AstraZeneca’s vaccines were administered to the masses, individuals began experiencing side effects. That is bad because initial vaccine clinical trials are done to gauge the safety and efficacy of a drug/treatment for the general public. After all, if clinical trials are not accurate, people will get hurt. So, something must have went wrong, right?
Here is the problem. You see, the Moderna, Pfizer , and AstraZeneca’s phase 3 clinical trials were very under powered. Said differently, they didn’t contain enough participants to account for rare side effects like myocarditis and pericarditis that are seen on average every 1/3000 – 1/8000 depending on extrapolation of data. To be more specific, in this case, extrapolations are calculations made in lieu of adequate data. Unfortunately, extrapolations are only as good as the data available. So, trying to quantify side effects based on already underpowered studies would be like trying to draw blood from a stone. What’s isn’t there, just isn’t there no matter what you do. Just so we’re clear, there should have been hundreds of thousands of participants in the initial clinical trials, NOT TENS OF THOUSANDS. Regardless of the speculative severity of COVID-19 at that time, it was not acceptable to do science differently from what is evidence based. If anything, we rely on tried and true measures to produce the best results, especially during a time so chaotic. Unfortunately, as certain safety steps were omitted, there are now people being harmed. Look at the figures below.
- Moderna’s phase 3 clinical trail only contained approximately 30,000 individuals
- Pfizer’s phase 3 clinical trail only contained approximately 43,000 individuals
- AstraZeneca’s phase 3 clinical trail only contained approximately 29,000 individuals
🔔 THE TAKEAWAY
It seems that initial clinical trials for Moderna, Pfizer, and AstraZeneca being so underpowered created a blind spot. As a consequence, myocarditis was not seen during initial testing, but was experienced by the general population after mass vaccination. That is because the number of people inoculated worldwide is larger than the number of people studied in the clinical trials. James Cintolo read more
Doctors Warn of Vaccine Damages in Patients: ‘People Are Being Deceived’
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