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  • Monica Harris

What the FDA Isn't Telling Us

Updated: Aug 27

The agency isn’t being transparent about its approval of Pfizer’s COVID-19 vaccine — and the proof is buried in the fine print

In the wake of the Food and Drug Administration’s approval of the Pfizer-BioNTech COVID-19 mRNA vaccine on Monday, government agencies and companies around the country wasted no time announcing sweeping mandates for employees. From United Airlines to the armed forces, the message to unvaccinated Americans is clear: the Velvet Glove of gentle persuasion has now come off; prepare for the Iron Fist.


Of course, these same agencies and companies had warned staff and employees for weeks that mandates were coming; decision-makers were just awaiting an FDA determination that would officially brand the vaccine “safe and effective.” After all, what reasonable person would be hesitant to receive a product approved by the government agency entrusted with safeguarding the health of Americans?


The problem, of course, is that many reasonable people no longer trust their government.


From alleged weapons of mass destruction in Iraq (that didn’t actually exist) to political elites who lock down entire cities while they cavort at super-spreader gala events, more Americans are coming to terms with the harsh reality that the people who are supposed to look out for their best interests aren’t always truthful with them. Many have even come to expect this — not because they want to, but because it’s getting so much harder to ignore what’s plainly staring them in the face.


And this is what makes the FDA’s highly-touted approval of the first Coronavirus vaccine so problematic.


Last year, the FDA insisted that it was committed to using an advisory committee comprised of independent experts to ensure that “deliberations about authorization or licensure [of Pfizer’s COVID-19 vaccine] are transparent for the public.” Yet at the last minute, the agency decided public discussion was no longer necessary. Incredibly, in its approval letter to Pfizer, the FDA claimed that the company’s application “did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”


Please understand what this means.


Pharmaceutical companies typically apply for full approval after a lengthy period has elapsed so that more data are available for review. If anything, a “warp speed” rollout should warrant greater transparency and public discussion, especially given heated public debate about the immediate and long term effects of this particular vaccine.


Instead, the exact opposite has happened. The FDA decided that a product issued under emergency use authorization   —  based on expedited clinical trials   —   did not warrant any public discussion. There was no “platform where questions [could] be raised, problems tackled, and data scrutinized in advance of [FDA] approval.”


None of this is normal. None of this make sense.


Yet just when you think you’ve seen it all from people who seem to be playing fast and loose with our lives, they still manage to surprise you. On Monday, we entered uncharted territory when the FAA did the unthinkable: it engaged in clever legal wordplay to make it appear that it had approved a vaccine that it is, in fact, still under an EUA.


What we’re about to dive into is somewhat convoluted and complicated, but there’s a reason for that: when things are convoluted and complicated, it’s much easier to hide the truth. That’s where legalese comes in, and any lawyer who reads Pfizer’s approval letter will recognize the handiwork of a lot of lawyers.


When the FDA announced that it had approved the Pfizer vaccine, most people probably assumed the agency was referring to the vaccine that had been authorized for emergency use and already injected into more than 150 million Americans. But buried in the fine print of the Pfizer approval letter is a critical detail: Pfizer has “legally” developed two different vaccines. One is the the Pfizer-BioNTech vaccine (the one we are all familiar with); the other is the fully approved vaccine introduced to the world this week as Comirnaty.


There are two things you need to know about Comirnaty. First, this vaccine is subject to “postmarketing” clinical trials that won’t be completed until October 31, 2025. Moreover, the FDA states on page 6 of its letter to BioNTech that these studies are required to assess “known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.”


Please re-read that. Cominarty carries “known serious risks of myocarditis and pericarditis.”


These are the same adverse effects that thousands of Americans have reported to the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccination for the past eight months and which the FDA, CDC, and media have consistently dismissed as “rare.” Yet these rare adverse effects are apparently serious enough to justify four more years of trials and studies for Pfizer’s newly approved vaccine.


Here’s what else you need to know about Comirnaty: it’s not even available to the public yet.


The vaccine the FDA approved this week won’t be injected into any arms in the foreseeable future. Why? The answer is tucked in footnote 9 of Pfizer’s approval letter: “[T]here is not sufficient approved vaccine available for distribution to this population in its entirety at [this] time.


So how are Americans supposed to be vaccinated with an approved vaccine that doesn’t yet exist? The answer to this question lies buried in yet another footnote.


While the Comirnaty vaccine and the Pfizer-BioNTech COVID-19 vaccine are “legally distinct,” the FDA considers them to be essentially the same. The agency asserts that because the two vaccines have “the same formulation,” any differences between them will “not impact safety or effectiveness.” Therefore, the two products “can be used interchangeably.”


Here’s why this matters. Since Comirnaty isn’t available yet, and because the two vaccines can be used interchangeably,” the FDA has determined that the “old” Pfizer-BioNTech (authorized for emergency use only) can be substituted for the newly “approved” Comirnaty until sufficient stocks of Comirnaty are available.


Now, you might be wondering why the FDA would go through these legal contortions to create the appearance that the Pfizer-BioNTech vaccine has been approved when it really hasn’t. If the two vaccines essentially have the same ingredients, why is there a need for two “legally” different vaccines? Why approve one vaccine and keep the other under an EUA? Why wouldn’t the FDA simply upgrade the existing Pfizer-BioNTech vaccine from EUA to full approval?


Here’s why I think this is happening.


Because vaccines authorized for emergency use are considered “investigational productsunder U.S. law, companies and institutions are reluctant to compel people to take them. But once a vaccine is FDA approved, it’s a whole different ballgame because the “safety” optics improve. Mandates can kick in because decision makers feel much more confident requiring employees, staff, and students to get injected with an FDA approved vaccine.


From a manufacturer’s perspective, however, EUA vaccines have one major advantage over those that are FDA approved: they enjoy an extraordinary liability shield. Whereas companies have extremely limited liability for injuries caused by EUA vaccines, manufacturers of FDA approved vaccines can be sued for adverse effects under state product liability law if they do not give “proper warning” to consumers, and the recipient can prove that they would not have taken the vaccine had they known of the risks.


This is extremely important because if the Comirnaty and Pfizer-BioNTech vaccines have the “same formulation,” then the same “known serious risks” of myocarditis and pericarditis from Comirnaty are also present with the Pfizer-BioNTech vaccine currently under EUA. Yet consumers are not being warned of these serious risks. This, of course, begs the obvious question: just how "rare" is the serious risk of injury mRNA vaccines? Let’s dive into the data.


Although the CDC has determined that only 3 deaths in the U.S. have been conclusively linked to COVID-19 vaccinations, the VAERS database reflects more than 13,000 deaths, in addition to more than 700,000 adverse events. These may not seem like large numbers, but keep in mind there were only a total of 8,087 deaths reported to VAERS between 1990 and 2019 for all vaccines administered over those 29 years. Put another way, nearly twice as many deaths have been reported to VAERS in the last 8 months following COVID-19 vaccinations than have been reported for all vaccinations over nearly three decades.


Imagine what this number might look like in three years.


Moreover, a 2011 report by Harvard Pilgrim Health Care for the U.S. Department of Health and Human Services found that fewer than 1% of all adverse events are included in VAERS, and it’s not hard to see why. Many doctors, nurses and other vaccine providers aren’t aware that they are legally required to report health problems that occur after vaccination. And how many Americans are likely to even call their providers to report less-than-debilitating side effects? This means that there could be tens of thousands of COVID-19 vaccine-related deaths that haven’t been reported.


While it’s true that VAERS only reflects self-reported (not verified) cases, the implications are clear. How likely is it that all, or even most, of these cases are coincidences that aren’t linked to vaccination? If even a fraction of these people successfully claim injury following vaccination with the FDA approved Comirnaty — because Pfizer was aware of “known serious risks” that it did not disclose to consumers — the damages could be astronomical. This is a huge liability noose.


But if the company is allowed to continue to distribute the EUA version of its vaccine and “pretend” that it’s just as good as the fully approved Comirnaty, then it enjoys the best of both worlds: a vaccine that Americans can be forced to take, while Pfizer and the governments, companies, and institutions that mandate vaccination remain immune from liability.


The winners in this shrewd bait-and-switch are clear: Pfizer gets to offload millions of doses of its “investigational” vaccine with no liability, and the government gets to push through mandates by convincing hesitant Americans that the vaccine is safe. The only losers are millions of unsuspecting people who choose to get injected with the same vaccine that’s been authorized for emergency use for the past eight months — because they’ve been misled to believe it finally has the FDA’s seal of approval.


In its bizarre desperation to vaccinate every single person on U.S soil, the FDA has gone to extraordinary lengths to deceive the very people it has a fiduciary duty to serve.


Right now, every American should be asking three questions: If the vaccine is as safe as the FDA claims, why are White House staff and employees of the CDC, FDA, WHO and Pfizer exempt from mandates that are sweeping the country? Why is our government insisting that all Americans, regardless of their age or risk level, be vaccinated with a product that clearly doesn’t stop transmission of the now dominant Delta variant? And perhaps most importantly, why is our government willing to deceive Americans to make this happen?

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