With the long-term clinical trials still underway, and tens of thousands of deaths, along with millions of serious vaccine injuries (see US
The FDA claimed in 2020 that their ‘rigorous testing means final vaccine approval in 2024!’ LIE! The FDA’s Pfizer vaccine approval letter contains the dates of when studies were to be completed. NOT COMPLETED! Why did the timetable change? Why were dates suddenly no longer applicable and the vaccine approved by the FDA?1
The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.
But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.
First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use.
Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”
There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.
EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.
U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.
EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability.
The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.
The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products. The program’s parsimonious administrators have compensated under 4% of petitioners to date — and not a single COVID vaccine injury — despite the fact that physicians, families and injured vaccine recipients have reported more than 600,000 COVID vaccine injuries.
At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.
When the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices places a vaccine on the mandatory schedule, a childhood vaccine benefits from a generous retinue of liability protections.
But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages.
And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.
Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.
Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.
The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.
Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.
The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product.
While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.
Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product.
If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse.
If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.
The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.
What this all means
The FDA approved Pfizer’s Biologics License Application (BLA). A BLA is the procedural process for “full approval” via the FDA. Pfizer may now directly market the mRNA injections to the public instead of relying on the government and media to push its agendas.
The mRNA injections can also now be sold in interstate commerce instead of governments buying up all the shots. The approved BLA will also increase Pfizer mRNA demand as it’s unlikely any new COVID-19 injections will receive EUA’s since one is now fully approved. Interestingly, the FDA granted Pfizer’s BLA but also extended its emergency use authorization (EUA) for “certain uses that are not included in the approved BLA.” That provision is specifically in reference to the EUA for children age 12 to 15.
This news changes only two things. First, it provides vaxx zealots celebration material and new talking points for defending their holy sacrament. It’s also a sure sign that those who refuse to be poisoned must be ready and willing to protect their lives and well-being by any means necessary.
This “full approval” was essentially purchased by the federal government. Pfizer profits will exceed $33.5 billion in 2021 from the mRNA injections alone, mostly courtesy of the U.S. and European governments. The facts about mRNA injections, the FDA and the Centers for Disease Control (CDC), however, remain unchanged. Keep this article handy to share with your Fauci-worshiping friends and family.
Unbelievably, the FDA also turned over the responsibility to conduct necessary vaccine trials on some of the most important subgroups, like pregnant women, to the manufacturer. Several mandatory studies that should have taken place before full approval still need to be conducted and it will be up to Pfizer to ensure their completion and report the results. In other words, Big Pharma now controls the outcome of key clinical research that will determine the effectiveness of their own product and has the ability to obscure results that could hold them liable or discourage people from taking their jab.
The FDA’s dereliction of duty didn’t end with that. In addition to all the other steps that were skipped, they never completed an advisory committee review because they claim there were no “concerns or controversial issues,” despite an overwhelming number of cases with adverse side effects like myocarditis.
Kim Witczak, a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, questioned the decision to grant full authorization so quickly, and said that the meetings are important for public transparency and to scrutinize any data, in comments she made to The BMJ.
“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightening speed under emergency use authorization.
The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems attacked, and data scrutinized in advance of an approval.
It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years. There is no control group after Pfizer offered the product to placebo participants before the trials were completed.”
The president of the National Center for Health Research, Diana Zuckerman, also criticized the lack of transparency.
“It’s obvious that the FDA has no intention of hearing anyone else’s opinion. But if you make decisions behind closed doors it can feed into hesitancy. It’s important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know.” – Zukerman said to to The BMJ.
The decision to fully approve the Pfizer vaccine is just the latest concerning decision by US Health Officials that have been either lying or outright wrong since the beginning of the pandemic. They have also been hiding relevant information from the public as it has been coming out the entire time.
The agenda behind this evil push remains a mystery. Money is obviously a priority, but is there a more diabolical intent?
The Cable News Network (aka: the Communist News Network, CIA News Network, Clinton News Network, Concocted News Network, etc.) is simply fake news. According to CNN’s own three-time Emmy award winning journalist, Amber Lyon, CNN is routinely paid by the US government to make up fake news and also to selectively report on certain events in ways that fit their narrative. Plus, the Obama administration even paid CNN for editorial control over their content, badly distorting the news in their(...)
— Disclose.tv (@disclosetv) August 23, 2021
“As I mentioned before, I’ve imposed vaccination requirements that will reach millions of Americans,” Biden said Monday.
“Today, I’m calling on more countries – more companies, I should say – in the private sector to step up with vaccine requirements that’ll reach millions more people.”
“If you’re a business leader, a nonprofit leader, a state or local leader who has been waiting for full FDA approval to require vaccinations, I call on you now to do that. Require it,” Biden insisted.
“Do what I did last month. Require your employees to get vaccinated or face strict requirements,” he added, referring to his recent order for federal workers to get the injection.
Biden insisted that Americans will “be protected” if they get the jab even after admitting that some vaccinated people are still contracting COVID-19.
“There are cases where vaccinated do get COVID-19,” Biden admitted. “But they are far less common than unvaccinated people getting COVID-19. And most importantly, their conditions are far less severe.”
“With today’s FDA full approval, there’s another good reason to get vaccinated. So, please get vaccinated now,” he whispered, urging Americans to visit “vaccines.com” instead of the actual website vaccines.gov.
mRNA is gene therapy
Let’s be clear – the Pfizer and Moderna mRNA injections are the same product. The Moderna June 30, 2020 Quarterly Report filed with the U.S. Securities and Exchanges Commission tell you exactly what the mRNA injections are on page 70:
Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain.
Despite their mitigation attempts with the foregoing word salad, mRNA injections are in fact gene therapy.