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2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine
Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.
Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine.
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) — available for use.
The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.
Second, the FDA pointed out that both the licensed Pfizer Comirnaty vaccine, and the existing vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”
There is a huge real-world difference between products under an EUA compared with those that 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-licensed 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 that 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.
And FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority of vaccines available in the U.S., if not all, remain unlicensed EUA products.
Here’s what you need to know when somebody orders 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.
Big Pharma pays off FDA advisors
An investigation by Science magazine found that:
- Of 107 physician advisers who voted on the committees Science examined, 72 were paid. 40 received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve. 26 gained more than $100,000; and six more than $1 million.
- Of the more than $24 million in personal payments or research support from industry to the 16 top-earning advisers—who received more than $300,000 each—93% came from the makers of drugs those advisers previously reviewed or from competitors.
- Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA.
Pfizer does not mandate COVID jab for its employees, internal documents revealed
Mainstream media may be reluctant to show just how much opposition there is to the worldwide push for injection mandates, but massive protests are happening in places like France, Australia, and California. Do not believe the propaganda: mandate-opposition is NOT coming from just one side of the political aisle.
But unlike millions of healthcare workers, students, and other hard-working Americans who risk being dismissed for not getting the jab, employees of Pfizer – one of two makers of the new mRNA COVID shot – remain free to choose whether to put this medical product in their bodies.
Is your local government or employer trying to mandate the COVID jab? You won’t believe who isn’t – the makers of the jab themselves
Far from facing termination, these employees can choose to remain uninjected, decline to declare their injection status, OR seek a medical or religious accommodation. Pfizer will require these individuals to participate in regular COVID-19 PCR testing, but the glaring hypocrisy remains:
People who work for the very company making and profiting off this novel drug are not required to take it under threat of termination, whereas millions of other Americans are.
And it’s not just Pfizer. It’s also been alleged that Johnson and Johnson and Moderna either do not mandate these experimental drugs, or require routine PCR testing as an alternative.
Moderna recently announced they are developing new vaccines for the flu as well as the common cold. Does this mean that someday we will not be allowed to go into public spaces if we don’t get our annual flu shot and rhinovirus shot, too?
Have we reached a point in history when adult vaccine schedules will be required in addition to childhood vaccine schedules? Must we all become patrons of Big Pharma in order to remain free citizens?
Do people not see the dangerous precedent that has been set?
If the idea of having to take medical products in order to move freely within your community and provide for your family worries you, we encourage you to keep taking action. Call your local representatives. Check your state’s exemption laws and, if able to, prepare your exemption letters.
Opposing COVID measures now tops the U.S. Department of Homeland Security’s list of potential terror threats
Public officials and media pundits are seemingly intentionally fanning the flames of unveiled hatred against those who choose to not participate in the COVID jab experiment
The rhetoric now hurled at unvaccinated people would under normal circumstances be considered hate speech. Now, it’s promoted as virtuous, while reporting a statistic or medical finding that counters the official narrative is considered hate speech
By convincing everyone that unvaccinated people are to blame for the never-ending pandemic, the pandemic industrial complex prevents the masses from identifying and turning on the real culprits
The World Health Organization is working with an artificial intelligence tool called EARS. It mines blogs, news articles and online forums in 20 countries, analyzing narratives and anticipating information spread. In all likelihood, it can also predict which narratives would most effectively counter the concerns people express. These propaganda narratives can then be disseminated through bot farms