“The FDA did NOT grant full approval to the Pfizer shots”

 

image:  Disney's Pinnochio

I continue to post updates on the COVID crisis because it is threatening our basic freedoms.  While some states have banned vaccine mandates, such as Texas, Ohio has not yet voted. And now we are being told that the FDA has given its full approval to the Pfizer vaccine.  I’ve already asked how long-term effects can be studied when there has not been a long-term testing period.  So below is an extract from Carl Schwitzer’s “The FDA did NOT grant full approval to the Pfizer shots” at AmericanThinker:

You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday.  Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining "vaccine-hesitant" into stepping forward to receive their jab.  The FDA even has a press release on its website about it.

There's just one problem.

If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you'll see that the FDA did no such thing.  In the sense that the term "FDA approval" is generally understood, this drug is not approved by the FDA.  It is still under EUA (Emergency Use Authorization).  It is still an experimental drug.

The FDA sent two letters.  The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.

The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY.  This letter also spells out the terms and requirements for nine additional clinical trials over five years [my emphasis], and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots.  This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials [my emphasis].

The EUA extension letter extends the term of the EUA for the current drug and authorizes (licenses) the experimental use of the brand-name drug COMIRNATY.  In the first paragraph on page 2, this letter references the license approval letter.  In the second paragraph on page 2, the August 12 EUA is re-issued to include the name-branded drug in the emergency use authorization, and to add "language regarding warnings and precautions related to myocarditis and pericarditis."  In the last paragraph on page 4, the EUA nature of the drugs is re-iterated, and COMIRNATY is additionally authorized for use for individuals aged 12 through 15 years.

The mRNA gene therapy shots are still experimental.  Mandating them is still wrong — by a wide variety of ethical standards.

Dr. Meryl Nass, M.D. found the truths that the FDA buried in the blather of these letters and offers a theory about why it was done this way.  The drug-manufacturers were granted immunity from liability for the drugs produced under the EUAs.  The granting of the license re-applies the customary liability for injury and death caused by the product.  Pfizer, the health officials, and the politicians get to take a fictitious victory lap for the "approval," while Pfizer-BioNTech continues to stealthily enjoy immunity from product liability because there are many millions of the unlicensed doses on the shelves and in the manufacturing pipeline that will be administered first.  The licensed version will not arrive on shelves or be jabbed into arms for many months to come.

. . .

The rest of the column is here. Becker News has another report on the same subject.  I am linking here, as the analyses are a bit difficult to follow, and a second report may help to clarify.  One thing is clear: we are being lied to again.

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COVID and ivermectin: who do you trust?

 

The FDA warns us not to take ivermectin for COVID.  Cleveland.com reported on that warning, which states that the FDA “has not approved the drug for that purpose” [my emphasis].The same can be said for a cocktail of hydroxychloroquine and zinc; that’s why a prescription is called “off-label.”

On the other hand, American Partisan links to various inexpensive over-the-counter or readily available therapeutics that are effective in mitigating symptoms of the WuFlu. Ivermectin tops the list.  Ivermectin has been taken extensively in, for example, India, with a high success rate;  Daniel Horowitz reports here.

Who do you trust?  

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The collapse of the FDA and Tyranny-by-vaccine

 

Image via Sundance from protest in Australia (see link below)

A few headlines --  from the hundreds crowding the internet today -- shows the corruption, the censorship, and the growing tyranny in the western world:

From American Greatness: FDA Approves Pfizer Vaccine Even Though Multiple Safety Studies Won’t Be Completed For Years

From Freedom First Network: Vaccine-Pimping Us Surgeon General Proclaims Americans Have No Right To Spread Disinformation Which Means Anything The Regime Doesn’t Like

From Conservative Playlist:  Pandemic Panic Theater: Why All 14 ‘Gold Standard’ Randomized Controlled Trials of Face Masks have been Suppressed 

From Epoch Times via Citizen Free Press: Connecticut Goes Full Vaccine Nazi

From InfoWars via Liberty Daily: Military & Blue States Announce Vaccine Mandates MINUTES After FDA Approves Injection

And for a preview of how bad this will get, here’s Sundance on the tyranny now on full display in Australia and New Zealand:

Australian Police Beating More People in the Streets Than the Taliban

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Pfizer vax: What is the rush at the FDA?

 

Why is the government so desperate to have everyone vaccinated?  The Aug 20 headline at Daily Caller:

REPORT: FDA Working To Fully Approve
Pfizer COVID-19 Vaccine By Monday

By Monday?  How can any long-term consequences have been fully tested in the short-term?  

At least Babylon Bee keeps its sense of humor:

'Pfizer+' Monthly Booster Subscription Program Announced

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Vaccine Passports: a bad idea

 

Although author Janet Levy is drawing on some California statutes, her analysis on vaccine passports applies to all of us. From American Thinker:

. . .digital records can be used to track people. Cyberattacks and data glitches could reveal private medical information. Worst of all, vaxxports create a two-tiered society. Those who choose not to be vaccinated – for religious reasons or because the non-FDA approved vaccines are of dubious safety and efficacy – won’t be able to move about freely and lead normal lives.

Peggy Hall, a community leader who runs the website The Healthy American, exposes the duplicity of the county’s Board of Supervisors. She says that by not formally mandating vaxxports, the county can affirm adherence to the California civil code (CIV Sec 51), entitling every individual free and equal access to “all services in any business establishment of any kind whatsoever, regardless of their medical condition.” The true fight, she says, is to get the Board of Supervisors to state on record that they will prosecute businesses for discrimination should they demand vaccine passports from customers.

Ms. Hall also draws on another California law – the Protection of Human Subjects in Medical Experimentation Act – giving individuals the right “to determine what is done to their own bodies” and “the right to decide or consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject’s decision.” Since all anti-COVID vaccines remain unapproved, they may be deemed experimental. Therefore, individuals have the right to refuse and should not be penalized in any way for doing so.

Ms. Levy’s full article is here.

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“I’m Still Not Getting the Vaccine”

 

Dan Gelernter posted “I’m Still Not Getting the Vaccine” at American Greatness:

. . . We have decided to make avoiding disease our full-time job. It’s more important than going to work or seeing your friends. It’s worth destroying the established Western social convention that we be able to see each other’s faces in public. 

I’ve got news for you: If you spend all your time worrying about getting sick, you’re sick already. America is having a giant, hysterical, hypochondriacal fit. 

. . .

As a young and healthy person, there is really no upside to vaccination. I’m simply not likely to get the disease. And, say what you will, we don’t know what the long-term effects of this vaccine will be. 

(Full article is here.) And America’s Frontline Doctors has a sort of “white paper” on why an “experimental” vaccine injection cannot be mandated, legally [endnotes not included in this extract]:

Covid-19 Vaccines are Experimental

Covid-19 vaccines are not approved by the FDA.  The Covid-19 vaccines are only approved under an Emergency Use Authorization, for investigational use only. Covid-19 vaccines lack requisite studies and are not approved medical treatment. The FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”

. . .

The right to avoid the imposition of human experimentation is fundamental, rooted in the Nuremberg Code of 1947, has been ratified by the 1964 Declaration of Helsinki, and further codified in the United States Code of Federal Regulations. In addition to the United States regarding itself as bound by these provisions, these principles were adopted by the FDA in its regulations requiring the informed consent of human subjects for medical research. It is unlawful to conduct medical research, even in the case of an emergency, unless steps are taken to secure informed consent of all participants

The white paper (just 3 pages including endnotes] specifies students but the legal constraints protect us all.

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coronavirus: treatment options

Ruth Papazian is “a Bronx-based health and medical writer, and a political junkie.”    She reports on the medical options available to those diagnosed with COVID-19, a/k/a  Wuhan virus, in a report at American Greatness titled “Fauci’s Folly.” Here’s a brief extract:

. . . a clinician’s job is to save lives. And in the midst of a burgeoning global pandemic when speed is of the essence, field experience with two drugs whose safety profiles are well understood suffices to treat patients who are likely to die. For this reason, the FDA-approved chloroquine and remdesivir, an Ebola treatment, for “compassionate use.” Both drugs can be administered immediately to patients who have serious or life-threatening cases of coronavirus.

The combination of HCQ+AZ could cause abnormal heart rhythms and would not be given to patients with known atrial flutter or atrial fibrillation. Research suggests one alternative for these patients: The combination of chloroquine and zinc, which can stop the virus from replicating.

Read the entire article here. If you or someone you know tests positive for COVID-19, this information would be extremely useful to take to the doctor’s office or hospital.  Ms. Papazian does not have a high opinion of Dr. Anthony Fauci.

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