Information obtained from Liberty Counsel.
There are currently no fully FDA-approved licensed COVID shots available. All COVID shots remain under federal Emergency Use Authorization, meaning individuals have the “option to accept or refuse” the product.
On October 20, 2021, the Food and Drug Administration (FDA) sent a follow-up letter to the original approval to Pfizer pharmaceutical company that stated, “having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 23, 2021 letter of authorization in its entirety with revisions incorporated to authorize for emergency use the administration of a single booster dose of COMIRNATY.”
On page 7, footnote 13 of that letter the FDA clearly states, “Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is no sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or to provide: an additional dose to the immunocompromised population, or a booster dose to the authorized population described in this EUA” (emphasis added).
On August 23, 2021, the FDA sent an approval letter to Pfizer regarding the BioNTech injection, Comirnaty. The letter states: “Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.”
The FDA did a bait and switch by announcing it approved its “first COVID-19 vaccine” in order to push the “vaccine” mandates and protect the Pfizer pharmaceutical company from legal liability. The Pfizer injection, on the other hand, is still considered experimental under U.S. law.
There is a legal difference between products approved under authorization of emergency use (EUA) compared with those the FDA has fully licensed. The FDA issued another letter for the existing Pfizer shots which confirms they are still under EUA, are not fully approved, and has a liability shield. That means people must be told the risks and benefits, and they have the “option to accept or refuse” the product. The federal Emergency Use Authorization law and the FDA, including the FDA Fact Sheet, state unequivocally that each person has the “option to accept or refuse” the shots.
- All existing Pfizer vials (in the hundreds of millions), remain under the federal Emergency Use Authorization (EUA) (meaning people have the “option to accept or refuse”);
- The third or “booster” Pfizer shot is identical to the above and remains under the EUA with limited use to certain categories of people;
- BioNTech received FDA approval for people ages 16 and above under the name Comirnaty, but there are no Comirnaty doses available in the United States;
- In other words, there is currently NO FDA-approved COVID-19 injection available anywhere in the United States. Every COVID shot in America remains under the EUA law and thus people have the “option to accept or refuse” them; and
- Even when an FDA-approved COVID shot becomes available, individuals are protected by federal law and many state laws from being forced to get these shots based on their sincere religious beliefs or conscience rights.
Liberty Counsel Founder and Chairman Mat Staver said, “The FDA has clearly stated there is currently no fully FDA-approved licensed COVID shot available to the population. The Pfizer injection that is currently available in the U.S. is not FDA approved and remains under emergency use authorization only. That means that people have the option to accept or refuse the shots.”
Quest for FDA-approved “Vaccine” (COMIRNATY) Leads to Mandates Built on Sand
Oct 13, 2021
“To be honest, I’ve never even seen Comirnaty in the wild.”
It was the first answer a Walgreens pharmacist gave me, this one in Salt Lake City, but it wouldn’t be the last. As a writer for Liberty Counsel, I was researching the assertion that FDA-approved shots were available nationwide. Nine conversations later—after speaking with pharmacists from East to West Coast and in large cities in between—their answers parroted each other in almost identical two-minute conversations:
Me: “Hi. Do you administer the Pfizer vaccine at this location? Yes? Great!! Can you do me a favor and check the labels of your vaccines in stock? Let me know if they say ‘Pfizer-BioNTech’ or ‘Comirnaty.’ I understand that the formulations are supposed to be the same, but the vaccine under the Comirnaty label is actually the only one that’s been approved by the FDA. Thanks so much.”
Pharmacist: “The Pfizer vaccine we have is labeled ‘Pfizer-BioNTech COVID-19 vaccine.’”
Me: “So, just to confirm, you don’t have any vials labeled ‘Comirnaty’? Nothing else in stock?”
Pharmacist: “All I have is Pfizer-BioNTech.” (Except for the pharmacist in Los Angeles who replied, “What’s Comirnaty?” Not the answer I expected, but that also answers my question.)
In addition to Salt Lake City and Los Angeles, I spoke with pharmacists in New York, Chicago, Miami, Seattle, Houston, Kansas City, Orlando and Boston. Not one of the stores I called stocked—or administered—the only COVID injection approved by the U.S. Food and Drug Administration.
I even googled, “Where can I get a Comirnaty vaccine near me?” and “Where is the Comirnaty vaccine available?” Search-engine results led me to websites for Comirnaty and the FDA. The only problem is once I clicked on those websites, to borrow the famed lyrics of U2, “I Still Haven’t Found What I’m Looking For.” This isn’t hard: Please just give me a brick-and-mortar location of where I can get your FDA-blessed COMIRNATY-BRANDED vaccine. Today, thank you. Crickets.
I set out on my own investigation after reading a Newsweek article fact-checking statements made by Sen. Ron Johnson (R-WI) on a recent Fox News Primetime interview. Newsweek gave him a “False” reading on its Truth-O-Meter, and I decided maybe Newsweek needed a Truth-O-Meter reading of its own. What did Sen. Johnson say that so triggered Newsweek? Did his words expose a false foundation for vaccine mandates that, if legally dissected, bring the whole house of cards down in one fell swoop?
BARING THE FACTS ON THE FDA-APPROVED SHOT
In his interview, Sen. Johnson told Fox News:
We do not have an FDA-approved vaccine being administered in the U.S. The FDA played a bait and switch. They approved the Comirnaty version of Pfizer drugs. It’s not available in the U.S. They even admit it. I sent them a letter three days later going, “What are you doing?”
What they did is they extended the emergency use authorization for the Pfizer drug vaccine that’s available in the U.S. More than 30 days later, they haven’t answered that very simple question: If you’re saying that the Pfizer drug is the same as the Comirnaty, why didn’t you provide FDA approval on that? So, there’s not an FDA-approved drug…”
Indeed, the FDA, in a letter dated Sept. 22, 2021, states, “Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA.”
Newsweek interpreted: “Its language does not imply there are no COMIRNATY doses available in the U.S.— merely that there were not enough vaccines for those aged 16 and above.” Newsweek went on to say they contacted the FDA to ask if Comirnaty-labeled doses were currently available in the United States, yet the article omitted whether or not the FDA answered. The article then pivoted to pointing out that Walgreens states that Comirnaty is available at its stores.
That’s when I decided to spend Friday afternoon calling Walgreens across the country. I made sure I called stores located in the heart of our mega metropolises—you know, the ones where lots of people are? I thought, surely if Comirnaty were available, initial shipments would go straight into locations with high population density. Like the Walgreens I called a few blocks from the Empire State Building in Manhattan, right? Oh, sorry, just not that one.
BLURRING THE LINES IN MARKETING
Walgreens markets the Pfizer-BioNTech COVID-19 vaccine as if it were one and the same with Comirnaty, placing the word “Comirnaty” in parentheses beside Pfizer on their website. By making no distinction between the two, Walgreens influences customers to make no distinction between the two either.
Except there’s one problem: The two injections are not the same according to the law. While the Comirnaty website says, “COMIRNATY (COVID-19 Vaccine, mRNA) is also known as Pfizer-BioNTech COVID-19 Vaccine,” the two are legally separate products. The FDA disclosed this in Footnote 1 in its fact sheet for Pfizer-BioNTech and Comirnaty products, stating, “The products are legally distinct with certain differences that do not impact safety or effectiveness.”
Mat Staver, founder and chairman of Liberty Counsel affirms this distinction.
“There is a legal difference between products approved under authorization of emergency use (EUA) compared with those the FDA has fully licensed. The FDA issued another letter for the existing Pfizer shots which confirms they are still under EUA, are not fully approved and have a liability shield. That means people must be told the risks and benefits, and they have the ‘option to accept or refuse’ the product. The federal Emergency Use Authorization law and the FDA, including the FDA Fact Sheet, state unequivocally that each person has the ‘option to accept or refuse’ the shots.”
BUILDING JAB-OR-JOB MANDATES ON SAND
Both Sen. Johnson and Liberty Counsel call what the FDA did a “bait and switch” by announcing the agency approved its “first COVID-19 vaccine” in order to push the shot mandates and protect Pfizer from being held liable. The injection labeled “Pfizer-BioNTech,” on the other hand, is still considered experimental under the law.
“So, there’s not an FDA-approved drug and, of course, they announced it so they could push through these mandates,” Johnson said. “People actually think, ‘Oh, okay, now these things are FDA approved.’”
What does that mean for the 100 million Americans affected by the Biden administration’s call for vaccine mandates in both the public and private sector?
“This means every individual has the right to accept or refuse the shot. Every ‘vaccine’ mandate that forces people to get the shots is violating federal EUA law,” says Mat Staver, founder and chairman of Liberty Counsel.
Hey Walgreens, you may want to change your website.
This article can also be viewed on THE STREAM.