Two media outlets last week requested, but failed to obtain, clarity from Pfizer on whether its fully licensed Comirnaty COVID vaccine is available in the U.S.
Reporting by The Ohio Star and National File highlighted the ongoing debate over whether the vaccine can legally be mandated, and whether Pfizer can be held liable for injuries related to the vaccine.
The Star reported that despite asking multiple times whether the Comirnaty vaccine is in use, Pfizer would not answer the question.
The U.S. Food and Drug Administration (FDA) in August granted full approval, or Biological License Application Approval (BLA) — for the Comirnaty vaccine for individuals age 16 and older.
The approval, granted without a formal advisory committee meeting or public comments, prompted a number of questions including:
- What, if any, differences exist between the formulations used in the fully licensed Comirnaty vaccine and the Pfizer-BioNTech vaccine being distributed under Emergency Use Authorization (EUA).
- If/when the fully licensed vaccine would be available in the U.S.
Seeking an answer to the latter question, The Star reached out to Pfizer, the FDA and to Ohio’s largest health system, OhioHealth.
A spokeswoman for OhioHealth confirmed the system’s 12 hospitals “are currently distributing the Pfizer vaccine that does not have the Comirnaty branding label.”
In response to whether the Comirnaty vaccine is being used elsewhere in the U.S., Pfizer told The Star in an email:
“The Pfizer-BioNTech COVID-19 Vaccine (EUA labeled product) is currently being shipped; however, please be advised that the COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably. They are made using the same processes, and there are no differences between them in safety or effectiveness.”
Pfizer’s claim that the two vaccines can “be used interchangeably” is inconsistent with FDA statements, The Star said, citing an FDA Q&A page that states the two vaccines are “legally distinct.”
The FDA reaffirmed that distinction, telling The Star the “statutory authorities governing BLAs and EUAs are distinct and provide different legal requirements.”
The FDA “did not directly address” The Star’s initial question about the specific difference between Comirnaty and the EUA vaccine, or why Pfizer is not shipping Comirnaty if the formulas are “interchangeable.”
However, in a Dec. 9 notice of reissuance of the EUA for the original Pfizer vaccine to give booster shots to 16 and 17-year-olds, the FDA said:
“[a]lthough 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.”
The Star also reached out to Ohio Attorney General Dave Yost, asking if Ohio’s public universities are following the state’s law, HB 244, which prohibits public institutions from mandating a vaccine that is not fully approved.
Bethany McCorkle, Yost’s communications director, responded that HB 244 does not apply because “the FDA fully approved the vaccines.”
National File, following up on The Star’s reporting, also contacted Pfizer to ask if Comirnaty is in use. Pfizer told National File the “EUA-labeled product will still be shipped and usable until its expiry date.”
Pfizer did not respond to National File’s follow-up requests for additional clarification.
Comirnaty ‘not available at this time’
According to the Centers for Disease Control and Prevention (CDC), a chart showing the current procedural terminology description for the Comirnaty BLA-licensed vaccine states Comirnaty is “not orderable at this time.”
The current procedural terminology description includes a statement from Pfizer:
“At present, Pfizer does not plan to produce any product with these new NDCs (National Drug Code) and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA (American Medical Association), and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”
According to a Dec.16 letter from the FDA’s acting chief scientist, Jacqueline A. O’Shaughnessy, Pfizer-BioNTech vaccines exported from the U.S. are allowed only if “the regulatory authorities of the country in which the vaccine will be used are fully informed that this vaccine is subject to an EUA and is not approved or licensed by FDA.”
O’Shaughnessy’s letter states there is “a significant amount of Pfizer-BioNTech COVID-19 Vaccine that was manufactured and labeled in accordance with this emergency use authorization. The authorization remains in place with respect to the Pfizer-BioNTech COVID-19 Vaccine for this population.”
In a Twitter exchange last weekend, Rep. Thomas Massie (R-Ky.) cited O’Shaughessy’s letter to refute a tweet by Joe Gerth, a columnist for the Louisville Courier-Journal, who claimed Comirnaty is available.
Can vaccines be ‘interchangeable’ and ‘legally distinct’ at the same time?
Misrepresentations by media and public officials — like those of the Louisville Courier-Journal and Ohio attorney general claiming the Pfizer vaccines in use in the U.S. are FDA-approved — coupled with the FDA’s own ambiguous documents and public statements have given rise to public confusion and legal questions.
Pfizer’s refusal to directly address questions posed by The Ohio Star and National File only adds to the lack of clarity. As political commentator and attorney Robert Barnes told The Star:
“It is an illicit bait and switch. There is no FDA-approved COVID-19 vaccine available in the U.S. The unavailable FDA biologic license approved drug is not medically identical and has to abide different manufacturing standards. As important, you have fewer legal rights and fewer legal remedies when you take an EUA drug than a biologic licensed drug. This directly impacts the legal rights of all Americans.”
The FDA’s assertion that the Comirnaty and Pfizer vaccines are “legally distinct” yet “interchangeable” is at the center of legal arguments around whether one, both — or neither — of the two vaccines can be mandated.
A lawsuit brought by members of the military against the U.S. Department of Justice (DOJ) challenging the DOJ’s COVID vaccine mandate for all service members highlights some of the arguments.
A federal judge on Nov. 12 denied plaintiffs’ request for a preliminary injunction against the DOJ mandates.
However, in his ruling, the judge stated — contrary to claims by Pfizer and the FDA — that the FDA-licensed Comirnaty vaccine is not interchangeable with Pfizer-BioNTech’s EUA-labeled vaccine.
Judge Allen Winsor of the U.S. District Court for the Northern District of Florida said the service members showed the U.S. Department of Defense (DOD) is requiring them to submit to EUA-labeled vaccines, yet “defense counsel could not even say whether vaccines labeled ‘Comirnaty’ exist at all.”
Judge Winsor wrote:
“In the DOD’s view, this is fine because the contents of EUA-labeled vials are chemically identical to the contents of vials labeled ‘Comirnaty’ (if there are any such vials). According to the DOD’s argument, this means servicemembers are not required to accept ‘a product authorized for emergency use.’ …
“Rather, the DOD argues that once the FDA licensed Comirnaty, all EUA-labeled vials essentially became Comirnaty, even if not so labeled. Thus, the DOD argues, the ‘product’ injected is a chemical formulation that has received full FDA licensure — not merely an EUA.”
Judge Winsor called that argument “unconvincing.”
The distinction between an EUA product and one that is fully licensed raises other legal questions. For instance, the FDA fact sheet on the Comirnaty vaccine states:
“This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.”
The statement appears to suggest the Pfizer-BioNTech and Comirnaty vaccines are EUA, and that both EUAs will end under the conditions noted.
Another key difference between fully licensed and EUA vaccines relates to the issue of liability. Under the 2005 Public Readiness and Preparedness Act (PREP Act), EUA vaccines are accompanied by a far-reaching liability shield that protects all parties involved with the product from lawsuits.
Specifically, if one is injured by an EUA vaccine, the only way to claim damages and receive compensation is to apply to the Countermeasures Injury Compensation Program, an administrative process under the U.S. Department of Health and Human Services (HHS), which authorized the vaccines.
At this time, the Pfizer Comirnaty vaccine may have no liability shield, making it subject to product liability laws that allow those injured by it to potentially sue for damages, although Pfizer asserts the vaccine is protected under the PREP Act as well.
After only three months in office, a prophetic President John F. Kennedy was fully aware at the time of dark forces swirling around him and our nation, firmly entrenched in power and posing an alarming threat to the safety and well-being of both America’s last great leader as well as our democratic way of life:
“The very word ‘secrecy’ is repugnant in a free and open society; and we are as a people inherently and historically opposed to secret societies, to secret oaths and to secret proceedings. We decided long ago that the dangers of excessive and unwarranted concealment of pertinent facts far outweighed the dangers which are cited to justify it.
Even today, there is little value in opposing the threat of a closed society by imitating its arbitrary restrictions. Even today, there is little value in ensuring the survival of our nation if our traditions do not survive with it. And there is very grave danger that an announced need for increased security will be seized upon by those anxious to expand its meaning to the very limits of official censorship and concealment… Our way of life is under attack.
Those who make themselves our enemy are advancing around the globe… no war ever posed a greater threat to our security. If you are awaiting a finding of ‘clear and present danger,’ then I can only say that the danger has never been more clear and its presence has never been more imminent…
For we are opposed around the world by a monolithic and ruthless conspiracy that relies primarily on covert means for expanding its sphere of influence – on infiltration instead of invasion, on subversion instead of elections, on intimidation instead of free choice, on guerrillas by night instead of armies by day. It is a system which has conscripted vast human and material resources into the building of a tightly knit, highly efficient machine that combines military, diplomatic, intelligence, economic, scientific and political operations. Its preparations are concealed, not published. Its mistakes are buried, not headlined. Its dissenters are silenced, not praised. No expenditure is questioned, no rumor is printed, no secret is revealed.”
A huge part of humanity’s current problem that we are all facing today is the direct result of allowing this very same monolithic, invisible shadow government that Kennedy so accurately confronted way back in 1961 to infiltrate, infest and continue to grow over the next six decades as today’s international crime cabal currently and brazenly operating as the crystalized enemy of all humanity in 2021, insidiously wielding its unsatiated power and control over the citizenry of both the US constitutional republic as well as the entire world.
As a grave consequence, we’re all now paying an enormously heavy price for collectively failing to heed JFK’s foreboding warnings.
But Kennedy was far from the first US president to alert citizens about the paramount importance of protecting and safeguarding our precious yet vulnerable freedoms. In 1912, former President Theodore Roosevelt alluded to this same elusively dangerous enemy of the people:
Behind the ostensible government sits enthroned an invisible government owing no allegiance and acknowledging no responsibility to the people. To destroy this invisible government, to befoul the unholy alliance between corrupt business and corrupt politics is the first task of the statesmanship of the day.
In three months, it’ll be a full century ago that then New York City Mayor John F. Hylan astutely stated:
The real menace of our Republic is the invisible government, which like a giant octopus sprawls its slimy legs over our cities, states and nation… The little coterie of powerful international bankers virtually run the United States government for their own selfish purposes. They practically control both parties, … and control the majority of the newspapers and magazines in this country.
They use the columns of these papers to club into submission or drive out of office public officials who refuse to do the bidding of the powerful corrupt cliques which compose the invisible government. It operates under cover of a self-created screen [and] seizes our executive officers, legislative bodies, schools, courts, newspapers and every agency created for the public protection.
Apparently President Woodrow Wilson felt so despairingly duped by those same invisible powers-that-be after signing into law the infamous Federal Reserve Act of 1913 that handed America’s money supply over to the private Rothschild central banks:
[W]e have come to be one of the worst ruled, one of the most completely controlled and dominated, governments in the civilized world – no longer a government by free opinion, no longer a government by conviction and the vote of the majority, but a government by the opinion and the duress of small groups of dominant men…
Since I entered politics, I have chiefly had men’s views confided to me privately. Some of the biggest men in the United States, in the field of commerce and manufacture, are afraid of something.
They know that there is a power somewhere so organized, so subtle, so watchful, so interlocked, so complete, so pervasive, that they had better not speak above their breath when they speak in the condemnation of it.
The Federal Reserve
It was exactly 108 years ago on December 23rd, 1913, after the vast majority of Congress had already gone home for the holidays that the Federal Reserve Act was snuck through in the dead of night, passed into law by order of the notorious secret 1910 Jekyll Island conspiracy between Rothschild, Rockefeller and JP Morgan bankers conspiring the financial coup d’état enabling the central banking cartel to begin printing fiat currency out of thin air. Such unbridled monopolistic power over America’s money supply gained purely by cunning deception and manipulation is how the psychopathic elite has stolen ungodly trillions from the ill-informed public.
That same year in 1913 the Federal Income Tax Act was also fenagled through, unconstitutionally swindling Americans out of tax dollars to pay off past war debt interests of engineered bankers’ wars. American citizens get reamed paying debtor interest on money the banks never even possess. This fraudulently rigged scheme was referenced by industrialist Henry Ford:
It is well enough that people of the nation do not understand our banking and monetary system, for if they did, I believe there would be a revolution before tomorrow morning.
Along those exact same lines, it was President George H.W. Bush who admitted in 1992 to longtime White House reporter Sarah McClendon:
If the people ever find out what we have done, they would chase us down the street and lynch us.
Today’s Fake Coronavirus Pandemic
For centuries it’s been more than evident that a relative handful of elite bloodline controllers have been calling the shots on planet earth, engaging in systematic rape, pillage and wholesale slaughter of all life forms that include both humans as well as natural resources.
But with the puppet masters’ Wuhan China launch of their fake Coronavirus pandemic outbreak in late 2019, inducing worldwide panic throughout 2020 based upon calculated lie after lie, the initial first step of their long-premeditated depopulation plan was sufficiently complete.
With nonstop mandated lockdowns and enforced mask wearing pumping unrelenting 24/7 fear porn propaganda into the increasingly paranoid public throughout 2020, the US lifespan from 2019 to 2020 has recently been reported by mainstream media to have dropped by an unheard of near two years, the largest drop in 75 years since WWII.
Then starting with Trump’s “warp speed” vaccine delivery that to this day he so proudly brags about, Step 2 of the elite’s depopulation agenda is the genocidal bioweapon that after one year in operation, by December 2021 is plunging humanity off its first Dark Winter die-off cliff.
So much for the great big lie of “flattening the curve” in two weeks for a back-to-normal life, or the incessant lies of a totally “safe and effective” nonvaccine. Bottom line, the earth controllers have used Big Pharma to globally buy off nearly every major politician, governmental public health “expert” corporate media and tech giant to perpetrate what is on track to becoming the worst and first global genocide in human history.
Meanwhile, the real experts, frontline doctors, nurses, virologists, that at great risk to themselves, have been courageously informing, educating and alerting the public about the Coronavirus hoax and lethal danger posed by experimental non-vaccines have been targeted for pervasive censorship, harassment or worse.
At the same time, 2020’s total number of human deaths worldwide due to Covid-19 turns out to be little different than any of the preceding pre-Covid years, anecdotally backed up by honest, brave whistleblowing morticians like UK’s John O’Looney.
Additionally, the near constant number of flu deaths that regularly occur every year, in 2020 was conveniently falsely blamed on the Covid-19 virus, and, as a result, the preposterous supposition that 2020’s number of flu deaths was virtually zero logically proves the pure absurdity and flagrantly false exposure that the crime cabal has been scamming the global population with the Gates-Fauci pre-concocted and gain-of-function patented, never scientifically isolated nor proven, virtually harmless so-called virus with a 99.7% survival rate.
But the Gates Foundation, the WHO, the Rockefeller Foundation and its NWO creation the United Nations in lockstep with the World Economic Forum’s Great Reset are all smelling mass blood sacrifice and like predatory sharks are zeroing in on their long-awaited dream of one world governance.
To head them off at the pass, legal pushback has arrived in the form of a 46-page lawsuit charging guilty parties with the genocidal crime against humanity filed December 6, 2021 at the International Criminal Court. Stateside challenges opposing imposter puppet Biden’s vaccine mandates have also been cropping up recently with several federal court judges ruling against his unconstitutional dictates.
One year after the vaccine rollout in combination with 2021’s widespread death jab mandates causing millions around the globe, including hundreds of healthy young athletes, to suddenly keel over and die en masse droves, the human lifespan in 2021 is fast plummeting to a far lower age of death like never before, all by diabolical elitist design.
And in keeping with the nonstop consistent deception, the nonvaccinated have been singled out, falsely blamed and scapegoated for spreading the virus and increasing the hospitalizations and deaths, bogusly hyped to justify booster shots every few months due to the latest confabulated variant “waves” like delta and now omicron, known to be so mild that its mortality rate is zero. In the West apartheid governments with vaccine mandates and passports are pitting the vaccinated against the unvaccinated, criminalizing the death jab resistors many of whom in 2022 are slated for concentration camp incarceration. But organized resistance to tyranny is growing.
Yet with worldwide death rates surging in nations with highest vaccination – Israel, Gibraltar, Singapore, Denmark, UK and Netherlands among them, there’s no denying it’s the vaccinations that are currently wreaking the most havoc, killing millions of hypnotized, brainwashed normies dying from blood clots, heart attacks, strokes, cancer and compromised autoimmune deficiency not unlike Fauchi’s AIDS.
It is the courageous dissenters worldwide, billions of us refusing to bow down and roll over and die, who are holding the line through active and peaceful civil disobedience that will be the difference between either succumbing to or defeating the Satanic enemy forces of evil bent on our destruction.
But it’s of paramount importance to recognize that there will be no external savior to rescue us from apocalyptic doom and gloom other than the brave souls exercising their freewill together who will successfully outlast the criminal elite’s agenda for mass extermination and total enslavement. Having recently taken his booster shot, Trump has shown his true colors as a sold-out Big Pharma cheerleader, publicly touting that his deluded, rushed experimental vaccine rollout has “saved millions of lives,” while his refusal to stand up for medical freedom and sovereign liberty clearly smacks of betrayal toward his loyal political base. Offering his lukewarm, tacit approval against forced vaccination is weak at best.
Likewise, all those “hopium pushers” who’ve been so cocksure their hero will be coming back any day, week, month and now year, constantly moving their goalposts back after being dead wrong so many times, have also posed a grave disservice to both humanity and the world wary, fragile truth movement.
For way too many years, too many of the pied piping hopium influencers on the internet with thousands of followers have been promising the patriot millions to sit back, break out the popcorn, and passively “trust the plan bro,” as their inside “intel sources” keep assuring us that all those thousands of unsealed indictments against all those high profile US traitors are receiving their just desserts, compliments of the military white hats quietly holding the evil ones accountable for their ungodly sins at their Gitmo military tribunals and still secret executions.
The masses have been patiently, complacently, desperately waiting and waiting and waiting for any real solid evidence that never seems to quite come, that the good guys are finally moving in to save the day, restoring what’s left of our battered and tattered US constitutional republic from a tragic fate of total ruin, collapse and controlled demolition, to destroy America from within.
Our window of opportunity for taking assertive action is fast closing. At this point, we’ve reached the endgame and it appears there will be no savior to rescue us, not Trump, nor his so-called white hats, not even advanced benign ETs, nope, it’ll be up to us alone to band together in solidarity with God’s support and guidance to stand up to evil, fight to right the wrongs and preserve our divine human species from utter decimation as an AI controlled, robotic transhuman cyborg hybrid.
Back in 2018 leading up to Christmas the Federal Reserve began publicly flirting with the notion of ending asset purchases, reducing their balance sheet and committing to an all-around taper of stimulus. I wrote about it extensively at the time along with my position that the Fed could and would taper, at least for a short period, which would lead to an accelerated crash of stocks. This did in fact happen, but as we all know the Fed reversed course not long after.
This reversal was seen by many as proof that the Fed would “never” actually pursue a full-blown taper and that stimulus measures would go on forever. I believed it could be a dry run for a more aggressive taper event down the road. I argued that the Fed would continue stimulus until stagflation became evident to the public, and then a careful game of scapegoating would have to be played and another taper would commence.
It is also important to understand that there were many in the economic media that also argued that because the dollar is the preeminent world reserve currency the central bank could print dollars perpetually without inflationary consequences. This notion became a basic fundamental of Modern Monetary Theory (MMT).
Of course, MMT is utter nonsense. There are ALWAYS consequences for overt money creation even for world reserve currencies. It doesn’t matter if you try to price your national currency without comparisons to foreign currencies; under globalism and economic interdependency the velocity of money matters. If a country is printing with wild abandon, those dollars are going to buy less labor, less production and less goods overseas. Nothing defeats the laws of supply and demand, not even strategic debt creation.
We are now at that stage again where price inflation tied to money printing is clashing with the stock market’s complete reliance on stimulus to stay afloat. There are some that continue to claim the Fed will never sacrifice the markets by tapering. I say the Fed does not actually care, it is only waiting for the right time to pull the plug on the US economy.
In previous articles I have described the Federal Reserve as an “ideological suicide bomber.” There are some people out there who still do not grasp this concept and it boggles my mind to see how they rationalize many of the Fed’s actions, as if the people running the fed are “oblivious” to the damage they are doing.
First and foremost, no, the Fed is not motivated by profits, at least not primarily. The Fed is able to print wealth at will, they don’t care about profits – They care about power and centralization. Would they sacrifice “the golden goose” of US markets in order to gain more power and full bore globalism? Absolutely. Would central bankers sacrifice the dollar and blow up the Fed as an institution in order to force a global currency system on the masses? There is no doubt; they’ve put the US economy at risk in the past in order to get more centralization.
At the onset of the Great Depression, the Fed increased interest rates into weakness after years of artificially stimulating markets with low cost debt. This prolonged the deflationary crash for many years. It was not until many decades later when former Fed chair Ben Bernanke gave a speech celebrating economist Milton Friedman’s 90th birthday that a central bank official finally admitted that the organization was culpable for the Depression debacle.
“In short, according to Friedman and Schwartz, because of institutional changes and misguided doctrines, the banking panics of the Great Contraction were much more severe and widespread than would have normally occurred during a downturn.
Let me end my talk by abusing slightly my status as an official representative of the Federal Reserve. I would like to say to Milton and Anna: Regarding the Great Depression. You’re right, we did it. We’re very sorry. But thanks to you, we won’t do it again.” – Ben Bernanke, 2002
What Ben Bernanke did not admit to was that the engineered deflationary crisis greatly benefited the allies of the Fed – The international corporate bankers. Companies like JP Morgan and Chase National were suddenly in a prime position to seize unlimited power in the US. But how?
Not many Americans today realize that a hundred years ago banking was highly decentralized. In fact, there were thousands of smaller community banks all across the country back then that were not attached to titanic banks like JP Morgan. One of the biggest coups of the Great Depression was that at least 9000 of these small banks were destroyed by the crash or absorbed by the international banks. There was no longer any local competition to the major corporations, they now dominated all lending markets.
If you wanted a loan or if you wanted to open a savings account after the depression, you would have to go through a small handful of mega-conglomerates. Complete centralization of finance had been achieved and the Fed helped to make this happen. Was this purely coincidence and negligence on the part of the Fed, or, did they know exactly what they were doing?
To be clear, the Catch-22 of taper vs stimulus and stagflation vs deflationary collapse is only a trap for the American public, it is NOT a trap for the Fed.
Again, they don’t ultimately care about the survival of the US economy. They’ve been destroying our financial system and currency slowly for over 100 years and they have been speeding up the process ever since the crash of 2008; why would they suddenly want to save it now? The Fed may taper or they may not. I predict they will once again officially taper at least for a time. Whether they continue to hold to that taper and for how long is a separate question. In either case, the dollar’s purchasing power still comes under threat and price inflation will still be the result…..
The military is actively trying to force bioweapon shots into servicemember’s arms despite their objections. Sgt. Brittany Puckett is one of those servicemembers who is objecting to this, however members of congress and many lawyers are ignoring her letters despite the fact that these mandates are clearly unconstitutional. Sgt. Brittany Puckett joins us to discuss.