Article 43

 

Friday, August 27, 2021

NWO - Pfizer Vaccine Approved

image cronavirus

In general, people are considered fully vaccinated: 2 weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or 2 weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine.  If you don’t meet these requirements, regardless of your age, you are NOT fully vaccinated.
- CDC, September 16, 2021

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Scandal Behind the FDA Fake Approval of Pfizer Jab

By F. William Engdahl
New Eastern Outlook
August 30, 2021

On August 23 as the FDA announced full approval for the Pfizer mRNA gene-edited substance. Or not quite, when the full papers of FDA are studied. Fauci, whose NIAID has financial interest in the vaccine, referred to the FDA decision as the final “stamp of approval.” It is however anything but final or an impartial, scientific rigorous medical evaluation. Rather it is a politically-motivated decision by an FDA that is corrupt beyond the imagination of most people.

Backtracking on its statement in 2020 that it would hold normal FDA advisory committee hearings with independent experts to discuss the Pfizer application for full approval, now the FDA told the British Medical Journal that they did not believe a meeting was necessary ahead of granting full approval of what is the most controversial vaccine in modern history. The BMJ quotes Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, These [FDA] public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under EMERGENCY USE AUTHORIZATION.

Witczak continued with the alarming note, “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.” Read that again, slowly. Pfizer tests destroyed their own control group mid-stream! And its six month rollout of the mRNA jab worldwide has resulted in catastrophic side effects which have been totally officially ignored. Is this “science” Dr Fauci?

The refusal of the FDA and its Acting Director, Janet Woodcock, to convene its Drugs Advisory Committee for discussion of the Pfizer and BioNTech decisions is even more shocking as in June three members of that same panel resigned in protest for being disregarded in another drug approval. NPR network reported, “Three experts have now resigned from a Food and Drug Administration advisory committee after the agency approved an Alzheimers drug called Aduhelm against the wishes of nearly every member on the panel.” One of the three, Dr. Aaron Kesselheim, in his resignation letter from the FDA Advisory Committee (June 10, 2021), wrote: “For both eteplirsen and aducanumab, the decisions by FDA administrators to ignore the Advisory CommitteeҒs clear recommendations led to their approval of two highly problematic drugs that offered little evidence that they would meaningfully benefit patientsWith eteplirsen, the AdComm (Advisory Committee) and FDA’s own scientific staff reported that there was no convincing evidence that the drug worked; both groups were OVERRULED by FDA leadership...”

Now the FDA refusal to convene their advisory committee for the Pfizer decision is all the more astonishing in light of the fact that the Government Centers for Disease Control (CDC) in its official VAERS data bank for recording vaccine negative effects has recorded 8,508 reports of fatalities following the Pfizer mRNA shot in the past seven months, a number MORE than for all vaccines combined in the past 30 years. By denying a public hearing the FDA avoided any discussion of these alarming fatality numbers, let alone the tens of thousands of SERIOUS SIDE EFFECTS including heart attacks, blood clots, miscarriages, permanent paralysis following the Pfizer-BioNTech jabs. The public declaration by Fauci before approval that he expected it, is also unethical influencing, but that is the least of the crimes.

Faked Approval

It seems the FDA executed a clever ruse in which it issued separate rulings for a Pfizer Inc.-BioNTech vaccine which is widely used in the USA, and another ruling for the similar vaccine of Pfizers German-based partner and developer of the mRNA platform, BioNTech of Mainz. It is only BioNTech that got FDA approval, but conditioned on completion of a series of further tests on select groups including infants, pregnant women and youth, by 2027. The US vaccine, Pfizer-BioNTech Covid-19 vaccine, only got extension of its Emergency Use Authorization (EUA), not full approval!

In their separate letter to Pfizer, the FDA stated, “On August 23, 2021, 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 12, 2021 letter of (Emergency Use) authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses...”

Buried in a footnote in the letter the FDA admits there are two legally separate entities and vaccines - Pfizer-BioNTech Covid-19 Vaccine and BioNTech GmbH of Mainz with its own vaccine trade-named Comrinaty. The FDA writes that “The products are LEGALLY DISTINCT WITH CERTAIN DIFFERENCES. Legally distinct means two separate vaccines. If you find this confusing it is meant to be. Only under an EUA ruling is Pfizer presently exempt from vaccine liability. Some lawyers are calling the FDA ruse a classic “bait and switch” tactic, a form of fraud based on deception.

US vaccinologist and a developer of the mRNA technique, Dr Robert Malone, has accused the FDA of playing a “bureaucratic shell game” with their supposed early approval of the Pfizer Covid-19 vaccine. He cites the two separate FDA letters, “There is a letter for Pfizer and a letter for BioNTech. The New York Times and the Washington Post got it wrong. The authorization is not for Pfizer. The authorization is for BioNTech, and it will only be initiated at the time BioNTech PRODUCT BECOMES AVAILABLE...”

Adding to the bizarre irregularities, in their two separate letters, one to BioNTech and another to Pfizer, the FDA repeatedly deletes the location of the vaccine manufacturing they approve. Why that? Is it in China where BioNTech has a joint agreement with Fosun Pharma of Shanghai to JOINTLY PRODUCE and market Comirnaty vaccine for COVID-19? Why do they need to hide that location data from the public? Would it expose the entire fraud?

FDA-Pfizer Conflicts of Interest

In 2019 Pfizer made a very conflicted appointment to its board of directors. It took Scott Gottlieb, who had just resigned as head of the FDA three months earlier. If this gives an appearance of a huge conflict of interest, it is. Alongside Gottlieb at Pfizers Board of Directors sits Dr Susan Desmond-Hellmann, who headed the Bill and Melinda Gates Foundation until 2020. The Gates Foundation is behind every single key part of the covid vaccine rush and owns stock in Pfizer to boot.

Another person who links Pfizer and Gates is Prof. Holly Janes, a bio-statistical expert in Gates’ hometown Seattle, at the Fred Huff cancer research center. Janes is also a member of the FDA Vaccine Committee until 2023. Notably, she co-designed the controversial trials for both Pfizer and Moderna mRNA vaccines for Fauci’s NIAID from her Seattle center, which is also FUNDED by the Gates Foundation.

Janes is Professor at the Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, known as Fred Hutch. Earlier she received Gates Foundation research money for a six year period when she worked for the Gates Foundation from 2006 to 2012 to develop “statistical and study design support for pre-clinical vaccine performance trials.” Prof. Janes also helped develop the program that TRACKS VACCINE DATA at John Hopkins University.

The person who runs FDA as “Acting Director” is Janet Woodcock. To call her tainted is mild. She has been at FDA since 1986, almost as long as Fauci at NIAID. Woodcock was Bidens choice to head FDA, but a massive opposition from 28 groups including state attorneys general and citizen groups forced him to name her “acting,” which does not need Congressional scrutiny.

Woodcock was directly responsible for the FDA approval of deadly opioids over the objections of her own scientists and other advisors. Two decades ago as head of the FDA unit responsible, Woodcock was instrumental in the approval of a powerful opioid, Zohydro, even though the FDA’s own scientific advisory committee voted 11-2 to keep the drug off the market because it was unsafe. The online Drugs.com writes, “Hydrocodone (Zohydro) can slow or stop your breathing. Never use Zohydro ER in larger amounts, or for longer than prescribed. .. Swallow it whole to avoid exposure to a potentially fatal dose. Hydrocodone may be habit-forming, even at regular doses”. Woodcock later approved the sale of a high-strength narcotic pill, OxyContin, as “safer and more effective” than other painkillers based on the false claims of the now bankrupt manufacturer, Purdue Pharma. Some 500,000 Americans have since died as a RESULT OF OPIOD ADDICTION.

Woodcock clearly is the key FDA person behind the duplicitous August 23 Pfizer decision, seeing to it that there were no public advisory hearings to review relevant data. It would be relevant to know what discussions or communications went on with her former boss, now Pfizer director, Scott Gottlieb.

Why?

There are many unanswered question in this twisted tale of corruption at FDA and Pfizer. Was this theater rushed through by the Biden Administration to accelerate the forced vaccination of millions of Americans uncertain or skeptical of taking an emergency or experimental jab? Why is there such an incredible pressure from mainstream media and politicians to vaccinate every man, woman and now child in the US? Are the vaccines really safe if there are so many dire cases of adverse events after the Pfizer jab? Why did the FD refuse to allow its independent vaccine committee to weigh in?

It is worth noting that as of August 14 Pfizer does not mandate vaccines for its own employees. Also the Biden White House does not mandate vaccines for its staff. These are all serious issues that demand serious and honest answers.

About the author:

F. William Engdahl is strategic risk consultant and lecturer, he holds a degree in politics from Princeton University and is a best-selling author on oil and geopolitics, exclusively for the online magazine NEW EASTERN OUTLOOK.

SOURCE

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image: deceoved

Yes, the FDA really HAS given full approval to the Pfizer/BioNTech COVID-19 vaccine

After the FDA announcement a week ago that Comirnaty, the COVID-19 mRNA vaccine developed by BioNTech and Pfizer, had been approved, it took less than a day for antivaxxers to spin a conspiracy theory claiming that the FDA hadn’t really approved the Pfizer vaccine at all and that Comirnaty wasn’t available, all to protect Pfizer from liability. Its a superficially plausible conspiracy theory that falls apart upon closer inspection.

By David Gorski
Science Based Medicine
August 30, 2021

One week ago today, the FDA granted FULL APPROVAL TO COMIRNATY, the mRNA-based COVID-19 vaccine developed by BioNTech and Pfizer, and there was much rejoicing. One reason for the rejoicing was the belief, widespread among health authorities, that one thing holding many back from getting vaccinated against COVID-19 was the knowledge of how the three COVID-19 vaccines currently available in the US (made by Pfizer/BioNTech, Moderna, and Johnson & Johnson) had been distributed under an emergency use authorization (EUA). Because this was less than full FDA approval in that it is a MECHANISM which permits the FDA to “allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives,” so the thinking goes, many vaccine-hesitant didn’t trust the vaccines but would trust them once the FDA formally approved them, as STEVE NOVELLA DISCUSSED LAST WEEK. To some extent, this might be true, although I rather suspect that the number of vaccine-hesitant who will be persuaded by full FDA approval of Comirnaty to get the shot will be relatively small compared to what was hoped for. I also know that full FDA approval won’t sway antivaxxers in the least.

Indeed, it was almost as though antivaxxers were ready with a line of propaganda about Comirnaty and the Pfizer/BioNTech vaccine. Just to be transparent, I will note that I wrote about this last week for my not-so-super-secret other blog, but this bit of misinformation has gone viral to the point where I thought it very much worthwhile to cover it for Science-Based Medicine as well. Obviously, there will be overlaps between my previous post and what I’m writing now, but there have also been developments since last week that weren’t covered, and as a result this post is substantially different from the previous one. (Also, if you don’t read my other blog, this will be all new to you anyway.) Moreover, since I wrote that post, I think Ive found an element from FDA messaging that left the door open to a new conspiracy theory that builds on this one. As I’ve said before, I do grudgingly almost have to hand it to antivaxxers. No matter how often their misinformation based on bad science, pseudoscience, and conspiracy theories is debunked with science, evidence, events, and reason, theyre always ready with a Talking Point B (and C and D and E) to replace the debunked talking point with a new one. In this case, after Comirnaty had been approved on Monday, antivaxxers came up with this conspiracy theory by Tuesday.

But what is this conspiracy theory? Follow me down the rabbit hole.

“The FDA pulled a bait and switch”

Although the sources that led me to this particular conspiracy theory were articles posted by Tuesday, I’ll begin with a Tweet from antivax “thought leader” Robert F. Kennedy, Jr.:

Here’s my latest with @NassMeryl… Buried in fine print of Monday’s approval by FDA of Pfizer Comirnaty COVID vaccine are 2 critical facts that affect whether vaccine can be mandated + whether Pfizer can be held liable for injuries.

The ARTICLE LINKED to claims:

The press REPORTED that VACCINE MNDATES 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.

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.

So what does that particular footnote in the FDA LETTER say? Let’s quote it:

The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

So the licensed vaccine (Comirnaty) has the same formulation as BNT162b2, the designation for the Pfizer/BioNTech vaccine that has been distributed since December under an EUA. However, for reasons not described in the FDA letter, the FDA says that the two are “legally distinct,” and there is the phrase that’s launched a major conspiracy theory among antivaxxers.

RFK Jr. and Meryl Nass continue:

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.

I’ve pointed out, here and elsewhere, many times before that the NUREMBERG CODE GAMBIT is nothing more than a convenient way of comparing vaccine advocates and those favoring vaccine mandates to Nazis. First, it deceptively conflates a legal definition of “experimental” or “investigational” (basically any drug or biological that hasn’t yet received full FDA approval) with a scientific definition of “experimental.” The way I like to show the deception is to point out that a product that has gone through phase 1, 2, and 3 testing involving tens of thousands of subjects, over 300 million doses of which have been administered with an excellent record of safety and effectiveness in just the US alone, is not, by any reasonable scientific definition, “experimental” any more. It’s just not yet FDA-approved. Moreover, the “Nuremberg Code” gambit intentionally ignores more recent statements of ethics regarding human subjects research, such as the BELMONT REPORT in the 1970s and the DECLARATION OF HELSINKI, which was most recently updated in 2018. Why would antivaxxers ignore a more recent and comprehensive statement on the ethics of human subjects research in favor of a 75 year old code that, while historically very important, is not the current standard? Isn’t it obvious? The more recent reports don’t involve a judgment against Nazis, and antivaxxers are about nothing if they aren’t about comparing doctors to Nazis and vaccine mandates to the Holocaust.

You can see the conspiracy theory here. To sum up its essence, antivaxxers are claiming that the FDA did a “bait and switch,” approving Comirnaty, the Pfizer vaccine given a trade name while leaving BNT162b2, the designation of the vaccine that had been granted an EUA under the same EUA, all in order to not just give the “appearance” that COVID-19 vaccine mandates are now legal but to allow the old BNT162b2 not to have to be covered under the National Childhood Vaccine Injury Act of 1986, the law that created the Vaccine Court and mandates that all claims of vaccine injury go through the Vaccine Court first before they can go through regular federal courts.

Of course, antivaxxers frequently forget to mention that the Vaccine Court is rather lax. The Vaccine Court was designed, if anything, to err on the side of paying out, as the Daubert standard for admissibility of expert witnesses isn’t always enforced, leading sometimes to “expert witnesses” who would never be allowed in regular courts. Speculation is permitted, and all that is required to potentially win a settlement is a “BIOLOGICALLY PLAUSABLE” MECHANIM mechanism, rather than a scientifically demonstrated mechanism. Also, it’s a civil court, and the standard of evidence for compensation is what some have called “50% and a whisker.” Moreover, compensation is AUTOMATIC for so-called “table-injuries” (known injuries that science attributed to vaccines listed on the VACCINE INJURY TABLE). Indeed, I frequently suspect that what drives so much of the antivax hatred towards the Vaccine Court is not just that it has rejected claims of causation of autism by vaccines, but from trial lawyers. Even though they can get a lucrative steady paycheck billing their hourly rates while representing families taking their case to the Vaccine Court, trial lawyers who want to sue vaccine manufacturers for fantastical “vaccine injuries” will never get a massive contingency fee percentage of a huge headline-making award.

In any event, UC-Hastings LAW PROFESSOR DORIT REISS has explained that vaccines issued under an EUA are probably not covered by the NCVIA of 1986 and the Vaccine Court, but under a much more restrictive system:

In essence, COVID-19 vaccines manufacturers, distributors, and administrators are currently almost completely exempt from liability because the vaccines and other COVID-19 products - are under a PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT (PREP) DECLARATION.

The only exception the only situation where you can sue these actors - is if you can show they engaged in “willful misconduct”.

The conditions are rather restrictive, too. The vaccine maker must have acted:

· intentionally to achieve a wrongful purpose;

· knowingly without legal or factual justification; and

· in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit

Reiss further notes:

People harmed by a vaccine covered by the declaration may turn for compensation to the Countermeasures Injury Compensation Program WHICH IS HARD TO USE.

So there you have the conspiracy theory in a nutshell. Ironically, RFK Jr.’s version of the conspiracy theory is the least wild one.

Robert Malone and Greg Hunter crank the conspiracy up to 11

Although I don’t know for sure, I think that this particular conspiracy theory originated with Dr. Robert Malone. Perhaps you’ve heard of him. He’s a scientist who’s made a name for himself in crank circles by claiming to be the “inventor of mRNA vaccines.” He isn’t, as far as I can tell, although that doesn’t stop him from ranting about how his contributions to the vaccine are being “ERASED FROM WIKIPEDIA” for going against orthodoxy on COVID-19 and mRNA vaccines against the disease. Amusingly, it appears that his wife got busted editing his Wikipedia entry under the nym Glasspool1 and that there were a lot of other suspicious edits to his entry, leading Wikipedia editors to take action to put the kibosh on this attempt to use Wikipedia for self-promotion.

In any event, the first instance of this conspiracy theory that I saw was published last Tuesday on Greg Hunter’s USA Watchdog as a post titled FDA LIED - VAX NOT APPROVED STILL EXPERIMENTAL:

The big news the FDA had given “full approval” to the Pfizer CV19 vaccine is a HUGE lie. The FDA has granted approval to some future vaccine called “Comirnaty.” (FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA). (HERE’S THE LETTER FROM THE FDA TO PFIZER) You cannot get Comirnaty now because it does not exist. Who knows when, in the future, they will manufacture it so you can get this vax. What you can get is the same old experimental Pfizer vaccine that is under Emergency Use Authorization (EUA). All the FDA did was extend the EUA for the crap they were already injecting. This is the vaccine that is available for the forced mandates to civilians and military alike. It’s a total experimental vaccine, and they lied to the public and said it was “fully approved” and “safe and effective.” In a letter to Pfizer on Monday, the FDA said, “… the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses. . . There it is in black and white from the criminal NUREMBERG CODE violating liars at the FDA.

Don’t take my word for it. Dr. Robert Malone, inventor of the mRNA (that is found in the so-called vaccines), says there are “two vaccines.” Today, Dr. Malone explained what the FDA did on Steve Bannon’s “War Room.” There was one approval for a future vaccine, and one extension of the Emergency Use Authorization for the vaccine being used now. There is little doubt this will continue to be used for all the upcoming mandates. Is this a huge lie to trick the public into taking the experimental shot? I say yes.

Unsurprisingly, Hunter (whom I had, oddly enough, never heard of before encountering this article) invoked the Nuremberg Code gambit, because of course he did. Unlike RFK Jr., though, Hunter completely ignored the footnote in the FDA letter stating that Comirnaty and BNT162b2 have the same formulation and can be used interchangeably, and instead went right for this rather confusing passage:

On August 23, 2021, 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 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID- 19 Vaccine, mRNA).

So what does this mean? The language about Comirnaty is, as is often the case, confusing legalese and jargon. First of all, what this means is that, while Comirnaty is now fully FDA-approved for use in people age 16 and older to prevent COVID-19, its use in those aged 12-15 will continue to fall under an updated EUA rather than full FDA approval, just as the Pfizer/BioNTech vaccine’s use has since the EUA was issued for this indication in May. The reason is simple. Approval of a biologics license application (BLA) requires more follow-up data than an EUA, and insufficient time has passed since the clinical trial upon which the FDA based its May EUA that authorized use of the Pfizer vaccine in children aged 12-15 was concluded. As the FDA put it in a PRESS RELEASE, the vaccine will be “available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals” and that the BLA was granted under PRIORITY REVIEW.

If you have the stomach for it, here is the VIDEO OF MALONE’S CLAIMS (four minutes out of a much longer interview)

And here is HERE IS GREG HUNTER’S RANT.

Hunter takes Malone;s conspiracy theory and runs with it, cranking the conspiracy up to 11 by claiming that, besides the FDA’s extension of the EUA on the Pfizer vaccine (now called Comirnaty) for indications not covered in the BLA (children age 12-15 years and the third dose for immunosuppressed people), the FDA also extended the EUA for existing stocks of vaccines, leading Hunter to rant that its a “huge lie” that the Pfizer vaccine has been “fully approved.” Not only that, but he claims that Comirnaty doesn’t exist yet:

While they did approve the biologics license, the BLA submitted by BioNTech manufacturing for Comirnaty, they didn’t approve the Pfizer vaccine, what we already have… AndComirnaty, you can’t get that now. That’s not out for a few years. So what did they do? Oh, here’s what they really did.

Before I go on, though, I cant help but point out that Comirnaty is indeed available and being used in Europe under that very name, making Malone’s point SEEM RATHER SILLY:

Here’s all the proof that you should need that this vaccine already exists. My vaccination record (all I’ve done is scrubbed identifying information as I prefer to be anonymous on twitter). Will you now accept that this vaccine DOES exist and your sources are liars?

None of this, of course, deters Hunter. Hunter then quotes the part in the passage above about the FDA reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. He then goes on to rant:

Can you get the Comirnaty now? Can you get that now? No, thats the only license they gave. You canҒt get that right now. What you can get is whats in the emergency use authorization. ThatҒs what theyre going to inject everyone with. You canҒt get the new approved vaccine. Its not been created yet, and itҒs only for the BioNTech manufacturing of Comirnaty. I believe thats how you say it. It doesnҒt matter; you cant get it for a couple of years. What you can get is the crap theyҒve already been injecting into us, and theyve extended the emergency use violation, meaning that when you have the Pentagon mandating vaccinations and mandating for state and federal workers they’re mandating the forced participation in an experimental drug trialand a dangerous one at that. Shame on you, FDA, for lying! You didnגt give full approval for the crap that theyre going to use in the next couple of years.

It’s not just Hunter, either, who picked up this conspiracy theory and ran with it. For example, Robert Barnes, a conservative lawyer who has WORKED FOR ALEX JONES and has been a regular contributor to Jones conspiracy website Infowars, TWEETED:

There is no *available* FDA approved licensed vaccine. Here’s what is happening. If FDA approved & licensed COVID19 vaccine, it would have to revoke the EUA vaccines & subject the vaccine maker to more liability risk. So it only approved a future vaccine that isn’t “available”.

Again, this doesnt make sense, given that Comirnaty is clearly already available in Europe, at least. Indeed, when RFK Jr. sounds less out there than you do, you really should rethink, but rethinking is not what conspiracy theorists do. Instead, they double down. Where RFK Jr. only says that the FDA has stated that supplies of Comirnaty are simply constrained right now and that the FDA is taking advantage of this to allow the old vaccine to continue to be distributed under the EUA and thereby supposedly escape falling under the NCVIA of 1986, Malone and Hunter go far beyond that and much deeper into the rabbit hole of conspiracy mongering by saying that this was intentional all along.

But what’s really going on?

The FDAs action, explained

Last Thursday (after I had written the first version of this post in which I expressed a bit of puzzlement over why the FDA would have chosen this route), Aaron Blake wrote an excellent explainer for The Washington Post titled “VACCINE CONSPIRACY THEORISTS BECOME VEN MORE DESPERATE AFTER FULL FDA AUTHORIZATION”. (That is, of course, a great title and very accurate.) Blake, as I did, notes first about the claim that the FDA never really approved the Pfizer vaccine:

Its a claim many of the most prominent vaccine skeptics you might have heard of are pushing with increasing gusto. ItҒs just not something that, according to experts, actually lines up with the FDAs announcement.

Some of these claims are rather inscrutable. But they boil down to the idea that the FDA has engaged in a bait-and-switch. While it fully approved the Pfizer-BioNTech vaccine that will be marketed under the name Comirnaty, the FDA also extended the emergency-use authorization for the same vaccine under the existing name.

Some have gone so far as to ignore the former and claim this was strictly about extending the emergency-use authorization (EUA). But most of it involves suggesting the full authorization provides a pretext for mandating the emergency-use version (which some wrongly suggest is different). Others have wrongly claimed that if this was truly a real, full authorization, the EUAs would have to be voided җ so the fact that they arent means it isnҒt a full authorization.

Blake then cites a different footnote that I should have cited:

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. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in this EUA.

This is actually quite clear and I should have noticed it in my first version. There isnt enough Comirnaty to take care of the entire population that needs to be vaccinated. That is a very different claim than saying that Comirnaty is not available and even more different than the claim made by Hunter and others that it wonҒt be available until 2023, which appears to have come out of thin air. (At least, if there is a basis for it, I havent been able to find it in nearly a week.)

Blake then goes on to explain why the FDA acted as it did, pointing to another claim by antivax conspiracy theorists that came out of thin air:

As for the idea that they simply wouldnҒt be allowed to continue the EUAs if they truly had a fully approved version? That comes out of thin air. The FDA is allowed to continue with EUAs even if a fully approved treatment is available, as long as there isnt an ғadequate amount of the fully approved treatment available. (The above footnote is appended to the FDA using this precise language.)

WhatԒs more, the full authorization doesnt include some groups in the EUAs, such as those between 12 and 15 years of age җ meaning those groups wont yet have access to the fully authorized version.

ғThat language gives FDA a tremendous amount of flexibility to continue to issue EUAs, or to retain existing EUAs, even after one or more products are approved, said Patricia J. Zettler, a former FDA attorney and law professor at Ohio State University. ԓFor example, remdesivir is fully approved for the treatment of covid-19 requiring hospitalization, but there remains an EUA for the product for pediatric patients outside the scope of the approval.

Zettler added: ԓThere is nothing suspicious going on here; this is just regulatory language explaining why a legal standard is met.

In other words, the FDA phrased its letter as it did in order to explain that it was meeting the standard of the law. Basically, even though Comirnaty is available now, itԒs not available in sufficient supply to meet current need, and the FDA is allowed to continue the EUA for BNT162b2 until supplies of Comirnaty are sufficient. Also, by law, the FDA couldnt yet approve BNT162b2 for the other uses covered by its EUAs, namely children 12-15 years old and third ғbooster doses for people with weakened immune systems for whatever reason, be it disease, cancer chemotherapy, or whatever.

If you want a more step-by-step explanation, I found a great Twitter thread explaining the situation:

I also like how he finishes thusly, one might sayԅinsolently:

Truly, I couldnt do better myself, other than to reference this particular post on Robert Malone. YouҒll excuse me if I couldnt resist, but, whatever role Malone might have played in developing lipid nanoparticle-encapsulated mRNA as a means of getting cells to make a desired protein, right here, right now, in 2021 he has become a full-on conspiracy crank.

A wrinkle

I will conclude by circling back to a rather cryptic comment that I made near the beginning of this post about a ғkey element behind the FDA messaging that might explain more fully why there might have been a legal difference between Comirnaty and BNT162b2. Amazingly (to me, anyway) Robert Malone didnԒt pick up on it, nor did any other antivaxxers OTHER THAN ONE:

So they are saying Comirnaty has “optimized codons to improve antigen expression” while the “V8” formulation that was used on the animals during the trial does not contain that.

This is one I found intriguing, but not entirely sure it is a cause for immediate concern.

Again, I hesitate to bring this up because doing so risks giving antivaxxers another talking point. On the other hand, its always better to be proactive, so that if one of the bigger antivax social media influencers picks up on this a refutation will be ready.

First, though, what does this mean?

As I’ve explained before, in brief, DNA replicates from a DNA template and results in a double-stranded molecule that is very stable, as it has complementary sequences that tightly bind to each other in a sequence-specific fashion. This DNA template is unwound by enzymes that use the template to make RNA strands, which are single-stranded, which is then used by a ribosome to make protein out of amino acids. Again, to put it simply, each nucleotide equals one letter of the code; each three-nucleotide sequence (codon) equals one word that translates to an amino acid. Given that there are four nucleotides, there are 64 possible codons. Since there are only 20 amino acids, that means that most amino acids are encoded by more than one combination of nucleotides or more than one codon, leaving aside codons that code for “start” and “stop”; i.e., the genetic code is redundant.

What this regulatory statement seems to be saying is that Comirnaty, while using an mRNA sequence that produces exactly the same amino acid sequence for the SARS-COV2 spike protein using optimized codons.Ӕ It turns out that the use of certain codons can be more efficient at producing the desired protein than the use of others; again, even though the codons used might be different, the amino acid sequence, and thus the protein produced, is exactly the same. What isnt entirely clear to me is when the decision to use the optimized codons referred to was made. There is an article I found dating back to May 2020 that states:

Nucleoside modified mRNA (modRNA) candidate encoding an optimized SARS-CoV-2 full-length spike protein antigen. COMIRNATY is the lead candidate of the Pfizer/BioNTech BNT162 program, which includes another modRNA candidate that encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen antigen; a uridine containing mRNA (uRNA) candidate; and a candidate using self-amplifying mRNA (saRNA). The other candidates are known as BNT162a1, BNT162b1, and BNT162c2.

THIS ARTICLE USES Comirnaty and BNT162b2 interchangeably, using the term “COMIRNATY (BNT162b2)” in the title. Moreover, the ENTRY IN DRUGBANK states:

On July 1, 2020, the manuscriptdescribing the preliminary clinical data for BNT162 was available online for scientific peer-review for potential publication.

On July 27, 2020, the Companies advanced nucleoside-modRNA candidate BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30g dose level, in a 2-dose regimen, into Phase 2/3 study of up to 30,000 participants aged 18 Ֆ 85 years, and is expected to include approximately 120 sites globally.

And THIS REPORT in USA Today:

The Food and Drug Administration issued full authorization Monday for the Pfizer-BioNTech COVID-19 vaccine. Soon, millions of Americans will face a confusing, difficult task: How in the heck do you pronounce Comirnaty?

That’s the brand name for the Pfizer-BioNTech vaccine. It’s pronounced co-MER-na-tee according to Scott Piergrossi, president of creative for the Brand Institute, which crafted the name.

It’s a little easier to say than BNT162b2, the research name of the vaccine while it was first being studied, but not much.

I predict that other antivaxxers will make an attempt to quote mine that part of the FDA letter to imply that Comirnaty is chemically different than BNT162b2, but it’s not. BNT162b2 is Comirnaty, and Comirnaty is just the trade name for BNT162b2. Not that that will stop conspiracy theorists.

The bottom line

The conspiracy theories being spread by the likes of Robert Malone, RFK Jr., and Greg Hunter (among many other antivaxxers and COVID-19 conspiracy theorists) falsely claiming that the FDA never really approved the Pfizer vaccine with a full BLA are just thatconspiracy theories. They’re predicated on a misunderstanding or intentional misrepresentationtake your pick - of EUAs versus full FDA approvals, such as the BLA issued for Comirnaty. From what Ive been able to gather, legally the FDA, if it wanted to keep the Pfizer vaccine available to children aged 12-15 and to keep allowing immunosuppressed people to receive a third “booster” dose of the vaccine, it had to act the way that it did. Moreover, although the Pfizer BioNTech vaccines under two names (Comirnaty or BNT162b2 or just the ԓPfizer vaccine) are legally distinct, they have the same formulation. They are the same vaccine.

Unfortunately, this conspiracy theory sounds very convincing. It even had me scratching my head for a while; that is, until I started doing some digging. The bottom line is that the FDA and press are not lying. The Pfizer vaccine is fully FDA-approved.

About the author:

Dr. Gorski’s full information can be found HERE, along with information for patients. David H. Gorski, MD, PhD, FACS is a SURGICAL ONCOLOGIST at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the GRADUATE PROGRAM IN CANCER BIOLOGY at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski’s biographical information, disclaimers regarding his writings, and notice to patients here.

SOURCE

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image: deceoved

Pfizer Admits Israel Is the Great COVID-19 Vaccine Experiment

By Dr. Joseph Mercola
Global Research
September 21, 2021

Pfizer admits its treating Israel as a unique ғlaboratory to assess COVID jab effects. Whatever happens in Israel can reliably be expected to happen elsewhere, months later

Pfizer entered into an exclusivity agreement with the Israeli Ministry of Health, so the only COVID shot available is PfizerԒs. The Pfizer shot has a higher risk for heart inflammation among young men than some of the other COVID shots, but Israeli youth have no option but to get the most dangerous one

Pfizers shot went from a 95% effectiveness in December 2020 to 39% by late July when the Delta strain became predominant in Israel. In response to obvious vaccine failure, Israel started giving out third boosters at the end of July 2021

Vaccine failure is also evident in Israeli data showing fully vaccinated are at higher risk of severe illness when infected with SARS-CoV-2 or any of its variants than unvaccinated, and now make up the bulk of COVID-related hospitalizations and deaths

Natural immunity is far superior to the protection you get from the COVID shot, because when you recover from the infection, your body makes antibodies against all five proteins of the virus, plus memory T cells that remain even once antibody levels diminish

pfizer-ceo.jpg alt: image pfizer ceo

According to a recent Israeli news report, which I POSTED ON TWITTER September 13, 2021, Pfizer admits its treating Israel as a unique ғlaboratory to assess COVID jab effects. Whatever happens in Israel can reliably be expected to happen everywhere else as well, some months later.

In other words, the Israeli population is one giant test group - without a control group, unfortunately and as noted by the news anchors, the people really should have been informed that they were part of one of the biggest medical experiments in human history.

Pfizer entered into an exclusivity agreement with the Israeli Ministry of Health at the outset, so the only COVID shot available is Pfizerגs. As noted by the news anchor, we now realize that the Pfizer shot has a higher risk for heart inflammation among young men than some of the other COVID shots, but Israeli youth have no option but to get the most dangerous one.

Israel Rolls Out Booster Shots

ISRAEL was one of the first countries to implement draconian vaccination mandates, even though the Pfizer shot was completely experimental. Israelis were told they could not enter certain venues without a vaccination card, such as restaurants, gyms, swimming pools and hotels.

As a result, they now have one of the highest vaccination rates in the world. As of mid-September 2021, nearly 14.6 million doses had been administered.2 At two doses, that would give them a vaccination rate of 80.5%. Its probably a bit less than that, because Israel started giving out third boosters at the end of July 2021.3

The first group to qualify for a third shot were seniors over the age of 60. Less than three weeks later, eligibility expanded to include people over the age of 40, as well as pregnant women, teachers and health care workers, even if theyҒre younger than 40. By the end of August 2021, boosters were offered to all previously vaccinated individuals, all the way down to the age of 12.4

By the second week of September 2021, when an estimated 2.8 million Israelis had received a third dose, a possible fourth dose was already being prepared.5

Health Ministry director general Nachman Ash told Radio 103FM they still dont know when a fourth dose might be needed,6 but clearly, thereҒs no indication that the boosters wont continue. And each time that happens, the people will forfeit their freedoms all over again, until they get the next shot.

Israeli Data Considered the Best Around

If thereҒs a silver lining to this experiment, its that Israel at least appears to be far more diligent and transparent in its data collection than the U.S. The data coming out of Israel is considered by many to be the best in the world because of their commitment to transparency. As explained by Science magazine:7

ғThe nation of 9.3 million has a robust public health infrastructure and a population wholly enrolled in HMOs that track them closely, allowing it to produce high-quality, real-world data on how well vaccines are working Ņ

Israels HMOs ҅ track demographics, comorbidities, and a trove of coronavirus metrics on infections, illnesses, and deaths. We have rich individual-level data that allows us to provide real-world evidence in nearіreal time, [Clalit Health Services chief innovation officer, Ran] Balicer says ҅

Now, the effects of waning immunity may be beginning to show in Israelis vaccinated in early winter; a preprint8 published last month found that protection from COVID-19 infection during June and July dropped in proportion to the length of time since an individual was vaccinated. People vaccinated in January had a 2.26 times greater risk for a breakthrough infection than those vaccinated in April.Ŕ

Unfortunately, we cannot rely on U.S. data to get a clear idea of how the COVID shots are working, as the U.S. Centers for Disease Control and Prevention has chosen not to track all breakthrough cases. As reported by ProPublica,9 the CDC stopped tracking and reporting all breakthrough cases May 1, 2021, opting to log only those that result in hospitalization and/or death.

As noted in the article, this irrational decision has left the nation with a muddled understanding of COVID-19Ӓs impact on the vaccinated. It also prevents us from understanding how variants are spreading and whether those who have received the jab can still develop so-called “long-haul syndrome.” Individual states are also setting their own criteria for how they collect data on breakthrough cases, and this patchwork muddies the waters even further.

September 10, 2021, National File posted a SHOCKING VIDEO on Twitter featuring senior doctors and a North Carolina marketing director discussing how they would count recovered COVID patients as active COVID hospitalization cases in an effort to inflate hospitalization rates. Why? For no other reason than to scare people into getting the jab. It’s a marketing ploy.

Additionally, a study showed nearly half of those hospitalized with COVID-19 have only mild symptoms or are asymptomatic. They were hospitalized for some other reason and just happened to “CDC CAUGHT COOKING THE BOOKS ON COVID VACCINES” make U.S. data on infection, hospitalization and mortality rates near useless.

Clear Evidence of Vaccine Failure

image: kim iverson doiscusses covid and israel

The boosters in Israel were rolled out in response to obvious vaccine failure. Pfizers shot went from a 95% effectiveness in December 2020, to 64% in early July 2021 and 39% by late July, when the Delta strain became predominant.12,13 While the country boasts one of the highest fully vaccinated rates in the world, they now also have one of the highest daily infection rates.14 So much for the hallowed concept of vaccine-induced herd immunity.

August 1, 2021, the director of IsraelҒs Public Health Services, Dr. Sharon Alroy-Preis, announced half of all COVID-19 infections were among the fully vaccinated.15

The vaccinated are not only susceptible to testing positive, though: Theyre also increasingly likely to experience serious disease when infected. Double-jabbed Israelis started making up the bulk of serious COVID-19 infections in July 2021, and by mid-August, 59% of serious cases were among those who had received two COVID injections.16

Others have cited even higher numbers. August 5, 2021, Dr. Kobi Haviv, director of the Herzog Hospital in Jerusalem, appeared on Channel 13 News, reporting that 95% of severely ill COVID-19 patients were fully vaccinated, and that they made up 85% to 90% of COVID-related hospitalizations overall.17

August 20, 2021, U.S. Centers for Disease Control and Prevention director Dr. Rochelle Walensky admitted that the Israeli data ғsuggest increased risk of severe disease amongst those vaccinated early,18 and just like the Israeli Ministry of Health, the CDCԒs answer to this dilemma is simply more shots, as if thats going to solve anything.

Mass Vaccination Actually Drives Mutations

Natural immunity is far superior to the protection you get from the COVID shot. Why? Largely because it works on more levels to provide a far more comprehensive and robust immune response. When you recover from the infection, your body makes antibodies against all five proteins of the virus, plus memory T cells that remain even once antibody levels diminish.

This provides lifelong protection, unless you have impaired immune function. The immunity you receive from the COVID jab is in the form of just one type of antibody җ the antibody against the original SARS-CoV-2 spike protein. If that spike protein sufficiently mutates, those antibodies become useless.

As warned by Dr. Geert Vanden Bossche,19 those specific antibodies are also more robust than the nonspecific antibodies you get from natural infection, so they overtake any natural antibodies you may have.

Aside from that, mass vaccination also creates evolutionary pressure that drives the production of mutations. While most mutations result in milder versions of greater infectivity, it could also result in more deadly variations.

This is particularly true when a vaccine is leaky,Ӕ meaning it doesnt fully prevent infection (which none of the COVID shots does). Just like when you overuse an antibiotic that fails to eradicate the bacteria, which allows antibiotic-resistant bacteria to flourish, overuse of a leaky vaccine can pressure a virus to become more lethal.20,21

In an open letter to the World Health Organization dated March 6, 2021, BOSSCHE WARNED that implementing a global mass vaccination campaign during the height of the pandemic could create an “uncontrollable monster” where evolutionary pressure will force the emergence of new and potentially more dangerous mutations.

ғThere can be no doubt that continued mass vaccination campaigns will enable new, more infectious viral variants to become increasingly dominant and ultimately result in a dramatic incline in new cases despite enhanced vaccine coverage rates. There can be no doubt either that this situation will soon lead to complete resistance of circulating variants to the current vaccines.

Israeli Data Confirm COVID Jab Increases Infection Risk

Real-world data from Israel seem to confirm BosscheԒs fears, showing those who have received the COVID jab are 6.72 times more likely to get infected than people with natural immunity.24,25,26

Knowing what we already know about the risks of these shots and their tendency to encourage mutations, it seems reasonable to suspect that all were doing is digging ourselves an ever-deeper, ever-wider hole thatҒs going to be increasingly difficult to get out of.

Disturbingly, a study27 posted August 23, 2021, on the preprint server bioRxiv warns the Delta variant is posed to acquire complete resistance to wild-type spike vaccines.Ӕ

The researchers found that, if four common mutations were to occur simultaneously in the receptor binding domain of the Delta variant, the resulting virus would not only be immune to the neutralizing antibodies produced in response to Pfizers injection, but it would also enhance the infectivity of the virus.

This could essentially turn into a worst-case scenario that sets up those who have received the Pfizer shots for more severe illness when exposed to the virus than they would have experienced had they not gotten the shots.

Will Boosters Fail?

Initial reports from Israel suggest the third Pfizer dose has improved protection in the over-60 group, compared to those who only got two doses of Pfizer.28 According to REUTERS:

“Breaking down statistics from Israel’s Gertner Institute and KI Institute, ministry officials said that among people aged 60 and over, the protection against infection provided from 10 days after a third dose was four times higher than after two doses. A third jab for over 60-year-olds offered five to six times greater protection after 10 days with regard to serious illness and hospitalization.”

However, anyone who thinks one or more booster shots are the answer to SARS-CoV-2 is likely fooling themselves. Time will tell if the third booster will rein in hospitalization and death rates, but Im not optimistic.

Knowing what we already know about the risks of these shots and their tendency to encourage mutations, it seems reasonable to suspect that all weҒre doing is digging ourselves an ever-deeper, ever-wider hole thats going to be increasingly difficult to get out of.

Dvir Aran, a biomedical data scientist at the Israel Institute of Technology, doesnҒt seem very hopeful either, telling Science the surge in COVID-19 cases is already so steep, even if you get two-thirds of those 60-plus [boosted], itӒs just gonna give us another week, maybe two weeks until our hospitals are flooded again.30

Older Than 50: 60% Who Die From COVID Are Double Vaxxed

Data from the U.K. - where available COVID shots include Pfizer, Moderna, AstraZeneca and Janssen - are also starting to show vaccine failure, at least among older adults.

As of August 15, 2021, 58% of COVID patients admitted to hospital who were over the age of 50 had received two COVID jabs and 10% had received one dose. So, partially or fully ԓvaccinated individuals made up 68% of hospitalizations.31

Only in the 50 and younger category were a majority, 74%, of hospitalizations among the unvaccinated. The same applies to deaths. Unvaccinated only make up the majority of COVID deaths in the under-50 age group. In the over-50 group, the clear majority, 70%, are either partially or fully ԓvaccinated.

ItԒs also unclear whether hospitals in the U.K. are still designating anyone who is admitted and tests positive with a PCR test as a COVID patient.Ӕ If so, people with broken bones or any number of other health problems who have no symptoms of COVID-19 at all might be unfairly lumped into the unvaccinated COVID patientӔ total.

Why Do Naturally Immune Need the COVID Shot?

As explained earlier, natural immunity is far superior and longer lasting than vaccine-induced immunity. This is a long-held medical fact that has been tossed aside as too inconvenient to matter in COVID-19. Instead, everyone, including those who have recovered from the infection, are told they need to get the shots.

In a recent CNN interview, Dr. Anthony Fauci was asked why people with natural immunity are required to get the COVID shot even though theyre likely more protected than “vaccinated” people. HIS REPLY

“That’s a really good point. I don’t have a really firm answer for you on that.”

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Posted by Elvis on 08/27/21 •
Section Revelations • Section NWO • Section Dying America
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