Originally published by Journal-NEO.org/.
The US Government regulator for drugs, the Food and Drug Administration, has just announced that it has voted full approval for the mRNA genetic vaccine of Pfizer and BioNTech, or did they? This supposed new status is being used by the Biden Administration and many states and companies to impose mandatory vaccinations. The notoriously conflicted Biden covid adviser, Tony Fauci of the NIAID, using that ruling, is calling for national mandatory vaccination for the country. What is not being revealed is the cesspool of corruption and conflicts of interest between the FDA and the major drug companies, including Pfizer, that stand behind the rushed approval. And it’s not full approval for Pfizer’s jab, only for BioNTech’s legally different vaccine.
“…final stamp of approval”?
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 Alzheimer’s 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 Committee’s clear recommendations led to their approval of two highly problematic drugs that offered little evidence that they would meaningfully benefit patients…With 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.
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 Pfizer’s 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…”(emphasis added).
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 Comirnaty. 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 Pfizer’s 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 Biden’s 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 opioid 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.
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.
This post was originally published by Journal-NEO.org/.