On Monday, August 23, 2021, the FDA “approved” Pfizer’s COVID-19 jab for 16 years and older – officially declaring it “safe and effective” – without even allowing public discussion or holding a formal advisory committee meeting to discuss data.
Despite the fact that the vaccinated people can still contract the virus, and despite the fact that the original safety trials aren’t scheduled to be completed until 2023, according to The Washington Post, this vaccine approval was the fastest in FDA history, coming less than four months after Pfizer/BioNTech filed for licensing in May.
In the words of Jon Rappoport:
The fix is in. We raced from “emergency use authorization” of experimental vaccines to “full approval.” Boom. Despite the promise of “transparency” prior to giving full approval to the COVID vaccines, the FDA gave its final green light today. Slam-dunk. And there was NO public hearing. Obviously, the FDA didn’t want to allow even mainstream “experts” to speak in a public hearing before approval; the agency is running a very tight ship. No slip-ups. No defections.”
Any smidgen of credibility that the FDA previously had is gone.
The FDA has zero long-term data in hand, while emerging short-term data shows the COVID-19 jab is deadly, permanently harming immune systems, and by the FDA’s own flawed counting system actually increasing COVID-19 cases.
Nonetheless … APPROVED!
But honestly, is anyone surprised?
Are we surprised when the mafia kills people and puts their bodies in 50-gallon drums full of acid?
Are we surprised when a lion eats a gazelle? Or when a shark attacks a swimmer?
It’s in their nature.
And it’s in the FDA’s nature to approve just about any pharmaceutical intervention that is thrown their direction, even if adverse reactions include death. Each year, more than 2.2 million Americans suffer serious adverse reactions from FDA-approved drugs, and the FDA openly admits that there are “over 106,000 deaths annually” due to adverse drug reactions from Big Pharma’s drugs that the FDA has “approved.”
For example, Pfizer’s drug Bextra was granted FDA approval in 2001. In 2005, the drug was recalled for adverse heart effects including death, heart attack, and stroke, as well as increased risk for serious skin reactions, such as epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome. Bextra also had the potential to cause gastrointestinal bleeding.
In 2009 Bextra was at the center of the “largest health care fraud settlement and the largest criminal fine of any kind ever.” Pfizer paid a $2.3 billion civil and criminal fine. Pharmacia and Upjohn, a Pfizer subsidiary, violated the United States Food, Drug and Cosmetic Act for misbranding Bextra “with the intent to defraud or mislead.”
You’ve heard about Vioxx, right? According to Drugwatch, at the time of its recall in 2004, “Vioxx had been taken by some 4 million Americans. Out of those patients who took Vioxx, the arthritis drug may have caused approximately 140,000 heart attacks resulting in an estimated 60,000 deaths.”
We could go on, but the point should be clear: The FDA routinely approves drugs that are later found to be unsafe, ineffective, and even deadly.
“Why would the FDA approve these toxic, deadly drugs?”
Here’s why: It’s called regulatory capture, which is a phenomenon that occurs when an allegedly “objective” regulatory agency (like FDA) ends up “promoting” the industries they are supposed to be “regulating.”
The reality is that the FDA has been captured for a long time. In a 2016 study published in the British Medical Journal, the majority of the FDA’s hematology-oncology reviewers who left the agency ended up working or consulting for Big Pharma. In a 2018 investigation by Science magazine, 11 of 16 FDA reviewers who worked on over two dozen drug approvals and subsequently left the agency were working or consulting for the companies they recently regulated.
For 40 years, every single FDA commissioner has gone on to sit on the board of a Big Pharma company (except one). Scott Gotlieb, who served as commissioner from 2017-2019, now sits on Pfizer’s board.
Janet Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021. If the name sounds familiar, yes this is the same woman who became director of the FDA’s Center for Drug Evaluation and Research in 1994, the year before the agency approved OxyContin. Woodcock presided over one of the worst regulatory agency failures in U.S. history as the opioid epidemic (fueled by the FDA’s approval of dangerous drugs like OxyContin) ravaged our nation.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Woodcock, in a press release issued Monday. Woodcock was once considered a possible nominee for the permanent job of FDA Commissioner, despite resistance from numerous senators who sent a letter to the White House in March calling for new leadership at the FDA, citing its “long track record approving dangerous opioids without considering public health.” In addition to the senators, a coalition of nonprofit advocacy groups asserted that Woodcock’s “inadequate” oversight of the FDA during the opioid crisis should disqualify her.
In a letter to officials at the Department of Health and Human Services, the coalition wrote:
In its opioid decision-making, Dr. Woodcock, and the division she supervised, consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis.”
The letter accused Woodcock of “dereliction of duty” for allowing opioid manufacturers to spend years disseminating false claims that narcotic painkillers were less addictive and more effective than they really were, contributing to the rise of mass opioid prescribing and spread of an epidemic that has claimed more than 500,000 lives.
More recently, the White House was dissatisfied over how the FDA under Dr. Woodcock handled the controversial approval of an Alzheimer’s drug over objections of some staff members and members of an advisory committee.
In the case of Pfizer’s latest FDA “approval,” there are more questions than answers. And those problems begin at the very top of the first page of the vaccine insert:
“COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.”
According to the CDC, “COVID-19 vaccines protect people against severe illness” but “breakthrough infections are expected. COVID-19 vaccines… are not 100% effective.”
Why is the FDA granting approval for a drug designed to stop COVID-19 when we know for an absolute fact that it does not?
The insert also confirms that the safety of Comirnaty is based on only two studies. The first has a sample size of only 60 participants. And get this … the second study had over 44,000 participants, but participants in the placebo group were offered the jab in December 2020!
This means that the vast majority of those who received a saline placebo injection were TOLD THEY HAD RECEIVED A PLACEBO AND OFFERED THE REAL SHOT! Placebos don’t work if you know you received a placebo, and control groups cease to be control groups when they’re given the same drugs as the vaccine groups. In other words, there was no true placebo group.
This is science 101. And the information provided above is literally in the package insert for Pfizer’s latest poison vaccine. Pfizer publicly admits that the study supporting the approval of the drug was RUINED.
Conspicuously, there has been no mention of the 13,608 deaths reported after administration of the COVID-19 shot. There have been more adverse events reported since these shots were released than in the 30 years prior. THIRTY YEARS!
The Pfizer jab, named “Comirnaty,” is the first injection for COVID-19 to be granted full approval by the FDA. Officials hope that full approval will make it easier for employers, the military, and universities to mandate vaccination and that it will somehow persuade people (who have seen the shocking number of adverse events and deaths and who are hesitant about the vaccine) that it is “safe and effective.”
Ummm…. Good luck with that….
Speaking of the military, just minutes after the FDA’s announcement, Pentagon spokesperson John Kirby announced that the military is now requiring soldiers to get the jab under threat of court martial.
Following FDA approval of Pfizer COVID-19 vaccine, Pentagon spokesperson John Kirby says Defense Department will issue updated guidance requiring all service members to be vaccinated. https://t.co/GubAuizEFg pic.twitter.com/odBpnshp43
— ABC News (@ABC) August 23, 2021
In an article published August 20th in the British Medical Journal, the authors mention Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, who is one of the more than 30 signatories of a citizen petition which called on the FDA to refrain from fully approving any COVID-19 vaccine to gather more data. She warned that without a [public FDA] meeting “we have no idea what the data looks like. 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.”
Apparently, the FDA ignored Ms. Witczak’s warnings, even though she is a member of one of their advisory committees. Amidst a tsunami of reports of COVID-19 vaccine injuries and deaths from around the world, the FDA is proving it is an agency that will certify maiming and killing without hesitation.
Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.” But in a letter to the British Medical Journal, the FDA said it did not believe a meeting was necessary ahead of the expected full FDA approval.
According to Robert F. Kennedy, Jr:
They know they can’t win this argument on the science and that’s why they had to abolish the public process and independent oversight. They believe themselves so powerful now that they are stripping off all pretenses that this is about public health and are baldly revealing the corruption.” He continued, “This is a sinister scheme for mandating a badly flawed vaccine that has already made history with record deaths and injuries, that neither prevents disease nor transmission, and does not improve mortality. Pfizer’s most recent six-month data show that while the jab prevents some COVID deaths, it causes more heart attacks yielding a net loss of life.”
As vaccine pushers celebrate the approval, we have a question: “How can a vaccine be fully approved when we don’t even know the optimal number of doses?”
We have another question: “Doesn’t it seem suspicious that Big Pharma provides 75% of the FDA’s drug review budget?”
The mantra of the MSM is that we should take the COVID-19 jab because “experts say they’re safe and effective” … but why do they never tell us to be vaccinated because “the data shows they’re safe and effective”?
Think about it…
It’s not a coincidence that Pfizer’s stock value has increased by over 35% in the past year alone. BioNTech is up almost 400% in that same period. According to Yahoo! Finance, discussing Pfizer’s soaring revenues, “Higher sales of brands like Eliquis … and significant contribution from new drug Vyndaqel/Vyndamax … drove this segment’s sales growth.”
“What’s Eliquis?” It’s a Pfizer drug used to prevents blood clots. “What’s Vyndaquel/Vyndamax?” It’s a Pfizer drug used to treat cardiomyopathy. Surprise, surprise… blood clots and cardiomyopathy are two of the side effects of Pfizer’s COVID jab! See how this works, folks? Follow the money!
As we already mentioned, with FDA approval, it will now be easier for schools, businesses, and the government to force vaccination. With COVID-19 boosters also set for approval, you can expect those numbers to increase.
These people are getting rich while Americans are injured and killed by an unsafe and untested vaccine that doesn’t do the ONE THING it was approved to do. The FDA has a horrendous track record of approving dangerous and ineffective drugs – especially when they do it in a hurry. The double-blind, placebo-controlled study cited for approval is neither “blind” nor “placebo-controlled.”
So much for the “gold standard.” This vaccine is a farce.
Now that it’s been approved by the FDA, you can expect the vaccine rhetoric and oppressive mandates to increase at an alarming rate. Even though the jab is still experimental. FDA approval does NOT mean that Pfizer’s shot is no longer experimental. Every COVID jab, including Pfizer’s, is less than a year in use and still experimental by definition. The fact is, Pfizer’s clinical trials don’t end until May 2023.
Here’s an excellent article titled “10 reasons why the FDA approval for Pfizer jab isn’t about health, but about forcing people to take the shot.” Don’t let yourself be a human guinea pig. We should all be prepared to stand up for our freedoms… before it’s too late.
Watch the video below of a brave Los Angeles Fire Captain (Christian Granucci) declaring that we are in tyranny and that he and his crew will not comply! This is powerful and moving!
Oh yeah, we almost forgot to mention that a recent investigation revealed that Bill Gates has major shares in both Pfizer & BioNTech, but we’re sure that’s just a “coincidence” in this FDA decision…
Oh yeah, we almost forgot this too. On August 17th, the CDC issued an alert of an expected outbreak of the polio-like disease (Acute Flaccid Myelitis) in the next four months. This is a serious neurological condition, which causes the muscles and reflexes in the body to become weak. Hmmm … interesting that would mimic the predicted downstream effects of the COVID-19 jab right around that time, isn’t it? Likely just another “coincidence” though … totally unrelated… nothing to see here…. move along sheep!
John Parson says
Reading this confirms to me the original reasons I don’t use any drugs, they are toxic poisons sold only for the profit of the drug companies and the payoffs for the FDA. the only medicines I take are growing around me here in the mountains where I live, and what has been used for thousands of years and were made by the Hand Of god as a gift to mankind.
I agree 100%….for profit and not for health. Shameful.
John, please share the things growing around your that you use to treat ailments.
I want and need to start growing food, herbs, etc here in the city in my small yard and am looking for the best use of my space.
Thank you
This isn’t correct. I read all the documents ofthe FDA “approval” it only reissued the emergency use approval for the vaccine. You should have this corrected. Please read the repost in it’s entirety.
https://www.fda.gov/media/150386/download
Sadyly, they did BOTH…. approve the injections for ages 16+ AND extend the EUA for situation s not covered byt he approval, i.e. 12-15 years.
Approval:
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by
BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and
older. ”
Extension:
“… authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA. “
The Bio N Tech vaccine has not even been approved yet, so basically they are forcing people to still take Pfizer at EUA because the companies are in a partnership.
@ Nicky, that’s not exactly true. It was approved as a vaccine for Covid-19 and can be marketed as such. It’s also still available thru the EUA. Here’s a small section from the FDA regarding this. Keep in mind, all of the results of the studies will not be known until 2023. FDA rushed this approval.
“Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to 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.”
While much of the letter/document repeats, ad nauseam, the term “emergency use authorization” (EUA), it also surreptitiously interjects, amongst all the obfuscation of the EUA language, this little tidbit, a tiny paragraph near the top of page 2:
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by
BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and
older”
Per Harvard Law:
“A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.”
Why do you suppose this is included in this document otherwise full of EUA language, if this is merely a “renewal” of the EUA?
While much of the letter/document repeats, ad nauseam, the term “emergency use authorization” (EUA), it also surreptitiously interjects, amongst all the obfuscation of the EUA language, this little tidbit, a tiny paragraph near the top of page 2:
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by
BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and
older”
Per Harvard Law:
“A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.”
Why do you suppose this is included in this document otherwise full of EUA language, if this is merely a “renewal” of the EUA?
This is a misconception that has been spreading rapidly. The language of the approval documents can be tricky for those unfamiliar with it. This approval is crazy, and the jab doesn’t work and has no basis for safety claims, but the approval documents are identical to virtually every vaccine that’s come before.
They do clarify that the approval is for 16+ while the EUA still exists for 12+, and they will have to submit the packaging and labels for final approval, but this is 100% approved by FDA standards.
Nicky is correct. The “jab” approved by the FDA is for a future shot, expected by year 2023. However, it appears to be the same thing under a different name. Here is an excerpt from the Pfizer letter:
Pfizer-BioNTech COVID‑19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech
COVID-19 Vaccine to provide the COVID-19 vaccination series.
The current global chaos (pandemic) is clearly a prophetic end time as stated in holy scriptures. I’m not surprised this will surely happen because God allows it. I believe there’s something in the vaccine and it is more sinister than the pandemic itself coupled with the hidden agenda that after people are forcedly vaccinated, hence deceived and eventually be controlled by a global system that is run by a devil incarnate and his prophet. He’s coming very soon to reveal himself. May God protect his own people.
The fact that it is killing mostly people who already have some time of medical problems, has made me wonder, if, while the reasons of those who concocted this mess, was evil, God’s intent might be to spare those of his who are too weak to withstand what is coming! I totally agree that we are probably in the “verry end times”, as does almost every minister/elder I know-not just in MY church (really God’s, not mine, but you know what I mean!) but those of every denomination. The Bible predicts a “plague” that will kill 1/3 of the population. I think we have it!! He didn’t say WHERE the plague would come from-I think we know! I think one of the others, was pestilence-Africa is consumed w/ locusts, destroying every living plant, as soon it peeps above the earth. FIRE? We are sitting on a line of volcanos from the Atlantic to Pacific (no pun intended). Old Faithful quit being “faithful about 3-4 yrs ago, and guess what? The largest volcano ever known, was sitting right below it! NO there’s another, still larger, off the coast of CA, THEN, there appeared ANOTHER still LARGER, off the eastern side of Hawaii! Scientists say they are GOING to erupt, and split this side of the earth 1/2 into. Wrong-the Old Mississip, is going to bust wide open when that split hits it! So then, we’ll have 4 burning islands, in the middle of ?? what do you call the ocean when it’s no longer divided ??At least there will be fewer people to fight it out!! BUT, let’s not forget, the whole earth is going to “disappear” “Where have all the people gone”?? “I Wish We’d All Been Ready!” Broad is the way, that leads to DESTRUCTION! Narrow the way that lead’s to heaven, and FEW there will be that will enter there-in! My favorite Car sticker: “Everyone has eternal life! Where will you spend yours?”
Hi!
Where does it say “original safety trials aren’t scheduled to be completed until 2023”?
Thank you!
Ana
Clinical Trials Part II & III have been in place for decades–read Code of Federal Regulations–211, Clinical Trials. This clinical trial data reports all adverse, and severely adverse reactions to new drugs. It usually takes over 2 years or longer, to regulate the new drug, gather and record new data, since it is done on a sick population, with necessary adjustments. Part I Clinical Trials are done on well-people, usually 6–12 months, and that’s all the data gathering that we had time for Covid-19 vaccine! This vaccine should never have been approved at this time, or ever–it’s attenuated, m-RNA unknown! That’s where they got 2023 for the actual, normal approval year!
Ty & Charlene, your article on vaccines, especially this one, was excellent. Thank you!
And God Bless you, and all the readers!
Excellent article, thank you, I will distribute it to all those on my email list.
THE INJECTION STILL ISNT APPROVED BY FDA
They only reissued the EUA – read the letter below where it states this –
https://www.fda.gov/media/150386/download
Sadly, they did BOTH…. approve the injections for ages 16+ AND extend the EUA for situation s not covered byt he approval, i.e. 12-15 years.
Approval:
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by
BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and
older. ”
Extension:
“… authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA. “
That’s Horrible I just lost my Dad to this Phizer Vaccine after his 2nd shot , these all have that Graphine Oxide in them Haserdous to the Human Organs
The White House staff and Big Pharma employees are not mandated and forced to take the vaccine. Then why are we? We all know is all about power and greed.
Keep up the good work and advice, am counting on you.
This article is a lie. As it clearly states on the FDA website, it is approved ONLY for emergency use, and it cannot be forced on anyone.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
This just happened, but it’s real.
I agree that the Vaccine is about Control, power & Greed & nobody should be forced to get the Jab or they lose their Jobs or our Military could be court Marshaled, “What happened to freedom of choice” or My Body my Choice” This is about Gates & how he wants to depopulation project please people open your eyes & don’t be sheep we need to stand up for our Human rights.
What is the source of the assertion that the placebo group received a “saline placebo injection”? I have seen neither full disclosure nor partial disclosure of the ingredients in used Pfizer/BioNTech COVID-19 Vaccine Studies. Was this assertion an assumption or a documented fact?
Page 7 of the package insert.
“Study C4591001 (Study 2) is a Phase 1/2/3 multicenter, multinational, randomized, saline placebo-controlled, double-blinded (Phase 2/3), dose-finding, vaccine candidate-selection and efficacy study that has enrolled approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) 16 years of age or older (including 378 and 376 participants 16 through 17 years of age in the vaccine and placebo groups, respectively).”
Like many said above, Pfizer’s vaccine under the new name Comirnaty is fully licensed as of August 23, 2021. Pfizer-BioNTech covid vaccine (not licensed) is still under emergency use authorization (EUA) for 12 years and up. I read on the FDA’s website that Pfizer and Comirnaty can be used interchangeable meaning they are the same. The site also said something like there is a legal distinction between them. Only Comirnaty will be accepted from the Countermeasures Injury Compensation Program (CICP) not Pfizer-BioNTech. Of course, I didn’t get that bit of legal information from the FDA.
Good information and I know it’s 100% correct, but we NEED SOLUTIONS! I’m watching as my college student son is agonizing over not wanting to “fight this fight”, but having no choice as his school is mandating the jab and/or weekly testing. I’m tired of everyone just firing off about how wrong it all is and how indignant we are…. it IS and we ARE, but we need answers and a plan for how to survive it all!
What can you do if your employer mandates the Covid jab in order for you to keep your job? We have to have an income to support our families. We need food, clothing & shelter & that takes money & we need our jobs to survive.
For years now: when a company claims FDA approved as part of their sales pitch; I RUN FAST and FAR!!!
Right there it tells you the product is toxic!!!