The mandates will now become crushing. I wonder how many people who got their first two shots are really going to get their third. Ask some friends and leave a comment.
August 23, 2021 | Sundance | 267 Comments
According to the New York Times and multiple media outlets, Pfizer is expected to get full FDA approval today. “The move would make it the first Covid vaccine to go from emergency use authorization to full FDA approval.” (read more) With that in mind, it is worth a reminder that both Pfizer and Moderna stopped the clinical trials the FDA was using in their review:
The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine. However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated. Almost all the control group were then given the vaccine.
Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues. Without a control group there is nothing to compare the vaccinated group against. According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:
(Via NPR) […] “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.
“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”
He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study. “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.
People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots. (read more)
Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials. As noted in the example above, the control group was intentionally lost under the auspices of “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.
24 thoughts on “With Pfizer FDA Approval It’s Worth Remembering Pfizer and Moderna Intentionally Lost The Clinical Trial Control Group Testing Vaccine Efficacy and Safety”
I was being treated by a Doctor a few months ago, seeing him for the first time, and during our small talk prior to discussion of my minor injury it emerged that I was not vaccinated nor did I intend to get vaccinated.
Treatment and evaluation came to a stop.
He then proceeded to lecture me about why I needed to get vaccinated pronto. I then proceeded to give him the other side of that story.
The interesting part of the story is when I informed them that I would not get vaccinated with a substance that had not been thoroughly tested in a controlled, scientific way which, if done properly, would take years rather than weeks.
His response was – “Oh it’s been thoroughly tested! It’s been tested by 300,000,000 people”.
This supposed scientist merrily supports the destruction of science based testing protocols in support of a new system where we are all guinea pigs. This is, quite literally, the testing protocols of Dachau, Auschwitz: Forced march, strap down, jab, observe what happens next.
My response to him – “I will happily participate in your society-wide testing program as a member of the control group. All science based testing requires a control group … right? Right”?!
Nuremberg Code violation. I’m with this guy … the penalty of violating this code is death. Serious stuff, as we knew way back when a group last committed crimes against humanity.
Unfortunately my 80 yr old father is planning to get the third (and presumably 4th, 5th, etc until he dies) shot. My 77 year mother plans to decline. I could not get a solid answer from him as to why he wants to get it.
Gabriela Probst: My parents are of similar age. So I know what it’s like in that demographic, via their experience. The pressure is intense from their peers. It is unprecedented, the level of vitriol and anger expressed towards those who choose to not participate. Life within a closed society of aged peers (independent/assisted living) can be significantly degraded at the level of the social and the practical.
And THAT is precisely what the Freemasons in charge of this ungodly program are aiming for.
They would prefer social media influencers (which consist of news programs at their age) and peer groups do their work for them so the job is done “voluntarily”. But I have zero doubt – compulsion is coming. And then we will all need a little bit of the fire in us, that is in the fellow I linked to above.
As if there was going to be any other outcome besides FDA approval. Does anyone really think that after hundreds of millions of people have already received this injection, there was any possibility that the FDA might come out and say: “we can’t approve this drug because we’re not sure it’s safe for people yet”? My guess is that most will get the third shot and many more will go ahead and get the first rounds of shots because they actually believe that FDA approval means something…
Big surprise the stock market is screaming today…
The FDA approval letter also comes with expected dates for completion of studies on severe side effects. Myocarditis, Pericarditis, Pregnancy termination etc? We won’t know for four more years, in 2025, when the studies will have all been submitted.
Approval now. Studies later after everyone is harmed.
We don’t even know anything about severe side effects and long term health degradations. FDA approval means nothing except they are bought and paid for.
The inverted approval process of “vaccine” reminds me of the similar Democrat plan to withdraw from Afghanistan.
Remove military. Evacuate civilians after the killing fields are filled.
This is so stupid even Democrats aren’t that dumb. This is intentional, willful seditious malpractice – crimes iow.
The answer to anyone asking for my vaccine status consists of two letters: an F and a U.
Jeff C: can you speak meaningfully in the FDA approval process for more than, say, five minutes? Be honest.
Oh Nicodemus, you found me out! I thought I could pass myself off as an Expert FDA Approval Process Analyst. My point was that there was zero chance that the FDA was not going to approve these “vaccinations” after more than two thirds of American adults have been injected.
My sister is a doctor. She’s had her two vactheens and I don’t even have to speak to her to know she’ll dutifully get her third and probably all subsequent editions. When people were just starting to line up for the injectable industrial waste and before she’d attended her first appointment, I emailed her the full lowdown on the abortion links of the shots. When I next saw her and asked what she thought, she said with a noticeable hint of disdain “Typical of you.” I then tried the science angle as regards the asymptomatic transmission fable and the kabuki theatre of masks but I might as well have been speaking Swahili. I pray for her daily but boy, is she a tough nut to crack.
Can anyone tell me how the FDA can approve a vaccine without clinical trials being completed? The Pfizer vaccine date is in 2023. Is this the normal process?
As I’ve been saying since Obama, and as was proven in Germany, it’s the will that matters. These people are counting on decent Americans to respect the rule of law while they grab as much power as they can.
And Republicans are counting on that same decency from us to elect them to do the right thing , just so they can claim their hands are tied.
Until you realize that the logic of evil is all about will, and manipulation, and hatred, we will always be shocked at their audacity.
The most powerful word we can use is “no”. It’s time we act like this is our country, and our future, not theirs.
Everyone that had to get Medicaid because of Obamacare, like me, will be ordered to get vaxxed. And if not that, I’m sure my doctor will mandate it. I am on Thyroid medicine and anxiety medication. I will have to buy black market medicines.
It will take a while, but by Christmas I bet States will roll out vaccine passports because retail companies, at the urging of Joe Biden, will be pressured. And, since states receive Monopoly money from the Feds, they will feel it too.
This is textbook fascism, which is how Marxists gain control in nation states. It’s all on the evil spectrum,.
Apparently the FDA didn’t approve the shot?
It has only extended Emergency Use Authorization for a renamed shot?
Can anyone confirm? Are they trying to pull a fast one?
Top of page 12:
This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
The link doesn’t seem to go anywhere for me
If you read the letter carefully, it grants emergency use approval “EUA” to the 12-15 age group, but full approval “BLA” to ages 16+.
From comments on ZeroHedge:
Link should work now.
This is the main page.
Letter of Authorization (Reissued) August 23, 2021
Page 1 & 2
On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use
Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the
prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the
Act. FDA reissued the letter of authorization on: December 23, 2020,
3 February 25, 202110, 2021,
5 June 25, 2021,
6 and August 12, 2021.7
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
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.
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 PfizerBioNTech
COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech
COVID-19 Vaccine to provide the COVID-19 vaccination series.8
Page 12 of 13
• This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
It sure reads like they are using sleight of hand.
Yes, it’s confusing. Page 12 seems to contradict page 2.
Seems they are only reissuing the December 11, 2020 letter of Emergency Use Authorization that was given to ‘Pfizer-BioNTech COVID-19’ that recieved continual extended Emergency Use Authorization by reissuing it on:
December 23, 2020,
February 25, 2021
5 June 25, 2021,
August 12, 2021
Which they say is now extending to both Pfizer-BioNTech COVID-19 and the newly named COMIRNATY for:
August 23, 2021
So COMIRNATY is being approved under the same Emergency Use Authorization.
They confirm that COMIRNATY is the same formulation as Pfizer-BioNTech COVID-19 and both can be used “interchangably.”
SURE SOUNDS TO ME LIKE THEY ARE PULLING A FAST ONE!
THIS SOUNDS LIKE A LIE AND DELIBERATE DISINFO CAMPAIGN TO MAKE YOU THINK THE FDA HAS GRANTED FULL APPROVAL!
SOMEBODY NEEDS TO CONFIRM THIS ASAP!
Footnote clarifing the “interchangability” Page 2:
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.
Only references to Emergency Use from Page 3:
FDA’s review of the available safety data from 37,586 of the participants 16 years of age and older, who were followed for a median of two months after receiving the second dose, did not identify specific safety concerns that would preclude issuance of an EUA.
FDA’s review of the available safety data from 2,260 participants 12 through 15 years of age, who were followed for a median of 2 months after receiving the second dose, did not identify specific safety concerns that would preclude issuance of an EUA.
Only references to Emergency Use from Page 4:
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Only references to Emergency Use from Page 5:
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:
A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and
C. There is no adequate, approved, and available alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.
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.
10 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
Only references to Emergency Use from Page 7:
The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Pfizer-BioNTech COVID‑19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act.
Pfizer-BioNTech COVID‑19 Vaccine is authorized for emergency use with the following product-specific information required to be made available to vaccination providers and recipients, respectively (referred to as “authorized labeling”):
• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)
• Vaccine Information Fact Sheet for Recipients and Caregivers About COMIRNATY (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease (COVID-19).
Only references to Emergency Use from Page 13:
IV. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
Will the emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine remain in effect after the approval?
The EUA will continue to cover adolescents 12 through 15 years of age and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. Additionally, for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years of age and older; this use is also now approved. – Huh???
How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE?
The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. – Huh??? Huh??? The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine.
There is only deliberate confusion here. They are trying to make it seem like it’s approved, but everything is still EUA Emergency Use Authorization… apparently for logistical/convenience/administration reasons.
So the only thing I’m seeing here is that dictionary definitions are being changed for administrative purposes.
The only thing new here is that they have now given an official name to the same shot, therefore resulting in new clarification papers concerning the product, and now also extending it to new participants.
I’m not seeing anything different here other than copying and pasting the same EUA information onto the new ‘brand.’ The only thing “approved” here is extending the EUA to cover the new ministerium version of the munus product.
Hopefully someone more qualified will soon expose this bait and switch. If this is the best they can get the FDA to do, then things are looking pretty grim for any actual approvals. Look forward to the media gaslighting.
More about the FDA “approval” and the mystery of the schrodinger vexxines as Dr. Malone sees it.
The “approved” CORMINATY is NOT AVAILABLE! Only the regular Pfizer Jab as EUA. FDA says both are pretty much the same. Use them interchangeably, don’t pay it any mind!
But the “approved” one is nowhere to be found. Only the EUA one! And it probably won’t be on the market until 2023, or 2024, when trials shall supposedly be finished, that’s if it ever comes out at all!
So it explains why all the other EUA jabs by other companies are still allowed, because the “approved” one is not yet on the market! Therefore there is only Emergency Use Authorization in effect!
They are tricking people! People will walk into clinics expecting the approved shot, be told it’s not available, but this EUA one is the same, and they’ll take it without any liability on the clot-shot’s part!
But the approved shot doesn’t exist! And who knows if it ever will?
So this is their back door way of entering into the public mindset the narrative that there is FDA approval in order to embolden businesses and other entities to force mandates and deceive people into thinking these vaccines are safe.
Another reading of the FDA “approval.”
“Pfizer has earned $33 billion on its unapproved RNA Covid-19 vaccine. An oddity is that the wording in the FDA’s press release of August 23 grants approval for Pfizer’s biological license application (BLA), but not for the vaccine itself. The BLA is approved and emergency use is extended. So, was this really a timed publicity stunt to get governmental, military and private employers to push vaccination down the throat of Americans?”