Pfizer’s COVID Shot Granted Full Approval
Part 1
Media Are Lying About Pfizer’s FDA Approval
Part 1
Media Are Lying About Pfizer’s FDA Approval
Analysis by Dr. Joseph Mercola
August 31, 2021 (1)
Story at-a-glance
* August 23, 2021, the U.S. Food and Drug Administration granted full approval to the COVID-19
mRNA injection developed by Pfizer/BioNTech, sold under the brand name Comirnaty, for use in
people aged 16 and older
* Normally, the FDA will hold a formal hearing and allow for public and expert input before a drug is moved from emergency use authorization to full approval but, in this instance, no such hearing was held
* The notion that a “vaccine” that has killed more people in nine months than all other vaccines combined in three decades is considered safe stretches beyond the bounds of credulity and further undermines public trust in the FDA
* The approval is based on six months’ worth of data from 44,047 people aged 16 and older. Half of them got the shots and half initially received a placebo. However, in early December 2020, Pfizer unblinded the control group and 93% of controls opted to get the real injection. This means we’ve had no control group since December 2020 and have nothing to compare the treatment group against
* The FDA’s prescribing information for Comirnaty includes the risk of myocarditis and pericarditis, two types of heart inflammation that typically develop within seven days after the second injection
* Normally, the FDA will hold a formal hearing and allow for public and expert input before a drug is moved from emergency use authorization to full approval but, in this instance, no such hearing was held
* The notion that a “vaccine” that has killed more people in nine months than all other vaccines combined in three decades is considered safe stretches beyond the bounds of credulity and further undermines public trust in the FDA
* The approval is based on six months’ worth of data from 44,047 people aged 16 and older. Half of them got the shots and half initially received a placebo. However, in early December 2020, Pfizer unblinded the control group and 93% of controls opted to get the real injection. This means we’ve had no control group since December 2020 and have nothing to compare the treatment group against
* The FDA’s prescribing information for Comirnaty includes the risk of myocarditis and pericarditis, two types of heart inflammation that typically develop within seven days after the second injection
August 23, 2021, the U.S. Food and Drug Administration granted full approval (#1) to the COVID-19 mRNA injection developed by Pfizer/BioNTech, sold under the brand name Comirnaty, for use in people aged 16 and older.
It’s the fastest approval in history, (#2) granted less than four months after Pfizer filed for licensing May 7, 2021. (#3) It’s also based on just six months’ worth of data from 44,047 people aged 16 and older. Half of them got the shots and half initially received a placebo.
However, in the second week of December 2020, Pfizer unblinded the control group and 93% of controls opted to get the real injection (#4) rather than remain in the control group for the remainder of the trial, which is slated to continue for another two years.
Pfizer CEO Albert Bourla commented on the FDA’s approval, saying it “affirms the efficacy and safety profile of our vaccine,” and that he’s “hopeful this approval will help increase confidence in our vaccine ...” (#5)
According to STAT News, (#6) public health officials hope the approval “will persuade some people who remain hesitant about the vaccine to get the shot,” and will “make it easier for some public and private organizations to require vaccination.”
FDA Ditches Public Hearing, Circumventing Established Norms
Normally, the FDA will hold a formal hearing and allow for public and expert input before a drug is moved from emergency use authorization to full approval, but nothing is normal when it comes to COVID.
In this instance, no such hearing was held, and an FDA spokesperson called it unnecessary, because the public had been allowed to comment on all three COVID-19 jabs — Pfizer’s, Moderna’s and Johnson & Johnson’s — during a December 20, 2020, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. According to many, that isn’t good enough. (#7) As reported by The BMJ: (#8)
“Kim Witczak, a drug safety advocate who serves as a consumer
representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision
removed an important mechanism for scrutinizing the data.
‘These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization,’ she said.
‘The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinized in advance of an approval.’
Witczak is one of the more than 30 signatories of a citizen petition calling on the FDA to refrain from fully approving any COVID-19 vaccine this year to gather more data. She warned that without a 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,’ she said. ‘There is no control group after Pfizer offered the product to placebo participants before the trials were completed.
Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.’”
‘These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization,’ she said.
‘The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinized in advance of an approval.’
Witczak is one of the more than 30 signatories of a citizen petition calling on the FDA to refrain from fully approving any COVID-19 vaccine this year to gather more data. She warned that without a 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,’ she said. ‘There is no control group after Pfizer offered the product to placebo participants before the trials were completed.
Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.’”
Media Are Lying About Pfizer’s FDA Approval
[Video/Interview not available in this site]
Before we go any further, let’s clear up what the FDA actually approved, because they did not approve the Pfizer shot currently given. In the interview above, Dr. Robert Malone, the inventor of the mRNA vaccine platform, explains how we are being misled, yet again.
The injection that got the FDA approval is a Pfizer/BioNTech collaboration, to be sold under the brand name Comirnaty, and this injection is not currently available. Malone explains:
“The little trick that they’ve done here, is they’ve issued two separate letters for two
separate vaccines. The Pfizer vaccine, which is what is currently available, is still under
emergency use authorization and it still has the liability shield. Once again, the mainstream
media have lied to you ...
The product that’s licensed is the BioNTech product, which is substantially similar but not necessarily identical, called Comirnaty, and it’s not yet available. They haven’t started manufacturing it or labeling it. And that’s the one the liability waiver will no longer apply to.
So, the one that’s actually licensed is not yet available, and when it does become available it will no longer have the liability shield. In the interim, the one that does have the liability shield is the Pfizer product and that is what is currently available and it’s still under emergency use authorization.”
The product that’s licensed is the BioNTech product, which is substantially similar but not necessarily identical, called Comirnaty, and it’s not yet available. They haven’t started manufacturing it or labeling it. And that’s the one the liability waiver will no longer apply to.
So, the one that’s actually licensed is not yet available, and when it does become available it will no longer have the liability shield. In the interim, the one that does have the liability shield is the Pfizer product and that is what is currently available and it’s still under emergency use authorization.”
What this means is, if you want to get the licensed COVID shot, you have to wait. This also means that if employers demand that employees get vaccinated because there’s now a licensed COVID injection, employees should then demand to actually receive the FDA licensed Comirnaty, (#9) not the emergency use only (#10) Pfizer product that is currently being given.
FDA ‘Tricking Us Into Giving Up Our Right to Refuse’
Now, while the two products are not necessarily identical, the FDA in its infinite wisdom has decreed that the two can be used interchangeably, but their legal statuses, however, are not interchangeable. As explained by Robert F. Kennedy Jr. and Dr. Meryl Nass in a recent article: (#11)
“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.
EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability.
The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.
The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products ...
At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products ...
Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages. And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.
Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.
Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.
The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.
Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.
The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product ... Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says ‘Comirnaty,’ it’s a licensed product.
If it says ‘Pfizer-BioNTech,’ it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse. If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.
The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.”
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.
EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability.
The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.
The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products ...
At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products ...
Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages. And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.
Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.
Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.
The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.
Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.
The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product ... Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says ‘Comirnaty,’ it’s a licensed product.
If it says ‘Pfizer-BioNTech,’ it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse. If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.
The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.”
Next Part of this Document
Source and Notes
(1) This document is part of an article by Dr. Mercola, 31-Aug-2021, "Pfizer’s COVID Shot Granted Full Approval" (only available in the original site for 48 hours after publication date)
(2) Sources and references as quoted in the original site:
# 1, 21 FDA.gov BLA Approval
Pfizer/BioNTech August 23, 2021
# 2, 7 The Defender August 23, 2021
# 3 Pfizer May 7, 2021
# 4, 25, 28, 29 The BMJ Opinion August 23, 2021
# 5, 6, 17 STAT News August 23, 2021
# 8 The BMJ 2021; 374:n2086
# 9 FDA BLA Comirnaty Approval August 23, 2021
# 10 FDA EUA August 23, 2021
# 11 The Defender August 24, 2021
# 12 OpenVAERS.com Through August 13, 2021
# 13 AHRQ December 7, 2007
# 14 The Vaccine Reaction January 9, 2020
# 15 BMJ 2005;330:433
# 16 The Defender August 24, 2021, Comment by Nick Quinlan
# 18 CDC COVID-19 Reported Adverse Events August 23, 2021
# 19 Pfizer Comirnaty Package Insert
# 20 CDC August 23, 2021
# 22, 24 NPR August 18, 2021
# 23 Politico August 24, 2021
# 26 Medicina 2021; 57: 199
# 27 The Lancet Microbe July 1, 2021; 2(7): E279-E280
# 30, 31 FDA.gov Comirnaty Package Insert
# 32 Zelenko protocol
# 33 Covid19criticalcare.com
# 34 Science, Public Health Policy and The Law July 2020; 1: 4-22 (PDF)
# 2, 7 The Defender August 23, 2021
# 3 Pfizer May 7, 2021
# 4, 25, 28, 29 The BMJ Opinion August 23, 2021
# 5, 6, 17 STAT News August 23, 2021
# 8 The BMJ 2021; 374:n2086
# 9 FDA BLA Comirnaty Approval August 23, 2021
# 10 FDA EUA August 23, 2021
# 11 The Defender August 24, 2021
# 12 OpenVAERS.com Through August 13, 2021
# 13 AHRQ December 7, 2007
# 14 The Vaccine Reaction January 9, 2020
# 15 BMJ 2005;330:433
# 16 The Defender August 24, 2021, Comment by Nick Quinlan
# 18 CDC COVID-19 Reported Adverse Events August 23, 2021
# 19 Pfizer Comirnaty Package Insert
# 20 CDC August 23, 2021
# 22, 24 NPR August 18, 2021
# 23 Politico August 24, 2021
# 26 Medicina 2021; 57: 199
# 27 The Lancet Microbe July 1, 2021; 2(7): E279-E280
# 30, 31 FDA.gov Comirnaty Package Insert
# 32 Zelenko protocol
# 33 Covid19criticalcare.com
# 34 Science, Public Health Policy and The Law July 2020; 1: 4-22 (PDF)
© Copyright by Dr. Joseph Mercola. However, since August 2021 he declared: "Again I will still be writing my daily articles that I started 25 years ago BUT they will only be available for 48 hours before they are removed. In this way I hope to continue my mission to help you take control of your health – but it's up to you to download, share and repost this content. I will not be enforcing my copyright on this information so that you may freely share it."