Why the FDA Did Not Approve Pfizer's Covid Vaccine (video)
It's all about money and liability
The FDA did not give final approval to Pfizer or Moderna Covid vaccines, and everyone who can read knows it. Instead, the FDA approved a similar vaccine that is not available in the United States.
Before I explain why, know this. The reason for withholding final approval of those vaccines is the same reason they are working so hard to approve the vaccines for children.
It’s all about liability protection. Robert F. Kennedy Jr. explains:
You Can’t Sue For Damages From Emergency Use Drugs
No one can be required to take a drug that’s under emergency use authorization. Therefore, taking a EUA drug is at one’s own risk.
If the FDA had given final approval to Pfizer’s drug, anyone injured by the vaccines (and there hundreds of thousands) could sue Pfizer.
To protect Pfizer while fooling gullible people into thinking the vaccine was approved, the FDA approved a drug that’s not available in the US. No one can explain exactly why this FDA-approved vaccine is not available in the only country that approved its use, but that’s the case.
The FDA, in its approval of the unavailable Comirnaty vaccine, actually disclosed the shell game:
You may label your product with the proprietary name, COMIRNATY, and market it in 2.0 mL glass vials, in packages of 25 and 195 vials.
And again in the supplemental approval letter:
We have approved your request submitted and received on November 18, 2021, to supplement your Biologics License Application (BLA) under section 351(a) of the Public Health Service Act for COVID-19 Vaccine, mRNA (COMIRNATY), to include a new 30 microgram dose formulation (Tris/Sucrose) of COMIRNATY manufactured at the Pfizer Manufacturing Belgium NV, Puurs, Belgium (Pfizer, Puurs) facility.
And it’s right on FDA’s website:
On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.
Again, Comirnaty is not actually a thing in the United States. You cannot get the approved drug.
Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two-dose primary series for individuals 5 years of age and older, as a third primary series dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 16 years of age and older at least six months after completing a primary series of the vaccine.
Remember, Comirnaty is not available in the United States. And the Pfizer drug that is available here has not received full approval from the FDA.
This means that Pfizer cannot be sued.
Legally Distinct Has Meaning
“But, Bill,” say the doctors, “Comirnaty is the same thing as the Pfizer vaccine.” Really, Doctor? Did you read the footnote on the FDA’s approval letter? Let me spell it out for you, since the print was very small:
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.
And here’s screenshot of the original letter:
No, doctor, you are not injecting a legally-approved drug into your patients. You’re giving them an EUA drug for which they have no legal recourse should things go sideways for them.
As of December 23, no vials of Comirnaty were available in the United States per the CDC.
You Can’t Sue for Damages from Vaccines Approved for Children
When will the FDA give final approval to the vaccine that is available in the United States? Maybe never, but definitely not before it gives final approval to that drug for pediatric use.
Vaccines fully approved for use in children are exempt from liability. This has been the law since the 1980s when pharmaceutical companies threatened to stop manufacturing all pediatric immunizations unless they received carte blanche immunity from lawsuits. The Reagan Administration buckled to the threats.
Of course, most people believe the Pfizer vaccine that is available in the US has received FDA approval, so Pfizer could go on with EUA protection forever. Either way, the hundreds of thousands (and growing) who were injured, killed, and permanently disabled from the vaccines have absolutely no recourse. They can’t even sue to have their injury-related medical expenses covered.
You Cannot Be Forced to Take a EUA Drug
Remember, you cannot be forced to take a drug that has emergency use authorization, and every Covid vaccine available in the US is such a drug. This news of little consolation to the millions of American workers whose jobs are threatened by employer or OSHA mandates, as corporate attorneys are afraid to take on the government and Pfizer.
It’s still important to know the status of these drugs, the law, and your inability to sue for vaccine injuries if you take any of the emergency-use Covid drugs currently available.