At a Glance:

  • FDA approval of Pfizer vaccine hasn’t been properly reported.
  • Comirnaty license granted to BioNTech. Original Pfizer vaccine still under EUA, not FDA approval.
  • Vaccines to be used interchangeably, however legally distinct.
  • Many studies still to be done on both Comirnaty and Pfizer.

This week, most sources rushed to announce the approval of the Pfizer vaccine. However, it appears that due to a bit of a bait and switch and lack of digging, what we all understood was approved may not have been. But nobody has chosen to correct the narrative on mainstream media.

So, what came out on Monday? In reading the FDA press release with fresh eyes, we can see that the approval was issued to Pfizer’s partner BioNTech Manufacturing GmbH.1 The formulation that has been known commonly as the Pfizer BioNTech vaccine will now be marketed as Comirnaty by BioNTech.1 The current vaccines available in pharmacies are still the same ones that are authorized under EUA (emergency use authorization). The newly approved Comirnaty hasn’t been produced yet. In fact, the license grants BioNTech the authorization to manufacture the vaccine that their partner, Pfizer, had manufactured previously.2 In a letter to Pfizer, the FDA said that Comirnaty and the previous vaccine, still available under EUA, can be used interchangeably. However, there are consequences.3

In a letter to Pfizer from the FDA on the date of approval:

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.2

Vaccines under EUA have a liability shield, protecting the manufacturer from lawsuits due to injury or death. With licensure, the liability shield is no longer relevant. In reality, what’s been commonly known as the Pfizer vaccine can be used in the place of a licensed product, while remaining under the liability shield. Once the vaccine is added to the childhood vaccination schedule, it, again, would receive a protective status.

Approved, Yet Without Data to Prove Safety

While which vaccine has been approved has been portrayed in a questionable way, we also know that the process and data used was also questionable. In fact, according to the approval letter:

The review of this product was associated with the following National Clinical Trial (NCT) numbers: NCT043687284 and NCT043807015.

No data has been reported to the clinical trial set yet. Estimated study completion dates are estimated to be completed in May and April of 2023 respectively.4,5

The Licensure also requires further testing in specific groups. Final research data will be due between 2021-2026.2 There are three studies related to pediatrics that must be, but are yet to be, completed:

  • Pediatrics aged 12-15 to be completed May of 2023. Reports to be submitted October 31, 2023.2
  • Pediatrics 6 months <12 years to be completed November of 2023. Reports to be submitted May 31, 2024.2
  • Pediatrics <6 months to be completed July of 2024. Reports to be submitted October 31, 2024.2

There are six studies regarding myocarditis and pericarditis that will proceed from current through 2026.2 One study relating to pregnancy and infant outcomes runs through June of 2025 with reports submitted by December 31, of 2025.2

The approval and licensure on the Comirnaty product is for people aged 16 years and over. The EUA on the Pfizer BioNTech remains in effect for those 12-15 years and as a booster for those with compromised immune systems.1,2

Hold the Phone — Doc’s Thoughts:

Media and several others have suggested that full FDA approval would help overcome vaccine hesitancy. If you want to be sure you are getting an FDA approved vaccine, you’ll have to ask to see the vial. I’d also bet that you won’t find a Comirnaty vaccine available for several months. When you consider the available stock left from all those doses they thought people would be flocking to, and the liability shield that can be used interchangeably with a licensed product, it sounds like a sketchy sleight of hand trick.

Several experts familiar with vaccine manufacturing and the mRNA technology have helped break down the information that was released on Monday. They all seem to agree that this is a rather questionable use of the approval stamp.

People are being denied their bodily integrity and their autonomy as illegal mandates are being passed down by governments and employers. They may think they will be receiving a fully licensed vaccine and give in to the mandates, when they are, in reality, getting the same vaccine that’s been proven neither safe nor effective and remains under EUA and a liability shield.

Interestingly, for the fanfare the press is giving Comirnaty, there is no website for the new product. That seems odd. Why? Think about who has been marketing this product. The CDC, FDA, NIH, media, and all of the celebrities and politicians who’ve been guilt-tripping and urging people to get the vaccine. Why are the manufacturing companies not celebrating their shiny new stamp? That doesn’t make sense.

It is crucial that we stand for our health freedoms. We must not give into coercion, a bait and switch, nor unconstitutional mandates. This the United States of America. If you need help with where to begin, please visit our site. We must also contact our elected to let them know that we are not going to tolerate such reckless approvals and mandates.