Did FDA Really Approve the Pfizer Covid Vaccine? Wait. What?
The pressure is building. “Take the vaccine.”
Many people are looking for a successful way to refuse the COVID vaccine in situations where the shots are mandated. I fully support such efforts.
Some people believe they can make the argument that the FDA didn’t actually give full approval to the Pfizer vaccine on August 23rd. Therefore, these people can refuse the vaccine on the grounds that it is still experimental, meaning it has only been granted Emergency Use Authorization.
I’ll discuss that practical strategy later in this article.
But first, I need to analyze the claim that the FDA didn’t truly approve (license) the Pfizer vaccine.
OK. Here we go.
The first FDA document I’ll reference is “Comirnaty and Pfizer-BioNTech COVID-19 Vaccine,” dated August 23, 2021. The document opens with this statement:
“On August 23, 2021, the FDA 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, 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.”
“The FDA approved” means full approval. The FDA has fully approved the Pfizer-BioNTech COVID vaccine.
And this vaccine “will now be marketed” as the Comirnaty vaccine.
They are the same vaccine, medically speaking. The ingredients are the same.
The FDA document ALSO says the vaccine will continue to be available under the prior Emergency Use Authorization (EUA), for uses that are not yet fully approved. For example, injecting children 12-15, and as a third dose for certain immunocompromised people.
The full approval and the EUA status are riding together, side by side. The EUA status covers uses of the vaccine not covered under full approval.
The rest of this FDA document offers links. One of the links leads to an FDA news release, dated August 23, titled, “FDA Approves First COVID-19 Vaccine.” The release states:
“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…”
“To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.”
The FDA, in this news release, is again asserting that the Pfizer vaccine is now approved, and makes a clear distinction between the prior EUA and this new approval.
Next, we move to a letter, also dated August 23, sent from the FDA to BioNTech Manufacturing GmbH, and Pfizer Inc. The letter is marked, “BLA Approval.” BLA stands for “Biologics License Application.” Here are key quotes:
“Please refer to your Biologics License Application (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA.”
Article from LewRockwell