By LIJ Publisher
On August 23rd, the Food and Drug Administration (FDA), granted approval for Pfizer-BioNTech’s vaccine for SARS Co-V2, the virus which causes COVID-19. The much-anticipated approval is expected to boost vaccinations, and potentially clear the way for additional mandates across the country, as more than half of all Louisiana residences still remains unvaccinated.
According to the Mayo Clinic tracking website, only 42.3% of the people in the state of Louisiana are fully vaccinated, while half have received at least one dose at the time this article was published.
The federal agency, which had previously only granted Emergency Use Authorization (EUA) for COVID vaccines, has now given its full approval after a three-month review of Pfizer-BioNTech’s application.
However, within the language of the press release from the FDA, and its two letters to the pharmaceutical companies, is the fact that the fully-approved vaccine, is actually the same vaccine as the one which has been distributed and administered since December of last year under an emergency use authorization.
Linguistic Sleight of Hand Regarding the Vaccine
The first paragraph of the press release from the FDA touting the approval reads: “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 […], for the prevention of COVID-19 disease in individuals 16 years of age and older.”
“The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty […].” What the FDA’s press release is openly and cleverly saying is we are renaming the current EUA-authorized vaccine; and under the new name—granting it full approval.
To support this fact the press release continues, “Comirnaty has the same formulation as the EUA vaccine […].” In specific verbiage, the FDA is stating that the vaccine, which it gave its full approval to, is indeed, the same vaccine that received emergency use authorization in December of 2020. The only differences now are that it has a formal marketable name, it’s fully-approved and it cannot be given to children 15 years-old or younger.
But highlighting the last sentence of the opening paragraph of the FDA’s press release, it concludes by stating, “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.”
This is a kind of bureaucratic double-speak. So not only is the “new” vaccine the same as the “old” vaccine, but it can still be given to children between 12 and 15 years old, after stating Comirnaty is only approved for “16 years of age or older.” These conflicting statements were made possible by the FDA granting only BioNTech—not Pfizer—approval for the new vaccine, and reissuing the EUA to Pfizer for the old one, which, as the FDA press release states, is the same vaccine.
Tale of Two Letters
In order for a vaccine to get FDA approval a pharmaceutical company must submit a biologistic license application (BLA) for review by the agency. On August 23rd, the FDA sent a letter to BioNTech, Pfizer’s German-based partner in the COVID vaccine, approving its BLA to manufacture “Comirnaty.”
On the same day, the FDA also sent a separate letter to Pfizer stating, the “FDA is reissuing the August 12, 2021 letter of [emergency use] authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine […] and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.” It is here, in this separate letter to Pfizer, the FDA is allowing Comirnaty to be given to children through an EUA, despite the fact that there are ongoing and required pediatric safety studies for this group.
To further explain how the FDA-approved shot is same as the EUA jab, the FDA’s letter to Pfizer states: “COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.” The corresponding footnote to this is statement reads: “The products are legally distinct with certain differences that do not impact safety or effectiveness.” Those “legally distinct” differences are liability—not formulation—meaning, they are the same in terms ingredients, safety and efficacy, and are only different from a legal standpoint.
Under the Public Readiness and Emergency Preparedness Act (PREP Act), when a medical emergency is declared, as it was at the end of January of last year because of the pandemic, vaccines and other medical countermeasures are given liability protection. The FDA granted the COVID-19 vaccines EUA status, placing them under the covered countermeasures in the emergency use categories of the PREP Act, and thus giving them a liability shield.
The BioNTech vaccine, Comirnaty, has full approval—not emergency use authorization—and therefore has no liability protection. This lack of liability shield exposes BioNTech to being sued for an adverse reaction to its vaccine.
At the same time, the original Pfizer-BioNTech COVID-19 Vaccine, which was granted an EUA in December of last year, then reissued August 12th of this year, is still being used under its emergency use authorization, thus maintaining its liability protection from lawsuits if they were to be sued for an adverse reaction to its vaccine.
This is important because, as mentioned previously, this version of the vaccine, according to the FDA “can be used interchangeably” with Comirnaty, and because of the large supply of the original EUA-authorized vaccine, this will be the case.
From the FDA’s letter to Pfizer: “There remains, however, a significant amount of Pfizer-BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product […].”
In other words, the only version available is the EUA-authorized vaccine—not the fully-approved Comirnaty.
In essence, what was created on August 23rd through the FDA approval was actually two separate legal classifications for the one Pfizer-BioNTech EUA vaccine people have been getting since last December.
This was presumably done to promote the legal mandating of what is now, a fully-approved vaccine, versus the experimental, emergency use authorized vaccine which is an obstacle to vaccine mandates due to the restrictions on mandating experimental treatments.
But more importantly, global corporations, government at all levels, big and small businesses, companies and organizations will presumably now have the legal high ground to mandate the vaccine because it has been fully-approved.
Only time will tell if the change of legal status for the vaccine will compel more Louisianians to get the jab; or if they don’t, will the powers that be push the limits of a free society and force the vaccine hesitant into an untenable position?