There are currently no fully FDA-approved licensed COVID shots available. All COVID shots remain under federal Emergency Use Authorization, meaning individuals have the "option to accept or refuse" the product.
On Sept. 22, 2021, the Food and Drug Administration sent a follow-up letter to the original approval to Pfizer pharmaceutical company that stated, "having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 23, 2021 letter of authorization in its entirety with revisions incorporated to authorize for emergency use the administration of a single booster dose of COMIRNATY."
On page 6, footnote 12 of that letter the FDA clearly states, "Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or to provide: an additional dose to the immunocompromised population, or a booster dose to the authorized population described in this EUA" (emphasis added).
On Aug. 23, 2021, the FDA sent an approval letter to Pfizer regarding the BioNTech injection Comirnaty. The letter states: "Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older."
The FDA did a bait and switch by announcing it approved its "first COVID-19 vaccine" in order to push the "vaccine" mandates and protect the Pfizer pharmaceutical company from legal liability. The Pfizer injection, on the other hand, is still considered experimental under U.S. law.
There is a legal difference between products approved under authorization of emergency use compared with those the FDA has fully licensed. The FDA issued another letter for the existing Pfizer shots which confirms they are still under EUA, are not fully approved, and has a liability shield. That means people must be told the risks and benefits, and they have the "option to accept or refuse" the product. The federal Emergency Use Authorization law and the FDA, including the FDA Fact Sheet, state unequivocally that each person has the "option to accept or refuse" the shots.
- All existing Pfizer vials (in the hundreds of millions), remain under the federal Emergency Use Authorization (EUA) (meaning people have the "option to accept or refuse").
- The third or "booster" Pfizer shot is identical to the above and remains under the EUA with limited use to certain categories of people.
- BioNTech received FDA approval for people ages 16 and above under the name Comirnaty, but there are no Comirnaty doses available in the United States.
- In other words, there is currently NO FDA-approved COVID-19 injection available anywhere in the United States. Every COVID shot in America remains under the EUA law and thus people have the "option to accept or refuse" them.
- Even when an FDA-approved COVID shot becomes available, individuals are protected by federal law and many state laws from being forced to get these shots based on their sincere religious beliefs or conscience rights.
Liberty Counsel founder and Chairman Mat Staver said, "The FDA has clearly stated there is currently no fully FDA-approved licensed COVID shot available to the population. The Pfizer injection that is currently available in the U.S. is not FDA approved and remains under emergency use authorization only. That means that people have the option to accept or refuse the shots."
This article originally appeared at lc.org.
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