There are no fully FDA-approved licensed COV shots available in the USA

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According to Liberty Counsel, 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 September 22, 2021, the Food and Drug Administration (FDA) 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 re-issuance 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). 

The current status of the Pfizer-BioNTech shots:

  1. 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”);
  2. The third or “booster” Pfizer shot is identical to the above and remains under the EUA with limited use to certain categories of people;
  3. 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;
  4. 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; and
  5. Even when an FDA-approved COVID shot becomes available, individuals are protected by federal law and many states laws from being forced to get these shots based on their sincere religious beliefs or conscience rights.

BACKGROUND

The FDA, the US Food and Drug Administration, announced in August that it granted full approval to the first Covid “vaccine” under the brand name Comirnaty. That is a Pfizer vaccine not available in the United States, Leo Hohmann reported.

Dr. Fauci, Joe Biden, the media all claimed Pfizer’s BioNTech COVID vaccine was approved. Many Americans ran to get the vaccine shot, but it was based on misinformation.

The truth is the Pfizer injection is still considered experimental under U.S. law.

There is a legal difference between products approved under the authorization of emergency use (EAU) compared with those the FDA has fully licensed.

THE BAIT-AND-SWITCH

The FDA issued another letter for the existing Pfizer shots which confirms they are still under EUA, are not fully approved, and have a liability shield. That is the legal difference. They can’t be sued while it’s experimental, Liberty Counsel reported.

EUA-approved COVID shots have a liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers, and government planners are immune from liability.

Additionally, the FDA reports: “We have determined that an analysis of spontaneous post-marketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.”

Therefore, follow-up studies will be required with children six months to 15 years as well as six studies for up to five years regarding the adverse effects of myocarditis and pericarditis.

Didn’t Governor Newsom just mandate it for children?

While people can sue, these suits have never succeeded.

The FDA’s approval letter to Pfizer regarding the BioNTech injection, Comirnaty, was for individuals 16 years and older.

This letter also states that the FDA has not approved the Pfizer/BioNTech injections for the 12- to 15-year age group, nor any booster doses for anyone.

In addition, the FDA bypassed and disregarded the normal advisory committee and public comment process for this license.

The FDA and CDC are politicized. Dr. Joe is making the decisions.

 


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