Senator Ron Johnson Exposes Vaccine Scandal Of The Decade

So do you then believe that the Moderna and J&J vaccines must have their EUA immediately rescinded and the products pulled from distribution because there is now an FDA-approved treatment available, which invalidates the EUA?

I would also would like DugwayDuke's answer on that question.

Yes it is the great deception, but don’t dare to call out those here on FR who are a part of it.

If I had to guess at an answer, I'd say that the only possible response would be the Clintonian "it depends on what the meaning of 'available' is."

I thought the EUA meaning of "available" was that there were no effective treatments in existence, hence the national (federal) emergency. But I wouldn't be surprised if someone tried to interpret it to mean it's not available at my local CVS.

If my CVS carries Moderna and the Walgreens down the street carries Pfizer, since Pfizer is not "available" in CVS that makes it an emergency (for CVS) and therefore CVS can distribute Moderna under the EUA.

That's how I'd spin it. The lack of national availability will be reinterpreted to become a local availability issue to keep them all on the market despite the FDA regulations.

-PJ

I would have to agee. That is about as Clintonian as could possibly be.

I am glad that I am retired and is not my immediate problem. My son works for SWA so it has become a real problem for him. He will not even take an aspirin.

Political Junkie Too wrote: “So do you then believe that the Moderna and J&J vaccines must have their EUA immediately rescinded and the products pulled from distribution because there is now an FDA-approved treatment available, which invalidates the EUA?”

Of course not.
The EUA remains in effect for some groups.
and
If your allegation were true, then there could only be one vaccine approved under the EUA. We have three. Once one was approved, then there could not be another.

Read this.

Here is the FDA's reissue of the EUA for the Pfizer-BioNTech vaccine dated September 22, 2021:

https://www.fda.gov/media/150386/download

Excerpt:

I. Criteria for Issuance of Authorization
I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine11 for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:
SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and
There is no adequate, approved, and available alternative¹² Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.¹³
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:
Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through authorized distributor(s),¹⁴ to emergency response stakeholders¹⁵ as directed by the U.S. government, including the Centers for Disease Control and Prevention (CDC) and/or other designee, for use consistent with the terms and conditions of this EUA;
The Pfizer-BioNTech COVID‑19 Vaccine covered by this authorization will be administered by vaccination providers¹⁶ and used only to prevent COVID-19 in individuals ages 12 and older with a two-dose regimen, to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, and to provide a single booster dose at least 6 months after completing the primary series of the vaccine to individuals: 65 years of age or older; 18 through 64 years of age at high risk of severe COVID-19; and 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19; and
Pfizer-BioNTech COVID‑19 Vaccine may be administered by a vaccination provider without an individual prescription for each vaccine recipient
Footnote 12: 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.

This means two things:

Comirnaty is not available in the United States, necessitating the reissue of the EUA for the Pfizer-BioNTech vaccine.
There are no non-EUA vaccines available in the United States.

It is clear that the FDA intended for Comirnaty and the Pfizer-BioNTech vaccines to be treated as separate and distinct vaccines.

The vaccine labeled Pfizer-BioNTech is still covered by the terms and conditions of the EUA. It is NOT an FDA-approved vaccine.

-PJ

Political Junkie Too wrote: “This means two things:
Comirnaty is not available in the United States, necessitating the reissue of the EUA for the Pfizer-BioNTech vaccine. There are no non-EUA vaccines available in the United States. It is clear that the FDA intended for Comirnaty and the Pfizer-BioNTech vaccines to be treated as separate and distinct vaccines. The vaccine labeled Pfizer-BioNTech is still covered by the terms and conditions of the EUA. It is NOT an FDA-approved vaccine.”

Vaccines manufactured under the EUA are legally referred to as Pfizer-BioNTech vaccines
Vaccines manufactured under fully approval are legally referred to as Comirnaty.
Both are identical and interchangeable.
Please describe how identical and interchangeable things can be different.

No. You refuse to address the FDA's actual statements and try to talk in circles.

Please explain to my why the FDA said:

"Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through authorized distributor(s),14 to emergency response stakeholders15 as directed by the U.S. government, including the Centers for Disease Control and Prevention (CDC) and/or other designee, for use consistent with the terms and conditions of this EUA;

The may be interchangeable in terms of administration of the drug, but they are not interchangeable in terms of the law.

The Pfizer-BioNTech vaccine can only be used within the terms of the EUA, the Comirnaty drug can be freely used.

They are different because the Pfizer-BioNTech vaccine requires informed consent with the option of refusal under the terms of the EUA and can only be administered by "emergency response stakeholders." The Comirnaty drug can be prescribed by doctors and administered by them.

Do you agree with those statements?

-PJ