FDA Approves BioNTech’s Comirnaty. Pfizer COVID Shot Remains Experimental.

The Vaccine Reaction ^ | Sept 4, 2021 | Marco Caceres

[SecAmndmt]

(...)

The FDA’s letter to Pfizer also stated clearly that the Pfizer-BioNTech COVID-19 Vaccine has “not been approved or licensed by FDA, but has been authorized for emergency use by FDA… “4

(...)

[SecAmndmt]

Ping

[Jane Long]

I thought Sen Ron Johnson, and others, have told us that this Comirnaty carp isn’t even available, here/yet.

Is this just for more gaslighting coercion?

[HypatiaTaught]

So if the only thing that is FDA approved is not available yet, there is no way the companies can force EUA “vaccines” on their employees.

GAME OVER SUCKERS.

[lizma2]

Early on I read the approval was for the company to make “Comirnaty” / Pfizer vaxx. Nothing about the approval of the vaxx itself.

[Paladin2]

Is there an actual difference between the two?

[frogjerk]

Yes, if there wasn’t why not just call the Pfizer EUA shot Comirnaty?

[for-q-clinton]

If it were approved Moderna and J&J would no longer be allowed.

So this makes what they are doing to the military a crime against humanity.

[Political Junkie Too]

Here is the FDA's reissue of the EUA for the Pfizer-BioNTech vaccine:

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

Excerpt:

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:

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

Given that the only vaccines available are Emergency Use Authorized, vaccine mandates are illegal due to violation of informed consent and opt-out requirements in 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies.

(e)(1)(A)(ii)(III) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed... of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

I underlined the part about "consequences, if any, of refusing administration of the product" because I believe this pertains to the medical "consequences" of not taking the drug (given this section of US Code). It does NOT give permission to businesses to place "consequences" of their own on employees who don't take the drug (that would be in the US Code sections on labor law). The former gives the recipient the choice, the latter is coercive consent under duress which is not consent under United States law.

Nobody can give a legally binding consent under these employer mandate conditions, and for that reason these mandates to take the EUA vaccines should be challenged in court.

-PJ

[nickcarraway]

It’s the same thing.

[Jane Long]

It’s the same thing.

Got a source for that? Because according to Sen Ron Johnson (and, FDA before they black holed their letter)....they are NOT.

FDA memoryholes original Comirnaty letter indicating Pfizer-BioNTech COVID-19 is not same
Wayback Machine ^ | 8/23/2021 | FDA

Posted on 10/13/2021, 7:16:49 PM by No.6

http://web.archive.org/web/20210922125540/https://www.fda.gov/media/150386/download Original text of 8/22 letter: “COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of PfizerBioNTech 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 for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and 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).”

(Excerpt) Read more at web.archive.org ...

And, this....

Sen. Ron Johnson: There is not an FDA approved COVID vaccine in the US
Fox News ^ | 10-2-21 | Senator Ron Johnson

Posted on 10/3/2021, 11:28:08 AM by Texas Fossil

Senator Ron Johnson, R-Wisc., claimed that the U.S. still doesn't have an FDA-approved vaccine as he exposed what was really approved by the government agency on "Fox News Primetime."

SEN. RON JOHNSON: We do not have an FDA-approved vaccine being administered in the U.S. The FDA played a bait and switch. They approved the Comirnaty version of Pfizer drugs. It’s not available in the U.S. They even admit it. I sent them a letter three days later going "What are you doing?" What they did is they extended the emergency use authorization for the Pfizer drug vaccine that’s available in the U.S., here that’s more than 30 days later, they haven’t asked that very simple question. If you’re saying that the Pfizer drug is the same as the Comirnaty, why didn’t you provide FDA approval on that? So, there’s not an FDA-approved drug and, of course, they announced it so they could push through these mandates so that people actually think, "Oh, OK now these things are FDA approved." They are not and again, maybe they should be, but the FDA isn’t telling me why.

[Political Junkie Too]

It’s the same thing.

The FDA is treating Comirnaty and Pfizer-BioNTech as separate and distinct products.

From 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 Vaccine 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:

1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
2. 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
3. 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:

1. Comirnaty is not available in the United States, necessitating the reissue of the EUA for the Pfizer-BioNTech vaccine.
2. 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

[Jane Long]

Thanks...this ties in with my #11, and, my original #3.

[Political Junkie Too]

The reason this is such an important distinction is that the EUA contains informed consent and opt-out provisions.

Biden's employer mandate is illegal because it coerces employees to consent to the vaccine in order to keep their jobs, their livelihoods, and the financial security of their families.

Consent under duress is not consent under US law.

As long as the vaccines are still under EUA, the vaccine mandates are illegal.

-PJ

[ViLaLuz]

Bookmark

[Irish Eyes]

Nobody can give a legally binding consent under these employer mandate conditions, and for that reason these mandates to take the EUA vaccines should be challenged in court.

I agree, but how long would this take, The deadlines are here now. If it ever got to the Supreme Court they would probably not even hear it. The Supreme Court has been a disappointment lately.

[Political Junkie Too]

A class action lawsuit was filed yesterday using this section of US Code.

Military, Federal Employees and Civilian Contractors Sue Biden.

-PJ

[Varsity Flight]

Blessed the man that does not take counsel in the ungodly. Psalm 1

[ransomnote]

This is article is false and meant to protect Pfizer from liability (stay under the EUA) while pressuring people to get the 'vax' by pretending it's FDA approved. NO VACCINE is FDA approved in the US. The woman who called Pfizer and got them to say over the phone there are no FDA approved Covid 'vaccines' in the US made another call yesterday, and once again Pfizer admits no FDA approved "covid vaccines'. 

10/13/21 - My second phone call with Pfizer about FDA approval -- SPOILER: it's not approved (bitchute.com)

[Irish Eyes]

A class action lawsuit was filed yesterday using this section of US Code.

Good news. I hope something good happens.