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Sen. Ron Johnson: 5 Questions for FDA About Pfizer Vaccine Approval
https://childrenshealthdefense.org ^ | 08.27.2021 | Children's Health Defense Team

Posted on 08/27/2021 2:26:26 PM PDT by rxsid

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To: rxsid

Even if it were approved after 5 years of rigorous testing, the committed anti vaxxers would not take it.

So why keep harping on it?


21 posted on 08/27/2021 3:27:43 PM PDT by Mariner (War criminal #18)
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To: Mariner
"Even if it were approved after 5 years of rigorous testing, the committed anti vaxxers would not take it.

So why keep harping on it?"

Because I can say, unequivocally, not true. Not for me, and not for my family.

We are not "anti vaxxers" like the liberals and assorted commies like to paint us as.

We are simply anti mandates for experimental medicine of any kind and anti mandates for any approved medication I don't need nor want.

This is all about pushback against the lies being forced fed to the public at large by the functionaries and progressive commies that run much of our fed gov.

22 posted on 08/27/2021 3:38:36 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
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To: rxsid
“FDA may revise or revoke an EUA if the circumstances justifying its issuance (under section 564(b)(1))…”

Exactly. The FDA can withdraw the EUA if they choose to but nothing automatically revokes it when a new drug is approved.

23 posted on 08/27/2021 3:40:18 PM PDT by semimojo
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To: rxsid

“We are simply anti mandates for experimental medicine of any kind and anti mandates for any approved medication I don’t need nor want.”

Is somebody trying to force you to get the shot?


24 posted on 08/27/2021 3:45:23 PM PDT by Mariner (War criminal #18)
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To: semimojo
"“FDA may revise or revoke an EUA if the circumstances justifying its issuance (under section 564(b)(1))…”

Exactly. The FDA can withdraw the EUA if they choose to but nothing automatically revokes it when a new drug is approved.

==============================================

No, not "exactly." You stated: "there’s no provision that revokes the EUA when alternatives emerge"

There is. It's in section 564. They may...or may not choose to revoke...but there IS a provision used to revoke.

And that's precisely the point of needing that question to be asked and answered.

Let the FDA explain to the American people why they should NOT revoke the other two, when there is an "approved" vaccine available.

Let's hear their answer.

25 posted on 08/27/2021 3:51:49 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
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To: rxsid
Per Pfizer Announcement:

PFIZER-BIONTECH COVID-19 VACCINE COMIRNATY® RECEIVES FULL U.S. FDA APPROVAL FOR INDIVIDUALS 16 YEARS AND OLDER

Indication & Authorized Use

COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older

It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to: prevent COVID-19 in individuals 12 through 15 years, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:

prevent COVID-19 in individuals 12 years of age and older, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

EUA Statement

This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Important Safety Information

Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they:

had a severe allergic reaction after a previous dose of this vaccine

had a severe allergic reaction to any ingredient of this vaccine

Individuals should tell the vaccination provider about all of their medical conditions, including if they:

have any allergies

have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart) have a fever

have a bleeding disorder or are on a blood thinner

are immunocompromised or are on a medicine that affects the immune system

are pregnant, plan to become pregnant, or are breastfeeding have received another COVID-19 vaccine

have ever fainted in association with an injection

The vaccine may not protect everyone.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full

26 posted on 08/27/2021 3:54:46 PM PDT by Lockbox (politicians, they all seemed like game show hosts to me.... Sting)
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To: rxsid

Yes, 6 needs an answer.


27 posted on 08/27/2021 3:54:58 PM PDT by Reno89519 (Respect America, Embrace America, Buy American, Hire American.)
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To: Mariner
“We are simply anti mandates for experimental medicine of any kind and anti mandates for any approved medication I don’t need nor want.”

Is somebody trying to force you to get the shot?

====================================

Does it matter about me, personally as an individual? Am I not supposed to take an interest in this story if it only affects people around me, and perhaps not me personally?

Have you considered the possibility that based on what's happened so far, and the trajectory of where were going that grocery stores, hardware stores (etc) will not let people in unless they produce a valid/verifiable covid vaccination card? Have you not heard the news starting to come out regarding this direction?

You ok with that?

Why are you so triggered by my posting of information?

28 posted on 08/27/2021 3:57:34 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
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To: qaz123

Yep, I might have to go back a ping a few people. Especially, the one that told me that I need to work on my reading comprehension.


29 posted on 08/27/2021 3:59:02 PM PDT by kara37 ( )
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To: Lockbox
"Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they:

...

have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart) have a fever"

And THAT is precisely what the FDA is requiring them to study over the next several YEARS. Admitting that there are "serious" concerns about these inflammations.

Additionally, I'd wager that a big majority of people who have had either of these inflammations probably didn't even know about it, or at least, were never diagnosed with it for a variety of reasons.

30 posted on 08/27/2021 4:05:54 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
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To: rxsid

Thanks for that... so FDA DOES have means to revoke EUA.

They still have not even talked about it.

Nor have they talked about issuing approval for other manufacturers like they did for Pfizer.

I am of the belief that Pfizer’s “vaccine” is itself STILL UNDER EUA.

This sham of an approval was just to take the political pressure off of themselves.

It’s only intended usage was for public consumption of yet another lie... so we would VOLUNTARILY submit to an EXPERIMENTAL drug.


31 posted on 08/27/2021 4:07:13 PM PDT by Safrguns
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To: Mariner

You are dangerously wrong. I will ask you why you would so eagerly jump to support an unproven emergency gene therapy that you don’t know the side effects. The emergency gene therapy to treat a lab leaked genetic experimental virus from China cooked up with the help of the NIH. BTW the same experiment that they claim is natural, the media, government and elite want you to pretend wasn’t a accidental virus release, hide negative vaccine side effects, have hidden use clauses with governments, won’t be used by the virus manufacturers….

Why so positive about the DS cure to the DS disease ? I really don’t understand the logic in this entire cluster f’ck.


32 posted on 08/27/2021 4:27:07 PM PDT by wgmalabama (We will find out if the Vac or virus risk was the correct choice - can we put truth above narrative)
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To: rxsid

Compare with the demand that all get the vaccine! No one is reading the fine print.


33 posted on 08/27/2021 4:29:36 PM PDT by Lockbox (politicians, they all seemed like game show hosts to me.... Sting)
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To: wgmalabama

“I will ask you why you would so eagerly jump to support an unproven emergency gene therapy that you don’t know the side effects. “

You presume I support it. I don’t.

But I do take some pleasure in watching simple people flail over it as it it’s the boogie man laying in wait for them.


34 posted on 08/27/2021 4:43:08 PM PDT by Mariner (War criminal #18)
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To: Mariner

Got it. Your an agitator. I like it. Keep it up. You are good at it.

Everything is going to be a disaster but we deserve it.


35 posted on 08/27/2021 4:47:00 PM PDT by wgmalabama (We will find out if the Vac or virus risk was the correct choice - can we put truth above narrative)
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To: rxsid

“You ok with that?”

Don’t comply.


36 posted on 08/27/2021 5:07:39 PM PDT by Mariner (War criminal #18)
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To: rxsid

My mom is at death’s door due to Pfizer. Do NOT get it.


37 posted on 08/27/2021 5:32:57 PM PDT by bgill (.Which came first, the vax or the virus?)
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To: Trillian

Probably, since her name is Natalie.


38 posted on 08/27/2021 5:43:58 PM PDT by EEGator
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To: Mariner

5 years to plan your own business where shots aren’t mandated.
5 years of employment without getting fired.
5 years of saving money for said business.
5 years to move to a state that values freedom of the individual.


39 posted on 08/27/2021 5:46:41 PM PDT by EEGator
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To: rxsid; All

Can’t get the general forum board to come up. 11pm central time. Any one else having this issue? Able to get into mail and pings. Thanks and blessings!


40 posted on 08/27/2021 9:10:58 PM PDT by foundedonpurpose (Praise Hashem, for his restoration of all things!)
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