Is the VAXX APPROVED or NOT approved?

If I understand it correctly, the FDA only approved an extension of the emergency use of it, not the jab itself.

And it isn't a vaccine.

yep and
WTF
They lied and misled you all!

Try it I did got to a kill center and read the consent form them refuse to sign! I did 2 places cvs and kasiser both had EUA only. Comorbitly or whatever they called it, is not available in the USA!

Only "Cominarty" is fully approved.

But it isn't manufactured or available yet.

The claim is that Pfizer/BioNTech is the exact same ingredients, yet it is only under extended emergency use authorization & is not fully approved.

Weird right?

Its ok. The FDA says its because of technical legal reasons you wouldn't understand. Safe & effective. Uh huh.

Sounds like someones finishing an experimental trial to me.

No fully approved vaccine is available in the United States- FACT.

Last Edited by GorillaGripPussyPal on 10/02/2021 07:47 PM

No, it was not approved. But for some reason in the news, they said that it was approved, probably to trick people into taking it.

Letter from Senator Ron Johnson

August 26, 2021
Janet Woodcock, M.D.
Acting Commissioner
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993

Dear Acting Commissioner Woodcock:
On August 23, 2021, the FDA reissued the Emergency Use Authorization (EUA) for the PfizerBioNTech COVID-19 vaccine.

1 This vaccine is currently available and used in the United States. At the same time, the FDA announced its approval of the biologics license application submitted by
BioNTech Manufacturing GmbH for Comirnaty (COVID-19 Vaccine, mRNA) against COVID-19 for individuals 16 years of age and older.

2 According to the FDA, “there is not sufficient approved vaccine [Comirnaty] available for distribution” in the U.S.

3 In the letter that reissued the EUA for the Pfizer-BioNTech COVID-19 vaccine, the FDA stated
that Comirnaty and the Pfizer-BioNTech COVID-19 vaccines are “legally distinct with certain
differences that do not impact safety or effectiveness.”

4 That statement, together with the fact that the FDA issued two distinct letters – one extending the EUA for the vaccine used in the U.S. and the other granting the FDA approval of the Comirnaty vaccine used in Europe and other countries – has caused a great deal of confusion.

As I stated to you in my letter dated August 22, 2021, “I see no need to rush the FDA approval
process for any of the three COVID-19 vaccines. Expediting the process appears to only serve the political purpose of imposing and enforcing vaccine mandates.”

5 Because the FDA-approved
Comirnaty vaccine is not generally available in the U.S., but the Pfizer-BioNTech COVID-19 vaccine will continue to be used in the U.S. under a reissued EUA, the FDA seems to be confirming my suspicion.

1 Letter to Elisa Harkins, Pfizer Inc., from Denise Hinton, Chief Scientist, U.S. Food and Drug Administration, Aug. 23, 2021
available at [link to www (secure)] fda.gov/media/150386/download.

2 Letter to Amit Patel, BioNTech Manufacturing GmbH, from Mary Malarkey, Director, Office of Compliance and Biologics
Quality, U.S. Food and Drug Administration, and Marion Gruber, Director, Office of Vaccines Research and Review, U.S.
Food and Drug Administration, Aug. 23, 2021 available at [link to www (secure)] fda.gov/media/151710/download.
3 Letter to Elisa Harkins, Pfizer Inc., from Denise Hinton, Chief Scientist, U.S. Food and Drug Administration at 5, Aug. 23,
2021 available at [link to www.fda.gov (secure)] (See footnote 9).
4 Id. at 2 (See footnote 8). 5
Letter from Ron Johnson, U.S. Senator, to Janet Woodcock, Acting Commissioner, U.S. Food and Drug Administration, et
al., Aug. 22, 2021.
Acting Commissioner Janet Woodcock
Aug. 26, 2021
Page 2
In order to address the confusion created by the FDA’s August 23, 2021 letters, I am asking that you expeditiously provide answers to the following questions:
1) Why didn’t the FDA grant full licensure for the Pfizer-BioNTech vaccine that is in use and available in the U.S.?
2) How are the Comirnaty and Pfizer-BioNTech COVID-19 vaccines “legally distinct” and what are the “certain differences”?
3) There is no doubt that the FDA’s action will lead to more vaccine mandates and increased pressure on those currently choosing not to get vaccinated. Your letter to Pfizer suggests that “there is not sufficient approved vaccine available for distribution.”6
Is there sufficient supply in the U.S. of the Comirnaty vaccine to ensure that those being vaccinated under mandates will be receiving the FDA-approved version? Or is it more likely (or certain) that they will be vaccinated using the vaccine administered under the reissued EUA?
4) If there is insufficient supply of Comirnaty vaccines for those succumbing to the coercion of
mandates, isn’t the FDA de facto endorsing vaccine mandates utilizing EUA vaccines?
5) Will individuals who receive either vaccine be afforded the same legal protections if they are
injured by the vaccine? If not, why not?
I look forward to receiving a response to this limited number of questions no later than August
30, 2021. Your answers are crucial to Americans who will now be forced into making potentially lifealtering decisions in response to the employer, military and educational mandates that your August 23,
2021 letters have triggered. I will also be sending you a more detailed follow-up letter to your
inadequate response to my August 22, 2021 letter in the next few days.
Sincerely,
Ron Johnson
U.S. Senator I love he is fighting for you!!!

6
Letter to Elisa Harkins, Pfizer Inc., from Denise Hinton, Chief Scientist, U.S. Food and Drug Administration at 5, Aug. 23,
2021 available at [link to www.fda.gov (secure)] (See footnote 9).

The “approved” shot is not available and is not being manufactured for the US.

Shell game.

FDA

VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS
ABOUT COMIRNATY (COVID-19 VACCINE, mRNA)
AND PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)
You are being 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.
This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and also includes information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA).

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the
FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.[1]

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 EUA to be administered to:
o prevent COVID-19 in individuals 12 through 15 years, and
o 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.
This Vaccine Information Fact Sheet contains information to help you understand the
risks and benefits of COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine, which you may receive because there is currently
a pandemic of COVID-19. Talk to your vaccination provider if you have questions. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine are administered as a 2-dose series, 3 weeks apart, into the muscle.

[1] The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns.
The products are legally distinct with certain differences that do not impact safety or
effectiveness.

Yes, the MSM lied to everyone.

There's no law against MSM lying in this country. Pretty fucked up when you think about it.

So that’s a no..

NOT

To justify illegal mandates.

You have been MANDATED TO PARTICIPATE IN AN EXPERIMENTAL DRUG TRIAL at the cost of losing your job.

Your "leaders" are tyrants and MUST be removed from office before they murder your children. FACT.

I suggest everyone go to several pharmacies and get copies of their promotional info, and especially side effects, and ask, what do I need to do to get the EGT , just get what ever you can, and give very little- to none info of your own. And observe their actions.

No. Only "Cominarty" is FULLY FDA APPROVED for anyone of any age.

Cominarty is NOT CURRENTLY AVAILABLE in the United States.

There is NO FULLY APPROVED COVID VACCINE AVAILABLE IN THE UNITED STATES.

If I am wrong, please point me to any official source showing that ANY COVID VACCINE, besides "Cominarty (which is not currently available 3 months after its approval) is fully FDA approved.

You can't, because Im not wrong & you are either lying purposefully or just misinformed and lying.

Last Edited by GorillaGripPussyPal on 10/02/2021 08:01 PM

What is EGT?

Probably experimental gene therapy.

I'm glad I'm not a conspiracy theorist.

If I were, I might think there's some sort of intentional deception going on here.

:b3241:

:vaxxtardum:

NOT approved by me.

current vaccines are only EUA, comirnaty which wont be available for at least 1 year is approved.

No, it's only EUA approved.

The vaccine they approved isn't even used in the U.S., but Europe is using it.

If you got to have a Pfizer mRNA ask for the one the FDA gave full approval for....bet you don't get it, and if you do...sue the person giving you the shot...you got a good case.

Trust the science!

Form hypothesis : we will develop a vaccine that will eradicate Covid
Test hypothesis : vaccine isn’t stopping it
Refine or develop a new hypothesis: our vaccine will make the Covid not as bad
Test hypothesis: still not stopping it, possibly making it worse.
Refine or develop a new hypothesis: this vaccine doesn’t do anything to stop Covid.
Test hypothesis: the vaccine isn’t doing anything to Covid.
Hypotheses proven.


They skipped a few steps

Depends who you listen to! LOL

Not the one available in the USA. The approved version is only available overseas. Of you are forced to take it demand the approved one a make sure you get the box it came in to verify it's comnarity or whatever it's called. The one available here is still under EUA

Legally they are DIFFERENT

Last Edited by Bloody Peasant! on 10/02/2021 09:01 PM

Pretty funny, if you have to ask such a question.

How is the fishing expedition going? The only bites you will get from this web site is on your ass.

Only the license to manufacture a biologic was approved. A biologic is a gene therapy drug.

It's the exact same formulation, so it doesn't matter what it's called.

If it was truly approved, it would be the only option from what I heard. The others would need to cease distribution.

Comorbidly is fully approved to help euthanise Americans against 99.8% survivable Covid-19 and its many variants...maybe.

Same stuff.
Different names.
Covid19 vax - available, no liability.
Comirbility - not available but Pfizer will be liable for adverse effects.

Last Edited by uscrusader1 on 10/02/2021 09:13 PM

as far as i under stand what i read. they approved a product called "comirnaty" a vaccine for covid that will be available at a later date.

to answer your implied question. the shots being given are not fully fda approved but are in a emergency action use.