Fox News Finally Admits Per VAERS Vaccine Hurts Kids & Senator States Pfizer Is NOT Approved By FDA Anymore

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.

That’s nonsense. There is no other Pfizer vaccine. The only Pfizer vaccine is the vaccine known as Comirnaty. If you can get the Pfizer vaccine, it is Comirnaty.

“And when you have something to promote, you need a brand name. That’s where “Comirnaty” (pronounced koe-mir’-na-tee) comes in. The shot has been called the “Pfizer vaccine” because that’s the name of one of the companies that developed it. However, the name change led some people to believe the Food and Drug Administration-approved Comirnaty is a different version of the Pfizer vaccine — it’s not.

That’s nonsense. There is no other Pfizer vaccine. The only Pfizer vaccine is the vaccine known as Comirnaty. If you can get the Pfizer vaccine, it is Comirnaty.

If they're the same thing, then why do they have to say they're the "same thing" and they can be used interchangeably? You don't interchange something with itself... And if Pfizer is now fully approved and available, then why are all the other EUAs still active? Should not Moderna or JnJ be pulled off the emergency market?

Comirnaty is only fully approved for first and second jabs. It’s still under the EUA for boosters and people under 16.

No it does not - try reading it carefully. Hint:There are two specific documents that are at the reference link - one for Comirnaty (FDA approved / not available in the USA) and one for the “Pfizer/BioNTech Covid-19 Vaccine” (what they have in the USA now / only available under EUA for Age 12 and up)

BioNTech is a German company that will distribute Comirnaty in Europe. Comirnaty is NOT available in the USA (even though it is the “same formulation”). The Pfizer/BioNTech Covid-19 “vaccine” is still only available under EUA in the USA.

The FDA intended to confuse people like you who do not read the fine print, so it is understandable that you would stop after one paragraph on the press release and not read the actual formal approval documents. That is exactly what the evildoers at the FDA and the White House want to happen. Folks like you will then believe it to be true and spread the word even though it is completely false.

Don’t be that guy. Read the attachments...

There is only one Pfizer vaccine

“And when you have something to promote, you need a brand name. That’s where “Comirnaty” (pronounced koe-mir’-na-tee) comes in. The shot has been called the “Pfizer vaccine” because that’s the name of one of the companies that developed it. However, the name change led some people to believe the Food and Drug Administration-approved Comirnaty is a different version of the Pfizer vaccine — it’s not.

LOL - there is just not getting through to you I guess.

I don’t need to read a newspaper link - I posted the actual FDA announcements that contain the links to the “restated EUA” for the US version of the shot AND the approval document for the BioNTech version called by brand name Comirnaty.

Here is Senator Ron Johnsons view from testimony in the Senate
https://www.foxnews.com/media/ron-johnson-no-fda-approved-covid-vaccine

Here is the first 1.5 pages of FDA explanatory document since you have apparently not opened the link (HERE: https://www.fda.gov/media/144414/download)

(following is copied and pasted directly from the FDA fact sheet).
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 provide:
• a two-dose primary series in individuals 12 through 15 years;
• a third primary series dose in individuals 12 years of age and older who
have been determined to have certain kinds of immunocompromise;
and
• a single booster dose in individuals:
o 65 years of age and older
o 18 through 64 years of age at high risk of severe COVID-19
o 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
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
• a two-dose primary series in individuals 12 years of age and older;
• a third primary series dose for individuals 12 years of age and older
who have been determined to have certain kinds of
immunocompromise; and
• a single booster dose in individuals:
o 65 years of age and older
[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.
2 Revised: 22 September 2021
o 18 through 64 years of age at high risk of severe COVID-19
o 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
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.

Here is another good blog article explaining some of the trickery in the FDA announcement: https://iowaclimate.org/2021/09/14/fda-fiction-fictional-approval-of-covid-19-vaccine/ DAILY NEWS14 Sep 2021 FDA Fiction — Fictional Approval of COVID-19 Vaccine As many have correctly noticed, the FDA has not approved any of the COVID-19 vaccines that. All currently used Covid-19 vaccines are still under Emergency Use Authorization (EUA). So, the obvious questions are: Has the FDA approved the BioNTech COMIRNATY vaccine, as alleged? Why would the FDA approve a vaccine not supplied to the US, instead of approving the equivalent formulation, manufactured and distributed by Pfizer[1], which has been injected in half of the US population, allegedly with enormous success? Finally, why has the FDA created an artificial legal distinction[2] between batches of the same product, manufactured at different plants? The FDA Approval Letter in the question is dated by August 23 and is signed by two directors of CBER offices. One of those directors is Marion Gruber, PhD, who has announced her future resignation, due to the CDC’s attempts to force an approval of a COVID-19 vaccine. The first thing that we notice in the letter is that it lacks the language “We have approved your BLA for effective ”, typically appearing at the beginning of such letters[3]. BLA stands for Biologics License Application. This letter does contain a few sentences authorizing BioNTech to manufacture a COVID-19 Vaccine and approving certain ways and undisclosed locations of manufacturing. It also approves labeling with the name COMIRNATY. This said, such form is used sometimes and is considered as an approval. The next important fact is that the alleged Approval Letter actually prohibits distribution of the drug named in it: “Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).” This language is not unusual in such approval letters. A company receiving such an approval letter from FDA/CBER considers the drug approved and frequently issues a triumphant press release. But this case is different. There is already a surplus of Pfizer’s product in the US[4], its manufacturing continues, and its EUA is re-issued on the same day. BioNTech has no intent to distribute COMIRNATY in the US, and probably has no right to do so under its agreement with Pfizer. Therefore, it is unlikely BioNTech would submit to CBER the requested samples and “protocols showing results of all applicable tests”. Pfizer and BioNtech have barely announced the alleged FDA approval in a joint press-release. The “approval” is incomplete. Each side must take at least one more step to complete the process – BioNTech must ship samples and test results and CBER Director must send a notification of release after that. Neither party is interested in taking these last steps. This answers our first question as to COMIRNATY being truly approved. No, it is not. The FDA approval letter is a fictitious document. The answer to the first question resolves two others. They issued a fictitious approval letter because they do not want to bear the consequences of a real one. A real approval would be in violation of relevant rules and guidelines and would approve a vaccine which targets the extinct virus variant (or serotype), is harmful for most targeted recipients. Pfizer and the CBER wanted to put as much distance as possible between themselves and this approval. The fictitious approval letter is only one part of the deception. The other part is the August 23 EUA, falsely claiming that the FDA has approved a formulation equivalent to Pfizer’s vaccine. Pfizer was then allowed to repeat this lie in its marketing materials. This EUA is signed by the FDA Chief Scientist Denise Hinton and promoted by the FDA acting commissioner Janet Woodcock. Of course, such deception would be unimaginable without the support from Big Tech and Fake News. They claim or insinuate that the Pfizer vaccine is approved by the FDA, and silence those who oppose this lie. This fictitious approval has been granted with hardly any evidence in favor of an approval and disregarding a lot of evidence against it. The science is out of the scope of this article, but the letter brazenly says: “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues…”. Clinicians and scientists outside Pfizer and BioNTech raised a lot of issues before the FDA. See, for example, the Citizen Petition (July 23, 2021) from Coalition Advocating for Adequately Licensed Medicines (CAALM). Also, read Does the FDA think these data justify the first full approval of a covid-19 vaccine? by Peter Doshi, a Senior Editor of the British Medical Journal. BioNTech filed BLA on May 18. The FDA announced granting it Priority Review on July 16. The alleged approval came six weeks later. What was the rush? The vaccine was manufactured freely available under the EUA. There are also lesser irregularities in the CBER letter. The letter is addressed to Amit Patel of BioNTech, but the address is that of Pfizer in New York. All other pages have headers with the name Elisa Harkins of Pfizer. Ms. Harkins was named on the EUAs. This is either a clever attempt to confuse readers, or sloppiness, suggesting that the letter was not proofread and was likely made in irregular ways. The manufacturing locations are redacted out, although BioNTech publishes the locations of its plants and invites journalists to tour them. Of notice, this letter was issued on August 23, when the public’s attention was on the Afghanistan disaster. [1] Pfizer-BioNTech COVID‑19 Vaccine, per May 10 EUA Expansion [2] “The products are legally distinct with certain differences that do not impact safety or effectiveness”, per VACCINE INFORMATION FACT SHEET, rev. 2021-08-23 [3] Examples 1, 2, 3, 4. [4] “There remains, however, a significant amount of PfizerBioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization,” – the re-issued and updated EUA for Pfizer, dated by August 23. via Science Defies Politics https://ift.tt/3loaLfp September 14, 2021 at 03:12PM

There is only one Pfizer vaccine

“And when you have something to promote, you need a brand name. That’s where “Comirnaty” (pronounced koe-mir’-na-tee) comes in. The shot has been called the “Pfizer vaccine” because that’s the name of one of the companies that developed it. However, the name change led some people to believe the Food and Drug Administration-approved Comirnaty is a different version of the Pfizer vaccine — it’s not.