FDA grants Pfizer COVID-19 vaccine full approval

[Cebu_4_2]

The Pfizer vaccine is the first COVID-19 shot to receive full approval, beyond emergency use authorization



The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer's COVID-19 vaccine for individuals 16 years and older.


"The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Acting FDA Commissioner Janet Woodcock said in a statement issued Monday. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."


This is a developing story, please check back for updates.

[Cebu_4_2]

The U.S. Food and Drug Administration gave full approval Monday to the COVID-19 vaccine made by Pfizer Inc and German partner BioNTech SE for use in people over the age of 16, in first such approval of a COVID-19 shot.

The vaccine has been authorized for emergency use since December and more than 204 million people in the United States have received it, based on Sunday's data. But none of the three authorized COVID-19 vaccines had previously received full FDA approval.

Public health officials hope it will convince more unvaccinated Americans that Pfizer's shot is safe and effective. Vaccine hesitancy among some Americans has hindered the United States response to the novel coronavirus.

"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," said Janet Woodcock, the U.S. Food and Drug Administration's acting commissioner.

About 51% of Americans have been fully vaccinated so far, even as a recent surge of infections spurred by the contagious Delta variant ravages parts of the country with low vaccination rates.

© 2021 Thomson/Reuters. All rights reserved.

[monty]

The U.S. Food and Drug Administration gave full approval Monday to the COVID-19 vaccine made by Pfizer Inc and German partner BioNTech SE for use in people over the age of 16, in first such approval of a COVID-19 shot.

The vaccine has been authorized for emergency use since December and more than 204 million people in the United States have received it, based on Sunday's data. But none of the three authorized COVID-19 vaccines had previously received full FDA approval.

Public health officials hope it will convince more unvaccinated Americans that Pfizer's shot is safe and effective. Vaccine hesitancy among some Americans has hindered the United States response to the novel coronavirus.

"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," said Janet Woodcock, the U.S. Food and Drug Administration's acting commissioner.

About 51% of Americans have been fully vaccinated so far, even as a recent surge of infections spurred by the contagious Delta variant ravages parts of the country with low vaccination rates.

© 2021 Thomson/Reuters. All rights reserved.

The folks at FDA will all be driving Rolls Royce automobiles.

[Ares]

The Pfizer vaccine is the first COVID-19 shot to receive full approval, beyond emergency use authorization



The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer's COVID-19 vaccine for individuals 16 years and older.


"The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Acting FDA Commissioner Janet Woodcock said in a statement issued Monday. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."


This is a developing story, please check back for updates.








You mean the same people who hold boatloads of Pfizer stock granted full approval to an untested vaccine when the trial period hasn't even completed and still unsure of the dosage requirements??

Nah... You don't say.

[Cebu_4_2]

FDA Approval of Pfizer Vaccine Sparks Wave of Mandates: Pentagon, New York City Public Schools Announce Requirements

https://www.thegatewaypundit.com/2021/08/fda-approval-pfizer-vaccine-sparks-wave-mandates-pentagon-new-york-city-public-schools-announce-requirements/

Biden’s Surgeon General Vivek Murthy on Sunday said the FDA’s approval of the Pfizer vaccine will likely lead to more vaccine mandates.

And that’s exactly what happened.

Within minutes of the FDA’s approval of the Pfizer vaccine, the Pentagon and New York schools announced new requirements.

The FDA on Monday granted a full approval to the Pfizer vaccine.

The Pentagon announced all 1.4 million active duty service members will be required to take the jab.

New York City Mayor Bill de Blasio also announced Monday that all of the city’s public school employees would be required to get the vaccine by September 27.

Joe Biden immediately called on Americans to get vaccinated after the FDA’s announcement on Monday.

Charlie Kirk asked a great question:

How can a vaccine, that according to Axios had a 42% efficacy rate in July, get FDA approval?

[Cebu_4_2]

Well this is all a bunch of BS. It has NOT been FDA approved. The EUA (emergency use authorization) has been reissued.

I would put a screen shot but you know, the thing...

If I find a link I will edit.

This is the best I can do short term:

https://twitter.com/CardinalConserv/status/1429891638977974301

This is it, page 2: https://www.fda.gov/media/150386/download

[Ares]

Well this is all a bunch of BS. It has NOT been FDA approved. The EUA (emergency use authorization) has been reissued.

I would put a screen shot but you know, the thing...

If I find a link I will edit.

This is the best I can do short term:

https://twitter.com/CardinalConserv/status/1429891638977974301

This is it, page 2: https://www.fda.gov/media/150386/download

Unfortunately the guy reading this document has little knowledge or understanding in reading / interpreting government documents. I'll break it down:

Cormirnaty (covid-19 vaccine licensed and approved name) - Approved for 16+

EUA still in affect and extended for the covid-19 vaccine for 12+ (i.e. children).

[Cebu_4_2]

Unfortunately the guy reading this document has little knowledge or understanding in reading / interpreting government documents. I'll break it down:

Cormirnaty (covid-19 vaccine licensed and approved name) - Approved for 16+

EUA still in affect and extended for the covid-19 vaccine for 12+ (i.e. children).

Yes they changed some terms (ages) is why they reissued the EUA. However it was NOT fully approved by the FDA which the entire USi is running with and locking things down again. Just heard propaganda news this morning for a few seconds, kids 5-12 are all coming down with the variant but the good news is kids 12 and above have been getting the covid shot so we shouldn't worry too much.

Edit: Okay I follow now. Comirnaty has been licensed but is not available and the current Pfizer one can be used interchangeably but not forced if it does not say Comirnaty. What a bunch of total shit. How the hell did Comirnaty pass FDA when not even available?

Edit 2: Same shit different name. Still how did it pass?

[vacuum]

Good summary of what happened


https://rumble.com/vlmce2-dr.-malone-sounds-alarm-on-liability-coverage-of-pfizer-vax.html

https://rumble.com/vlmce2-dr.-malone-sounds-alarm-on-liability-coverage-of-pfizer-vax.html

[Amanda]

Robert Barnes
@barnes_law
If your employer or school mandates you get the FDA approved vaccine, you can let them know that’s not possible because that product isn’t available yet.
11:32 PM · Aug 24, 2021
Robert Barnes
@barnes_law
Past mRna vaccines failed because they couldn’t pass clinical 3 stage trials. FDA solved that by approving these vaccines before those trials can place.
11:29 PM · Aug 24, 2021·


Dr Malone: Phizer still Under EUA and Waiver. Comirnaty is Fully Approved, Not Currently Available

https://www.bitchute.com/video/DZQFYRGDkB6s/

2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine

Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.

https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/

(https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/)Monday, the U.S. Food and Drug Administration (FDA) approved (https://www.fda.gov/media/150386/download) a biologics license application (https://www.fda.gov/media/151710/download) for the Pfizer Comirnaty vaccine.

The press reported (https://www.washingtonpost.com/health/2021/08/23/pfizer-vaccine-full-approval/) that vaccine mandates (https://childrenshealthdefense.org/defender/vaccine-mandates-an-erosion-of-civil-rights-chd-e-book-available-now/) are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required (https://www.nydailynews.com/new-york/ny-schools-vax-mandate-20210823-4oszhp6nfnbh7bexjftqflnhai-story.html) the vaccine for all teachers and school staff. The Pentagon (https://apnews.com/article/business-health-coronavirus-pandemic-e08a6e68308b27ad7653ca9210d953dc) is proceeding with its mandate (https://childrenshealthdefense.org/defender/military-mandate-covid-vaccines-exemption-rights/) for all military service members.

But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.

First, the FDA acknowledges that while Pfizer (https://childrenshealthdefense.org/defender/emily-jo-14-year-old-son-aiden-myocarditis-pfizer-vaccine/) has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization) (EUA) — still available for use.

The FDA decrees (https://www.fda.gov/media/150386/download) that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8 (https://www.fda.gov/media/150386/download)) with the newly licensed Comirnaty product.

Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.

EUA products are experimental (https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application#Introduction) under U.S. law. Both the Nuremberg Code (https://www.fhi360.org/sites/all/libraries/webpages/fhi-retc2/Resources/nuremburg_code.pdf) and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III) (https://www.law.cornell.edu/uscode/text/21/360bbb-3), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.

U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.

EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act (https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx). Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.

The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program (https://www.hrsa.gov/cicp), to redress injuries from all EUA products. The program’s parsimonious administrators have compensated under 4% of petitioners (https://www.hrsa.gov/cicp/cicp-data) to date — and not a single COVID vaccine injury — despite the fact that physicians, families and injured vaccine recipients have reported more than 600,000 COVID vaccine injuries (https://childrenshealthdefense.org/defender/vaers-cdc-deaths-adverse-events-covid-vaccines-booster-shots-september/).

At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.

When the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices places a vaccine on the mandatory schedule, a childhood vaccine benefits from a generous retinue of liability protections.

But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup (https://childrenshealthdefense.org/defender/bayer-roundup-cancer-trial-appeal-rules-plaintiffs-alva-alberta-pilliod/), people injured by the Comirnaty vaccine could potentially sue for damages.

And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.

Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.

Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.

The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System (https://vaers.hhs.gov/) have exposed as unreasonably dangerous, and that the Delta variant (https://childrenshealthdefense.org/defender/brian-hooker-covid-delta-variant-vaccine-less-effective/) has rendered obsolete.

Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.

The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product.

While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses (https://childrenshealthdefense.org/defender/scientists-booster-shots-weak-evidence-vaccine-resistant-variants/) for anyone.

And the FDA has not licensed any Moderna (https://childrenshealthdefense.org/defender/the-peoples-testaments-polly-tommey-sally-kirkland-moderna-vaccine-constant-pain/) vaccine, nor any vaccine from Johnson & Johnson (https://childrenshealthdefense.org/defender/fda-warning-jj-vaccine-serious-rare-autoimmune-disorder/) — so the vast majority, if not all, of vaccines available in the U.S. remain unlicensed EUA products.

Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product.

If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb (https://www.law.cornell.edu/uscode/text/21/360bbb-3), you have the right to refuse.

If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.

The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.

*****

Did FDA really approve the Pfizer COVID vaccine? Wait. What? by Jon Rappoport (https://blog.nomorefakenews.com/author/jonrappoport/)

https://blog.nomorefakenews.com/2021/08/25/did-fda-really-approve-the-pfizer-covid-vaccine-wait-what/

The pressure is building. “Take the vaccine.”
Many people are looking for a successful way to refuse the COVID vaccine in situations where the shots are mandated. I fully support such efforts.
Some people believe they can make the argument that the FDA didn’t actually give full approval to the Pfizer vaccine on August 23rd. Therefore, these people can refuse the vaccine on the grounds that it is still experimental, meaning it has only been granted Emergency Use Authorization.
I’ll discuss that practical strategy later in this article.
But first, I need to analyze the claim that the FDA didn’t truly approve (license) the Pfizer vaccine.
OK. Here we go.
The first FDA document I’ll reference is “Comirnaty and Pfizer-BioNTech COVID-19 Vaccine,” dated August 23, 2021. The document opens with this statement:
“On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”
“The FDA approved” means full approval. The FDA has fully approved the Pfizer-BioNTech COVID vaccine.
And this vaccine “will now be marketed” as the Comirnaty vaccine.
They are the same vaccine, medically speaking. The ingredients are the same.
The FDA document ALSO says the vaccine will continue to be available under the prior Emergency Use Authorization (EUA), for uses that are not yet fully approved. For example, injecting children 12-15, and as a third dose for certain immunocompromised people.
The full approval and the EUA status are riding together, side by side. The EUA status covers uses of the vaccine not covered under full approval.
The rest of this FDA document offers links. One of the links leads to an FDA news release, dated August 23, titled, “FDA Approves First COVID-19 Vaccine.” The release states:
“Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty…”
“To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.”
The FDA, in this news release, is again asserting that the Pfizer vaccine is now approved, and makes a clear distinction between the prior EUA and this new approval.
Next, we move to a letter, also dated August 23, sent from the FDA to BioNTech Manufacturing GmbH, and Pfizer Inc. The letter is marked, “BLA Approval.” BLA stands for “Biologics License Application.” Here are key quotes:
“Please refer to your Biologics License Application (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA.”
“We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany…Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA…You may label your product with the proprietary name, COMIRNATY…”
The FDA officially licensed this vaccine. This is approval. It is not merely a continuation of Emergency Use Authorization (EAU).
And now we come to another key FDA document, a letter sent to Pfizer Inc. on August 23, 2021 (addressed to Ms. Elisa Harkins). It also mentions the full licensure (approval) of the vaccine:
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
This letter is further acknowledgement that the vaccine has been fully approved.
Now we enter the thick weeds of the letter, during a discussion of how Emergency Use Authorization will continue to be used. The language is very dense. It’s taken me a while to separate out the strands.
To help you with what I’m going to untangle, understand that the FDA is making a distinction between what we could call the “old Pfizer vaccine” and the “new Pfizer vaccine.” They are identical in their ingredients. They are the same vaccine. But the “old vaccine” vials were granted Emergency Use Authorization (EUA) before the August 23rd FDA full licensure of the vaccine; and the “new vaccine” vials will certainly be used under full licensure (approval).
Splitting hairs? Yes. But in order to understand what the FDA is saying in this letter, you have to grasp the distinction between “the old” and “the new.”
The “old” vaccine is labeled “Pfizer-BioNTech COVID-19 vaccine,” and the “new” vaccine is labeled “COMIRNATY.” Again, they are exactly the same vaccine.
The FDA letter to Pfizer (the one addressed to Ms. Elisa Harkins) states:
“On August 23, 2021, having concluded that revising this EUA [Emergency Use Authorization for the vaccine] is appropriate to protect the public health or safety…FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.”
The “old vaccine” will continue to have EUA status: it can be injected in people 12 and older, and it can be used as a third dose for certain immunocompromised individuals.
The “new vaccine”—which has full FDA approval—CONTINUES TO ALSO HAVE EUA STATUS—and therefore it too can be injected in people 12 and older, and used as a third dose for certain immunocompromised individuals.
Strange? Yes. The “new” and fully approved vaccine retains its former EUA status. It’s BOTH fully approved and certified as an emergency experimental product.
I believe the FDA reasoning goes this way: the agency wants to make sure vials carrying the label of the “new” fully approved vaccine can be injected into people to whom the full approval doesn’t apply—people between 12 and 15, and certain immunocompromised people, as a third shot. In other words, people covered under EUA status.
If you continue to read this FDA letter, you’ll see this reasoning spelled out.
Bottom line, and my conclusion: The FDA has fully approved the “new vaccine” AND it has also retained the Emergency Use Authorization (EUA) for the “new vaccine.” Both.
—So what does all this mean for people who want to find a workable reason for refusing the vaccine?
For example, suppose you work for a major corporation or a government agency, and you’re told you must get the shot. You say, “No, I won’t take the shot, because the FDA never approved it. It’s still an experimental medicine, because it only has EUA status.”
I believe you’ll lose. You’ll be told, “The FDA HAS approved it.”
Suppose you take a somewhat different approach. You say, “I’ll need to see the actual vial containing the vaccine you want to inject me with. Is it labeled ‘Pfizer-BioNTech COVID-19 vaccine’ (the ‘old’ vaccine) or ‘COMIRNATY’ (the ‘new’ vaccine)?”
Your boss says, “What difference does it make? Either way, it’s the same vaccine.”
And you say, “Not legally speaking. I understand it may take some time for the new shipments of the COMIRNATY to arrive. I won’t take the Pfizer-BioNTech shot because it only has Emergency Use Status, and therefore it’s an experimental medicine. Under federal law, I have the right to refuse an experimental medicine. I’m invoking that right.”
Will that fly?
I’m giving you non-lawyer opinions here. Understand this.
It’s possible this approach could buy you time. Maybe your boss will suddenly become a bit nervous—he tells you he’s going to talk to his company/agency attorneys, and he’ll get back to you.
Or maybe he threatens to fire you on the spot, and he tells you to hire (and pay through the nose for) a lawyer. You do. Do you think your argument will stand up in court? I don’t. Maybe I’m wrong. I’d like to be wrong about that.
Maybe your lawyer will suggest other approaches. A religious exemption, for example. Or, depending on the circumstances, a medical exemption.
But after reading the FDA documents I’ve cited above, I say that if you think the FDA hasn’t actually approved the vaccine, you’re mistaken.
This country, and other countries, are being split into the vaccinated and the unvaccinated. Communities are dividing. Families are dividing and fracturing. It isn’t a pretty picture.
Here in America, we’re used to living life as usual and believing that coercion isn’t going to come to our front doors. Despite the lockdowns and the mask mandates and the vast financial destruction of the past year, many people still think things are “all right.”
That’s not true.
I support all legal efforts to keep freedom of choice alive. I support the unions that are demanding NO VACCINE MANDATES. I also support those governors who are defending their states against COVID restrictions and vaccine mandates. People who criticize these governors because they aren’t perfect or are partially compromised are barking up the wrong tree. We need all the help we can get.
However, as far I’m concerned, putting all our eggs in the basket of court cases, legal filings, unions, and governors is shortsighted, to say the least.
Freedom always needs more. Freedom needs brave business owners to stay open and maskless, despite government edicts. Freedom needs parents to keep showing up at school board meetings, to demand an end to COVID restrictions and mandates.
Most of all, freedom needs patriots, in the best sense of the word, to do what people in Europe and Australia are doing: come out in the street in great numbers. Over and over.
Not by the thousands. By the millions.
For as long as it takes.
The enemies of freedom have to feel the heat. They have to see that the people can’t be forced beyond a certain point.
Whether we like it or not, whether we know it or not, the day is coming when, not the minority, but the majority of us will know we are living under tyranny.
Not just insanity; tyranny.
We will know it in ways that are undeniable.
Some of us already know it.
We’re all living through a test of faith. Each individual; and whatever he/she has faith IN. How deep is that faith? How strong?

[keehah]

Turkish 'dream team' couple behind Pfizer's Covid-19 vaccine
The global success of a scientific couple has left Germany's Turkish community with a deep sense of pride. The pair, Ozlem Tureci and Ugur Sahin, hit the world's headlines this week with the news that they'd found a vaccine that could combat the coronavirus. Their research company BioNTech is now worth billions of dollars. TRT World's Sibel Karkus is in Berlin with more on the couple whose Turkish parents came to Germany as migrant workers.
Nov 11, 2020

https://www.youtube.com/watch?v=arwDVhJVrxk
2:52

nbcnews.com: Pfizer is testing a third Covid vaccine dose in young kids, delaying trial results (https://www.nbcnews.com/health/health-news/pfizer-testing-third-covid-vaccine-dose-young-kids-rcna9148)

Dec. 17, 2021
Pfizer and BioNTech are testing a third dose (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-ongoing-studies-covid-19) of their Covid-19 vaccine in an ongoing trial of children ages 6 months to under 5 years after the companies found that the two-dose regimen didn’t generate a strong enough immune response in some children, the companies announced Friday.

The change to the trial protocol means that the companies won't have data to submit to regulators until the first half of 2022. That's a change from earlier this month, when Pfizer CEO Albert Bourla said the company could have data on young kids by the end of this year...

[W]we have decided to modify each of the pediatric studies to incorporate a third dose to the series and seek licensure for a three-dose series rather than a two-dose series as originally anticipated," Jansen said.

[ziero0]

It is not hard to achieve a cure for something that doesn't exist.

The infection rate for the newest variety of flu is 500 per 100,000. Or .5 percent.

FDA approval exists for those things authorized to engage in INTERSTATE COMMERCE. Has nothng to do with whether it works.

[keehah]

usatoday.com: Fact check: Pfizer's FDA-approved vaccine is available in US (https://www.usatoday.com/story/news/factcheck/2021/10/20/fact-check-comirnaty-pfizers-fda-approved-vaccine-available-us/8538861002/)

Daniel FunkeUSA TODAY
Oct. 20, 2021
The claim: Pfizer's FDA-approved coronavirus vaccine is not yet available in the United States...

Comirnaty is the brand name for Pfizer's coronavirus vaccine. The FDA approved the shot in late August for Americans ages 16 and older.

But posts claiming Comirnaty is not yet available in the U.S. have racked up thousands of interactions on Facebook and Instagram over the past month, according to CrowdTangle, a social media insights tool...

"I can confirm that our vaccine has been granted FDA approval and that Comirnaty is available," Kit Longley, a spokesperson for Pfizer, said in an email...

Our rating: False

Based on our research, we rate FALSE the claim that Pfizer's FDA-approved coronavirus vaccine is not yet available in the U.S.

nationalfile.com: CDC Confirms Comirnaty NOT Available In USA, Meaning No FDA-Approved COVID Vax Is Available To Americans (https://nationalfile.com/cdc-confirms-comirnaty-not-available-usa-meaning-no-fda-approved-covid-vax-available-americans/)

December 23, 2021
Previously, the Pfizer vaccine and all other COVID-19 vaccines were being used under an Emergency Use Authorization (EUA), and this is what was granted to the Pfizer vaccine as it was originally manufactured and labeled.

News reports, including “fact checks” from USA Today, claim that the Comirnaty vaccine is simply the rebranded name of the original Pfizer-BioNTech vaccine that initially received the EUA.

Therefore, the news reports argue, a full FDA-approved COVID-19 vaccine is available to Americans. “The authorization changed, but the vaccine didn’t,” USA Today claims.

However, this is not the case...

It has now been confirmed, through the CDC’s own website, that “Comirnaty products are not orderable at this time.”
The CDC notes that Pfizer “does not plan to produce any product [under the Comirnaty label] with EUA authorized product [the original vaccine] is still available and being made available for U.S. distribution.”...

This would seem to confirm previous reports from National File and Star News reporter Peter D’Abrosca, which included statements from Pfizer that refused to plainly state whether the Comirnaty vaccine was available to people living in the United States or its territories...

With Comirnaty not being available anywhere in the United States, it would seem impossible for any entity within the state to legally mandate a COVID-19 vaccine.

fda.gov: FDA NEWS RELEASE (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children)Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children)

June 17, 2022
Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age...

The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age.

[keehah]

pfizer.com: Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19 (https://www.pfizer.com/news/announcements/statement-pfizer-chairman-and-ceo-albert-bourla-testing-positive-covid-19)

AUGUST 15, 2022 – Pfizer Inc. (NYSE: PFE)
I would like to inform the public that I have tested positive for COVID-19. I am grateful to have received four doses of the Pfizer-BioNTech vaccine... I have started a course of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), I am isolating in place as well as following all public health precautions.

We have come so far in the past two years in our efforts to battle this disease..

About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)
PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

U.S. FDA Emergency Use Authorization Statement
PAXLOVID has not been approved but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg)...

is not approved for any use, including for use for the treatment of COVID-19...

IMPORTANT SAFETY INFORMATION

[several pages warning why not to take the PAXLOVID experimental drug]

[keehah]

Have the Feds even approved this vaccine yet? Probably not if this authorization still requires Trump's and Biden's "emergency use."

The August 2021 approval of "COMIRNATY™" was a legally different and not being distributed vaccine rather than the "Pfizer-BioNTech COVID-19 Vaccine" being used.


fda.gov: Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-bivalent-pfizer-biontech-covid-19-vaccine-booster-dose)

March 14, 2023
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine...

“Today’s authorization provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine.”

wikipedia.org/wiki/Democide (https://en.wikipedia.org/wiki/Democide)

[keehah]

fda.gov: FDA NEWS RELEASE (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines)Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines)

April 18, 2023

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States...

The safety and effectiveness of Moderna COVID-19 Vaccine, Bivalent is based on FDA’s previous analyses of clinical trials data of monovalent Moderna COVID-19 Vaccine in individuals 6 months of age and older and an investigational bivalent Moderna COVID-19 vaccine (original and omicron BA.1) in individuals 18 years of age and older. ...

The data accrued with the investigational bivalent Moderna COVID-19 vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process...

With today’s authorizations, the fact sheets have been updated and consolidated for the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Each vaccine now has one fact sheet for healthcare providers and one fact sheet for recipients and caregivers, rather than different fact sheets for the various authorized age groups.

Vaccines and Related Biological Products Advisory Committee

Today’s authorizations follow discussions that occurred during a meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Jan. 26. At that time, by a unanimous vote, the committee recommended harmonizing the strain composition of COVID-19 vaccines used in the U.S. There was also support for simplifying the vaccine dosing schedule.

In June, the FDA will hold a meeting of its VRBPAC to discuss the strain composition of the COVID-19 vaccines for fall of 2023. Much like the FDA does yearly with the influenza vaccines, the agency will seek input from the committee on which SARS-CoV-2 variants and lineages are most likely to circulate in the upcoming year. Once the specific strains are selected for the COVID-19 vaccines, the FDA expects manufacturers to make updated formulations of the vaccines for availability this fall.

The amendments to the EUAs were issued to ModernaTX Inc. and Pfizer Inc.

reuters.com: Fact check: The COVID-19 vaccine is not an operating system designed to program humans (https://www.reuters.com/article/uk-factcheck-operating-system-idUSKBN2A913W)

By Reuters Staff FEBRUARY 9, 2021
“DID YOU EVER WONDER WHY BILL GATES, A SOFTWARE DEVELOPER, BECAME THE EXPERT ON COVID-19?”, the post reads (here). “BECAUSE THE COVID-19 VACCINES ARE AN “OPERATING SYSTEM” DESIGNED TO PROGRAM HUMANS AND HACK THEIR BIOLOGICAL FUNCTIONS.”..

On its website, the pharmaceutical company Moderna, which has developed a COVID-19 vaccine, compares the mRNA science in its vaccine to an “operating system” (here (https://www.modernatx.com/mrna-technology/mrna-platform-enabling-drug-discovery-development))...

According to Moderna, mRNA science is comparable to an operating system because it can be used to tackle multiple different diseases.

“Recognizing the broad potential of mRNA science, we set out to create an mRNA technology platform that functions very much like an operating system on a computer.

“It is designed so that it can plug and play interchangeably with different programs. In our case, the “program” or “app” is our mRNA drug - the unique mRNA sequence that codes for a protein.”

This is possible, Moderna explains, because the only thing that changes from one potential mRNA medicine to another is the genetic code that instructs ribosomes to make protein...

VERDICT
False. COVID-19 vaccines are designed to provoke an immune response against the SARS-CoV-2 virus.