Pfizer vaccine still NOT fully approved by FDA

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As of August 23rd, it has been widely reported that the Pfizer drug has now been fully approved by the FDA to be used to vaccinate against Covid19. Up until that time, it was authorized for emergency use.

Lo and behold, on the FDA's own website, it is shown that the Pfizer drug is still under Emergency Use Authorization. Here's text from page 2 of the link:

"On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, 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."

Also from the end of page 4 and continuing to the middle of page 5:

"Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or Page 5 – Pfizer Inc. 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. 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: A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; B. 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 C. There is no adequate, approved, and available alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.

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

BobRyan

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from: FDA Approves First COVID-19 Vaccine
=============

"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 (koe-mir’-na-tee), 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’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older,
 
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prodromos

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from: FDA Approves First COVID-19 Vaccine
=============

"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 (koe-mir’-na-tee), 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’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older,
Where are your article's citations?
 
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hedrick

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It appears that there are two separate authorizations, one full approval for 16 and older, and an emergency approval fir 12 and older and third doses. In the new emergency approval, footnote 8 refers to this, saying that the regularly approved and emergency approved vaccines are the same, and can be used interchangeably.
 
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prodromos

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Interesting that the article states that large numbers of people who have been vaccinated, in actuality only received a placebo. How does that work in places that require their staff to be vaccinated?
 
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Tanj

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Interesting that the article states that large numbers of people who have been vaccinated, in actuality only received a placebo. How does that work in places that require their staff to be vaccinated?

That happened during the trials, not on an ongoing basis.
 
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Interesting that the article states that large numbers of people who have been vaccinated, in actuality only received a placebo. How does that work in places that require their staff to be vaccinated?

Apparently the paper is what matters, not the vaccine... lol.
 
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prodromos

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Where is the information regarding those trials?
Also, the report understates the severity of myocarditis in some recipients of the vaccine.

Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support.

They neglect to mention how many of those people died.
 
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KCfromNC

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Where is the information regarding those trials?

Here's some of that data - Use of mRNA COVID-19 Vaccine After Reports of .... There's a bunch of references her as well Myocarditis Occurring After Immunization With mRNA-Based COVID-19 Vaccines.

They neglect to mention how many of those people died.
From the first link above :
Acute clinical courses were generally mild; among 304 hospitalized patients with known clinical outcomes, 95% had been discharged at time of review, and none had died.
 
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prodromos

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Here's some of that data - Use of mRNA COVID-19 Vaccine After Reports of .... There's a bunch of references her as well Myocarditis Occurring After Immunization With mRNA-Based COVID-19 Vaccines.


From the first link above :
Acute clinical courses were generally mild; among 304 hospitalized patients with known clinical outcomes, 95% had been discharged at time of review, and none had died.
So again, they neglect to mention how many people have died. Both the VAERS data in the U.S. and the Yellow card data in the U.K. record significant numbers of deaths due to the onset of heart issues shortly after receiving the Pfizer vaccine. It is disingenuous to limit their data to clinical trials in order to claim it is safe when the non clinical trials (the general population) show otherwise.
 
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prodromos

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How many have died?
In the U.K. data, 4640 suffered cardiac disorders after taking the Pfizer vaccine and of those, 92 were fatal. I haven't figured out how to narrow down the VAERS data for the U.S. but over 3000 people have died after receiving the Pfizer vaccine. I don't know how many are cardiac related.
 
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2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine

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 an 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, 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 have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.

Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume that 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.

Here’s what you need to know when somebody orders 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, you have the right to refuse.
 
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