Vaccine Not Approved, Simple EUA Is Extended

FDA ^ | 08/23/21

[Enlightened1]

What is going on here?

Are we being lied to?

Specifically check page 2 and page 12.

Page 2:

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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID19 Vaccine, mRNA).

page 12: This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an 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.

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

[TexasGurl24]

I just posted the facts for you. You can’t cut pieces of the FDA press release and then make up a narrative like magic.

The actual approval is here: https://www.fda.gov/media/151710/download

Again: full approval for 16+
EUA reextended for 12-15 and third doses.

[AFreeBird]

Bait and switch? Parsing language?

The oligarchs are pushing this. They are in control.

[gas_dr]

I agree. I think some businesses will require it. Some will not. I do not think there will be a federal mandate for all Americans. I think that is irresponsible and unconstitutional. Please

[blackdog]

Beagles in basement cages at big pharma everywhere are celebrating.

[Enlightened1]

I cut and pasted it for you so you can see what part I am talking about.

[week 71]

Appears to me, whether the government mandates it or businesses mandate it, since they have been frightened -it coming for everyone. And many folks will grin like the Cheshire Cat at the thought of healthy young people getting forced to be vaccinated in order to work, travel or whatever. Interesting to see some people pretend that they have not contributed to this folly.

[Cboldt]

Same product under two different names. One is approved, the other is not.

[Pollard]

Vaccine have been exempt for years thanks to Bush W. Requirement is that a Public Health Emergency has to be declared. I think Trump declared that to enable him to block travel and do the warp speed thing.

https://en.wikipedia.org/wiki/Public_Readiness_and_Emergency_Preparedness_Act#Liability_protection_and_consolidation_of_oversight

Then there’s this but I don’t know if it comes into play as it’s geared towards childhood vaxxes; https://en.wikipedia.org/wiki/Vaccine_injury#United_States

[Jim Noble]

EUA was extended to allow ages 12-16 to continue.

[Enlightened1]

Read page 12,

“for use in individuals 12 years of age and older”

[Flick Lives]

legally the APPROVED Covid vaccine from Pfizer is now called “COMIRNATY”

Comirnaty? Catchy. Sounds like comorbidity and maternity.

[TexasGurl24]

Yes, I told you what that references.

16+ full approval.
12-15 and third doses continue to operate under the EUA.

The press release contains a lot of legalese, but it says what it says. Perhaps a different version should have been written for lay people, but it wasn’t.

[Enlightened1]

The FDA’s Pfizer vaccine letter contains the dates of when several safety and efficacy studies (ie. Vaccine exposure during pregnancy and infant outcomes, occurrence of myocarditis + pericarditis, etc.) are set to be completed.

 

[ETCM]

You are posting a link to an EUA for 12-15 year olds and vaccine produced prior to full approval.

Here is the actual FDA Approval

https://www.fda.gov/media/151710/download

This misinformation has been posted on numerous threads.

[TexasGurl24]

Yep. Full approval was rubber stamped. I’m not suggesting otherwise.

There are ongoing trials.

That doesn’t change that they approved it anyway.

[JD_UTDallas]

Go back and read it again. Ask a lawyer friend to help you if the terms are confusing.

The FDA issued full approval for 16 and up as of today.

Here is the actual text.

“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.”

The BLA is the full approval licence. It’s a done deal for all people 16 years of age and over.

The second part is the extension of the EUA for children 12 and up and also the continued authorization to test and then approve for us via the secondary EUA that was extended for children younger than 12.

[Roman_War_Criminal]

If government is involved I would say - yes we’re being lied to.

[packagingguy]

“My understanding is full approval for 16 y/o and over.
The EUA has been extended for 12 - 15, and for the booster shot.”

It took me a long time to reconcile the extended EUA with the clearance to market the vaccine. I came to the same conclusion as you did and I believe you are correct.

What concerns me is there are a number of new vaccines in development which may not be as dangerous as an mRNA vaccine. In particular is Novavax which is only the proteinaceous component of the virus. It is due out in the fourth quarter. I am watching this one carefully.

It seems as though the public is being stampeded into one type of vaccine when there are other alternatives that will come to market. Individuals should use their own judgement as to which vaccine they want to take or if they even want a vaccine.

[liberalh8ter]

Reading through the FDA letter is a nightmare. Here's an example:

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:

II.

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 available9 alternative to the emergency use of Pfizer-BioNTech COVID‐19 Vaccine to prevent COVID-19.10

Scope of Authorization

I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:

• Pfizer Inc. will supply Pfizer-BioNTech COVID‐19 Vaccine either directly or through authorized distributor(s),11 to emergency response stakeholders12 as directed by the U.S.

9 Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in this EUA.

So as you can see here, the author keeps saying it's a re-issuance of the EUA.

[JD_UTDallas]

I was right about full approval by this Monday you were 100% WRONG. So now I can officially tell you to bugger off.

As I said once full approval happens the mandates will be here by at least November.

It’s coming bank on it, I will be right yet again.

https://www.politico.com/news/2021/08/23/covid-vaccine-mandate-biden-506609