Vaccine not approved, simple EUA is extended

I love it. They get to say on all the morning programs that they are approving it, and then quietly... they don't

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.

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.


Today's FDA letter explains that they are only revising the original scope of authorization to add the Comirnaty shot. No where does it say any shot has been granted approval now...

This is as of today. What's going on here?

Very deceptive.

It sounds like they're relabeling it Comirnaty, which was approved, but then they also say it's the same exact make up and formulation as the current Covid shot today, which was updated and again reissued as an updated EUA.

How can you have both?

Interestingly enough, they state that ongoing tests, studies, and updates are expected through 2025. So, it's not approved then?

I’m still reading this closely, but I ‘think’ it’s approved for 16 and older, the eua for 12 and older remains in place.

Someone PIN this!

It's confusing.

"Pfizer-BioNTech COVID19" is still under EUA.

The brand name "COMIRNATY" has been approved and licensed.

They have a lot of unused unbranded vials to use still. The language appears to allow use of original name labeled vials under EUA.

Comi-r-naughty....

How subtle.

You have to read page 2 carefully. The revised EUA is to allow them to jab people that are not fully authorized to be jabbed under the new BLA.

The BLA will be used to increase the number of companies mandating that adults get vaxxed or get fired. The EUA is so they can also jab more children.

I’ll know Wednesday if I have to retire earlier than planned. I’m not taking the vax unless they say they will line me up in front of the ditch so that our machine gunned bodies can be buried quickly.

Revised to include name change info and keep emergency use 12+ under that name…

Still completely approved 16 and up is the way I read it…

The Highlights you should know listed below.
Please read the whole linked document/report Link Here
[link to www.ncbi.nlm.nih.gov (secure)]

They can only deceive you under the Emergence Use Authorization (EUA)!
Will they actually inform people now!

International Journal of Clinical Practice
Published online 2020 Dec 4.

COVID19 vaccines were reviewed to determine if risks were properly disclosed.

Informed consent disclosure to vaccine trial subjects of risk of COVID19 vaccines worsening clinical disease via Antibody Dependent Enhancement (ADE).

Patient comprehension is a critical part of meeting medical ethics standards of informed consent to disclose the specific risk that COVID19 vaccines could worsen disease upon exposure to challenge or circulating virus.

COVID19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated.

Vaccines for SARS, MERS and RSV have never been approved.

irrespective of delivery method, may worsen COVID19 disease via antibody dependent enhancement (ADE).

This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

The specific and significant COVID19 risk of ADE should have been and should be prominently and independently disclosed.

After vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.

COVID19 vaccine could convert a subject from someone who experiences mild disease to someone who experiences severe disease, lasting morbidity or even death ..

Medical ethics standards required that, given the extent of evidence in the medical literature reviewed above, the risk of ADE should be clearly and emphatically distinguished in the informed consent.

Based on the published literature, it should have been obvious to any skilled medical practitioner in 2019 that there is a significant risk to vaccine research subjects that they may experience severe disease once vaccinated. while they might only have experienced a mild, self limited disease if not vaccinated.

The consent should also clearly distinguish the specific risk of worsened COVID19 disease from generic statements about risk of death and generic risk of lack of efficacy of the vaccine.

Given the strong evidence that ADE is a non theoretical and compelling risk for COVID19 vaccines and the “laundry list” nature of informed consents, disclosure of the specific risk of worsened COVID19 disease from vaccination.

Who's Ms. Harkins?

That is the correct take of it.

They re-issued the EUA.

But it does look like they blessed it.

[link to www.fda.gov (secure)]

BioNTech is not approved, still under EUA.

COMIRNATY is approved apparently but it's a different vaccine with different ingredients.

OP, you are deceiving yourself, the actual letter of BLA is this one:

[link to www.fda.gov (secure)]

It is approved, and the EUA is only for not approved ages.

yep that how I'm reading it. 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

so what is the BLA approved for

edit I see 16y/o and older

Last Edited by miabelieves on 08/23/2021 01:38 PM

oh ok.


ty

The whole thing is bs.

After reading the cdc letters of approval it sounds like they are letting them manufacture and sell the same vaccine under a new name and something to do with dosage sizes, storage and how to mix the vials pre injection.

Then they go on to say that biontech has to submit adverse reactions periodically until 2025. Makes it sound like the clinical trials are still on going but with the public at large now and not control groups.

But after reading it, they only listed a few adverse reactions and it made it out like people got over them quickly with bed rest. Things like fatigue, headaches, soreness at injection site etc.. All piss ant symptoms and none of the really nasty shit people have reported on. Nothing about deaths either..

They didn't mention the seizures or deaths but mentioned a concern for heart inflammation which occurred up to 7 days after the second shot and with bed rest people recovered.

The whole thing is fucked. These CDC shills are corrupt and traitors. You can tell they were heavily pressured by someone above them i.e biden, to push this shit through because it is some kind of national security issue.

The whole thing is based on lies and catalyzed by greed. Pfizer makes 1 billion a month off this vax.. And thats competing with other pharma companies.. Can you imagine 1 billion a month? That is utterly insane..

The final paragraph before the sig.:

"This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act."

At least that is what Jim says...

https://imgur.com/s2WF4N7

Nope.

"COMIRNATY"


COM = Communication

IR = Infrared

NAT Y = Network Address Translation Y-protocol

Here is what it's all about... money... again. Excerpt ripped straight from the document.

Notice the part I put in bold, that's money right there. Licensed is the key word, may as well have said "commercial product".

"This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine,
mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15
years, or 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."

pfizer makes a billion a month so far off this shit.

there is no Placebo Groups anymore....just what kind of EUA Test are they conducting? This is so bogus, I smell a rat many, many rats.

They authorized it as a BLA.
Per the FDA BLA means not a vaccine.

[link to www.fda.gov (secure)]

Read the report yourself:
[link to www.fda.gov (secure)]
Final_Pfizer LOA to issue with BLA approval 08.23.21_v2.pdf

Page 2:
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.

=======

From the 8/6/2021 release of VAERS data:
where Vaccine is COVID19 and Patient Died
Table

PFIZER/BIONTECH 9,247 72.29%

† Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table. This is the reason why the Total Count is greater than 12791 (the number of cases found), and the Total Percentage is greater than 100.

======Deaths:
They approved the Most Deadly of the Shots.
9,247 X100 = 924,700 for under reporting to VAERS

Thread: The VAERS Under Reporting of Vaccine Deaths and Injuries at a rate of Less than 1 Percent
The VAERS Under Reporting of Vaccine Deaths and Injuries at a rate of Less than 1 Percent
07/18/2021 09:17 AM

Last Edited by CNews113p on 08/23/2021 02:13 PM

COMIRNATY = CO(vid)m(i)RNA(ty) "vaccine"

Those are good too.

They are naughty with their pro choice hypocrisy. They can choose to remove a living being from their body but others can't choose to not inject something we don't know enough about yet in theirs.

Both are medical procedures. One requires prior medical examination before procedure, the other is drive thru with a side of fries and a donut.

:Clownworld: