Posted on 08/26/2021 8:16:23 AM PDT by SeekAndFind
You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining “vaccine-hesitant” into stepping forward to receive their jab. The FDA even has a press release on their website about it.
There’s just one problem.
If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you’ll see the FDA did no such thing. In the sense that the term ‘FDA approval’ is generally understood, this drug is NOT approved by the FDA. It is still under EUA (Emergency Use Authorization). It is still an experimental drug.
The FDA sent 2 letters. The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.
The BLA approval letter approves Pfizer’s application for a license to label their COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for 9 additional clinical trials over 5 years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.
(Excerpt) Read more at americanthinker.com ...
You shouldn’t believe everything claimed on the internet.
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You should actually read the 2 letters by the FDA. That’s why there is 2.
I found out that I do more critical research on the COVID and Vaccines than my wife’s civilian doctor or my VA doctor. They either have their head up their fourth point of contact or they are on the take.
The FDA in its own press release says it is approved.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
However, I want people to be prepared to fight employer mandates with facts and the law and not internet fantasy.
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I’m not believing internet fantasy, I read the two letters from the FDA.
I believe NOTHING from the government or any agency associated with the government. Period.
Then you need to brush up on your reading comprehension and study up on the Code of Federal Regulations.
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.
Approved BLA(biologics license application)
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.
Extended vax "for certain uses that are not included in the approved BLA"
Same vaccine but being given a brand name of COMIRNATY to go along with FDA approval and being able to market it as COMIRNATY, an FDA approved vax for 16+. The newly named vax had it's EUA reauthorized and revised for 12-15 year olds.
It's amazing how many supposedly smart people can't read English if there are sentences with more than one comma. They need to read the classics, starting with kids' books from the late 1800s and then onto adult books of the same era. That's how I homeschooled our kids and I'd say they probably have better reading comprehension skills than most adults.
How did the Taliban just defeat US Forces without vaccines or masks?
Believe what you want. I really don’t care.
It's not a belief. It's reality.
Your claim: "Comirnaty has not even been manufactured yet."
False:
Your claim: "It's not covered under the PREP act."
False:
https://www.federalregister.gov/documents/2021/08/04/2021-16681/eighth-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for
If you really think it’s ok to force people to take this you might be happier over at DU where they think its the greatest thing ever
Personally, not joking, I think every single f*cking person who thinks people should be forced to take this or lose their livelihoods, or be severely restricted for non compliance should be deported and exiled permanently. And that’s the generous option.
You are correct about the legal protections for the “emergency” vaccine.
FDA: “...The products are legally distinct with certain differences that do not impact safety or effectiveness....”
“LEGAL” differences, hmm. wonder what THAT could be? /s
BUT! as to not having been approved, I disagree.
FDA: “The licensed vaccine has the same formulation as the EUA-authorized vaccine...”
They are THE SAME!
FDA: “...the products can be used interchangeably...”
Why? Because they are THE SAME.
8 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.
Its like cigarettes. The gubmit required cancer warnings on packaging. Any newly manufactured cigarettes would require the new package labeling.
Were the cigarettes the SAME? Yes
Could they sell the unlabeled cigarettes they had? Yes
Could they sell the unlabeled cigarettes and the newly manufactured interchangeably? Yes
The YUGE difference is that they can continue manufacturing and selling the “emergency” vaccine until they jump through all the hoops imposed on the “approved” vaccine”.
How long will that take? Who knows. Another “emergency” extension possible if necessary? Sure.
Bottom line...
THE VACCINE IS APPROVED! PERIOD! It is just a “LEGAL” distinction, having nothing to do with the vaccine itself.
“this drug is NOT approved by the FDA.”
WRONG, it is.
“It is still under EUA (Emergency Use Authorization).
TRUE, it is.
It is still an experimental drug.
TRUE, it is.
FDA: 8 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.
The “drug” is approved.
“The licensed vaccine has the same formulation as the EUA-authorized vaccine”
Find a different hill to die on.
I’m still waiting on for JD_UTDallas to the bet on a federal, Jacobsen style national mandate, by November.
He keeps asserting that one is coming, and desperately wishes that the government can force people to take the vaccines, but he won’t take my bet that would impose consequences on him for being wrong.
Why? Because he’s a coward.
I printed the package insert, and you are correct.
Pfizer mRNA vaccine is fully licensed for a 2-dose schedule for anyone 16 or older.
My Default position is that anything the Government puts out is always Half truths, Lies and Obfuscations, kind of like CNN on Steroids.
The takeaway on this is to remember every person who suggested people should be forced or face sanctions/limitations for not taking it.
Somewhere down the road there will need to be an accounting.
Absolutely agree with you there. Mandates are evil.
What are some adult classics you recommend?
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