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 ...
If it really is just misinformation and word games then these mandates should fall to the simplest of legal challenges.
Sadly, if the word “approved” appears (which it did) in an official document, that’s all this lying admin needs to push it as “fully approved”. Despite a lot of us knowing it DOES NOT perform as touted. Obviously does NOT prevent people from contracting CONvid-19. 💉🐂💩
I thought the paperwork looked questionable.
More:
“Dr. Meryl Nass, M.D., found the truths that the FDA buried in the blather of these letters, and offers a theory about why it was done this way. The drug manufacturers were granted immunity from liability for the drugs produced under the EUAs. The granting of the license re-applies the customary liability for injury and death caused by the product. Pfizer, the health officials, and the politicians get to take a fictitious victory lap for the “approval,” while Pfizer-BioNTech continues to stealthily enjoy immunity from product liability because there are many millions of the un-licensed doses on the shelves and in the manufacturing pipeline that will be administered first. The licensed version will not arrive on shelves nor be jabbed into arms for many months to come.
Of great concern, considering the factual content of the FDA EUA letters to Pfizer, is the breezy way the press release on the FDA website repeatedly uses the words ‘approve’ and ‘approval’ in reference to the Pfizer drug. If only there were a word for intentionally saying things to the public that do not match reality…”
The media’s favorite word of late is full because they are full of it and full of themselves.
I heard from a physician friend and he thought it was approved...I said take a closer look!
I disagree with the article.
It’s approved for 16 y/o and over. The EUA extension is for 12-15 y/o and the booster.
It states both of the vaccines can be used interchangeably.
I’m never getting it, but I want to be correct in my analysis.
The American Thinker, Carl Schwitzer, may be hanging on every word that comes form the FDA, but I hope American Patriots do not.
The FDA is an utterly unconstitutional federal agency. There is NO constitutional delegation of power to the feds to interference with or regulate healthcare. Forget what the FDA says. Instead, shut them up forever!!!
Patriots: do whatever it takes to
1) understand the Declaration of Independence (DOI) and the Constitution (the Supreme Law of the Land) that LIMITS the feds to coincide with our unalienable rights and freedoms motioned in the DOI, and
2) do whatever it takes to dismantle the 80%+ unconstitutional and totalitarian portion of the feds and PUT THE FEDS BACK INTO THIER CONSTITUTIONAL CAGE where they belong!!!
The devil is in the details.
Meanwhile, another vaxx, Moderna’s is in the news for all the wrong reasons.
Japan just raised contamination issues with that vaxx, and they’ve been vaccinating defense forces and airline employees with that stuff.
SeekAndFind spreading dis-info, and American Thinker being stupid. I know this, because the pro-Poke folks here on FR were roundly mocking anyone that came to the conclusion that it was just an extension of the EUA as not being able to read the day the letters came out.
Get vaxxed and either die from the jab or get the virus anyway; and oh yeah, wear a mask.
Employers who require the shot are exposing themselves to several forms of liability: 1) increased health care expenses when employees have a reaction, like myocarditis or blood clots; and 2) potential for lawsuits over suffered side effects.
Why are they all aboard?
LOL! Good one!
AND every government employee and all their families must take 3 jabs before they can mandate anymore of these experimental drugs. That includes city, state and federal PERIOD.
How many in Congress have taken at least two of these with their families included??
If their rate is not 100%, then they need to STFU.
They should not be able to fly or cross state lines if they haven’t had TWO.
How many has the demented puppet had?
How many has each congressional member had?
It states both of the vaccines can be used interchangeably.
***********************************************
The devil is in the details.
Yes, they can be use interchangeably, except the one that was approved isn’t even manufactured yet.
You see, the one that is approve would be subject to liability claims. The experimental one is not.
It just so happens that they have more than enough experimental vaccine left, so they really don’t need to manufacture the one that is approved.
Get it, they will never manufacture the approved one, because it would set themselves up for liability claims.
Sounds like approval to me.
You do understand that a BLA is the approval for that licenced product under the FDA system. That product is called COMIRNATY. That product is only approved for people 16 and older. The FDA extended the EUA for 12 to 15 years of age and also boosters for immune compromised. Anything else is world games for an agenda. The FDA considers COMIRNATY approved for use in adults in the USA 16 and over that’s just fact now.
Read the actual BLA letter and then tell the class what a BLA is, why it’s issued and what additional licencing is needed after a BLA is issued. I’ll save you the trouble with the last part the BLA is the last step it opens the manufacturing to a licenced product hint it’s called a biologics license application for a reason and once approved it then becomes the biologics license itself. You don’t have to like what the FDA has done but they now issued everything Pfizer needs to manufacture a licenced product. If the State governments via Jacobson vs Mass. Wish to use their power to mandate it they have full Supreme Court blessing to do so. Silly word games won’t change the approval like I said read the 13 pages Pfizer has what it needs now for 16 and up period.
It’s also my understanding that they’re indemnified even after approval.
Name just one time the media ever got something wrong before...just one! Bet you can’t...because once you start its just too hard to stop listing them...
This can’t be true. Texasgurl was in here yesterday calling anyone who didn’t believe it was authorized and idiot and Q-tard. Don’t believe this Anti-vaxxer from American Thinker, he’s lying.
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