TLDR - FDA authorized a version not available... will keep giving the EUA version which still makes the manufacturer NOT liable. Millions of doses that are EUA only will be given under the impression of full authorization...

STUPID FCUKING DEMOCRATS
1. Why didn’t the FDA grant full licensure for the Pfizer-BioNTech vaccine that is in use and available in the U.S.?
2. How are the Comirnaty and Pfizer-BioNTech COVID-19 vaccines “legally distinct” and what are the “certain differences”?
3. There is no doubt that the FDA’s action will lead to more vaccine mandates and increased pressure on those currently choosing not to get vaccinated. Your letter to Pfizer suggests that “there is not sufficient approved vaccine available for distribution.” Is there sufficient supply in the U.S. of the Comirnaty vaccine to ensure that those being vaccinated under mandates will be receiving the FDA-approved version? Or is it more likely (or certain) that they will be vaccinated using the vaccine administered under the reissued EUA?
4. If there is insufficient supply of Comirnaty vaccines for those succumbing to the coercion of mandates, isn’t the FDA de facto endorsing vaccine mandates utilizing EUA vaccines?
5. Will individuals who receive either vaccine be afforded the same legal protections if they are injured by the vaccine? If not, why not?
It’s Pfizer’s brand name. It and the “Pfizer vaccine” are one and the same pharmacologically except in the minds of conspiracy theorists. Originally Posted by TinyAnd in the CONTRACTS that spell out the EUA and the FDA Approval. THey may be in fact one in the same... but the existing drugs (even though it's supposedly fully approved) are still being used under EUA... so if you get an EUA dose, you're shit out of luck.. because THAT still hasn't been approved.
If you worked around the pharma industry and FDA approval process you'd know that even different packaging requires FDA approval and version control... the FDA did not approve the vax that you took and that is currently being given out... it approved a FUTURE version that they do not have enough of to actually distribute. Originally Posted by texassapperMaybe this is a matter of word-choice, but I am familiar with FDA approvals and the processing to get them, and I do not recall having seen an "approval" for a "FUTURE version" for public consumption.
Maybe this is a matter of word-choice, but I am familiar with FDA approvals and the processing to get them, and I do not recall having seen an "approval" for a "FUTURE version" for public consumption.Yes it's word choice... the version approved exists but not in enough quantity that it will be distributed until remaining stocks of the doses created under the EUA are used up. And that means the FDA has approved a version that is effectively unavailable... And now mandates are being created that effectively mandate the EUA doses. A direct violation of the law.
Can you be a bit more specific? Originally Posted by LexusLover
Yes it's word choice... the version approved exists but not in enough quantity that it will be distributed until remaining stocks of the doses created under the EUA are used up. Originally Posted by texassapperWith all due respect I have never heard of the FDA AUTHORIZING the prescription of a medication for which there has been a lack of production for the distribution of the approved drug. In short: It has not been APPROVED by FDA for prescription usage to the public.
Ongoing Safety MonitoringEarly on in another discussion in this forum I mentioned "genetic" cloning of cells for stimulating the immune system and the basis for the development of the injection of cells into the system to attach to "contaminating" and dangerous cells that are affecting the system. FYI: That research was begun in the lab under investigation at the moment and it was originally intended (as publicized) as an alternate treatment for cancer. The injected cells would seek and attach itself to cancer cells to alert the immune system. Those cell configurations have been patented beginning in around 2014 through 2017 when Fauci started privately funding the lab.
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
FDA decides on the review designation for every application. However, an applicant may expressly request priority review as described in the Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics. It does not affect the length of the clinical trial period. FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement. Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary.The above quotes came from the FDA site.
That's sum bullshit broadcast by a pharma distributor cornering the market in anticipation of approval for general distribution. Originally Posted by LexusLoverI'm unclear as to what you are trying to say. This isn't pharma saying this.. it's the government. You can see it in the release documents and the fact that the EUA has NOT been rescinded...
I'm unclear as to what you are trying to say. This isn't pharma saying this.. it's the government. You can see it in the release documents and the fact that the EUA has NOT been rescinded...As I said ... and I thought it IS CLEAR ...
The FDA approved the Pfizer-Comirnaty version but the Pfizer-BioNTech is what is being given. The government is mandating the shot to US soldiers now... but they will give the the Pfizer-BioNTech EUA jab.... effectively they've mandated an experimental biological agent be taken.
That's illegal. by the terms of the EUA and FDA regulations. Originally Posted by texassapper
It has not been APPROVED by FDA for prescription usage to the public.Sounds like Bitten has carried over some defective habits from his prior "experience" as VPOTUS under the defective guidance of his mentor ... Obaminable. Not only is he trying to reduce the size of the military by leaving them defenseless on the tarmac of a commercial, city airport, he's having them mandatorily injected with an unapproved, experimental drug.
Maybe this is a matter of word-choice, but I am familiar with FDA approvals and the processing to get them, and I do not recall having seen an "approval" for a "FUTURE version" for public consumption.President Trump relentlessly pushed development and emergency use authorization from the FDA of the vaccines. Hillary Clinton or Joe Biden would not have done as well. Tens of thousands of lives were saved by getting safe, effective vaccines into the arms of people months early.
Can you be a bit more specific?
I would further comment that the infatuation with the FDA approvals as reflected in this forum and at times on the "news" seems to overlook the "political" and "economic" status of the FDA, which is a branch of any current administration.
The current "status" of the injections of the defective vaccine, which has resulted in further "augmenting" injections of other substances, creates scientific-medical issues with the "vaccine" that was not addressed by the current administration as a history of treatment is revealed, which should have been a LARGE part of the government's approval of the medication ...
...BEFORE IT WAS DELIVERED TO THE PUBLIC and CLEARLY BEFORE IT IS MADE MANDATORY.
As far as the current "administration" of Bitten & Kumola, it is a curiosity (academically) how THE VACCINE was not safe last year before the first part of November, but the SAME VACCINE is NOW SAFE TO MAKE MANDATORY even though there is now a push to REQUIRE FOLLOWING MEDICATIONS TO ENHANCE IT'S EFFECTIVENESS.
This is beginning to sound like an environmental issue ... smoke and stench from ovens pollute. Originally Posted by LexusLover