Full FDA Approval of Vaccine
- Thread starter PoliTalker
- Start date
I do keep up. There has always been discussions that vaccines would be needed. I follow the experts, especially Peter Hotez of Baylor, he’s a very sharp guy.
FDA "approved"? So, what and where are the results from the control group(s)? They dissolved it back in February.
So, again...what and where are the official control group results/legitimate data required for "approval"?
I'll wait here.
Still waiting.
https://www.fda.gov/emergency-prepa...valuated and analyzed the,by Pfizer-BioNTech.
PoliTalker
Diversity Makes Greatness
One of the things that Dr. Fauci said tonight on PBS Newshour was that part of the full approval process involves detailed inspections of the manufacturing facility and process, looking for anything that could compromise the quality.
That's reassuring to know they went to that level, instead of simply looking over documents and data, or testing samples.
That's reassuring to know they went to that level, instead of simply looking over documents and data, or testing samples.
Aaaaaaaaaah...still for just emergency use then...there's been accelerated approval...for months. No full approval of it yet.
No emergency with 99.8% recovery rate either.
Under accelerated conditions, the drug maker is required to conduct post-marketing clinical trials to verify and describe the
drug's benefit. If further trials fail to verify the predicted clinical benefit, the FDA may withdraw approval.
A half billion serious reactions world-wide could do the trick.
I remember in the last flu-demic with Bama...they shut down the vax after only 8 deaths.
And, now???
Found 595,622 cases where Vaccine is COVID19
https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=CAT&EVENTS=ON&VAX=COVID19
No sainthood here. It's MANDATORY to conduct post-marketing clinical trials to verify and describe the drug's benefit. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval.
This is because there is no FULL approval yet. It's still "accelerated approval."
David Jeffrey Spetch
Verified User
So it's not genuinely approved, they just say so to help the globalist narrative go for the push on the sheep. There is no such thing as a covid vaccine if you can still get covid after the shot.
David Jeffrey Spetch
Verified User
right [sainthood (religion / the religious) is the problem, religious set the example and modern day retards follow their example of ignore fact, make up lies, call their lies their belief then start trying to force such rubbish upon everyone else. So that part is shot down but other than that, right.)]
Taichiliberal
Shaken, not stirred!
No "myth"....if you've put out on the general public a treatment that has NOT been given the standard vetting process, then play down the negative side effects while playing with the numbers of "cases" (using a process that is NOT designed to diagnose and is rift with false results) and deaths, and HAVE YET TO ASCERTAIN THE FULL LONG TERM EFFECTS, that's an experiment. Period.
PoliTalker
Diversity Makes Greatness
Hello Taichiliberal,
At this point, anyone still calling this experimental, is just determined from the outset to reject it.
Full FDA Approval is full approval. There's nothing experimental about it. The full approval process has been completed.
At this point, anyone still calling this experimental, is just determined from the outset to reject it.
Full FDA Approval is full approval. There's nothing experimental about it. The full approval process has been completed.
Taichiliberal
Shaken, not stirred!
Throwing out medical precedent is not safe nor a valid basis for approval: https://www.livescience.com/coronavirus-vaccine-trial-no-animal-testing.html
Your parroting the company mantra does not make it true. At this "point" you have the following information to which folk like you are readily put your cognitive reasoning skills on hold:
https://www.timesunion.com/news/art...XEAZ74SIREYDuo7TzmXDsbhl7Dhp_RtUs6Vr7IRH4-uWg
Then there's always this: https://dryburgh.com/kary-mullis-pcr-anthony-fauci/
Carry on.
PoliTalker
Diversity Makes Greatness
Hello Taichiliberal,
Mullis sounds pretty weird. I get the impression he was a government hater with a level of self-resentment because he was on the dole of government contract money. It's so easy for the rank and file to pick apart management, but it's a whole different thing to actually be management.
Kinda like the Taliban were really great at attacking the government, but so far they have been pretty lousy at being what they used to attack.
Mullis would have drowned in Fauci's job.
Mullis sounds pretty weird. I get the impression he was a government hater with a level of self-resentment because he was on the dole of government contract money. It's so easy for the rank and file to pick apart management, but it's a whole different thing to actually be management.
Kinda like the Taliban were really great at attacking the government, but so far they have been pretty lousy at being what they used to attack.
Mullis would have drowned in Fauci's job.
PoliTalker
Diversity Makes Greatness
Hello Nordberg,
We are gonna be hearing a lot of concocted excuses now for doubting the Full FDA Approval.
That just indicates an individual with prejudice who is looking for a reason to avoid the vax.
They weren't ever going to get it anyway, now just finding new excuses to fulfill their predetermined decision.
We are gonna be hearing a lot of concocted excuses now for doubting the Full FDA Approval.
That just indicates an individual with prejudice who is looking for a reason to avoid the vax.
They weren't ever going to get it anyway, now just finding new excuses to fulfill their predetermined decision.
Taichiliberal
Shaken, not stirred!
That was a total load you just shoveled to avoid conceding a point that the man who SET A PRECEDENT IN THE MEDICAL SCIENCE FIELD TO THE TUNE OF A NOBEL PRIZE told the world that PCR test HE INVENTED was NOT designed to diagnose disease infection in patients.
Kind of pulls the rug out from under this "get vaccinated, it's safe because Covid 'cases' are rampant", n'cest pas?
What you did was EXACTLY the type of smoke blowing dodge our resident right wing wonks do when faced with facts and logic they cannot disprove, dispute or ignore. Sorry PT, but you should have known that you can't BS past me on a printed medium, as the reader can clearly see your lame attempt at character assassination to cover your inability to logically/factually prove me wrong or defend your position. Sad, as I expected better of you.
I'll put you in the bin with your buddies on this topic. Maybe in a month or so you'll see the error of your ways. So long for now, PT.
One letter went to Pfizer which is still EUA because it still has the liability shield. ( https://www.fda.gov/media/150386/download )
The BioNtech vax is still in development, not ready for use yet and will be conditional until "fully approved" without a liability shield.
DHHS has issued a license to BioNTech (in Germany) controlling manufacture and sale of biological products. The license will then
authorize Pfizer to introduce or deliver for introduction into interstate commerce. That license will authorize them to manufacture
the product COVID-19Vaccine, MRNA. It will then be labeled by Pfizer as Comirnaty.
Also, the FDA completely bypassed the always necessary external advisory commissions with public comment period and unilaterally decided that there probably
wouldn't be any concerns that would have benefited from an advisory decision. Amazing. Sure. Nothing to see here. No questions. No cardio toxicity issues anywhere.
They just went ahead and authorized it. The only data they have is outdated because THIS Comirnaty is a brand new vax, not even on the market yet! Nothing in
there shows them dealing with the Delta variant. It's all about the original studies.
Plus the FDA letter only authorizes use for those 16 years of age and above. So, Deblasio needs to cool his jets on shooting up kids with this stuff. The studies
for kids won't be done until '23 or '24. Bet they'll probably shove another EUA out, this time for the kids.
The media and the pols have played a little shell game here and stated that the regular old Pfizer vax for EUA with its liability shield still in place
has the full formal approval. It does not. It will be the new one by the name of Comirnaty...in a couple years.
On page 6 they admit they do not have sufficient amount of data through VAERS system to determine risks properly. Unreal. But, they'll push it through.
They admit their system is inadequate, but again....so what. They'll just do what they want.
I see there that they at least acknowledge the myocardial issues and will require a 5 year follow-up.
They issued 2 separate letters for 2 separate vaccines.
The currant Pfizer still has the EUA classification and the liability shield. (no change) Pfizer always wants that liability shield.
The licensed BioNTech product, is similar, called Comirnaty, is not yet available until '23 or '24 and will not have a liability shield.
Nice bait and switch there lyin' fake state media! Show the public BOTH letters! Maybe just sloppy reporting and confused the two? Or, didn't read them both? LOL
https://www.fda.gov/media/151710/download
The BioNtech vax is still in development, not ready for use yet and will be conditional until "fully approved" without a liability shield.
DHHS has issued a license to BioNTech (in Germany) controlling manufacture and sale of biological products. The license will then
authorize Pfizer to introduce or deliver for introduction into interstate commerce. That license will authorize them to manufacture
the product COVID-19Vaccine, MRNA. It will then be labeled by Pfizer as Comirnaty.
Also, the FDA completely bypassed the always necessary external advisory commissions with public comment period and unilaterally decided that there probably
wouldn't be any concerns that would have benefited from an advisory decision. Amazing. Sure. Nothing to see here. No questions. No cardio toxicity issues anywhere.
They just went ahead and authorized it. The only data they have is outdated because THIS Comirnaty is a brand new vax, not even on the market yet! Nothing in
there shows them dealing with the Delta variant. It's all about the original studies.
Plus the FDA letter only authorizes use for those 16 years of age and above. So, Deblasio needs to cool his jets on shooting up kids with this stuff. The studies
for kids won't be done until '23 or '24. Bet they'll probably shove another EUA out, this time for the kids.
The media and the pols have played a little shell game here and stated that the regular old Pfizer vax for EUA with its liability shield still in place
has the full formal approval. It does not. It will be the new one by the name of Comirnaty...in a couple years.
On page 6 they admit they do not have sufficient amount of data through VAERS system to determine risks properly. Unreal. But, they'll push it through.
They admit their system is inadequate, but again....so what. They'll just do what they want.
I see there that they at least acknowledge the myocardial issues and will require a 5 year follow-up.
They issued 2 separate letters for 2 separate vaccines.
The currant Pfizer still has the EUA classification and the liability shield. (no change) Pfizer always wants that liability shield.
The licensed BioNTech product, is similar, called Comirnaty, is not yet available until '23 or '24 and will not have a liability shield.
Nice bait and switch there lyin' fake state media! Show the public BOTH letters! Maybe just sloppy reporting and confused the two? Or, didn't read them both? LOL
https://www.fda.gov/media/151710/download
PoliTalker
Diversity Makes Greatness
Hello Taichiliberal,
It's strange how frequently you say you're not going to comment for another month, but then a few days later you're back at it again.
It is also notable that you treat the pandemic as if it is only a USA problem. Attacking the credibility of the leaders in the USA, but the measures they are taking are mirrored all across the world. Are you prepared to attack the credibility of all the scientists and leaders all over the world?
The way you question the effectiveness of testing suggests that you are trying to establish that there is no pandemic. The testing we are using is indeed not perfect. But if we wait for a perfect method, we would have nothing. We are using the most effective means of testing that we have. It is better than nothing.
The very fact that people who test positive often go on to die indicates the effectiveness of the testing.
If you are hinting at trying to establish that there is no pandemic, that can't be the case because something is filling up our hospitals, ICUs, morgues and funeral homes and it's not hypochondria.
You have objected the literally everything the USA has done in response to the pandemic, but you've given no alternatives, made no suggestions for a better way to deal with the pandemic.
It all really points to creative ways to distract from a basic reluctance to coordinate with your fellow citizens against a common threat. Deny the threat exists. Deny the measures being taken to deal with it.
It's a darn good thing the whole country doesn't take your position or a lot more people would be dying.
That was a total load you just shoveled to avoid conceding a point that the man who SET A PRECEDENT IN THE MEDICAL SCIENCE FIELD TO THE TUNE OF A NOBEL PRIZE told the world that PCR test HE INVENTED was NOT designed to diagnose disease infection in patients.
Kind of pulls the rug out from under this "get vaccinated, it's safe because Covid 'cases' are rampant", n'cest pas?
What you did was EXACTLY the type of smoke blowing dodge our resident right wing wonks do when faced with facts and logic they cannot disprove, dispute or ignore. Sorry PT, but you should have known that you can't BS past me on a printed medium, as the reader can clearly see your lame attempt at character assassination to cover your inability to logically/factually prove me wrong or defend your position. Sad, as I expected better of you.
I'll put you in the bin with your buddies on this topic. Maybe in a month or so you'll see the error of your ways. So long for now, PT.
It's strange how frequently you say you're not going to comment for another month, but then a few days later you're back at it again.
It is also notable that you treat the pandemic as if it is only a USA problem. Attacking the credibility of the leaders in the USA, but the measures they are taking are mirrored all across the world. Are you prepared to attack the credibility of all the scientists and leaders all over the world?
The way you question the effectiveness of testing suggests that you are trying to establish that there is no pandemic. The testing we are using is indeed not perfect. But if we wait for a perfect method, we would have nothing. We are using the most effective means of testing that we have. It is better than nothing.
The very fact that people who test positive often go on to die indicates the effectiveness of the testing.
If you are hinting at trying to establish that there is no pandemic, that can't be the case because something is filling up our hospitals, ICUs, morgues and funeral homes and it's not hypochondria.
You have objected the literally everything the USA has done in response to the pandemic, but you've given no alternatives, made no suggestions for a better way to deal with the pandemic.
It all really points to creative ways to distract from a basic reluctance to coordinate with your fellow citizens against a common threat. Deny the threat exists. Deny the measures being taken to deal with it.
It's a darn good thing the whole country doesn't take your position or a lot more people would be dying.
OldMercsRule
Verified User
They never gave "full approval". It is a Trojan horse, smoke n' mirrors. FDA approved a "vaccine" that hasn't been manufactured or used. They also renewed the experimental "vaccine", (the only Covid-19 "vaccine available from Pfizer.
When dealing with the current corrupt Federal Gubment, n' medical community "the devil is always in the details!!! BTW: if you could get the "approved vaccine", (that doesn't exist), you could sue Pfizer over adverse issues.
Taichiliberal
Shaken, not stirred!
I thought the Shrub let Big Pharma re-write the rules so that it's a huge hurdle (if any) to sue them for a bad product?