FDA Fully Approves Pfizer’s Coronavirus Vaccine

[jimnyc]

I'm glad this is the shot I chose to get but at the same time the study being 6 months is a little shy.

---

FDA Fully Approves Pfizer’s Coronavirus Vaccine

The Food and Drug Administration (FDA) has fully approved Pfizer’s coronavirus vaccine, marking the first coronavirus injection to receive the FDA’s full approval outside of emergency use authorization.

The FDA’s full approval of Pfizer’s shot, which applies to the vaccine given to those ages 16 and older, is based on a study involving over 44,000 people for six months, with data showing the vaccine to be 91 percent effective in preventing infections, per reports. Pfizer’s vaccine for those ages 12-15 will still operate under emergency use.

USA Today reported that the license application “included more than 340,000 pages of material, three times the earlier emergency use authorization submission, which weighed in at 110,000 pages.”

Rest - https://www.breitbart.com/politics/2021/08/23/fda-fully-approves-pfizers-coronavirus-vaccine/

[Tyr-Ziu Saxnot]

I'm glad this is the shot I chose to get but at the same time the study being 6 months is a little shy.

---

FDA Fully Approves Pfizer’s Coronavirus Vaccine

The Food and Drug Administration (FDA) has fully approved Pfizer’s coronavirus vaccine, marking the first coronavirus injection to receive the FDA’s full approval outside of emergency use authorization.

The FDA’s full approval of Pfizer’s shot, which applies to the vaccine given to those ages 16 and older, is based on a study involving over 44,000 people for six months, with data showing the vaccine to be 91 percent effective in preventing infections, per reports. Pfizer’s vaccine for those ages 12-15 will still operate under emergency use.

USA Today reported that the license application “included more than 340,000 pages of material, three times the earlier emergency use authorization submission, which weighed in at 110,000 pages.”

Rest - https://www.breitbart.com/politics/2021/08/23/fda-fully-approves-pfizers-coronavirus-vaccine/

If that seal of approval is supposed to mean something- it does not to we that understand the FDA IS--GOVERNMENT!!!
They are not an independent and trustworthy entity that inspires anybody that has knowledge, forethought and understands exactly where their loyalties lay.
To me- it is about on par with the local wino give his personal seal of approval.....
However, the sad reality is it will booster the scam with those fully blinded...
And give them another reason to demand that-- ALL- must take the stab....
Or else be thoroughly PUNISHED/OSTRICIZED and destroyed in any manner that enforces the Nazi type mandate, imho..
Yet another malignant seed of division, which the totally corrupted leftist/lib/dem party excels at...
A corrupt government's corrupt seal applied........--Tyr

Those not stupid, see it for what it truly is, imho ....- :salute: -Tyr

[Juicer66]

A DECISION THAT LONG TERM WILL SEND MANY PEOPLE TO GAOL FOR THE REST OF THEIR LIVES

When we reach the tilting point later in the year such people will risk being torn limb from limb . I dread to think how the Sheeple will react when the 'penny ' drops and Deaths reach ten million ( just the start ) and Injuries are multiple millions more .

QUOTE
“Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinising the data.”




“'It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,’ she said. ‘There is no control group after Pfizer offered the product to placebo participants before the trials were completed'.”


“'Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals'.”


Understand---this devastating criticism of the FDA is coming from a person who operates WITHIN the public-health establishment.


Amidst a tsunami of reports of vaccine injuries and deaths from around the world, the FDA is proving it is an agency that will certify maiming and killing without hesitation.

[jimnyc]

If that seal of approval is supposed to mean something- it does not to we that understand the FDA IS--GOVERNMENT!!!
They are not an independent and trustworthy entity that inspires anybody that has knowledge, forethought and understands exactly where their loyalties lay.
To me- it is about on par with the local wino give his personal seal of approval.....
However, the sad reality is it will booster the scam with those fully blinded...
And give them another reason to demand that-- ALL- must take the stab....
Or else be thoroughly PUNISHED/OSTRICIZED and destroyed in any manner that enforces the Nazi type mandate, imho..
Yet another malignant seed of division, which the totally corrupted leftist/lib/dem party excels at...
A corrupt government's corrupt seal applied........--Tyr

Those not stupid, see it for what it truly is, imho ....- :salute: -Tyr

All of a sudden you have some mandates back again, this FDA approval and other things happening - in order to push the vaccine.

In fact, just read a story stating that this approval may lead to more mandates of the vaccine. :rolleyes:

[fj1200]

No longer experimental...

[Abbey Marie]

I'm glad this is the shot I chose to get but at the same time the study being 6 months is a little shy.

---

FDA Fully Approves Pfizer’s Coronavirus Vaccine

The Food and Drug Administration (FDA) has fully approved Pfizer’s coronavirus vaccine, marking the first coronavirus injection to receive the FDA’s full approval outside of emergency use authorization.

The FDA’s full approval of Pfizer’s shot, which applies to the vaccine given to those ages 16 and older, is based on a study involving over 44,000 people for six months, with data showing the vaccine to be 91 percent effective in preventing infections, per reports. Pfizer’s vaccine for those ages 12-15 will still operate under emergency use.

USA Today reported that the license application “included more than 340,000 pages of material, three times the earlier emergency use authorization submission, which weighed in at 110,000 pages.”

Rest - https://www.breitbart.com/politics/2021/08/23/fda-fully-approves-pfizers-coronavirus-vaccine/

Me too. And I’ll be lined up to get the booster in October.

[jimnyc]

See, if they didn't do crap like this then I think more people in fact would be confident. Instead they try forcing things again.

---

FDA Approval of Pfizer Vaccine Sparks Wave of Mandates: Pentagon, New York City Public Schools Announce Requirements

Biden’s Surgeon General Vivek Murthy on Sunday said the FDA’s approval of the Pfizer vaccine will likely lead to more vaccine mandates.

And that’s exactly what happened.

Within minutes of the FDA’s approval of the Pfizer vaccine, the Pentagon and New York schools announced new requirements.

The FDA on Monday granted a full approval to the Pfizer vaccine.

The Pentagon announced all 1.4 million active duty service members will be required to take the jab.

New York City Mayor Bill de Blasio also announced Monday that all of the city’s public school employees would be required to get the vaccine by September 27.

Joe Biden immediately called on Americans to get vaccinated after the FDA’s announcement on Monday.

Rest - https://www.thegatewaypundit.com/2021/08/fda-approval-pfizer-vaccine-sparks-wave-mandates-pentagon-new-york-city-public-schools-announce-requirements/

[Juicer66]

They know they are going to be busted over election fraud and hence treason -- outside interference .

They are panic stricken over the Durham report .

This is their last chance saloon effort.

Wicked and evil .

[Tyr-Ziu Saxnot]

Me too. And I’ll be lined up to get the booster in October.

I believe that each person has the right to take the vaccine or else not take it.
As each after a careful study and with some level of knowledge should decide if they want to gamble on the shot or on their chances of not getting
Covid 19- and if getting Covid their chance of surviving it.....
The fact that they made it political from the start is what has caused the confusion, the concern and then the other main problem is it did not go through the lengthy trials as have other vaccines.
My third concern is dem party and mainstream media pushes it..
I have learned to be quite leery of both those worthless abhorrent entities.--Tyr

[jimnyc]

I believe that each person has the right to take the vaccine or else not take it.
As each after a careful study and with some level of knowledge should decide if they want to gamble on the shot or on their chances of not getting
Covid 19- and if getting Covid their chance of surviving it.....
The fact that they made it political from the start is what has caused the confusion, the concern and then the other main problem is it did not go through the lengthy trials as have other vaccines.
My third concern is dem party and mainstream media pushes it..
I have learned to be quite leery of both those worthless abhorrent entities.--Tyr

I still believe in the vaccine somewhat from a ton of reading over time. And if not for politics that might be a stronger case for many others. Instead, they turned many away with lies, mandates and a seemingly non-caring about other folks rights.

[revelarts]

One-Third Of New Drugs Had Safety Problems After FDA Approval
May 9, 2017
https://www.npr.org/sections/health-...r-fda-approval (https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval)
The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients.
Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.
"While the administration pushes for less regulation and faster approvals, those decisions have consequences," Ross says. The Yale researchers' previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe does and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.

It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted "accelerated approval" and drugs that were approved near the regulatory deadline for approval.
Drugs ushered through the FDA's accelerated approval process were among those that had higher rates of safety interventions. These approvals typically rely on surrogate endpoints, meaning that researchers measured something other than survival, such as tumor size, to determine whether the drugs worked.
"This [finding on surrogate endpoints] has the greatest relationship to policy today," Ross says. "In the 21st Century Cures Act, there's a push to have the FDA move to further support the use of surrogate markers ... [but] they're more likely to have concerns in the post-market setting."

President Barack Obama signed the 21st Century Cures Act into law on Dec. 13. It offers ways to speed drug approval by pushing the FDA to consider evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for approvals of drugs that haven't been adequately tested.
"I'm actually sympathetic to the idea that there are ways in which the FDA can be more streamlined and do a quicker job," says Dr. Vinay Prasad, a hematologist-oncologist and professor at Oregon Health and Sciences University who did not work on the study. "The one place you don't want to cut a corner is safety and efficacy prior to coming to market."
The FDA's system for reporting drug- and device-related health problems is voluntary. The reports are not verified, and critics say this system is underutilized and filled with incomplete and late information. The FDA also monitors other available studies and reports to determine whether it needs to take action on a particular drug.
...
Above is part of the reason I'm still not on board with any of the vaccines.
IF I were in a high risk category and If the vaccines were the ONLY option I might be more open.
But they are not.

IMO Ivermectin is a better alternative.
More tested over time. Even at high doses.
Side effects well known and less than Advil's.
Can be taken as a preventative and a treatment.
Low Cost.
From the Meta studies so far it seems to do as well or better than the vaccines.
No problems with continued or long term use.

When ... IF ... the truth comes to the mainstream, I think Ivermectin will shut down the covid vaccine money train.

[Tyr-Ziu Saxnot]

One-Third Of New Drugs Had Safety Problems After FDA Approval
May 9, 2017
https://www.npr.org/sections/health-...r-fda-approval (https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval)
The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients.
Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.
"While the administration pushes for less regulation and faster approvals, those decisions have consequences," Ross says. The Yale researchers' previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe does and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.

It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted "accelerated approval" and drugs that were approved near the regulatory deadline for approval.
Drugs ushered through the FDA's accelerated approval process were among those that had higher rates of safety interventions. These approvals typically rely on surrogate endpoints, meaning that researchers measured something other than survival, such as tumor size, to determine whether the drugs worked.
"This [finding on surrogate endpoints] has the greatest relationship to policy today," Ross says. "In the 21st Century Cures Act, there's a push to have the FDA move to further support the use of surrogate markers ... [but] they're more likely to have concerns in the post-market setting."

President Barack Obama signed the 21st Century Cures Act into law on Dec. 13. It offers ways to speed drug approval by pushing the FDA to consider evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for approvals of drugs that haven't been adequately tested.
"I'm actually sympathetic to the idea that there are ways in which the FDA can be more streamlined and do a quicker job," says Dr. Vinay Prasad, a hematologist-oncologist and professor at Oregon Health and Sciences University who did not work on the study. "The one place you don't want to cut a corner is safety and efficacy prior to coming to market."
The FDA's system for reporting drug- and device-related health problems is voluntary. The reports are not verified, and critics say this system is underutilized and filled with incomplete and late information. The FDA also monitors other available studies and reports to determine whether it needs to take action on a particular drug.
...
Above is part of the reason I'm still not on board with any of the vaccines.
IF I were in a high risk category and If the vaccines were the ONLY option I might be more open.
But they are not.

IMO Ivermectin is a better alternative.
More tested over time. Even at high doses.
Side effects well known and less than Advil's.
Can be taken as a preventative and a treatment.
Low Cost.
From the Meta studies so far it seems to do as well or better than the vaccines.
No problems with continued or long term use.

When ... IF ... the truth comes to the mainstream, I think Ivermectin will shut down the covid vaccine money train.


"" IMO Ivermectin is a better alternative. ""

I agree.
But they needed to stop Trump and to have the Covid 19 be feared as if it was worse than the bubonic plague.
Thus they lied and lied and lied and lied...
With false numbers, etc...
And now they want to mandate everybody be forced to take the stab...
F-that bullshit.....--Tyr

[SassyLady]

Above is part of the reason I'm still not on board with any of the vaccines.
IF I were in a high risk category and If the vaccines were the ONLY option I might be more open.
But they are not.

IMO Ivermectin is a better alternative.
More tested over time. Even at high doses.
Side effects well known and less than Advil's.
Can be taken as a preventative and a treatment.
Low Cost.
From the Meta studies so far it seems to do as well or better than the vaccines.
No problems with continued or long term use.

When ... IF ... the truth comes to the mainstream, I think Ivermectin will shut down the covid vaccine money train.

My doctor told me today the FDA is putting pressure on pharmacies to not fill prescriptions for ivermectin if it's prescribed for Covid.

[revelarts]

My doctor told me today the FDA is putting pressure on pharmacies to not fill prescriptions for ivermectin if it's prescribed for Covid.

There's going to be hell to pay for some the Shite done around the covid mess.

[Juicer66]

Germany has called a halt on all Covid Vaccines ---cited as unsafe and not recommended until further detail evaluation results are available .

Looks like a Tilting point has been reached .

Too late for over two billion unlucky and /or stupid people who never saw the science and/or who were too lazy to investigate .

Is this why Sleepy was forced to run the wholesale joke operation in Afghanistan --- hoped for deflection ?

Developments will be most interesting . To put it mildly .

World records for BS per minute will be broken daily , imho .


I favour public executions

[JakeStarkey]

Look at how quickly the vaccines were out and used by the public.

Look at the amazing time in getting Pfizer fully approved.

Trump and his goobers would not have had the vaccine approved until next year.

[fj1200]

Look at how quickly the vaccines were out and used by the public.

Look at the amazing time in getting Pfizer fully approved.

Trump and his goobers would not have had the vaccine approved until next year.

Now that's just a stupid thing to say given that most of the EUA was completed under trump.

[Juicer66]

MOST PENETRATING AND ACCURATE ASSESSMENT

Pfizer's full authorization should void all emergency use authorization for other vaccines, since a fully authorized alternative now exists.

Emergency use authorization can only be given when no safe and effective alternative exists. Since Pfizer's COMIRNATY has been deemed safe and effective, it is now illegal to administer any other vaccine that has not.

It is also correctly pointed out that the FDA's approval of COMIRNATY is itself illegal, since it did not follow statutory requirements for a finding of full approval, including the completion of trials. Stage three of the

trials has not even begun yet, and stage two was compromised by lack of control groups. In addition, the proper panels were not convened to study evidence: they could not have been convened since the evidence is not in.


I am being told that Moderna and other vaccines will be allowed to keep their EUA until COMIRNATY hits the shelves, but they can't have it both ways.
either, 1) There is an existing approved Pfizer vaccine, in which case all EUAs are void ,

or, 2) there is not an existing approved Pfizer vaccine, in which case all these mandates by military and colleges are void. In either case, everything now happening is illegal.


The only EUA that other vaccines like Moderna could continue to claim is for age groups not approved for Pfizer's COMIRNATY. That is, children. But that is not what is happening.