FDA grants Pfizer vaccine full approval

[LV426]

ROFL. please let us know when you catch covid again.....though i'm sure you'll blame it on the unvaccinated, again

IF he catches COVID again, and that's a big if, he will not end up on a ventilator nor will he die of it.

[LV426]

a vaccination that doesn't work.

It does work.

No one dying of COVID right now is vaccinated.

Everyone dying of COVID right now is unvaccinated.

Unvaccinated people are superspreaders, and they are making it impossible to achieve herd immunity...which is weird because last year, those same people said we could achieve herd immunity without a vaccine if everyone just went out and infected themselves with COVID.

is not effective.

Of course it's effective...that's why the only poor fucks dying of COVID now are the assholes who refused the vaccine.

And I'm perfectly OK with that...in fact, I hope every unvaccinated person gets COVID and dies because those assholes didn't care about my safety or well being.

So I'm happy to watch them choke to death. In fact, I get off on it.

[Stretch]

From the 8/13/2021 release of VAERS data:
Found 595,622 cases where Vaccine is COVID19
https://medalerts.org/vaersdb/findfi...ON&VAX=COVID19

The Vaccine Adverse Event Reporting System (VAERS) Results
https://wonder.cdc.gov/controller/da...4B7126C09BEF14

Federal Vaccine Reaction Reporting Requirements
NVIC Reporting Systems
NVIC worked with Congress to pass the National Childhood Vaccine Injury Act of 1986 and was responsible for urging the creation of safety provisions in that historic law. This included a centralized vaccine reaction reporting system, the Vaccine Adverse Events Reporting System (VAERS), that is jointly operated by the federal Food and Drug Administration (FDA) and Centers for Disease Control (CDC). Prior to this law, there was no centralized reporting system for vaccine reactions.

Although this law requires doctors and other vaccine providers to report hospitalizations, injuries, deaths and serious health problems following vaccination to VAERS, it is estimated that between less than one to ten percent, of all vaccine-related health problems are ever reported to VAERS.

Reporting & Searching for Vaccine Reactions
As a society we need to know how many people who get vaccinated are getting sick after vaccination and how many go on to die or are permanently injured. It is very important that ALL serious health problems, which develop after vaccination, be reported to VAERS. You should make a vaccine adverse event report to VAERS if you or your child has regressed physically, mentally or emotionally after vaccination or has experienced acute symptoms within hours, days or weeks of vaccination.

Please visit our Ask 8, If You Vaccinate webpage for information on vaccine reaction symptoms and our injury compensation webpage to learn more about filing an injury claim. No vaccine is 100 percent safe for everyone. Vaccine reactions, injuries and deaths are real and by federal law vaccine adverse events must be reported to federal health officials. Click here learn more about reporting serious health problems following vaccination, how to view federal vaccine reaction reports, and the federal Vaccine Injury Compensation Program (VICP).
https://www.nvic.org/reporting-systems.aspx

Accelerated Approval
In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. This approach allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that occurs earlier but may not be as robust as the standard endpoint used for approval. This approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect. After the drug enters the market, 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, FDA may withdraw approval.
https://www.fda.gov/drugs/developmen...cess-drugs#FDA

[Jarod]

Sad you fear monger an lie

Just data.

[Nordberg]

ROFL. please let us know when you catch covid again.....though i'm sure you'll blame it on the unvaccinated, again

I did not catch it at all because I got vaccinated as quickly as possible. Sure, the science shows that the unvaccinated are getting sick and are hospitalized, while extremely few vaccinated are in the hospital. The vaccine works to stop it from getting serious too, if you are a person who can still get it. We who read the facts think that is a sign to take it.
As the doctors are saying, it is now a disease of the unvaccinated. Enjoy your combination of stubbornness and ignorance. It may hurt you badly. A free shot MIGHT prevent that.

[Cypress]

"the Pfizer vaccine is still highly protective against severe illness and death, even amid the spread of the highly contagious delta variant."

Good news!

[Stretch]

Are you kidding me, Pfizer, volume 1 gazillion
They want booster approval based on studies covering about 300 people - with no control arms. BUT IT GETS BETTER. They tested it in 12 (yes, 12!) people over 65.

Alex Berenson
Sept. 15, 2021

The FDA just released its briefing book for Pfizer’s request for a third dose of Comirnaty (or is that BNT162b2? No matter! It’s approved either way, sorta).

It is every bit the mess we all expected.

Let’s go to the highlights:

Pfizer basically hasn’t bothered to test the booster AT ALL in the people actually at risk - it conducted a single “Phase 1” trial that covered 12 people over 65. The main Phase 2/3 booster trial (beware efforts to cover multiple “phases” of drug research at once, you want it bad you get it bad) included no one over 55.
No one.
As in NONE.
Which makes total sense - why test the booster in people who actually need it because they’re at high risk from the ro? Nothing good can come of that.
So that’s our trial design.

Now safety:

Of the 300 people who received the booster, one had a heart attack two months later. No worries, Pfizer concluded it wasn’t related. Yay!
Five percent of recipients had enlarged lymph nodes.
How about effectiveness?
Well, we don’t have enough data - or any data, really - telling us how well the booster will work.
But the FDA made Pfizer go back and review its data from the pivotal clinical trial from last year. Pfizer compared people who received the vaccine with those who received the placebo and THEN the vaccine (the best we can do at this point, since Pfizer blew up the trial by giving placebo subjects the vaccine, double-yay!)
Pfizer concluded that your annual risk of getting Covid-19 IF YOU ARE VACCINATED is about 7 percent.

Further:

“An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2 at the start of the analysis period.”
Oh.
But don’t worry, Uncle Joe already told you you can get your booster on September 20. If it’s good enough for our fearless leader, it should be good enough for the FDA, amirite?
SCIENCE!

SOURCE: https://www.fda.gov/media/152176/download
https://alexberenson.substack.com/p/...-pfizer-volume

[Cypress]

Alex Berenson
Sept. 15, 2021

^^^ Not a doctor, not a trained medical researcher, and did not even attend nursing school.

[PoliTalker]

Booster shots will begin soon for everyone over 65, and those with health conditions.

Right on!

[Stretch]

^^^ Not a doctor, not a trained medical researcher, and did not even attend nursing school.

What part of the FDA link was incorrect?

[Stretch]

FDA panel endorses COVID-19 booster shots for older Americans, rejects widespread use
BY NATHANIEL WEIXEL - 09/17/21 03:34 PM EDT
A federal advisory panel on Friday unanimously voted to recommend the Food and Drug Administration (FDA) authorize a third booster dose of Pfizer and BioNTech's coronavirus vaccine for people over the age of 65 as well as for other groups of people who are at high risk for COVID-19.

But that vote only occurred after the panel overwhelmingly voted against recommending the widespread use of boosters for everyone over the age of 16. The move represents a rebuke of the Biden administration and deals an unexpected blow to the president's plan to administer booster doses to all Americans over 16 beginning Sept. 20.

The targeted recommendation is much narrower than what the companies and top officials in the Biden administration had initially sought.

"The incremental benefit to the younger population has not been shown at all," said panel member Michael Kurilla, ​a clinical director at the National Institutes of Health.

"We just can't simply be in a position where we would just be vaccinating people every time we think there's a problem."

The panel's vote is not binding, so the FDA doesn't have to accept the results. But if it doesn't, it would likely raise significant questions of political interference and pit agency scientists against political officials who signed off on the booster plan.

Peter Marks, the agency’s top vaccine regulator, noted that the recommendation could be tweaked.

Should the FDA sign off on the recommendation, a Centers for Disease Control and Prevention (CDC) advisory panel will meet next week to decide more details about who specifically should qualify for the boosters, and when they'll be administered.

The FDA panel members did not vote to define who is considered high risk, but the category will likely include health care workers as well as people with pre-existing conditions like diabetes, heart disease and obesity.

Following the panel's vote, the White House said it was ready to move forward.

"Today was an important step forward in providing better protection to Americans from COVID-19. We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week," assistant press secretary Kevin Munoz said.

People with severely weakened immune systems are already eligible for a third dose, though the broader booster recommendation will only apply to the vaccine from Pfizer-BioNTech.

People who received Moderna's vaccine and the Johnson & Johnson vaccine will not be eligible until FDA gives those companies the green light. Moderna submitted booster data at the beginning of September, and Johnson & Johnson has not yet submitted evidence.

In an unusual move last month, President Biden and top health officials, including Surgeon General Vivek Murthy, acting FDA Commissioner Janet Woodcock and CDC Director Rochelle Walensky, publicly announced a booster shot program would begin next week, well before the FDA and CDC examined the evidence.

While officials have been careful to say the booster program is contingent on the FDA and CDC giving the green light, they have been criticized by some public health experts for speaking as if the approval was a given.

The increasingly contentious issue of boosters has divided outside scientists as well as some inside the FDA.

Research in the U.S. indicates that immune response does wane over time, but the current COVID-19 vaccines still afford protection against severe COVID-19 disease and death.

Panel members felt that level of protection was enough, and they disagreed with the importance of vaccinating to stop mild infections.

“It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don’t think we’re there yet in terms of the data,” said Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

FDA's Marks noted that many other vaccines are used to prevent mild infections. He also mentioned the importance of preventing the spread of the virus to vulnerable populations such as children who are currently too young to be vaccinated.

Updated at 7:08 p.m.
https://thehill.com/policy/healthcar...recommendation

[Micawber]

Hopefully several more tards will get a jab.

[Stretch]

How about focusing on treatment as well as worthless failed synthetic spike jabs where the jabbed are falling ill again. It wears off in 3 to 4 months.

You want doctors?

NIH “A” Rating for mAbs
May 26, 2021
Watch Dr. H. Clifford Lane (NIH) and Dr. Raj Gandhi (Harvard) discuss the updated recommendations on the use of
monoclonal antibodies released by the NIH COVID-19 Treatment Guidelines Panel in April 2021. Moderated by Ms. Cicely Waters (HHS/ASPR.)

[Cypress]

What part of the FDA link was incorrect?

You posted his words, not the words of FDA researchers.

Anyone can post a link to an FDA website.

The question is, does your hack have the medical and scientific expertise to interpret medical data, and if they are hacks with no expertise can they be trusted to not cherry pick information to support pre-conceived conclusions?


Why not post the words of a world class, trained epidemiologist, instead of some rube who doesn't have the slightest medical training?

You have a habit of posting Kraken conspiracy theories and predictions of raptures, so you lost all credibility or latitude to post the opinions of obscure, untrained hacks.

[OldMercsRule]

FDA grants full approval to Pfizer-BioNTech’s Covid shot, clearing path to more vaccine mandates


https://www.google.com/amp/s/www.cnb...-mandates.html

"Why the FDA’s Pfizer Vaccine Approval Is Controversial, Disingenuous and Facing A Lawsuit"

"The law cited in the suit is 21 U.S. Code § 360bbb–3 which concerns “Authorization for medical products for use in emergencies.” The code states that a EUA designation must only be used when there is no “approved” alternative for preventing or treating the specific disease. Granting approval to Comirnaty should naturally make the EUA licenses of existing Pfizer vaccines void. In addition, the EUA status for other COVID-19 vaccines should also not be preserved."

https://www.visiontimes.com/2021/09/...a-lawsuit.html

Do you guinea pigs actually think the available Pfizer "vaccine" is approved?????

Wow. Yer drinkin' FDA cool aid. All the AVAILABLE Covid-19 "vaccines" are still experimental. The FDA approved a legally distinct Pfizer "vaccine" called Comirnaty which hasn't yet ben manufactured.

If the bottle says Comirnaty you could sue Pfizer for adverse side effects, butt: Comirnaty isn't available and The FDA played smoke n' mirrors hoping you and the corrupt media wouldn't pay attention.

BTW: the two other experimental "vaccine" providers are doing the same thing that Pfizer has done, creating shells that they can use to fool you lemmings.

Please try to use yer brains. THERE IS NO APPROVED Covid-19 "vaccine" available: PERIOD!