FDA approves Pfizer jab

sbeaudry

Jedi Council Member
Well, that was fast... here come more mandates???



FDA NEWS RELEASE

FDA Approves First COVID-19 Vaccine​

Approval Signifies Key Achievement for Public Health​



Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older​

The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring​

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.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

Related Information​

###
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Inquiries​

Media: FDA Office of Media Affairs 301-796-4540
Consumer: 888-INFO-FDA
    • Content current as of:​

      08/23/2021
  • Regulated Product(s)​

    • Biologics

    Health Topic(s)​

    • Infectious Disease
    • Coronavirus
 
From deployment to full FDA approval in 8 months - you have to be so gullible to think something nefarious isn't going on here. I will probably be mandated to take the jab soon because of my job as a federal contractor. I guess I should've accepted it would come to this and tried to change jobs in the last 16 months but I didn't , holding out that it wouldn't come to this - stuck in my own wishful thinking.. ugh..
 

Lilou

Ambassador
Ambassador
FOTCM Member
Surprisingly (or not), but the White House said it will not mandate the jab for its employees, per J. Psaki. I also read Pfizer and the CDC announced no mandates for their employees as well.

@SubnetUnMask , you may want to start working on a religious exemption.
 

psychegram

The Living Force
Surprisingly (or not), but the White House said it will not mandate the jab for its employees, per J. Psaki. I also read Pfizer and the CDC announced no mandates for their employees as well.

It amazes me that people aren't making a bigger deal about that and questioning the entire basis for the mandates.

I jest. The livestock have lost all ability to question anything. They simply believe what's programmed into them from their glowing entrainment boxes, and that's that.

Looking forward to mandates at my own employer. Soon enough I'm sure....
 

Alejo

Ambassador
Ambassador
FOTCM Member
It was a matter of time, a lot of the hesitancy was around the idea that the vaccine had not been approved, and so... they weren't safe. I do think that this is simply a formality in order to carry on as per usual.

Not that it not being approved was ever a reason to stop with their mandates and their encouragement. It has played the way these things always play, like MH17 in Ukraine played, the conclusions about the event were ready immediately after without any research being done.

Same thing with the vaccines, they're safe whether they're approved or not, the approval was always going to arrive whether they were safe or not.
 

MichaelM

Jedi Master
FOTCM Member
FDA has a page saying that it is fully approved: FDA Approves First COVID-19 Vaccine
(presser dated today, August 23, 2021)

!!! BUT !!!

Document on the FDA website, also dated today, August 23, 2021, says that the EUA was just extended for the Pfizer mRNA shot; https://www.fda.gov/media/150386/download
page 2
On August 23, 2021, FDA approved the biologics license application (BLA) submitted by
BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and
older.
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in
place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and
uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved BLA.
page 11-12
All descriptive printed matter, advertising, and promotional material relating to the
use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state
that:
• This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
 

sbeaudry

Jedi Council Member
FDA has a page saying that it is fully approved: FDA Approves First COVID-19 Vaccine
(presser dated today, August 23, 2021)

!!! BUT !!!

Document on the FDA website, also dated today, August 23, 2021, says that the EUA was just extended for the Pfizer mRNA shot; https://www.fda.gov/media/150386/download
page 2

page 11-12
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
 

MatiaS

The Force is Strong With This One
My girlfriend is telling me she's seeing multiple posts on Instagram where people are saying they called Pfizer to ask about the approval, and the response they apparently got was "No."... ???
 

Hi_Henry

Dagobah Resident
It amazes me that people aren't making a bigger deal about that and questioning the entire basis for the mandates.

I jest. The livestock have lost all ability to question anything. They simply believe what's programmed into them from their glowing entrainment boxes, and that's that.

Looking forward to mandates at my own employer. Soon enough I'm sure....
I read something similar at some college. I would not be surprised if many colleges/universities were not pulling off this trick. Organizing placebo shots for their employees would create too many witnesses, so they can't go that route. Hence, the exemptions.

As to approval, I found this comment on ZH
1 hour ago

All FDA drug approvals must be published in the Federal Register, so far there is nothing in the Federal Register indicating that the Pfizer shots have been approved by the FDA.


zh-default-avatar.png

green_dog

57 minutes ago

Thank you for the info; I checked at
Document Search Results for 'pfizer'
and see that it isn't listed.
If the above is true (though it might be just a matter of days before it appears) they could be playing word games with people. No way to figure this out, as what they say today has no bearing on what they will say tomorrow.
 

psychegram

The Living Force
This approval is looking to be a misdirection play by the Federal gov. utilizing "word salads" and procedures.

That wouldn't surprise me, but it also probably doesn't matter. Everything done over the last two years has happened under color of law. If the FDA approval isn't actually an approval, that won't stop the minion class from using it as an excuse to roll out mandates.

All that matters at this point is whether people will stand firm or cave under pressure.
 

sbeaudry

Jedi Council Member


Sorry for the cut and paste job, but here's the article from children's health defense. Full approval for 16 and up. "Pfizer’s vaccine will remain under EUA for 12- through 15-year-olds, and for a third dose in certain immunocompromised individuals."





FDA Grants Full Approval of Pfizer Vaccine, Critics Blast Agency for Lack of Data, Scientific Debate​

Critics said it was concerning that full approval was based on only six months’ worth of data — despite clinical trials designed for two years — and that there was no public discussion of the data.

The U.S. Food and Drug Administration (FDA) today granted full approval to the Pfizer/BioNTech COVID vaccine for people 16 years and older — without allowing public discussion or holding a formal advisory committee meeting to discuss data.

This is the first COVID vaccine approved by the FDA, and is expected to open the door to more vaccine mandates by employers and universities.

“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” U.S. Surgeon General Dr. Vivek Murthy on Sunday told CNN’s Brianna Keilar.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Dr. Janet Woodcock, acting FDA commissioner in a press release issued Monday.

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”

Woodcock said she believes FDA approval will instill additional confidence in people to get vaccinated.

“It’s been remarkably fast,” said Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania, who said careful handling of the approval was crucial to potentially persuading the “vaccine hesitant” to receive the licensed product.

The approval of Pfizer’s COVID vaccine was based on its clinical trial of 44,000 people — half of whom got the shots, the company said. The median six-month follow-up period for safety and efficacy began after participants received their second dose, Pfizer said.

“Based on the longer-term follow-up data we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in a statement. “I am hopeful this approval will help increase confidence in our vaccine.”

The company plans to follow the 44,000 enrollees for a total of 24 months, from the start of the trial. In order to qualify for FDA Emergency Use Authorization (EUA) last December, Pfizer followed trial participants for a median of only two months after participants received their second dose.

Pfizer’s COVID vaccine received EUA on Dec. 11, 2020, for use in individuals 16 years and older. On May 10, the authorization was expanded to include 12- through 15-year-olds.

According to the FDA, EUAs can be used by the agency during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing or treating a disease, provided the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose or treat the disease, outweigh the known and potential risks of the product.

Pfizer’s vaccine will remain under EUA for 12- through 15-year-olds, and for a third dose in certain immunocompromised individuals.

However, full approval gives doctors flexibility in using vaccinations for “off-label use,” which is not permitted for EUA products. This would allow doctors to give patients booster shots before the FDA clears them.

Data released Friday by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020 and Aug. 13, 2021, a total of 326,535 adverse events had been reported to the Vaccine Adverse Events Reporting System (VAERS) attributed to Pfizer’s COVID vaccine, including 9,027 deaths and 56,607 serious injuries.
Critics said it was concerning that full approval was based on only six months’ worth of data — despite clinical trials designed for two years — and that there was no public discussion of the data.

This is the first COVID vaccine approved by the FDA, and is expected to open the door to more vaccine mandates by employers and universities.
“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” U.S. Surgeon General Dr. Vivek Murthy on Sunday told CNN’s Brianna Keilar.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Dr. Janet Woodcock, acting FDA commissioner in a press release issued Monday.
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”
Woodcock said she believes FDA approval will instill additional confidence in people to get vaccinated.
According to The Washington Post, Pfizer’s vaccine approval was the fastest in the agency’s history, coming less than four months after Pfizer/BioNTech filed for licensing on May 7.
“It’s been remarkably fast,” said Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania, who said careful handling of the approval was crucial to potentially persuading the “vaccine hesitant” to receive the licensed product.
The approval of Pfizer’s COVID vaccine was based on its clinical trial of 44,000 people — half of whom got the shots, the company said. The median six-month follow-up period for safety and efficacy began after participants received their second dose, Pfizer said.
“Based on the longer-term follow-up data we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in a statement. “I am hopeful this approval will help increase confidence in our vaccine.”
The company plans to follow the 44,000 enrollees for a total of 24 months, from the start of the trial. In order to qualify for FDA Emergency Use Authorization (EUA) last December, Pfizer followed trial participants for a median of only two months after participants received their second dose.
Pfizer’s COVID vaccine received EUA on Dec. 11, 2020, for use in individuals 16 years and older. On May 10, the authorization was expanded to include 12- through 15-year-olds.
According to the FDA, EUAs can be used by the agency during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing or treating a disease, provided the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose or treat the disease, outweigh the known and potential risks of the product.
Pfizer’s vaccine will remain under EUA for 12- through 15-year-olds, and for a third dose in certain immunocompromised individuals.
However, full approval gives doctors flexibility in using vaccinations for “off-label use,” which is not permitted for EUA products. This would allow doctors to give patients booster shots before the FDA clears them.
Data released Friday by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020 and Aug. 13, 2021, a total of 326,535 adverse events had been reported to the Vaccine Adverse Events Reporting System (VAERS) attributed to Pfizer’s COVID vaccine, including 9,027 deaths and 56,607 serious injuries.

Critics accuse FDA of ‘unprecedented, naked power grab’
According to an article published Aug. 20 in the BMJ, transparency advocates have criticized the FDA decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval — an important mechanism used to scrutinize data.
Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”
But in a statement to The BMJ, the FDA said it did not believe a meeting was necessary ahead of the expected full FDA approval.
An FDA spokesperson said the agency held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to COVID vaccines in 2020, and did not believe a meeting was needed related to this biologics license application for Pfizer.
According to the BMJ, companies typically apply for full approval after a longer period has elapsed so that more data are available for review.
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 scrutinizing the data.
“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization,” said Witczak. Wticzak was one of 27 experts who launched a citizen’s petition demanding the FDA “slow down and get the science right” before approving COVID vaccines.
“The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing,” Wticzak said. “These meetings offer a platform where questions can be raised, problems tackled and data scrutinised in advance of an approval.”
Witczak said it’s concerning that full approval is based on only six months’ worth of data — despite clinical trials designed for two years — and there’s no control group after Pfizer offered the product to placebo participants before the trials were completed.
“They know they can’t win this argument on the science and that’s why they had to abolish the public process and independent oversight,” said Children’s Health Defense Chairman Robert F. Kennedy Jr. “They believe themselves so powerful now that they are stripping off all pretenses that this is about public health, and are baldly revealing the corruption.”
Kennedy told The Defender:
“This is a sinister scheme for mandating a badly flawed vaccine that has already made history with record deaths and injuries, that neither prevents disease nor transmission, and does not improve mortality. Pfizer’s most recent six-month data show that while the jab prevents some COVID deaths, it causes more heart attacks yielding a net loss of life.”
Diana Zuckerman, president of the National Center for Health Research, told The BMJ it’s obvious the FDA has no intention of hearing anyone else’s opinion, and says making decisions behind closed doors can feed vaccine hesitancy.
“It’s important to have a public discussion about what kind of data are there, and what the limitations are,” Zuckerman said. “As we think about risk versus benefit, we need to know.”Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and former FDA deputy commissioner during the Obama administration, said advisory committee meetings are more than just a way of receiving scientific input from outside experts.
“It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” Sharfstein told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence.”
 
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