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The Food and Drug Administration has formally approved Pfizer's COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.

This is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.

The full approval could make it easier for employers, the military and universities to mandate vaccination and may reassure some people hesitant about the vaccine.

A June poll from the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once one receives full approval from the FDA.

The FDA acted Monday without convening a customary public meeting of expert advisers to vet information about the vaccine and make recommendations to the regulator.

As of Sunday, 73% of adults have had at least one dose of the Pfizer, Moderna or Johnson & Johnson vaccine. Pfizer's vaccine is most commonly administered, accounting for about 56% of the doses administered overall, according to data from the Centers for Disease Control and Prevention.

Moderna's COVID-19 vaccine remains under FDA's review, but its approval is expected to follow in the near future.

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Pfizer's COVID Vaccine Gets Full Approval From The FDA

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The Food and Drug Administration has formally approved Pfizer's COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December. This is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.

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Scott Hensley edits stories about health, biomedical research and pharmaceuticals for NPR's Science desk. During the COVID-19 pandemic, he has led the desk's reporting on the development of vaccines against the coronavirus.

Hensley has worked on award-winning investigations in collaboration with journalistic partners.

He was the lead NPR editor on an investigation with the Center for Public Integrity in 2018 that exposed drug industry influence on the choices of preferred medicines by Medicaid programs. The work won the 2019 Gerald Loeb Award for audio reporting.

In 2017, Hensley was the lead NPR editor on an investigation with Kaiser Health News that showed how the pharmaceutical industry exploits government incentives intended to encourage the development of treatments for rare diseases. The stories won the 2019 digital award from the National Institute for Health Care Management.

Hensley has been editing in his current role since 2019. He joined NPR in 2009 to launch Shots, a blog that expanded to become a digital destination for NPR health coverage.

Before NPR, Hensley was a reporter and editor at The Wall Street Journal. He was the founding editor of The Wall Street Journal Health Blog, which focused on the intersection of health and business. As a reporter, he covered the drug industry and the Human Genome Project.

Hensley served on the board of the Association of Health Care Journalists from 2012 to 2020.

He has a bachelor's degree in natural sciences from Johns Hopkins University and a master's in journalism from Columbia University.

Before becoming a journalist, Hensley worked in the medical device industry. He remains, now and forever, a lover of Dobermans, lacrosse and Callinectes sapidus.

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Scott Hensley edits stories about health, biomedical research and pharmaceuticals for NPR's Science desk. During the COVID-19 pandemic, he has led the desk's reporting on the development of vaccines against the coronavirus. Hensley has worked on award-winning investigations in collaboration with journalistic partners.

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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

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FDA approved the first COVID-19 vaccine, which has been known as the Pfizer-BioNTech COVID-19 Vaccine, and is now marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

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Many people are looking for a successful way to refuse the COVID vaccine in situations where the shots are mandated. I fully support such efforts.

Some people believe they can make the argument that the FDA didn't actually give full approval to the Pfizer vaccine on August 23rd. Therefore, these people can refuse the vaccine on the grounds that it is still experimental, meaning it has only been granted Emergency Use Authorization.

I'll discuss that practical strategy later in this article.

But first, I need to analyze the claim that the FDA didn't truly approve (license) the Pfizer vaccine.

OK. Here we go.

The first FDA document I'll reference is "Comirnaty and Pfizer-BioNTech COVID-19 Vaccine," dated August 23, 2021. The document opens with this statement:

"On August 23, 2021, the FDA 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, 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 approved" means full approval. The FDA has fully approved the Pfizer-BioNTech COVID vaccine.

And this vaccine "will now be marketed" as the Comirnaty vaccine.

They are the same vaccine, medically speaking. The ingredients are the same.

The FDA document ALSO says the vaccine will continue to be available under the prior Emergency Use Authorization (EUA), for uses that are not yet fully approved. For example, injecting children 12-15, and as a third dose for certain immunocompromised people.

The full approval and the EUA status are riding together, side by side. The EUA status covers uses of the vaccine not covered under full approval.

The rest of this FDA document offers links. One of the links leads to an FDA news release, dated August 23, titled, "FDA Approves First COVID-19 Vaccine." The release states:

"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..."

"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."

The FDA, in this news release, is again asserting that the Pfizer vaccine is now approved, and makes a clear distinction between the prior EUA and this new approval.

Next, we move to a letter, also dated August 23, sent from the FDA to BioNTech Manufacturing GmbH, and Pfizer Inc. The letter is marked, "BLA Approval." BLA stands for "Biologics License Application." Here are key quotes:

"Please refer to your Biologics License Application (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA."

"We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany...Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA...You may label your product with the proprietary name, COMIRNATY..."

The FDA officially licensed this vaccine. This is approval. It is not merely a continuation of Emergency Use Authorization (EAU).

And now we come to another key FDA document, a letter sent to Pfizer Inc. on August 23, 2021 (addressed to Ms. Elisa Harkins). It also mentions the full licensure (approval) of the vaccine:

"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."

This letter is further acknowledgement that the vaccine has been fully approved.

Now we enter the thick weeds of the letter, during a discussion of how Emergency Use Authorization will continue to be used. The language is very dense. It's taken me a while to separate out the strands.

To help you with what I'm going to untangle, understand that the FDA is making a distinction between what we could call the "old Pfizer vaccine" and the "new Pfizer vaccine." They are identical in their ingredients. They are the same vaccine. But the "old vaccine" vials were granted Emergency Use Authorization (EUA) before the August 23rd FDA full licensure of the vaccine; and the "new vaccine" vials will certainly be used under full licensure (approval).

Splitting hairs? Yes. But in order to understand what the FDA is saying in this letter, you have to grasp the distinction between "the old" and "the new."

The "old" vaccine is labeled "Pfizer-BioNTech COVID-19 vaccine," and the "new" vaccine is labeled "COMIRNATY." Again, they are exactly the same vaccine.

The FDA letter to Pfizer (the one addressed to Ms. Elisa Harkins) states:

"On August 23, 2021, having concluded that revising this EUA [Emergency Use Authorization for the vaccine] is appropriate to protect the public health or safety...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."

The "old vaccine" will continue to have EUA status: it can be injected in people 12 and older, and it can be used as a third dose for certain immunocompromised individuals.

The "new vaccine"-which has full FDA approval-CONTINUES TO ALSO HAVE EUA STATUS-and therefore it too can be injected in people 12 and older, and used as a third dose for certain immunocompromised individuals.

Strange? Yes. The "new" and fully approved vaccine retains its former EUA status. It's BOTH fully approved and certified as an emergency experimental product.

I believe the FDA reasoning goes this way: the agency wants to make sure vials carrying the label of the "new" fully approved vaccine can be injected into people to whom the full approval doesn't apply-people between 12 and 15, and certain immunocompromised people, as a third shot. In other words, people covered under EUA status.

If you continue to read this FDA letter, you'll see this reasoning spelled out.

Bottom line, and my conclusion: The FDA has fully approved the "new vaccine" AND it has also retained the Emergency Use Authorization (EUA) for the "new vaccine." Both.

-So what does all this mean for people who want to find a workable reason for refusing the vaccine?

For example, suppose you work for a major corporation or a government agency, and you're told you must get the shot. You say, "No, I won't take the shot, because the FDA never approved it. It's still an experimental medicine, because it only has EUA status."

I believe you'll lose. You'll be told, "The FDA HAS approved it."

Suppose you take a somewhat different approach. You say, "I'll need to see the actual vial containing the vaccine you want to inject me with. Is it labeled 'Pfizer-BioNTech COVID-19 vaccine' (the 'old' vaccine) or 'COMIRNATY' (the 'new' vaccine)?"

Your boss says, "What difference does it make? Either way, it's the same vaccine."

And you say, "Not legally speaking. I understand it may take some time for the new shipments of the COMIRNATY to arrive. I won't take the Pfizer-BioNTech shot because it only has Emergency Use Status, and therefore it's an experimental medicine. Under federal law, I have the right to refuse an experimental medicine. I'm invoking that right."

Will that fly?

I'm giving you non-lawyer opinions here. Understand this.

It's possible this approach could buy you time. Maybe your boss will suddenly become a bit nervous-he tells you he's going to talk to his company/agency attorneys, and he'll get back to you.

Or maybe he threatens to fire you on the spot, and he tells you to hire (and pay through the nose for) a lawyer. You do. Do you think your argument will stand up in court? I don't. Maybe I'm wrong. I'd like to be wrong about that.

Maybe your lawyer will suggest other approaches. A religious exemption, for example. Or, depending on the circumstances, a medical exemption.

But after reading the FDA documents I've cited above, I say that if you think the FDA hasn't actually approved the vaccine, you're mistaken.

This country, and other countries, are being split into the vaccinated and the unvaccinated. Communities are dividing. Families are dividing and fracturing. It isn't a pretty picture.

Here in America, we're used to living life as usual and believing that coercion isn't going to come to our front doors. Despite the lockdowns and the mask mandates and the vast financial destruction of the past year, many people still think things are "all right."

That's not true.

I support all legal efforts to keep freedom of choice alive. I support the unions that are demanding NO VACCINE MANDATES. I also support those governors who are defending their states against COVID restrictions and vaccine mandates. People who criticize these governors because they aren't perfect or are partially compromised are barking up the wrong tree. We need all the help we can get.

However, as far I'm concerned, putting all our eggs in the basket of court cases, legal filings, unions, and governors is shortsighted, to say the least.

Freedom always needs more. Freedom needs brave business owners to stay open and maskless, despite government edicts. Freedom needs parents to keep showing up at school board meetings, to demand an end to COVID restrictions and mandates.

Most of all, freedom needs patriots, in the best sense of the word, to do what people in Europe and Australia are doing: come out in the street in great numbers. Over and over.

Not by the thousands. By the millions.

For as long as it takes.

The enemies of freedom have to feel the heat. They have to see that the people can't be forced beyond a certain point.

Whether we like it or not, whether we know it or not, the day is coming when, not the minority, but the majority of us will know we are living under tyranny.

Not just insanity; tyranny.

We will know it in ways that are undeniable.

Some of us already know it.

We're all living through a test of faith. Each individual; and whatever he/she has faith IN. How deep is that faith? How strong?

SOURCES:
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine https://www.fda.gov/media/151710/download https://www.fda.gov/media/150386/download childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/ https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx This article first appeared at NoMoreFakeNews.com. Human Sacrifice: Exposing Klaus Schwab's Engineered Failed State Collapse

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Did FDA Really Approve the Pfizer COVID Vaccine? Wait. What?

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Many people are looking for a successful way to refuse the COVID vaccine in situations where the shots are mandated. I fully support such efforts. Some people believe they can make the argument that the FDA didn't actually give full approval to the Pfizer vaccine on August 23rd.

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Alex Jones Selling supplements on amazon

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Alex Jones Selling supplements on amazon

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The far-right conspiracy theorist Alex Jones has been banned from Facebook, Apple, YouTube, Instagram, Pinterest, Twitter, Spotify and even PayPal for violating those sites' policies against hate speech. But Jones continues to have a platform to sell expensive dietary supplements through one of the world's biggest online retailers: Amazon.

Just as Amazon provides massive third-party sellers - such as Starbucks, Coca-Cola or Apple - with their own online storefronts, Jones' Infowars Store has a home on the site, too. There, he sells products such as " Super Male Vitality" drops, " Lung Cleanse Plus Spray" and " Prostaguard" pills.

"Thank you for supporting the Infowar!" the storefront states above its listings, suggesting that Jones is not just selling supplements but providing a path for consumers to fund his extremist causes. Meanwhile, Amazon provides support to Jones and gets a percentage of all the sales - called a "referral fee" - as it does with all third-party sellers. For supplements priced over $10, the referral fee is 15%.

Neither Amazon nor Jones responded to NPR's requests for comment.

One of the only other major sites to provide Jones with a platform is eBay. "Your purchase directly supports Alex Jones and his Infowars operations," the eBay storefront states above a similar group of Infowars dietary supplements. However, eBay is a small fraction of the size of Amazon, and brought in a little more than $10 billion in revenue in 2020, compared with Amazon's $386 billion. NPR also contacted eBay for comment but did not receive a response.

Jones is known, in the words of the Anti-Defamation League, for "spreading violent, bigoted conspiracy theories," which is what led several tech platforms to ban him years ago. Among the theories he pushed: the baseless idea that the Sandy Hook Elementary School shooting in 2012, which killed 26 people, including 20 young children, was a "hoax." Afterward, families of the slain children said they experienced waves of harassment that have lasted for years. Jones later stated in a deposition that he was experiencing "like a form of psychosis" at the time and said that "my opinions have been wrong, but they were never wrong consciously to hurt people."

Jones has also been a supporter of former President Donald Trump and embraced the false conspiracy theory that the election was "stolen." Jones marched in Washington, D.C., on Jan. 6, though he did not breach the U.S. Capitol building. According to The Wall Street Journal, Jones also helped coordinate a $300,000 donation to support the rally at the Ellipse, where Trump spoke before the riot. The Journal reported that he also gave nearly $100,000 of his own money to a pro-Trump event the night before, where he also spoke. Jones has also repeatedly featured the leader of the anti-government militia the Oath Keepers on Infowars. Other members of the Oath Keepers are now facing conspiracy charges related to the Capitol riot.

Since Jones' businesses are private, exact figures about the amount of revenue he generates, including through Amazon, are unknown. But court records and news reports suggest that much of Jones' fortune, which he can use to fund his far-right causes such as that rally, comes from marketing dietary supplements. In addition to Amazon, he also sells supplements directly through his own site.

In 2014, his businesses brought in $20 million, according to court testimony cited by The New York Times. The Times also viewed some of his financial documents and reported that most of that money came from supplements that year. The German magazine Der Spiegel profiled Jones in 2017 and reported that about two-thirds of his income came from product sales, including supplements. A filmmaker who worked with Jones in 2019 told the Southern Poverty Law Center that Jones bragged about making $60 million in a year, though that figure is unverified.

"He is making, at a minimum, tens of millions of dollars," said the SPLC's Michael Edison Hayden, who has looked into Jones' finances. "As far as I can tell, the dietary supplements are the absolute bread and butter, the foundation of his entire business at this point."

On his shows, Jones pitches the supplements as not just a health item, but a contribution to his political movement. "There's a lot of people that need my help, and it's gonna take money to do it," Jones said recently. "Please buy products from us whenever you can." He then pivoted to hawking his "Alpha Power" - recently sold on Amazon and available with Prime shipping in some areas - which he said, "I can't even tell you, it makes me so aggressive and virile, it's ridiculous."

The dietary supplement industry is largely unregulated in the United States. But Jones' supplement business has gotten scrutiny from government agencies. Near the beginning of the coronavirus pandemic, Jones marketed colloidal silver products - such as a "Nano Silver toothpaste" and a "Superblue Silver Immune Gargle" - as treatments for COVID-19.

Leading medical authorities say colloidal silver is not safe or effective for treating any medical condition, let alone COVID-19. At high enough doses, colloidal silver can permanently turn a person's skin blue. So the Food and Drug Administration sent Jones a warning letter, demanding that he stop making false and misleading claims about his products. The New York attorney general also sent Jones a cease-and-desist letter. The products cited by the FDA were sold on Amazon back then but no longer appear on the site.

It's unclear why Jones has so far evaded scrutiny from Amazon.

In recent years, Amazon has blocked some products it deems hateful. After a white supremacist murdered nine Black churchgoers in Charleston, S.C., in 2015, Amazon removed listings for Confederate flags. This month, Amazon said it would no longer "sell books that frame LGBTQ+ identity as a mental illness."

But the retailer has struggled to combat false and misleading claims by third-party sellers as well counterfeit products and other items found unsafe by regulators. A 2020 NPR investigation revealed that amid the coronavirus pandemic, more than 100 dietary supplements sold on Amazon made misleading and potentially illegal claims that they could treat viruses.

The SPLC's Hayden said that Amazon has generally been reactive - rather than proactive - when dealing with problematic products and sellers, often waiting until public pressure builds.

"So Amazon is going to turn a profit, and they're going to turn a blind eye until somebody else points it out," he said.
Editor's note: Amazon is among NPR's financial supporters.

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Alex Jones Still Sells Supplements On Amazon Despite Bans From Other Platforms

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The far-right conspiracy theorist Alex Jones has been banned from Facebook, Apple, YouTube, Instagram, Pinterest, Twitter, Spotify and even PayPal for violating those sites' policies against hate speech. But Jones continues to have a platform to sell expensive dietary supplements through one of the world's biggest online retailers: Amazon.

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While U.S. Democrats turn to a variety of outlets for political news, no source comes close to matching the appeal of Fox News for Republicans.

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Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky endorsed an independent expert panel's recommendation to use the Pfizer vaccine for people 16 years and older under full FDA approval. The panel's standard recommendation on Monday followed its interim recommendation given under emergency approval.
CLICK HERE TO FIND A COVID-19 VACCINE NEAR YOU
The COVID-19 Vaccine Safety Technical (VaST) Work Group, which presented during the Advisory Committee on Immunization Practices (ACIP) meeting Monday, reiterated an increased risk of heart inflammation among vaccinated males under 30, but maintained that the shot's benefits far outweigh any potential risks.

The vote was 14-0.

"We now have a fully approved COVID-19 vaccine and ACIP has added its recommendation," Walensky said in a written statement. "If you have been waiting for this approval before getting the vaccine, now is the time to get vaccinated and join the more than 173 million Americans who are already fully vaccinated."

Committee members were tasked with discussing the following question:

Should vaccination with the Pfizer-BioNTech COVID-19 vaccine be recommended for people 16 years of age and older?

According to Dr. Matthew Daley, ACIP COVID-19 Vaccines Work Group chair, "when considering recommending a licensed vaccine for use, never before has the ACIP made such recommendations with such a breadth and depth of information..." The recommendation Monday stemmed from updated clinical trial data and further follow-up on safety, beyond the data under review last December under emergency approval.

Panel members said the vaccine remains available to adolescents 12-15 under emergency approval, as well as third doses among immunocompromised patients.
FDA APPROVES PFIZER'S COVID-19 SHOT: WHAT IS LICENSURE?
As of Aug. 18, the panel reported 327 confirmed myocarditis cases through VAERS, a national surveillance system, against a backdrop of 17 million second doses of Pfizer vaccine administered among people 16-29. Males aged 16-17 saw the highest reporting rates at about 72 cases of myopericarditis per million second doses administered. Of 845 cases among people under 30, at least 77% recovered from symptoms.

However, COVID-19 patients face an estimated 6-34 times greater risk of heart inflammation following infection, compared to those who received mRNA vaccines, according to slides presented during the meeting.

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CDC panel recommends Pfizer/BioNTech COVID-19 vaccine for anyone 16 and older under full FDA approval

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Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky endorsed an independent expert panel's recommendation to use the Pfizer vaccine for people 16 years and older under full FDA approval. The panel's standard recommendation on Monday followed its interim recommendation given under emergency approval.