The Pfizer Covid Shot Has Just Been (Fully?) Authorized for Use in the United States – IOTW Report

The Pfizer Covid Shot Has Just Been (Fully?) Authorized for Use in the United States

UPDATE: Is it really fully authorized? Or is the EUA being extended on this one. Or is it fully approved, just not for under 16? Not that it’s any better. The government sure has a way with muddy ‘explanations’, doesn’t it?
Which is why no one trusts them.


Read this— https://www.fda.gov/media/150386/download
[copy/paste the link on your search bar]
h/t Teresa, via ToreSays+|Telegram

Page 2 – Pfizer Inc.
10, 2021,
5 June 25, 2021,
6 and August 12, 2021.7

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. In addition, the Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide
updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to
update language regarding warnings and precautions related to myocarditis and pericarditis. The
Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for
Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech
COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID19 Vaccine, mRNA).
Pfizer-BioNTech COVID‑19 Vaccine contains a nucleoside-modified messenger RNA
(modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid
particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the PfizerBioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech
COVID-19 Vaccine to provide the COVID-19 vaccination series.8

Becker News: The U.S. Food and Drug Administration has issued full authorization to Pfizer’s Covid-19 vaccines, the agency announced on Monday.

“The Food and Drug Administration granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine – becoming the first in the U.S. to win the coveted designation and giving even more businesses, schools and universities greater confidence to adopt vaccine mandates,” CNBC reported.

“Up until now, the mRNA vaccine was on the U.S. market under an Emergency Use Authorization, which was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention,” the report added. more

SNIP: And now, they will begin the process of trashing the competitors’ ‘vaccines’…

U.S. officials wonder if Moderna’s vaccine leads to higher risk of uncommon side effects.

MSN:
United States federal health officials have a new task — figuring out if the Moderna COVID-19 vaccine leads to more uncommon side effects, like the heart condition myocarditis.

Does Moderna vaccine lead to myocarditis?


Federal health officials — including the Food and Drug Administration and the Centers for Disease Control and Prevention — are reportedly conducting a new investigation into the Moderna COVID-19 vaccine because new data suggests the vaccine “may carry a higher risk” for young people, compared to other vaccines, The Washington Post reports.

  • The investigation will review if the Moderna vaccine is linked “with a higher risk of a heart condition called myocarditis in younger adults than previously believed,” according to The Washington Post.

Unnamed officials told The Washington Post that it’s too early to tell if the vaccine leads to the heart condition myocarditis, but the researchers plan to do research to figure out if there is a link. MORE


Surgeon General: COVID-19 Booster Shot Likely Needed for J&J Vaccine Recipients.

Epoch Times: U.S. Surgeon General Dr. Vivek Murthy said on Aug. 22 that people who have received the Johnson & Johnson single-dose vaccine will likely need COVID-19 booster shots, after other federal health officials and he said days ago that those who got the Pfizer and Moderna vaccines would be recommended to get a third shot starting in September. more


Healthcare Workers Pack Hearing to Support Bill to Ban Vaccine Mandates in Michigan.

Epoch Times:

LANSING, Mich.—A public hearing on a proposed new law to ban employers from requiring workers to be vaccinated against the CCP (Chinese Communist Party) virus drew hundreds of people, many dressed in hospital scrubs, to the state capital on Thursday morning.

The overwhelmingly supportive crowd jammed into a hearing on the bill conducted by the House Committee on Workforce, Trades, and Talent, filling the spacious committee room and four overflow rooms to capacity.

The Informed Consent in the Workplace Act (pdf), offered by Rep. Sue Allor (R-Wolverine) and 16 other sponsors, prohibits employers from threatening, firing, discriminating, retaliating against, or refusing to hire workers that decline to receive vaccinations for the CCP virus, tetanus, diphtheria, and pertussis. more here


Chevron Adopts COVID-19 Vaccine Requirement for Some Employees: Report.


Epoch Times:
Chevron has adopted a COVID-19 vaccine requirement for some employees and is mulling extending the mandate to its entire workforce, according to a company spokesman who spoke to The Wall Street Journal.

Braden Reddall, spokesman for Chevron, told The Wall Street Journal that the oil major is now requiring expatriate employees, workers traveling internationally, and employees on U.S.-flagged ships to receive a COVID-19 vaccine. Offshore workers in the Gulf of Mexico and some onshore support staff will also be required to receive the vaccine by Nov. 1, according to the report.

Chevron did not immediately respond to an Epoch Times request for confirmation of and further details about the reported new policy.

With the move, Chevron joins a growing list of major corporations—including Disney, Facebook, Google, McDonald’s, Twitter, United Airlines, and Walmart—announcing COVID-19 vaccine mandates for staff. more here


California Bill Seeks Jail Time For People Who Protest Vaccination Sites Including Hospitals

BLP: A bill in the California legislature seeks to ban anti-vaccine protests outside of vaccination sites including hospitals and doctor’s offices. Protesters would face six months of imprisonment and a fine if the bill passes into law. Freedom protesters including doctors and nurses have been peacefully demonstrating outside of hospitals recently, sparking panic among a globalist medical class that pushes the vaccination agenda at all cost. Can patriots in California stop the Senate bill SB 742 and protect some semblance of free speech in the G0lden State?

On August 19, SB 742 was placed in the legislature’s “Suspense File” category, which means the bill will be considered at a later date in a rapid-fire process alongside other bills that have been placed in the file for being fiscally significant to the state. more

29 Comments on The Pfizer Covid Shot Has Just Been (Fully?) Authorized for Use in the United States

  1. $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

    21
  2. “Let the word go forth from this time and place, to friend and foe alike, that the torch has been passed to a new generation of Americans, born in this century, tempered by war, disciplined by a hard and bitter peace, proud of our ancient heritage, and unwilling to witness or permit the slow undoing of those human rights to which this nation has always been committed, and to which we are committed today at home and around the world. Let every nation know, whether it wishes us well or ill, that we shall pay any price, bear any burden, meet any hardship, support any friend, oppose any foe to assure the survival and the success of liberty.” JFK

    Bring it on.

    21
  3. I already have a second job I can fully migrate to if my first one, or the Federal government that contracts with them, requires the Jab.

    Not for me.

    I will not damage my body to fight a seasonal flu that I already have natural immunity to, and didn’t make me very sick in the first place.

    If you need a test to tell you that you’re sick,

    You’re not sick.

    The whole thing is built on political lies.

    I will not comply.

    37
  4. I want to see it’s approved PDR reference too.

    I’m particularly interested in the teratogenic, mutanagenic, and long-term study findings typically listed, as well as side effects and contraindications.

    They have to publish that now.

    …and if it’s so very, very “SaFe AnD eFfEcTiVe” that the FDA “fully approved” it, then SURELY they don’t need that emergency liability protection now, hmmmm?

    …If they REALLY believe in their crap, they should ask it be recinded THEMSELVES, to build trust and show their confidence in their product.

    …IF they believe in it…

    15
  5. Hepatitis, herpes, shingles, are all FDA approved vaccines but I ain’t going out and get jabbed with any of them. My body my choice. BTW, does this mean since it’s FDA approved that if anyone gets sick, they can sue the FDA, and the person who administered it? Look at all the once approved FDA jabs have been removed from the public:

    https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls

    I was taking a black-boxed drug and if I hadn’t of seen it being recalled and told my doctor, I’d still be taking it. Be your own advocate.

    4
  6. ǝpɐɥsʇɥɓᴉuɹǝdnS August 23, 2021 at 10:44 am

    …IF they believe in it…
    ————————–

    They only believe in money, power, population control. Only way to do it is to inject you with poison and let the jab do its thing. whose stopping them? Get the jab meet the slab.

    6
  7. I can see the commercials now:

    “Side may effects include – body rash, seizures, irregular heartbeat, partial paralysis, Bell’s Palsy, protein spikes, Covid-19 and possible death.”

    Side effects part will be read by the fast talking Fedex commercial guy.

    5
  8. The FDA had no choice but to approve it. Mind you, with NO public trials. What’s next, are they going to tell us that opioids are addictive? Fuck sake.

    BOOSTER regime has to undergo a whole separate approval, and of course that will be approved as well. Because real scientists (known as politicians) have already said they are needed.

    Welcome to the first day of the rest of your life living in government approved medical tyranny.

    Clinical trials aren’t even expected to be complete until 2023.

    https://files.catbox.moe/pm0dzk.jpg

    4
  9. When was the last time you took a flu shot this year, for a virus that has already mutated, from a shot with at best 40% relative efficacy that was designed for last year’s flu that doesn’t prevent transmission and wanes in 3 months?

    6
  10. I may have missed it but I didn’t see anything stating that Pfizer can be held liable if someone is adversely affected by the shot.
    That seems to be an important part of one deciding whether to get it or not.

    5
  11. Credibility, once lost is regained very slowly if ever at all. FDA still had a shred with me prior to this politically motivated move. Long term trials are not possible for a ‘vaccine’ that was developed last year. NOT POSSIBLE. If anything this move makes me adamant in my refusal to take the shots. In the absence of credibility government can only rule by threat of force. Rule by threat/use of force is tyranny by definition.

    3
  12. If you EVER credit someone who lied to you, you’re a damnable fool.

    We had a guy at work who’d say “This is REALLY the truth!” and tell another lie.
    (harmless bullshit lies, but lies nonetheless)

    izlamo delenda est …

    4
  13. As I scrawled yesterday:

    What will be special is a factoid that a friend pointed out to me yesterday. As soon as one RONA treatment is approved, the other emergency authorizations become void. Whoopsie! How are the competing “vaccine” makers going to deal with that dropped boner?

    ———————–

    Without the emergency authorizations, companies will not be “inoculated” against lawsuits.

    He he he.

    ———————–

    Shhh. Don’t tell the trial lawyers, (pronounced lieyers.)

    1
  14. Tim
    AUGUST 23, 2021 AT 1:21 PM

    “We had a guy at work who’d say “This is REALLY the truth!” and tell another lie.”

    I had a boss like that once. If he started a hunting or fishing story with “This ain’t no lie”…

    ..it WAS…

    1
  15. I had a truck driver friend that could tell the most intricate, outlandish, interesting and totally believable stories.
    He always ended with “If you believe that one, I’ll tell you another”.
    And he did.

    2
  16. Where are the attorneys? Where are the product liability lawsuits?

    Surely if it’s FDA approved it cannot enjoy immunity from liability?

    There are NO other products or services offered to the public that are immune from liability, why would an FDA approved vaccine be any different?

    Although that hasn’t stopped the makers of oxcy/opioids from trying to escape their criminal culpability by seeking immunity from liability!

    Watch TV for any length of time and you’ll see numerous, ongoing, sometimes class-action product liability lawsuits being advertised for many, many FDA approved drugs.

    The immunity from liability was a sold to the public as being a necessary compromise because of the severity of the disease and the need to use an untested, unapproved, and experimental vaccine to prevent the deaths of millions of Americans.

    Of course, that never happed because the disease is basically no more deadly than the seasonal flu.

    Now that the vaccine is FDA approved, SURELY the manufacturers must be responsible for their products and be exposed to product liability just like all other manufacturers!

    Given the very nature of product liability lawyers, I can’t believe they’re not clouding the sky as they circle overhead waiting to feast on the rotting corpse of “Big Pharma”!

    Come on all you defenders of the public interest…SUE THESE BASTARDS INTO OBLIVION!

    It should be extremely easy given the magnitude of the harm being done by these drugs!

    1

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