No clinical trials. No advisory committee. Newly formulated boosters to be injected starting in 10 days !?!

FDA Plans to Approve Omicron-Targeting Booster Vaccines

Pfizer-BioNTech
and Moderna have developed new booster shots optimized for Omicron.
They could be approved as soon as Labor Day.

Pfizer-BioNTech and Moderna have developed new booster shots optimized for Omicron. They could be approved as soon as Labor Day.

The
Food and Drug Administration (FDA) will likely authorize new
Pfizer-BioNTech and Moderna vaccine boosters, updated to combat the
emerging COVID-19 variants.

Both
mRNA vaccine manufacturers submitted their bivalent booster vaccine
candidates to the FDA for Emergency Use Authorization (EUA). The Moderna
and Pfizer-BioNTech bivalent boosters are both designed to target the
Omicron BA.4/BA.5 and original wild-type COVID-19 strains.

As
COVID-19 mutates, it has become more resistant to the vaccines intended
to combat its earliest iteration. Additionally, the COVID-19 vaccines
naturally wane over time. The highly infectious BA.5 variant is now
responsible for an estimated
90% of COVID-19 cases in the United States. This has motivated
Pfizer-BioNTech and Moderna to rapidly produce “new and improved”
boosters; the BA.5 variant only emerged in June 2022.

Moderna’s
EUA seeks approval to administer the updated booster to adults 18 years
and older. Pfizer-BioNTech filed their EUA for persons 12 years and
older.

Notably, the FDA’s Vaccine and Related Biological Products
Advisory Committee (VRBPAC) is not expected to convene and offer a
recommendation on the EUAs. If the FDA authorizes these boosters, as the
agency is expected to do, the decision will then go to the US Centers
for Disease Control and Prevention (CDC).

The CDC’s Advisory
Committee on Immunization Practices (ACIP) will convene on September 1
and 2, after which CDC Director Rochelle Walensky, MD, MPH, must sign
off on the updated boosters.

Pfizer-BioNTech and Moderna have
presented positive data of these new boosters in animal models, human
studies have not been completed.  [Have they even started yet?]

If Walensky does approve the new
Omicron boosters after next week’s meeting, the shots could be rolled
out within a couple days of Labor Day.

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10 Comments

  1. Trump & Biden are not physicians to prescribe warp speed experimental emergency only inoculations?

  2. "Vaccines, Testing, & Placebo's"! Heads Up!

    Here is a conversation about the actual content of placeboes, how side effects in the drug being tested are disguised by including things in the placebo that will cause side effects. This is from the documentary series, The Truth About Vaccines. This info is prior to COVID, but I suspect nothing has changed.

    ''Barbara Loe Fisher:'' In these clinical trials, they’ll often use an active placebo instead of an inactive placebo.

    ''Dr. Suzanne Humphries'': That was really one of the real surprising elements to me when I started to research because conventionally, I mean, I worked in a lab, I know what a placebo should be. It should be an inert substance that has no physiological effect. When it comes to vaccines, it’s very rare to find the studies that are actually used for the FDA approval to use a saline placebo. Instead what will be used is either the background substance of a vaccine, which might have aluminum in it, or Polysorbate-80, or some amino acids, or even more commonly, another vaccine that has already been proven safe. So, for instance, if you want to test this year’s flu shot you will test it against last year’s flu shot for its safety rather than testing it against a saline placebo.

    ''Brandy Vaughn'': This is one of the things that I wish I could make every parent in the U.S. understand, is that vaccines are not studied against placebo. They are studied against the toxic additives that are in the vaccines and then they give a shot in their safety testing so the vaccine goes up against the toxic additives in a shot. So, the aluminum, the formaldehyde, the Polysorbate-80. So that in the safety testing, both categories have the same level of damage, right? So then therefore vaccines are safe. If vaccines were safety-tested against a saline-based placebo like they should be, like is the gold standard for pharmaceutical drugs, they would not be on the market today because they do so much damage.

  3. 'Jabs – 'The Secret Weapon Against Trump' 2024'!

    All that said, probably the most important secondary goal of these jabs was an insurance policy against the Donald getting a second term. Trump is the single biggest potential threat to globalist control so protecting against another “Trump setback” is essential to these monsters. In October of 2020 an FDA meeting leaked with extensive discussion of serious side effects that were expected from these jabs (this is before they were available).

    'I sincerely doubt the Donald Trump was ever given this information and do not know if he has seen it to this day.'

    https://tomrenz.substack.com/p/jabs-the-secret-weapon-against-trump

  4. *HOT*! Pls. Bump and Share!

    ''NOW IS THE TIME PRESENTS LAWYERS ON THE LINE-AMAZING INTEL FROM AMERICA'S FRONTLINE LAWYERS.''

    Meri interviews 3 Attorneys who are on the frontlines of this ''battle against the Covid-19 mandates and jabs''. Hear their ''courageous testimonies'' of how they have stood up against tyranny and they are seeing the impossible happening. GOLIATH IS READY TO FALL!! MUST WATCH!!!

    https://rumble.com/v1hbwtz-now-is-the-time-presents-lawyers-on-the-line-amazing-intel-from-americas-fr.html

  9. Earlier today, I was trying to look for the FDA's actual authorization letters for Novavax – first for adults, and then for adolescents. All I found was page after page of media reports and links to FDA statements issued to the public on the matter. What I wanted was the actual wording, as I have previously seen in such letters to e.g. Pfizer in December 2019 and August 2021. Particularly, I wanted to see if they used the language of "an investigational vaccine not licensed for any indication," since there certainly isn't even a phony "approval" for Novavax – yet. But my search for such an official letter was totally unsuccessful, even with specific searches for "FDA authorization letter to Novavax".

    Does anyone here know where one can go for easy access to such FDA letters for all the manufacturers?

  10. Here they explain EUA and FDA Approved Vaccines.
    No FDA fully approved Vax availiable in USA!

    Dr. Lee Vliet and Army whistleblower Lt. Mark Bashaw join me to shine the light of TRUTH on the vax bioweapon and the ''DOD and Biden administration’s conspiracy to harm, maim or kill our military members'', and ''the general population with it.''

    https://www.sgtreport.com/2022/08/rats-scurry-as-d-o-d-approved-vax-bioweapon-truth-emerges/

    ''Whistleblower Report of Illegal DoD Activity''
    https://www.truthforhealth.org/2022/08/whistleblower-report-of-illegal-dod-activity/

    2.) 'Skipping Almost All Studies, ''LYING US Govt'' Says Omicron mRNA Boosters WAY More Effective'!

    https://www.sgtreport.com/2022/08/skipping-almost-all-studies-lying-us-govt-says-omicron-mrna-boosters-way-more-effective-2/

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