Thursday, August 25, 2022

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.


Anonymous said...

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

Anonymous said...

"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.

Anonymous said...

'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.'

Anonymous said...

*HOT*! Pls. Bump and Share!


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!!!

Anonymous said...

''GREAT INFO'' 'Pls. Bump and Share! Get Your Popcorn!'

'NIH - CDC - FDA 'Do NOT Want You to See This Interview' with Tom Renz'!

Anonymous said...

A question about the DC Schools mandate.

Their webpage states that on July 8, 2022, the FDA fully approved the Covid vaccine commonly known as Pfizer BioNTech Vaccine for individuals ages 12-15.

Did I miss something?

Anonymous said...


Breaking… DC judge rules 'Vaccine Mandate' is illegal…Hitting The Wires!
DC Judge rules the 'city's vaccine mandate' for employees 'unlawful'!

Anonymous said...

This proven anti-cancer drug is ignored by doctors and drug companies – you can buy it for pennies  Vernon Coleman GP MB ChB DSc FRSA

The Startling History of Polio Vaccination Dr Vernon Coleman  GP MB ChB DSc FRSA

Steven Athearn said...

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?

Anonymous said...

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.''

''Whistleblower Report of Illegal DoD Activity''

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