It’s baaack! FDA approves omicron booster shots without human trials

After the failure of the mRNA vaccines to prevent infection and transmission of COVID-19, the U.S. Food and Drug Administration announced Wednesday it has granted emergency use authorization for boosters that target the predominant omicron variant.

Follows failure of COVID vaccines touted as 100% effective

Art Moore
WND News Center

After the failure of the mRNA vaccines to prevent infection and transmission of COVID-19, the U.S. Food and Drug Administration announced Wednesday it has granted emergency use authorization for boosters that target the predominant omicron variant.

The FDA said it is authorizing a “single booster dose at least two months following primary or booster vaccination.”

The “updated boosters,” the agency said in a statement, contain “two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.”

The reference is to two, highly contagious major sub variants of omicron that have produced mild symptoms in most people infected with the virus, regardless of vaccination status.

In fact, studies and real-world data indicate people who have been vaccinated for COVID-19 have a greater chance of infection, hospitalization and death.

Nevertheless, FDA Commissioner Robert Califf claimed in the statement that “the COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19.”

“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” he said.

The omicron Moderna boosters are authorized for individuals 18 years or older. The Pfizer-BioNTech doses are for those 12 years or older.

The FDA predicts the BA.4 and BA.5 sub variants will “circulate this fall and winter.”

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency has “worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently.”

Marks was at the center of the resignations of the two top FDA scientists one year ago, Marion Gruber and Philip Krause, Politico reported. The news site cited a former FDA official who said the two officials quit because they were angered by the agency’s lack of autonomy regarding its approval of the vaccines.


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Keith Anvick
Keith Anvick
2 months ago

Approved without any human trials??? No thank you, I don’t want to be a human lab rat for the FDA and CDC……

Melissa
Melissa
2 months ago

According the to FDA, the bivalent boosters produce a strong “immune response.” But that term, “immune response,” is only defined as making a lot of antibodies. The original bivalent booster attempt (Wuhan strain plus BA1) got a human phase 3 trial. It produced a “strong immune response” but didn’t offer sufficient protection against covid, so the FDA did not approve, asking drug companies to make a booster with the BA4/5 strain instead. So… this new bivalent booster (Wuhan strain plus BA4/BA5), did it protect the pre-clinical trial mice from getting covid? Or did they just make a lot of antibodies?

Sylvia
Sylvia
2 months ago
Reply to  Melissa

It seems the initially high titers were of short duration and were ineffective against (re)infection and transmission.
Where are exact details on mice vs humans. Some similarities, and ???? Alzheimer research used a very cute “Mouseheimer” in the early stages, but it certainly did not end there. Not to mention there were no pharma drugs in the protocol for humans.
So what exactly are the bivalent jabs good for, other than for revenue generating purposes?
Of extreme concern is the shedding by the jabbied. Is it just S1, other or plus?
Ongoing research on the furin cleavage is progressing, no final results as yet but certainly worrying.
The current reappearance of multiple past diseases could be caused by the impairment of the immune system. Perhaps caused by the blocking of interferon, thereby suppressing the innate immune system. Suddenly various diseases just pop up around the world.
What are your thoughts?

Wolfie
Wolfie
2 months ago

They were tested on mice. That should be good enough for the jabby crowd. No thank you. Nope.

Sylvia
Sylvia
2 months ago
Reply to  Wolfie

Have you come across this unbiased analysis of the newest jab? Dr Nass discussed actual data from CDC, FDA etc, as well as data on adverse events. The rapid waning of antibodies from the jabs was a shocker, far worse than expected.

https://default.salsalabs.org/T64040da2-cf63-4e05-8719-57c6440068f1/1f3f68f1-1e32-4c05-aaa5-2940af3c4f91

The latest jab includes the ‘ancestral’ Covid jab plus 2 new substances supposedly BA4 and BA5 (are they?).
As for all the remaining ingredients – my guess is we’ll never know for sure. That is what happens when trust is eroded and confidence is below zero.
Since the ‘ancestral’ component is part of the new jab, what is the likelihood of immune imprinting (Hoskins effect)? Interesting that it is also referred to as the “original antigenic sin”.
Like you, Wolfie, I remain unjabbied.
Please be aware of ‘shedding’ from the jabbied, and take care!

Sylvia
Sylvia
2 months ago

Since the early days of the PLANdemic it became blatantly obvious that the mere mention of “immune system” or “immunity” has become taboo. FDA, CDC, MSM, etc, either avoid it or dismiss it or quickly change the subject.
Why is that?
We have inherent immunity from birth; We gain natural immunity after recovering from a disease. Healthy people have a robust immune system that will always be superior than any drug or jab can ever be! This is a fact confirmed by scientific research.
Over 70% of our immune system is in the gut – they are the good critters that are killed by antibiotics along with the bad ones.
It is important to nurture our microbiome so that they help us ward off disease.

Wolfie
Wolfie
2 months ago

Those of us of a certain age remember when we were not so ‘sheltered’ as children. We drank from hoses, ate sour grass, ran around in the dirt and when we fell down, we brushed it off. We spent hours outside unsupervised and got into everything and then some. Most of us hardly got sick. We would get a seasonal cold but that would not keep us home from school. In fact, most of our parents were pretty darn strict about allowing us to stay home. And we, for the most part, had pretty good outcomes health wise. Today, its like children are fragile little things to wrap in cotton (masks), drug up and keep sheltered. How is that working out?

Sylvia
Sylvia
2 months ago
Reply to  Wolfie

The healthy and happy days.
In the Blue Zones, including Okinawa and Loma Linda, people have never stopped the wellness way of life. Check it out, it is truly remarkable to see so many 100+ years folks on bikes, exercising, dancing etc. Little or no illnesses.

Sylvia
Sylvia
2 months ago
Reply to  Wolfie

Wolfie, your post reminds me of this quote from Bessel van der Kolk, author of “The Body Keeps The Score: Brain, Mind, and Body in the Healing of Trauma.”
In this book, he states:
“We have the ability to regulate our own physiology, including some of the so-called involuntary functions of the body and brain, through such basic activities as breathing, moving, and touching…. When we ignore these quintessential dimensions of humanity, we deprive people of ways to heal from trauma and restore their autonomy.”
I believe that he is absolutely right. Centuries of human experience and decades of science validate this.
Just thought I would share it with you.

Sylvia
Sylvia
2 months ago

The new bivalent jab was not tested on humans – yet the FDA granted EUA. This means that those who take the jabs become the test subjects!

Rapid Rollout of New COVID Boosters With No Human Trials — ‘A Tale of Recklessness’ Meryl Nass MD

So far the jabs have proven to be neither safe nor effective.
They do not prevent transmission.
They do not prevent people from catching Covid.
There have been many cases of serious adverse reactions, eg myocarditis, thrombocytopenia etc, including deaths.
Question: what exactly are the jabs good for other than generating money with zero risk? Remember that jab makers are 100% exempt from liability of any kind in US.
The obvious conclusion is that the health RISKS far outweigh any benefits.

Sylvia
Sylvia
2 months ago

In case you have not come across the articles below:

COVID Vaccines Linked to Excess Deaths in Germany — Where’s the Investigation?

Fauci’s Team Involved in Research to Create Deadly Version of Spanish Flu Virus

Leaked Video Suggests Israeli Health Officials Covered Up Serious Safety Problems With Pfizer COVID Vaccine

‘God Gave Us Two Arms — One for the Flu Shot, One for the COVID Shot,’ White House COVID Response Coordinator Says

Authorities in various parts of the world unite in covering up anything that even questions, let alone contradicts, their lies and subterfuge in persisting to sell the jabs! Self delusion is a dangerous game.
Desperation must be setting in now that the public is waking up to the realities of the jabs.

Sylvia
Sylvia
2 months ago

The discussion below is super brilliant. It would be worth your time, lots of news about the latest bivalent jab,
and great to welcome The Wellbess Company which offers ethical personalized telemedicine treatment.

Friday Roundtable: With Peter McCullough, M.D., M.P.H. + Harvey Risch, M.D., Ph.D.

It also briefly mentions the failed test results of the current mRNA bivalent booster on the 8 mice. The 8 mice had been genetically modified because mice do not have the same receptors as humans. Never before had any vaccine/jab been injected in humans until full clinical trials on humans had been successfully completed.
Nations, health practitioners, and scientists are usually in agreement on medical treatments, yet on Covid-19 the response has been extremely disparate.
Hopefully Anericans appreciate that we have a Bill of Rights which gives us, the people, the right to decide what goes into our body. The Nuremberg Code also reaffirms that right.
I am neither anti- nor pro-vaccines/jabs.
Suggestion: please educate yourself on the factual risks and benefits of any health treatment. MSM propaganda is not factual, nor is it scientific.
I am not a disciple of any political side.
My vote is based on a rational assessment of each party’s merits and demerits, particularly its record of trustworthiness.
I am 100% pro-choice and personal accountability. That means that I am fully responsible for maintaining the robustness of my immune system and the overall wellness of my being.
Remember: the body keeps the score!

Sylvia
Sylvia
2 months ago
Reply to  Sylvia

Please note that the above reference to “The Wellbess Company” should read:

The Wellness Company

Apologies for the typo.

Sylvia
Sylvia
2 months ago

Art, this is such a great article – the three a’s in “baaack” reflect the endless number of jabs! Thanks for sharing.

The newly released bivalent booster for Covid includes approx 50% of the ‘old’ mRNA strain plus approx 50% of BA.4 and BA.5. It may be the latest pharma money spinner (despite unsuccessful tests on the 8 mice), but it was outpaced by the virus well before it even left the laboratory.
Initially, Omicron spawn BA.2.75, or “Centaurus,” is likely to be the COVID variant to watch this summer, and could potentially wreak unprecedented havoc later in the year. More jabs?
Instead, one of its offspring, BA.2.75.2, has outperformed it, eliminating it as a major threat, but replacing it with a more potent one. Among BA.2.75.2’s traits: Its spike protein binds to human cells more tightly, and far stronger than any other variant so far, making it more difficult for antibodies to launch an attack. The new variant also shows formidable escape ability. The virus has consistently infallible foresight, impeccable planning, and perfectly timed and executed implementation skills. I have the utmost respect for it.
Viruses are an integral part of nature, as are we. There is no way that humans will ever succeed in permanently eradicating any natural elements; antibiotics, drugs, vacccines, gene therapies, antifungals, pesticides and the like may drive them away for some time, often at our own detriment from side effects, but they will always be around, regroup, and come back stronger than ever, at a time humans cannot predict. Nor can we match the speed.
Viruses are in the air, in oceans, in the soil, and in our bodies. Whether we get sick or not is dependent on the robustness of our immune system. Like it or not, we all share the same space. These natural elements, which many call ‘germs’ and erroneously treat as our mortal enemies, have incredible intelligence and sophistication far beyond ours. Bacteria (MRSA) are now resistant to antibiotics – tuberculosis has come back. Polio, cholera, ebola, and other previous ones are revisiting. Influenza needs boosters each year as do shingles and pneumonia. Were they ever eradicated? Obviously not. Do we still have deaths by influenza? Yes!
Research should focus on why some jabbed people get sick, and so many unjabbed others do not.
Viruses very rapidly develop stronger strains that easily circumvent or defeat any human-made substances. They are toying with our futile attempts, and likely having a great fun time watching us. Game Set and Match to the Virus, as always.
That is just the way it is. Learn to accept it, and let’s turn our research into how we, humans, can upregulate our overall wellness, always keep our biological age less than our chronological age, and actually enjoy our life at any age, free from serious diseases and free from pharma drugs. It is very realistically achievable.

Sylvia
Sylvia
2 months ago

Very encouraging developments:

https://default.salsalabs.org/Tedb6e13e-a595-413a-99f2-dbf2500bb5dc/1f3f68f1-1e32-4c05-aaa5-2940af3c4f91

https://default.salsalabs.org/Tbcba5009-372f-4f81-a2b8-6aba6b6ec645/1f3f68f1-1e32-4c05-aaa5-2940af3c4f91

These successful lawsuits show the increasing anger, pushback and open rejection to the government’s lies and manipulative agenda.
Governments are elected by the People – we have the Power of the Vote. Let’s use it in a positive way for every American.

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