210 Comments
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Amy Morgan's avatar

I would not listen to a single thing that the FDA approved. They need shut down

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The BarefootHealer's avatar

The FDA is not in charge. They approved it because the both the PREP act allows it, and the Emergency status negates the requirements for traditional placebo blinded trials. Until the Emergency declarations (which in your country goes through until 2029/30) is rolled back it's a veritable wild west rules game, where industry decides, not regulatory. Check in with others like Sashya Latypova and Katherine Watt, Debbie Lerman, they explain it better than i

#follownone #mistakesareNOTmade .

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Roger Kimber, MD's avatar

That being the case, letters to congressmen & senators need to be written post haste to end the PREP act & declare the emergency over!!

There may be an opportunity here, as it is demonstrable that the extension was signed by POTUS AutoPen and that ex president Biden aka AutoPen I am sure can demonstrate no recollection of having signed that extension or what it was about. Thus it should be easy to get a friendly court (hell, by recent precedent, a municipal traffic court could issue a nationwide preliminary injunction that would last until 2030) to declare the extension null and void.

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Stephen Korn's avatar

Roger, in addition to RFK’s prior statement of the need to include placebo controlled studies in all future vaccines, didn’t the earlier studies by Moderna and Pfizer include very few “at risk” people (ie older than 65, or those with significant co-morbidities?)

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Roger Kimber, MD's avatar

They may well have, but I don’t remember & since learning from Sasha Latypova’s work that it was all a PsyOp, performance as the PREP Act & EUA completely cut the FDA out of the approval loop, I haven’t paid that much detailed attention, except to note that, yes, they falsified, misinterpreted, etc. yet again—look @ SL’s earlier work here on SS.

It has been a goat rodeo from the beginning, on top of the inherent corruption of the FDA and the medical industrial complex since at least the 1980’s.

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Stephen Verchinski's avatar

DHHS in the Federal Register at end of 2024 extended the PREP ACT for Covid to December 2029. This law needs to be eliminated along with each states draconian Public Health Emergency Acts.

This is set up as a global caging system so you cannot exercise your own health autonomy.

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The BarefootHealer's avatar

Yes the studies were typical in that they were done on healthy subjects. They had very strict parameters on what denoted "healthy" too.

That's called stacking the deck, in everywhere but "the science".😉

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Jennifer Jones's avatar

Correct

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Health Lyceum's avatar

Gotta be at the local level. There is a county commissioners template on Katherine's stack. This has to be a ground-up action, and it is spontaneously

birthing.

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Irunthis1's avatar

Sorry!! Those judges only care about illegals and democrat priorities and were obviously no where to be found during the worst abuses of our constitution since it's founding (2020-24). They are tits on a boar hog IMO.

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Roger Kimber, MD's avatar

Or worse. Tits on a boar hog are just non functional, not overtly dangerous as these Judges are.

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Reginald Thibodeau's avatar

Good point.

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joyce wright's avatar

Dr, YOU are brilliant ! Especially the latter part of your note !! 😊😂 We love it !!

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Mike H's avatar

That PREP ACT extension will be permanent, I bet....They are showing us to our face that all transparent safety protocols have been abandoned.

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SomeDude's avatar

prep act is permanent until revoked by Congress.

the 2029 extension is on one of the many State of Emergency declarations still active since 2001, this one for convid.

without the State of Emergency declaration they couldn't apply the prep act to the toxic injections

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Not Me's avatar

The only safety protocol I follow is don’t trust the FDA or CDC!

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Paul Ashley's avatar

But there is no emergency. Has Trump not rescinded the faux emergency?

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Fred's avatar

I don’t understand that one either…

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mike wade's avatar

just learned something from mistakes are NOT made. If Kennedy does not point this out …millions will think he is ok with it….

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Fred's avatar

RFK Jr. promised that he would not take away shots from those (willfully ignorant) who want them, and maintaining credibility is crucial. Not enough time to test for this round. Please cut him some slack!

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Maha's avatar

Unfortunately, the FDA is approving this new self-amplifying mRNA swill without a placebo-controlled trial. They are getting around it by say "fit people" don't need the trial done. As Sasha Latypova notes:

"I would like to repeat that this clinical trial had NO PLACEBO CONTROL! Please, all MAHA-mates - note that this trial is fully compliant with the current, brand new MAHA-FDA policy by Makary & Prasad: there is no requirement for a placebo-controlled trial before the approval of new versions of mRNA, even radically new versions like this self-amplifying RNA shot."

"What is spelled out in the MAHA-FDA policy is very clear:

For “healthy” (aka “fit”) people - placebo controlled trials testing for safety and efficacy; Note - these will not be done because there is neither time for them between “updated strains” nor enforcement from the FDA.

For “unhealthy” (aka “unfit”) - no such trials needed! Untested poison is ok for these folks. Why don’t they start loading them into the boxcars already, I wonder?

No placebo-controlled study was done or was required by the FDA, because this “approval” is for the “unfit”:"

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Fred's avatar

Thank you for this! I hadn’t read this post, nor the FDA release because I have to retain some hope for removal of all mRNA technology…maybe for terminal cancers, and we know that there will be no shortage of patients. If RFK Jr. can’t geterdone, I fear no one can.

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Fred's avatar

As an addendum, I don’t know anyone who would voluntarily enter such a trial.

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TexBritta's avatar

You know what my 65 year old healthy as S ass says about their poison? Haha 🖕🖕🖕

Only fools at this point!

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User's avatar
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4dEdited
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John Ransley's avatar

tammy needs more boosters and tequilla shots daily

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Mike H's avatar

I have adopted the attitude, many years ago, that anything FDA approved is something I probably don't want. And if the FDA forbids it, it might be something I should look at that could be beneficial.

Our owners operate on a principle known as The Law Of Reversal, also known as The Law Of Inversion. Meaning...whatever they say they are doing, if you flip it backwards, that will almost always be the outcome.

Example: They can generate 90 billion in "vaccine" revenue, and generate 360 billion treating the "side effects" they created.

"raw milk bad"....give me some.

"needs more study"....i'm checking this out, might be good.

"no peer reviewed studies"......i'm checking this out, probably good......

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Reginald Thibodeau's avatar

When they say, "peer-reviewed study withdrawn/recanted" it must be a truly safe, effective, and cheap drug or supplement, e.g. ivermectin, hydroxychloroquine, DMSO, etc. or has proven something that they want suppressed, such as autism being caused by the MMR vaccine.

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Mike H's avatar

truth

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Toobguy47's avatar

Well, did this get by Makary or did he approve it? Can it be reversed? Finally, whoever did approve this needs to be immediately fired, walked out the door, 5 minutes to clean out there desk of personal items - no thumb drives, etc. All clearances and access revoked.

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Jean's avatar

Not going to happen, we should all wake up to the fact that the Trump Administration and RFK, Jr. are compromised and the American people are under attack. No one will escape this, the shedding alone from this atrocity will sicken everyone.

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Fred's avatar

Do you hear yourself? 🙄 They’re trying to unwind decades of cr— while maintaining credibility. He did promise not to take away shots from the (idiots) who want them.

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michael janket's avatar

Empty nutsacks will do it every time. Bobby is hamstrung with limited power, notice

his new, moderated views. He's a Democrat at heart and we all know where that leads.

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Roger Kimber, MD's avatar

Read the 6:30 PM post by Barefoot Healer referencing the PREP Act and EAU regulations, & Sasha Latypova’s: The FDA Has no jurisdiction or input into this decision until the PREP ACT & EUA are repealed and Emergency is declared over (Biden allegedly extended it to 2029-30).

All you can do is ignore the FDA now. You can’t keep my colleagues from harming others if they are determined to…😭☹️🤮.

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Mike H's avatar

I might be mistaken about this, but I think, that the people with the last and strongest word right now is the military, because of all this PREP ACT, EUA shenanigans.....

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Roger Kimber, MD's avatar

You mean the DARPA or similar spooks, not the grunts on the line & probably not Hegseth, as I doubt that he has been briefed or read in on it, but I could be wrong, as I am just going by conjecture.

It is, IMHO, the deepest of the deep state that is behind the whole Plandemic, & even though Fauci is gone, I’m sure he has got his moles dug in throughout.

It is going to be a long hard slog to eradicate the evil in our government.

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Mike H's avatar
4dEdited

Yep. DARPA and BARDA. BARDA is under the DARPA command. They actually dreamed up and coordinated this fiasco in the first place. Then they used the Pfizer, Moderna etc...names and let pharma license it.

Remember when this shit first started we had a military general at the podium on the microphone, and he was flanked by several other military uniformed people.

He announced "we are in the middle of a live exercise".....and then he told us the military would be distributing the poison under military guard at minus 70 degrees below zero....and yadda yadda yadda....

Far as I can figure they are still in charge.

and Hegseth et al...are nothing but actors in suits, they have no power.

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The BarefootHealer's avatar

👏👏👏👏👏🎯👍😉

And if in doubt- look at the newly approved military budgets....😉

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Evelyne's avatar

Where IS that post, please? (Thanks in advance!)

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sandy's avatar

Sasha Latypova is on Substack

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Roger Kimber, MD's avatar

I hope I answered your question.

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Roger Kimber, MD's avatar

Barefoot Healer’s post?—it is in this string.

Sasha L’s post would be in the archives of her SubStack, between 6 & 12 months ago, IIRCC, but could be further back.

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Cindi's avatar

Makary & Battacharia had no problem w/ the jab for older people back in the day so this is no surprise. But I thought RFKJ / HHS is over FDA & all the rest. WTF

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Tip's avatar

Yeah they want the pensions clawed back after in timely death by injection! 🇨🇦

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Nancy Parsons's avatar

You nailed all the right points!

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Gerald D. Williams's avatar

I just checked Grok, and this is what he says:

"Yes, the U.S. FDA approved Moderna’s new COVID-19 vaccine, mNEXSPIKE®, on May 31, 2025, for adults 65 and older and those aged 12–64 with at least one underlying risk factor, as defined by the CDC. Posts on X and some reports claim this approval was granted without placebo-controlled trials, which contradicts a recent Department of Health and Human Services (HHS) statement that all new vaccines would require such trials prior to licensure."

Reading further Grok could not find evidence of any new placebo testing.

Perhaps they have a few more months to present the evidence.

But either way, it seems like a physician's prescription would be required for ages 12 -64, to validate a risk factor. That should severely limit its use as physicians will be reluctant.

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Maha's avatar

No. Many physicians will be convincing patients to GET THE DAMN THING by saying "Wow, Johnnie had two bad colds this year, his immune system is under attack... or Susie, your BMI is 29, and the guideline is 30, but we can't be too careful...Note the guideline is at least one "risk factor", and guess what they include in the 2025 CDC List of underlying medical conditions? Pregnancy and recent pregnancy.

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Gerald D. Williams's avatar

For ages 12 through 64 they would have to sign their own prescription and take responsibility for side effects.

For 65 and over patients could just go to any pharmacy on their own.

As this past season suggests, only a fraction of the public is subjecting themselves to the jabs voluntarily. I would guess most are Democrats, who don't hear the warnings from Conservative media.

For the Winter of 25-26, I'd expect that percent to drop even further.

Under age 12 are banned from receiving jabs.

Would be great if HHS could crack down on bonuses for physicians talking their patients into getting more jabs.

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Gerald D. Williams's avatar

Perhaps it is only approved for 65 and older and that for everyone else the results of the placebo testing will apply. And if it fails, then only a physician's prescription will allow someone under age 65 to get a jab.

RFK Jr. is becoming more powerful every month.

He knows what he is doing.

The newer formulation doesn't come out until August. Plenty of time to limit its use.

I am expecting Makaray and RFK Jr. to clarify the conditions surrounding the approval.

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Jean's avatar

You have got to be kidding.

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Reginald Thibodeau's avatar

I expected them to do that BEFORE it was approved - like banning it. This is the equivalent of Patel and Bongino swearing Epstein committed suicide.

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Gerald D. Williams's avatar

No, it was going to be approved regardless, for those over age 65 and allow physicians to prescribe for ages 12 through 64.

The formulation has to be available before testing.

But if Dr McCullough is correct, the new formulation will not be effective against the Fall viruses. This time there will be data to prove its ineffectiveness and there should be increasing available data to show the serious risks.

Ending the EUA should be the next step, while reducing Big Pharma advertising.

Maybe HCQ/Zn/Vit D/Ivermectin will be formally backed by HHS, leading to the death of mRNA for respiratory viruses in the next year.

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Maha's avatar

They are always playing catchup. It's was never about protecting people from a strain anyway, was it? Seriously?

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Gerald D. Williams's avatar

I did more checking via Grok:

There are questions about the status of the upcoming Moderna/Pfizer mRNA vaccines not requiring placebo testing. HHS/RFK Jr. needs to clarify.

Grok says that FDA has independence from HHS as the latest formulation by Moderna was approved unanimously by the advisory board:

Per GroK:

"While HHS under RFK Jr. could still attempt to require placebo-controlled trials for the 2025-2026 COVID-19 vaccine formulations, it is unlikely for this season due to the FDA’s prior approval, ethical concerns, logistical constraints, and resistance from scientists and manufacturers. The lack of a formalized policy and internal FDA autonomy further reduce the likelihood, though public support on X and RFK Jr.’s influence keep the possibility alive. More likely, HHS may push for such requirements in future seasons (e.g., 2026-2027) or negotiate compromise studies to align with transparency goals without delaying access."

If I were RFK Jr., I would remove the EUA for the mRNA jabs and begin to promote inexpensive protocols that were established in 2020 by Drs Zelenko, McCullough and others.

It would also require serious side effects to be announced, with inserts that physicians would be aware of before prescribing to high risk ages 12 thought 64.

And also, RFK Jr. could summon NIH to have its own trials this Fall/Winter, that would be independent of Pfizer/Moderna placebo studies.

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Maha's avatar

As noted above, they can't even get a Placebo controlled study finalized until 2027.

Remember when drugs had to be tested before release on the public?

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Reginald Thibodeau's avatar

And were denied if there were 50 or more deaths.

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michael janket's avatar

Such moderation.......whoever is behind this needs immediate dropkicking out the door, never to be seen again.

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Mary Ann's avatar

What the hell is going on with RFK, Marty Makary, Jay Battacharya.? We want these mRNA vaxxes REMOVED NOW! They are killing people!

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240Gordie's avatar

Then you and many others will have to do what Joseph Sansone suggests and put pressure on your government.

"We have them on the run. It is long past time that people that voted for Trump put maximum pressure on his administration to stop the biowarfare campaign against Americans. One way to put pressure on them is to help get my bill introduced in more states. I have a version of the ‘Sansone mRNA Bioweapons Prohibition Act’ adapted to all 50 states’ laws."

https://www.lewrockwell.com/2025/05/no_author/cdc-new-covid-recommendations-a-limited-hangout/

"The world won't be destroyed by those that do evil, but by those that watch them without doing anything" - Albert Einstein

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Reginald Thibodeau's avatar

Especially to stop injecting children [plus young adults] and pregnant women.

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240Gordie's avatar

I know what you're saying but No,....EVERYONE! We need to stop giving them slack. After everything that they have done to us they don't deserve any.

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Reginald Thibodeau's avatar

Yes, they should be stopped completely. To be clearer than I was, it is especially egregious that they are still injecting children - even newborns - and pregnant women - many of who lost their babies due to the injections, either miscarried or stillborn. That is so vile the people responsible should be terminated with the greatest prejudice.

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Fred's avatar

We all know that, but please look at the mountains that they’re climbing. Much of the literature still supports the cr—. They need time!

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Health Lyceum's avatar

FDA has always been rogue.

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dmickg's avatar

So.....it sounds like are you are telling us that the FDA operates without oversight from HHS, congress or the executive??

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Health Lyceum's avatar

Always has; it is under the auspices of the pharmaceutical industry.

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Roger Kimber, MD's avatar

This is different see my posts & Barefoot Healer’s post.

Don’t give up hope just yet.

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Health Lyceum's avatar

This is not stated from a despairing stance, rather, it is stated as a matter of fact.

Have been a nurse in ’trenches‘ since 1975, and the average American has had it with the established medical/ insurance system.

The shift must come from the ground up, and it is in process.

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Roger Kimber, MD's avatar

Agree: See the IMA & VSRF & Dr. Peter McCullough among others.

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Reginald Thibodeau's avatar

The IMA (which I respected when it was the FLCCC) lost my vote when it made it sound like stopping the RECOMMENDATION was a major win. For whom? Certainly not children and pregnant women. Does that keep schools, universities, and hospital OB departments from requiring the injections on neonates, children and pregnant women? No, it doesn't, and their claiming that it does is/would be disingenuous.

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Snooze's avatar

Yes. I feel it. Hope was the gift from Pandora’s box. 🙏

And we can’t sit on our hands either. Though admittedly it feels like wading through quicksand sometimes or molasses to get anywhere ~ stickier but less deadly. 💪

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Roger Kimber, MD's avatar

Read Barefoot Healer’s post 6:30 (18:30) 5/31/25.

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Gabriella's avatar

Can’t find it

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Roger Kimber, MD's avatar

Then go to Sasha Latypova’s SubStack and look in her archives over the period from 6 months to 1 year (or maybe longer ago). Time flies when you are having fun.

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Timothy Winey's avatar

Don't worry, Bobby will save us! He's going to get red dye out of candy.

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Proberta's avatar

Yes, RFK Jr is protecting us from turbo Fruit Loops.

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Coincidence Theorist's avatar

😂 turbo Fruit Loops

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Snooze's avatar

🤣🎶💕 Thanks!

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Gary0072's avatar

ROFL

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ArnoldF's avatar

Low hanging fruit is easy. But will he go after the bigger targets where criminals will get indicted or will he just dance around them pretending to do the real hard work which the American people voted for Trump to make it happen? So tired that these agencies have this much power over our leaders.

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Reginald Thibodeau's avatar

Yeah - two years from now, while the same companies have been shipping their products to Europe sans dyes for years now.

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Franklin O'Kanu's avatar

🤣🤣🤣🤣

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Melissa Eftimovski's avatar

You would have to be batshit crazy to inject any of these so called vaccines into your body 🤯

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Autumn's avatar

Or a bat shit sheep..

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AMV's avatar

I don’t give a s**t what the FDA says about anything. I will not listen. If people do listen after the humongous dangerous deceptions of Covid I cannot have any sympathy.

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Bill's avatar

Like I have said on numerous post we can no longer trust any of our officials.. Its time to take matters into our own hands.. We will no longer comply.. We are not taking any more poison shots and neither are our children.. We will home school them first or lose our jobs if need be.. You cannot learn anything in school or make any money on your job if you are dead!!!!No MORE!!!!!!! If we do that they will back off after about a week at most of the whole country doing that, maybe even a few days.. Time to make a stand for ourselves, our children, our country and our Earth..,

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Health Lyceum's avatar

Many are taking that stand.

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Reginald Thibodeau's avatar

I wish more airline pilots had taken that stance. And whoever approved choosing DEI applicants to hire for airport control towers and entrance to medical schools need to be stood against a wall and shot.

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Momma_Swain2's avatar

This isn’t good and not enough nothing has been done to stop the mRNA vaccines from remaining on the market. This must be taken off the market and if Kennedy doesn’t, then I have to ask the question?

Who has investments in mRNA Technology and how much are their profits??

Follow the money

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TE's avatar

History has always shown that people are way ahead of governments when it comes to seeing fraud and calling it out for what it is, then taking action against it. In Moderna's case (as with Pfizer and J&J) the repudiation of their ineffective and unsafe mRNA products can be gauged by the public's uptake of it. Regardless of their ad campaigns and our government's complicity to haphazardly approve and recommend these products, the ever increasing discernment by the public is only growing and similarly seen through peoples' refusal to take the flu vaccine. The world is waking up and is well served by up-to-date truth telling professionals as here in Focal Points Courageous Discourse. Informed consent is no longer obtained in the doctor's office, let alone from our sheepish and pharma captured regulators but through publications like this. Thanks FP.

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Will Hayden's avatar

Who the hell is running this Country again? Big Pharma comes from Nazi Germany and they are running USA Inc. I want to see Fauci, Gates, Soros and their minions in prison. We are going on 6 months into 2025 and still no arrests of the biggest criminals at the top of the For Profit world-wide killing and the Government Mafia still ruling our Country. Times Up!

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DAVY Udal's avatar

The sentence for treason is 'hung by the neck until dead'.

Nobody needs to feed and clothe them for the rest of their lives. Just end their lives and save the effort.

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Reginald Thibodeau's avatar

For crimes against humanity.

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dmickg's avatar

We are going to need more rope.......

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Gary0072's avatar

I'm feeling generous, please give these unproven vaccin es to all those who researched, promoted, advocated for, and distributed them to test for efficacy and to have them take the moral high ground. Please test the efficacy on Fauci, Gates, Bourla, and Tedros to make sure that they are safe and effective for the general public to take. This is the very least you should do so you don't come across like the "psyko tierents" that we all know you are, as displayed by past dealings. Much love

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Connie's avatar
4dEdited

FDA, fucking devil’s advocates!

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John Day MD's avatar

It is still open-season upon the trusting-people...

;-(

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