Posted on 06/01/2025 9:12:55 AM PDT by delta7
The FDA has officially gone rogue.
It just approved Moderna’s newest COVID-19 mRNA shot—mNEXSPIKE—without a single placebo-controlled trial, directly contradicting recent public assurances from HHS that “all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure.”
However, this authorization appears to align with their so-called “evidence-based approach to COVID-19 vaccination” published in NEJM —a policy that permits the continuation of mass experimentation on many Americans without clinical proof of benefit:
FDA Unveils New Plan to Limit COVID-19 Vaccine Use — Keeps Deadly Program Alive NICOLAS HULSCHER, MPH · According to Moderna:
The U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).
The FDA's approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax®), Moderna's original COVID-19 vaccine.
Moderna expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA®, the Company's approved respiratory syncytial virus (RSV) vaccine.
mRNA-1283 is Moderna’s next-generation COVID-19 mRNA vaccine, designed to encode the receptor-binding domain (RBD) and N-terminal domain (NTD) of the SARS-CoV-2 spike protein—unlike the original mRNA-1273 vaccine, which encodes the full-length spike protein.
But buried in the FDA’s May 30 approval letter is a concerning admission: the critical placebo-controlled trial that would actually assess the safety and efficacy of this new mRNA injection hasn’t even started yet.
According to the FDA, Moderna is only planning to begin a Phase 4, randomized, observer-blind, placebo-controlled study in adults aged 50–64 years without high-risk conditions on November 30, 2025—with final results not expected until January 2027.
Meanwhile, the trial used to justify this approval—NCT05815498—was not placebo-controlled. Instead, it merely compared mNEXSPIKE to Moderna’s previous COVID-19 shot (mRNA-1273/Spikevax)—a product already linked to serious adverse events and mass death.
This means the FDA fully licensed mNEXSPIKE for broad use without ever having seen placebo-controlled safety data in the exact population now being targeted.
This approval directly contradicts a recent public statement by an HHS spokesperson, who told The Washington Post:
“All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices.”……..more…
Stupid bureaucrats. Some of them may be good people, but they should not be going along with this. The immediate pandemic, with its much more severe strains, is over! Surely they can afford to do a placebo-controlled trial?
I took the first two Pfizer doses in March and April of 2021. I did not take any boosters after finding out about the heart problems; my family has a heart problem history on both sides, and the two doses apparently were responsible for a couple months of heart palpitations. I actually did have symptomatic COVID in February of this year, so I now have a full immunity to some strains; another reason not to get any more hideous mRNA.
Prayers of strength sent to you in Jesus’ Mighty Name!
As someone above said don’t beat yourself up. Many I know are several degreed individuals who ‘did all the research’ but took the shots because Fauci was the overall guru. Most have had issues but still deny they did the wrong thing. They will not even entertain ivermectin/Fenbendazole because they can only identify it as a dog/cat/horse parasite medication. Nevermind it has saved tens of million from River Fever before being used in animals. BUT, I was called a life threatening oddball for not taking the jab...never apologized when truth came out....
Given all the crap other folks have gone through, I should have listened to people like you. I only got 2 or 3 months of heart palpitations from my 2 Pfizer doses. I fortunately understood enough not to take any boosters. So far, I’ve otherwise been healthy, but other things could crop up long term, for all I know.
If such things happen, I will take full responsibility and go by that old maxim: I did this to myself.
I’m sorry about your mother, Salamander.
I couldn’t agree more.
My sister scared her into the shots and my mom believes everything her little princess tells her.
That’s where she is now and of course, my sister is “ handling her money” now and keeps saying “what little will be left to inherit “ which is a sick joke.
My mom was well off plus the house and property after she’s gone but my greedy sister who lives in a 1.2 million dollar house and only came up her to do her adultery thing for years can never get enough.
Her adultery partner and she have already made off with mom’s car ( which I desperately needed to borrow since my SUV’s motor now has a literal hole in it) and I just found out they walked off with her pistol.
Who knows what else they’ll carry off while mom isn’t looking.
Mom had a 50/50 will for us but 50% of already gone is nothing.
While he’s been stomping around in her house alone doing who knows what, I was asked if I took her drawer money “ accidentally “.
This has been my life with her.
Dad bought me this house because he knew he could trust me to take care of after he was gone but the ones currently robbing her blind have convinced her I’m a thief.
I have no idea why I hang had a nervous breakdown yet
Oh well.
God knows and sees what is true or not so that’s something.
He knows who turned down a really nice rental house offered by the insurance company because it was 50 miles from mom, when I’ve been less than a minute/mile away 24/7 on call duty all these years.
😕
This shouldn't come down to an action that the president has to take; even if he were to issue an executive order, it's a subject far outside of his lane. (It would make as much sense for him to publicly act on taking the jabs off the market as it did for him to push them on the market through Operation Warp Speed; he was (and would be) far outside of his wheelhouse.)
There is overwhelming evidence of harm caused by these shots to have them pulled from the market; the CDC has all of the evidence it needs. That they have not been pulled is all the evidence we need that our institutions are still under the control of psychopaths.
Give me a couple days and I’ll scrounge up all the stuff I told my vaxxed friend to take and she’s been tested repeatedly and no trace of it left in her.
I will do my best to get it to you asap.
❤️
Not quite as deadly as the last version
—————-
A few noted in the field ( I posted them in other threads) state those that took the mRNA jabs the last time are now extremely vulnerable to any further Covid mutations.
Asia is seeing deaths from the latest minor “ Razor Throat” Covid variant, normally just a nuisance to the unvaccinated, but now deadly to those that took the mRNA Covid vaccines. Has to do with the mRNA spike proteins they injected into their bodies.
Asian countries are reporting this , unreported in the Western media.
Correct. Bump!
Why?
CACHING!
“Follow the MONEY!
Thank you for posting. I have long thought the reason so many rushed to the clot shots was spiritual….I can go on with spiritual “ proof”, but I will give my story which says it all.
My mother, 93, a holy and prophetic woman told me BEFORE any Covid clot shots were even on the radar, “ Do NOT take any shots for Covid when they come out”……
The most common reply from the many I asked, Why are you getting the mRNA vax?….every single person replied, I want to go to movies, “ I” want to go to restaurants, “ I” want, “ I” want….my standard reply , Did you ask God if you should inject yourself? …ALL had no reply.
It’s common knowledge that you never invent a vaccine for a “ pandemic” in progress.
The flu shots people take are derived from the last years strain otherwise you get the whole rapidly shifting antigen/mutation stuff.
As I’ve said before, after the 3am post here announcing “ COVID”, I watched “The Stand”, again.
I knew what was coming.
/cursed with Second Sight
*sociopaths
Psychopaths are still somewhat able to contact their conscience, even if they ignore it.
Sociopaths have none.
OK, that sounds cool. Thanks!
☺️
Period.
I’m down with this.
I knew from the moment I first read about it here late at night that this was NOT about some theoretical “virus “.
It was dark and evil and not at -all- what it claimed to be.
I wish I’d been more persuasive to people I know so they’d not take it.
I’m still highly empathetic to those who did.
I cannot imagine how they must feel now.
Personally, I’d be losing my mind and that’s why I never bust their chops for getting the jabs.
Too much worry and compassion for them all.
This was a global crime against humanity.
“unreported in the Western media.”
Unreported by western MSM.
A SECRET STASH OF TSAR’S GOLD WORTH BILLIONS WAS FOUND IN AN OLD RAIL TUNNEL NEAR LAKE BAIKAL
posted on 3/15/2025, 7:41:05 PM by delta7
Now, yes, I’d call them incredibly gullible and unwise but the first time, people (wrongly) trusted the “ experts” because we tend to assume our doctors aren’t trying to kill us.
Many were forced to submit or be fired/censured/outcast and there are so many lonely souls who have only their social networks to keep them going, especially the elderly.
Kids had no real choice.
Families were destroyed when some members refused to get them.
Some are not as immune to “ peer pressure” as others.
This gaslighting was so effectively executed that only those who didn’t have to or want to stay employed, stay in social groups (etc) could afford the luxury of telling the deep state to GFY.
The small percentage of us who are not in the workforce anyway ( and who watched The X Files 😆 ) had the luxury of refusing with little or no real effect.
Far too many were not so blessed.
Completely agree, yet it hasn’t happened yet.
I'm immune system compromised due to a genetic defect for which I have to take a very expensive biologic medication to manage and stay alive.
My specialist explicitly WARNED me against taking any of the mRNA vaccines because of all warnings about it when it first came out. He actually read the potential side effects and determined I needed to STAY AWAY from it.
His recommendation? The J&J shot because it was far less dangerous. So I did that to keep my job and not get fired. I was recently divorced and my ex was looking for any reason to demonize me with my kids.
I was scared as hell when it was linked to sudden heart attacks and blood clots. Thankfully I didn't have any of those "side effects."
I've not taken a SINGLE mRNA shot, period. In fact, any medication I was on from Pfizer specifically, I demanded alternatives from, from OTHER pharmaceutical companies that weren't "on the take" for the mRNA vaccine or related to Pfizer in any way.
If I was "ordered" by my employer to get this new "shot" because of my age (I'm 63) I'd tell them to do fck themselves and quit.
It's not just the "experts" trying to kill us old farts, it's our employers too!!! The bastards don't want to pay my pension that I worked my ass off for!
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