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…
With new and improved deaths/disabilities?
Time to sue and get a judge to rule the FDA cannot control drugs..... ;)
Kingston has been covering the mRNA death/ disabling numbers since day one.
“Karen KingstonMay 31 · The Kingston Report
The FDA, CDC, and HHS are aggressively violating human clinical safety standards and their promises by approving a next-generation Moderna mRNA C19 shot, mNEXSPIKE – no placebo, no blinding.
The observer-blinded term is nonsense. The patients and study investigators were unblinded, so that damning data can easily be distorted or discarded.”
Whatever happened to that illegal EUA when effective multi-drug treatments exist? Why can’t RFK kill it and make them pass the trial?
Not to mention the early studies that showed negative immunity seems to be panning out.
With new and improved deaths/disabilities?
——————
“ mRNA jabs kill and disable”, simple and easy to remember.
Spike Protein is a PATHOGEN
They dont even hide it
“ SpikeVax”
“ mNEXSPIKE”
How can people…and doctors…still be pushing people to inject it even into infants….and program their cells to keep producing it…perhaps in perpetuity?
Someone is in line for a high paying private sector job when they retire soon.
Illegal aliens lining up for this while promising to come back for the 19 boosters?
Don’t worry, never have, never will.
WHO is the HEAD of this??
The entire chain of command that approved this ought to lose their jobs.
Those who do what the doctor or the government says will take the shots Those who have seen the results of the last rounds of MRNa shots will not. The population thinning operation will thin out the idiot left population somewhat and will not affect the rest of us.
Maybe the new round of shots will thin out antifa a bit.
Maybe the new round of shots will thin out antifa a bit.
Maybe the new round of shots will thin out antifa a bit.
Our favorite Trump aide, Renaissance Man Stephen Miller:
Agreed—RFK Jr. has fired a lot of folks—apparently not enough...
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