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…
I’m just speechless
All I can say is God bless you and keep you and I’ll pray for you
I am SO sorry for your forced march through Hell.
😢💔😢
You mother is a wise woman, you are very blessed to have her discernment to help you.
The Holy Spirit absolutely does warn us about things to come. He also sometimes lets us see the battle field ahead in dreams and visions like when we are praying for a hedge of protection around our families and around others.
It is my opinion the real danger is still coming in the future where they will require DNA ‘vaccines’
We just saw a precursor where evil manifested its authority to act, to begin to come to pass.
Where they will overlay their Godless Social Credit Score systems and Corporate control Environmental Social Governance (ESG) scoring along with Central Bank Digital Currency’s (CBDCs) over mandatory tyrannical requirements, and we will begin to witness exactly what the bible warned us would come as shown in Revelation Chapter 13. How much more work do they really need to do to bring this to reality.
The good news is Satan is not in control of the timing and that these evil ones promoting this wicked scheme upon the Earth will have only a very short time left to them when they do achieve their authority.
I'm ok. I came through that trial just fine. I know so many more people who didn't, who lost loved ones through no fault of their own, and more tragedy of others I've known and cared about that I can tell you here.
My march through hell made me STRONGER. God was with me. He knew my prayers, He heard them and He carried me through.
I'm so on the other side of all the garbage I had to go through and I'm ok.
So many others ARE NOT! While I genuinely appreciate your prayers, pray for those who continue to suffer, for those who cannot speak for themselves, for the unborn, for those afflicted with all the cancers these clot shots have caused and for those crying out in pain to our God.
That's who I pray for. Our God is good! All the time!
The evidence is overwhelming that these shots are dangerous and deserve to be pulled from the market, but they are not. The lunatics are still running the asylum.
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