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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.”
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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: read here.
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.
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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.
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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.”
Based on this extremely disappointing and dangerous development, it can be assumed that the Bio-Pharmaceutical Complex still exerts majority control over our regulatory agencies:
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If we truly want to Make America Healthy Again, this global syndicate has to be properly dealt with.
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Nicolas Hulscher, MPH, Epidemiologist and Foundation Administrator, McCullough Foundation
Featured image is from Children’s Health Defense
The Worldwide Corona Crisis, Global Coup d’Etat Against Humanity
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