BREAKING: FDA Goes Rogue — Approves Moderna’s Next-Gen COVID-19 mRNA Injection Without Placebo-Controlled TrialThis move directly contradicts a recent HHS statement: “All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices.”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: According to Moderna:
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:
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: If we truly want to Make America Healthy Again, this global syndicate has to be properly dealt with. Epidemiologist and Foundation Administrator, McCullough Foundation www.mcculloughfnd.org Please consider following both the McCullough Foundation and my personal account on X (formerly Twitter) for further content.
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