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Seattle Keith's avatar

@Seattle Keith: re: the new saRNA vaxx- "On May 31st, the FDA announced its approval of Moderna’s new COVID-19 vaccine, mNexspike, a self-amplifying mRNA (saRNA) product authorized for use in individuals 12 years and older with at least one risk factor, and for all adults over 65. On its surface, this approval might seem like just another iteration in the long sequence of pandemic-era decisions. In reality, it marks a sharp pivot in platform regulatory precedent—a pivot that will almost certainly face future regulatory scrutiny as the consequences of this decision unfold.

What distinguishes mNexspike is not merely its antigen target or dosage—it is the platform leap. Self-amplifying mRNA is an entirely different molecular system than first-generation mRNA shots. Its capacity to replicate inside cells confers both heightened expression and prolonged presence of synthetic RNA. That is not an incremental modification; it is a structural transformation. Yet, the FDA approved this product not as a new platform, but through an equivalence framework that compares it only to Spikevax, Moderna’s existing COVID-19 shot.

This approach—comparator trial without placebo control, using a non-inert reference product—should raise eyebrows. It raises scientific, ethical, and procedural questions that will almost certainly attract policy-level attention as standards evolve and expectations of transparency rise." (Dr. James Lyons-Weller) https://www.globalresearch.ca/moderna-mnexspike-approval/5889300

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Al X G's avatar

That’s the same FDA that tried to put the release of Pfizer vaccine data on ice for 75 years. So where is Dr Malarkey [sic] on this?

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