mFLUSIVA: Unnecessary Genetic Shot Without Proven Survival Benefit, Lacking Preclinical Safety Data, and No Justification for FDA Reversal

Moderna twists arms and scores a major victory for the mRNA industry with FDA approval

Jun 20, 2026

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By Peter A. McCullough, MD, MPH

Robert F. Kennedy, Jr and the MAHA Coalition appear powerless in stopping the onslaught of genetic mRNA vaccines entering the market for widespread use.

🧬 The mFLUSIVA Approval: Efficacy Theater, Missing Safety Data, and the Influenza Vaccine Industrial Complex

📋 A Regulatory Process in Reverse

The FDA’s pathway to approving Moderna’s mRNA influenza vaccine—branded mFLUSIVA (mRNA-1010)—reads less like a rigorous scientific evaluation and more like a negotiation between business partners. After the agency issued a Refusal-to-File letter in February 2026, then reversed course within days, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened on June 18, 2026, and voted unanimously to recommend approval. The PDUFA date is set for August 5, 2026. By the time the 2026–2027 flu season arrives, this product will almost certainly be on the market.

What makes this approval trajectory notable is what was not required before granting market access.

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