FDA Approves Moderna’s First-Ever mRNA Flu Shot Despite 75.3% Adverse Reaction Rate

https://needtoknow.news/2026/08/fda-...is-2026-aug-13

August 12, 2026

Nicholas Hulscher and Focal Points 1



The FDA has approved Moderna’s mFLUSIVA for adults 50 and older, making it the first seasonal mRNA influenza injection authorized in the United States. 75.3% of senior mRNA-vaccine recipients experienced at least one adverse reaction within seven days, compared with 49.3% of those receiving Fluzone High-Dose.

Even more concerning, severe systemic reactions occurred in 6.7% of mRNA recipients versus 1.7% with the traditional high-dose flu vaccine—nearly four times as frequently.

In a dark day for MAHA, the FDA has approved Moderna’s mFLUSIVA for adults 50 and older, making it the first seasonal mRNA influenza injection authorized in the United States. Adults ages 50–64 received traditional approval, while adults 65 and older received accelerated approval based largely on antibody responses.

The FDA’s own briefing document reveals that 75.3% of senior mRNA-vaccine recipients experienced at least one solicited adverse reaction within seven days, compared with 49.3% of those receiving Fluzone High-Dose.

Even more concerning, severe (Grade 3) systemic reactions occurred in 6.7% of mRNA recipients versus 1.7% with the traditional high-dose flu vaccine—nearly four times as frequently.

Even worse, the pivotal efficacy trial contained no placebo group. Instead, Moderna compared mFLUSIVA against traditional flu vaccines.

A novel mRNA injection produced adverse reactions in three out of four recipients, induced severe systemic reactions nearly four times as often as the traditional high-dose vaccine, lacked a placebo-controlled pivotal efficacy trial, and the FDA approved it anyway.

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