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ICAN sent an urgent letter to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) before its last meeting, documenting alarming safety and efficacy failures with Moderna’s new mRNA flu vaccine, mFlusiva. Shockingly, the committee voted unanimously to recommend mFlusiva anyway. It now goes to FDA Acting Commissioner, Kyle Diamantas, for official approval.
Among the many issues ICAN identified with mFlusiva were the following:
- Unfavorable Benefit-Risk Ratio: mFlusiva’s trial claimed it reduced absolute influenza risk by a mere 0.8%, while a staggering 6.4% of recipients suffered severe reactions—five times the rate of the standard flu shot.
- Concerning Pattern of Deaths: Five mFlusiva recipients died in Part A of the Phase 3 immunogenicity trial, compared to just one in the group that got the standard flu shot.
- Cardiac Risk: Cardiac events—including fatal cardiac arrest and congestive cardiac failure—occurred during the trials, echoing the well-documented cardiac dangers of mRNA technology learned with Covid vaccines.
- No Placebo and Wrong Comparator: mFlusiva was not tested against a placebo in its Phase 3 safety trial and its efficacy was measured only against a standard flu vaccine, not the enhanced flu vaccines recommended for ages 65 and up.
- Single-Season Data: Efficacy results covered just a single flu season—leaving serious questions about how this vaccine will perform over time.
- Efficacy Fails the Most Vulnerable: Among frail and vulnerable adults 65 and older, mFlusiva’s efficacy was not shown to be statistically significant—in other words, it may not work at all for the very population that needs protection the most.
The most infuriating part of the VRBPAC meeting was that the members actually acknowledged and discussed some of these concerns, but instead of postponing its recommendation, the committee simply recommended further studies be done after mFlusiva’s approval. Meaning, America’s most vulnerable seniors will once again be used as guinea pigs while FDA takes years to figure out if the vaccine is actually harming people.
ICAN will not back down. We will continue to raise concerns about mFlusiva and if it is approved, we will be filing FOIA requests to obtain the full clinical trial data the FDA doesn’t want you to see.
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