The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously on Thursday that the “benefits” of Moderna’s experimental mRNA influenza vaccine, mFlusiva (mRNA-1010), “outweigh its risks,” clearing the way for potential FDA approval in adults aged 50 and older.
The vote comes just weeks after Moderna’s own Phase 3 trial confirmed that the shot produced roughly six times more severe reactions than standard-dose influenza vaccines while providing less than one percentage point (<1%) in absolute risk reduction.
The advisory committee nevertheless voted 9-0 in favor of the vaccine for adults aged 50 to 64 and 9-0 in favor of the vaccine for adults 65 and older.
The vote does not itself approve the vaccine.
Rather, it provides a recommendation that FDA conclude the vaccine’s benefits outweigh its risks, significantly increasing the likelihood that the agency will grant licensure for use in adults aged 50 and older.
Members of Congress have warned that the FDA “is not meeting important federal safety requirements to protect its employees and the public while also failing to prioritize scientific data quality delivered from FDA laboratories.”
And according to Kaiser polling, fewer than half of American adults say they have confidence in the FDA to ensure the safety and effectiveness of vaccines approved for use in the U.S.
Only 42% believe the FDA makes decisions based on science rather than the personal views of agency officials.
Just 37% believe the FDA acts independently, without influence from outside interests.
For many Americans, the 9-0 vote is not a rebuttal to concerns about regulatory capture—it is the evidence.
Especially when it’s their own tax dollars funding the research behind Moderna’s mRNA-1010.
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Committee Composed of Moderna, Other Vaccine Industry Figures
The committee’s composition draws scrutiny in light of the unanimously favorable vote for a drug that provides less than 1% protection.
Committee member Flor Munoz-Rivas previously served on Moderna’s Vaccines Advisory Board and participated in multiple Moderna vaccine Data Safety Monitoring Boards.
For critics, the obvious concern is that former Moderna insiders should not be sitting on FDA panels tasked with judging Moderna products in the first place.
Meanwhile, the roster includes a current GlaxoSmithKline vaccine executive and a Merck vaccine executive serving as industry representatives, alongside CDC immunization officials, NIH personnel, vaccine researchers, infectious-disease specialists, and “public-health” academics.
With the panel drawn overwhelmingly from the vaccine industry, critics argue the vaccine establishment is effectively reviewing and approving its own products.
You can find VRBPAC member contact information here.
You can contact FDA here.
Relative & Absolute Risk Explained
According to FDA briefing documents presented to VRBPAC, the primary efficacy analysis found protocol-defined RT-PCR-confirmed influenza-like illness in 411 of 20,179 mRNA-1010 recipients (2.0%) compared with 557 of 20,124 recipients of standard-dose influenza vaccines (2.8%).
FDA characterized the result as 26.6% “relative” vaccine efficacy, even though 2% to 2.8% represents an absolute difference of only 0.8 percentage points between the two groups.
Relative efficacy is used to make differences appear larger than they really are.
Relative risk is often the bigger, more attention-grabbing number because it measures the percentage change between groups, while absolute risk measures how much a person’s actual chances changed.
For example, if a risk falls from 2 people out of 10,000 to 1 person out of 10,000, marketers can advertise a 50% reduction even though only one additional person out of 10,000 benefited.
Likewise, Moderna’s 26.6% relative efficacy figure came from reducing the study endpoint from 2.8% of participants to 2.0% of participants—an absolute difference of just 0.8 percentage points.
Moreover, the adverse-event coding category “death” appeared 23 times in the mRNA-1010 group and only nine times in the comparator group.
But the committee believes the high death count in the mRNA-1010 group is “unlikely to represent a vaccine safety signal for mRNA-1010.”
Bottom Line
A committee drawn from former Moderna board members, vaccine manufacturers, vaccine research institutions, and government immunization programs unanimously endorsed Moderna’s mRNA flu shot despite trial data showing less than 1% absolute benefit, roughly six times more severe reactions, and 23 deaths in the mRNA group compared with 9 in the comparator group.
The vote highlights the growing divide between what regulators consider an acceptable risk-benefit profile and what many Americans would conclude after examining the underlying data for themselves.
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Why not call a spade a spade? This is such blatant Racketeering it's absurd to think otherwise. NONE of these committee members are *elected* officials. They are members of a Racketeering cabal representing corporate syndication and franchise.
The Food and Drug Administration is in violation of it's own Charter, period. Revocation of Corporate Charter needs to be initiated, with ALL financial assets and physical properties seized. The Delaware Court of Chancery has record of agency. Wake up.
The former Moderna board members, vaccine manufacturers, vaccine research institutions, and government immunization programs unanimously endorsed Moderna’s mRNA flu shot despite trial data showing less than 1% absolute benefit, roughly six times more severe reactions, and 23 deaths in the mRNA group compared with 9 in the comparator group. Obviously they stand approved by this product, so they can roll up their sleeves and take a shot from this beneficial vaccine and compare your results for peer reviewed scientific studies. Your results will determine my approval for voluntary vaccination.