by Jon Fleetwood, Jon Fleetwood:
VRBPAC members revealed: a former Moderna advisory board member, current GlaxoSmithKline and Merck executives, federal and university figures whose careers depend on vaccines.
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.
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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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