A federal advisory committee has voted to recommend the controversial seasonal shot, while simultaneously urging Americans not to draw any hasty conclusions about whether it prevents influenza. The agency stressed that the word "endorsement" should be viewed purely as an observational construct.
The Food and Drug Administration's independent advisory panel formally backed the Moderna mRNA vaccine on Thursday, though spokespeople were quick to clarify that the vote was not peer-reviewed and suffers from an inherently small sample size of just 14 committee members. The vaccine, which generated controversy earlier this year when preliminary data suggested it might actually do something, was approved under the strict condition that no one rely on it entirely.
Representatives for the FDA noted that while a recent paper in The Lancet indicated a strong association between the Moderna shot and a lack of severe respiratory illness, patients must remember that association is not causation. The panel's 400-page supplementary guidance document warned that avoiding the flu after receiving the shot could be entirely attributable to confounding variables, such as washing one's hands, eating a balanced diet, or standing alone in a dark room until May.
While the in-vitro assays demonstrate what we might loosely term an 'immune response,' we must remember that surviving the winter without contracting influenza could simply be a statistical anomaly.
Moderna executives, who themselves disclosed severe financial conflicts of interest in wanting the vaccine to work, acknowledged the panel’s hesitancy. The company has agreed to fund a 30-year retrospective longitudinal study to determine if the mRNA technology actually targets the influenza virus, or if the pathogen simply mutates on its own out of boredom.
FDA Commissioner Robert Califf issued a separate statement appending a black-box warning to the committee's optimism. Until the efficacy data is rigorously replicated in a multi-center, double-blind trial, Califf advised anyone receiving the vaccine to continue acting as though they are actively infected with every known respiratory pathogen, cautioning that life itself is a pre-existing condition with a 100 percent mortality rate that no injection can alter.