Science-Based Medicine

The FDA:  Promoting Quack Nostrums Based on “Incredible Stories” While Rejecting Vaccines Despite Successful RCTs

The U.S. FDA declined to review Moderna's mRNA influenza vaccine, even though two phase‑3 trials involving 43,800 participants demonstrated a 27% efficacy advantage over the standard Fluarix vaccine and a 49% reduction in hospitalizations. FDA officials cited the comparator arm as not reflecting the best‑available U.S. standard of care, a stance that contradicts earlier guidance and approvals in Canada, the EU and Australia. The decision has sparked criticism from Moderna, industry leaders, and investors, who argue the agency’s shifting criteria undermine confidence in innovative vaccine platforms. The controversy highlights broader tensions between regulatory consistency and rapid biotech innovation.