Europe—not US—first to authorize Moderna's combo mRNA flu-COVID vaccine

Europe leapfrogged the US to become the first regulatory bloc authorizing Moderna’s combined mRNA flu-COVID vaccine, a single-shot that targets both respiratory viruses. The European Medicines Agency approved the shot 47 days faster than the FDA’s typical review timeline, citing real-world data from 18,000 trial participants showing 87% efficacy against severe COVID and 65% against influenza. This accomplishment outpaces the runner-up US approval by 2 months, as US regulators continue reviewing safety data. Moderna’s combo vaccine is 30% more convenient than separate flu and COVID shots, reducing clinic visits by half. The approval sets a benchmark for combination vaccines, with industry projections estimating $8 billion in annual sales by 2028—a 20% premium over standalone products.