Moderna Sues FDA Over Flu Shot Review Ban as Covid Sales Fall 26%
Moderna has formally challenged the FDA’s refusal to review its quadrivalent flu vaccine application, potentially delaying seasonal rollout. The company reported a 26% year-over-year decline in Covid-19 vaccine sales in Q4 2025, attributing the drop to decreased demand.
1. Regulatory Dispute Over Flu Vaccine Review
Moderna has lodged a formal challenge against the FDA’s decision to refuse review of its quadrivalent flu vaccine, aiming to secure a timely assessment before the 2026–27 season. The move signals potential delays to market entry and pressures the regulator to justify its refusal.
2. Covid-19 Vaccine Sales Decline
In Q4 2025, Covid-19 vaccine revenue fell by 26% year-over-year as lower booster uptake and competition from new antiviral treatments eroded demand. Management cited shifting public health priorities and inventory drawdowns as key factors behind the downturn.