Moderna (MRNA) Shares Drop 9% Pre-Market After FDA Waives Review of Experimental Flu Vaccine

FDA notified Moderna (MRNA) in a letter signed by Center Director Vinay Prasad it will not initiate review of its application for an experimental influenza vaccine, citing an absence of an adequate and well-controlled comparator-arm study reflecting the best-available standard of care. The decision follows sweeping shifts in U.S. vaccine policy under Health Secretary Robert F. Kennedy Jr., reducing vaccine usage and complicating future approvals. Moderna shares fell 8.9% in premarket trading on February 11, 2026, as analysts warn the outcome could lengthen the path to approval in the U.S. The vaccine is under review in the EU, Canada, and Australia, with potential approvals expected late 2026 or early 2027.