Moderna Influenza Vaccine Approval Application Rejected by FDA, Shares Drop 8%

The U.S. Food and Drug Administration has refused to review Moderna's application for its influenza vaccine mRNA-1010, sending its shares down 8% in extended trading on February 10, 2026. The Center for Biologics Evaluation and Research cited the use of an already licensed seasonal flu vaccine as the comparator, stating the study lacks an "adequate and well-controlled" design reflecting the best-available standard of care. Moderna plans to request a meeting with the regulator to discuss the next steps. The company previously withdrew its application for a flu-COVID combination vaccine pending mRNA-1010 data and is pursuing approvals in the EU, Canada, and Australia, with potential approvals expected late 2026 or early 2027.