Overview
- CBER Director Vinay Prasad issued a refusal-to-file letter stating Moderna’s study was not “adequate and well-controlled” because participants 65 and older were not compared against a high-dose influenza vaccine.
- Moderna says the design was discussed with FDA and that regulators had indicated a licensed standard-dose comparator would be acceptable, using GSK’s Fluarix across age groups.
- The company reported its vaccine was 27% more effective against symptomatic flu and 49% better against hospitalization versus Fluarix in trials enrolling over 43,800 participants, with no explicit safety or efficacy shortcomings cited in the refusal, according to reports.
- An unnamed senior FDA official told reporters the study raised ethical concerns and said the company went against advice not to include adults over 65 under those conditions, Salon reported.
- Critics accuse the FDA of political interference under HHS Secretary Robert F. Kennedy Jr., while reviews continue in the EU, Canada and Australia and commentators note refusals-to-file without review are uncommon.