Home / Business and Economy / FDA Rejects Moderna's Flu Shot Application
FDA Rejects Moderna's Flu Shot Application
11 Feb
Summary
- FDA declined to review Moderna's influenza vaccine application.
- The decision was based on the comparator study's standard of care.
- Moderna shares fell 8% following the FDA's announcement.
Moderna's bid for approval of its mRNA-1010 influenza vaccine has been rejected by the U.S. Food and Drug Administration (FDA). The regulatory agency informed the company on Tuesday that it would not initiate a review of the application.
The FDA's letter specified that the reason for refusal was Moderna's decision to compare its mRNA-1010 vaccine against an already licensed standard-dose seasonal influenza vaccine. The agency stated this comparison did not meet the requirement for an "adequate and well-controlled" study reflecting the best available standard of care. No specific safety or efficacy concerns were raised.
Following this announcement, Moderna's shares experienced an 8% decline in aftermarket trading. The company had previously reported that its mRNA-1010 vaccine demonstrated 26.6% greater effectiveness compared to an approved annual flu shot from GSK. Moderna has requested a meeting with the FDA to clarify the pathway forward for its vaccine candidate.
