FDA Refuses to Review Moderna's Flu Vaccine
The FDA has refused to review Moderna's influenza vaccine, dealing a major blow to the biotech company's strategy of diversifying its product portfolio beyond COVID-19 vaccines. The decision means Moderna will face delays in bringing a flu vaccine to market, a key part of its plan to become a broader respiratory disease vaccine maker.
The refusal to review, known in regulatory terms as a "refuse to file" action, typically indicates that the FDA found the application insufficiently complete to warrant a full review. For Moderna, which has invested heavily in mRNA technology for multiple vaccine candidates, this setback raises questions about the timeline for its pipeline and its ability to generate revenue from products other than its COVID-19 vaccine, which has seen declining demand.
The refusal to review, known in regulatory terms as a "refuse to file" action, typically indicates that the FDA found the application insufficiently complete to warrant a full review. For Moderna, which has invested heavily in mRNA technology for multiple vaccine candidates, this setback raises questions about the timeline for its pipeline and its ability to generate revenue from products other than its COVID-19 vaccine, which has seen declining demand.