The latest
The Food and Drug Administration has approved the first mRNA-based influenza vaccine, opening a new option for adults aged 50 and older. Moderna said Wednesday that mFLUSIVA could reach selected retailers within weeks, although no price was immediately available. The agency used different pathways by age: approval for adults 50 to 64, and accelerated approval for those 65 and older, tied to a post-marketing study confirming clinical benefit.
Details
- Trial results: In a late-stage trial involving more than 40,000 participants, recipients received either Moderna’s candidate or a standard-dose flu vaccine. Moderna’s shot was nearly 27 percent more effective against seasonal influenza, according to the reported clinical data. Flu vaccines are updated annually, and their effectiveness depends partly on matching the strains in circulation.
- Older adults: A smaller trial compared immune responses from mFLUSIVA with those from a high-dose influenza vaccine recommended preferentially for adults 65 and older. The FDA said direct comparative evidence with high-dose shots still requires further evaluation.
- Safety profile: FDA data associated the mRNA vaccine with higher rates of temporary injection-site pain and fatigue. In a June presentation, the agency said seasonal influenza mRNA vaccine data had shown “generally robust” immune responses and cited the need for vaccines that can be reformulated quickly.
- Review reversal: Then-FDA vaccine chief Vinay Prasad initially argued Moderna’s application lacked an adequate, well-controlled study. After expert pushback, the agency resumed review under a revised approach. Moderna proposed approval for ages 50-64 and accelerated approval for older adults during a mid-February meeting.
- Adviser vote: In mid-June, FDA vaccine advisers voted unanimously that the benefits outweighed the risks for both age groups. Former senior FDA regulator Jesse Goodman said before approval that he would strongly consider the vaccine for people aged 50-64, especially those with underlying conditions.
- Coverage outlook: KFF’s Jennifer Kates said Medicare would cover the shot, while coverage below age 65 could vary by state. Pharmacy stocking is harder to predict without recommendations from the Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention.
Background
The approval follows sustained political criticism of mRNA technology, including from Health Secretary Robert F. Kennedy Jr., who previously sought to wind down federally supported mRNA projects valued by his department at nearly $500 million. During the pandemic, experts credited the platform with speeding coronavirus vaccine development and deployment.
What’s next
Moderna expects selected retailers to begin offering mFLUSIVA within weeks. The next measurable indicators are announced pricing, state and insurer coverage decisions for ages 50-64, pharmacy stocking levels, and the required post-marketing study of clinical benefit in adults 65 and older.
