Moderna Extends 3% Gain Following 11.5% Surge Ahead of FDA Flu Vaccine Vote
MRNA•Moderna shares gained 3% following an 11.5% rally as an FDA advisory committee reviews its mRNA flu shot application. The panel will evaluate full approval for ages 50-64 and accelerated approval for those 65+, determining next steps including required post-approval studies.
1. Stock Performance
Moderna shares rose 3% on Thursday after an 11.5% increase the previous session, reflecting investor optimism ahead of a key FDA advisory committee meeting. The momentum underscores market focus on regulatory developments for the company’s mRNA-based influenza vaccine.
2. FDA Advisory Committee Review
The FDA’s Vaccine and Related Biological Products Advisory Committee is set to vote on whether the benefits of mFlusiva outweigh its risks in older adults. This review follows a reversal of an earlier rejection, reopening the path toward potential approval for the shot.
3. Approval and Post-Approval Requirements
Moderna is pursuing full approval for adults aged 50 to 64 while seeking accelerated approval for those 65 and older. Accelerated approval would obligate the company to conduct additional post-approval studies to confirm clinical benefit in the older population.
4. Clinical Data Highlights
Moderna’s trials demonstrated superior immune response to standard-dose influenza vaccines in adults aged 50-64 and robust results versus high-dose formulations in those over 65. Regulators noted uncertainties about vaccine performance in immunocompromised and frail elderly groups excluded from the studies.
