Moderna (NASDAQ:MRNA) shares moved higher on Thursday, building on the previous session’s strong gains as investors focused on a key review of the company’s influenza vaccine by a U.S. Food and Drug Administration advisory committee.
The stock advanced 3% after surging 11.5% on Wednesday, with market attention centred on the regulatory outlook for the company’s mRNA-based flu shot.
FDA Panel Set to Weigh Risks and Benefits
The FDA’s Vaccine and Related Biological Products Advisory Committee is scheduled to vote on whether the benefits of Moderna’s influenza vaccine outweigh the associated risks in older adults.
The review comes after regulators reversed an earlier decision to reject the company’s original application, reopening the path toward potential approval.
Moderna Pursues Traditional and Accelerated Approvals
Moderna is seeking full approval for mFlusiva in adults aged 50 to 64, while pursuing accelerated approval for individuals aged 65 and older.
If granted accelerated approval, the company would be required to conduct additional post-approval studies to further confirm the vaccine’s clinical benefit in the older population.
Regulatory Review Follows Leadership Changes
The advisory committee meeting comes against the backdrop of recent changes within the FDA, including the departures of Commissioner Marty Makary and vaccine chief Vinay Prasad.
Both exits followed debates surrounding vaccine and rare-disease drug evaluations, including scrutiny of Moderna’s flu vaccine programme.
FDA officials had previously raised concerns that Moderna’s clinical trial design may have exposed patients to additional risk because the study did not use a higher-dose influenza vaccine as the control treatment for participants aged 65 and older.
FDA Documents Highlight Strengths and Limitations
In briefing materials released ahead of the meeting, FDA reviewers said evidence showing a strong immune response to mFlusiva could support its effectiveness in adults aged 65 and above.
However, regulators also noted uncertainties regarding the vaccine’s performance in immunocompromised individuals and frail elderly patients, groups that were not included in the clinical studies.
Moderna Points to Positive Trial Results
According to Moderna, mFlusiva demonstrated superior performance compared with standard-dose influenza vaccines among adults aged 50 to 64.
The company also cited findings from a separate smaller study showing the vaccine generated a robust immune response when compared with a high-dose flu vaccine in adults aged 65 and older.
The outcome of the advisory committee’s review is expected to play a key role in determining the regulatory path forward for Moderna’s influenza programme as the company seeks to expand its portfolio beyond COVID-related products.