Moderna Flu Shot Heads To FDA Advisory Panel

Moderna Inc. (NASDAQ:MRNA) will have its experimental mRNA-based flu vaccine reviewed by a Food and Drug Administration (FDA) advisory panel next month, a move that may signal a more transparent approach from the agency following criticism over recent regulatory decisions.

Citing a notice, Bloomberg reported that the FDA scheduled the advisory committee meeting for June 18.

In February, the FDA issued a refusal-to-file letter regarding its investigational influenza vaccine, mRNA-1010.

Later, the FDA notified Moderna that its biologics license application for mRNA-1010 will proceed to review.

The agency is expected to decide on the vaccine application by August 5.

FDA Advisory Meetings Have Become Less Common

Public advisory panel hearings were once a routine part of the FDA approval process for new drugs and vaccines. The Bloomberg report added that such meetings became less frequent during U.S. President Donald Trump's second administration.

The upcoming Moderna review stands out as one of the more visible public evaluations of a drug application in recent months.

The advisory committee process typically allows outside experts to publicly discuss clinical data, safety findings, and potential risks before the FDA reaches a final decision.

Review Comes After Industry Frustration

The hearing also comes shortly after former FDA Commissioner Marty Makary left the agency last week.

Some biotechnology companies, including Moderna, had previously expressed frustration over unexpected regulatory hurdles and approval delays during Makary's tenure.

Companies reportedly raised concerns about limited communication and surprise setbacks in the review process.

The FDA's decision to hold a public advisory committee meeting for Moderna's flu shot could indicate a broader effort to provide more visibility into how the agency evaluates drug applications.

MRNA Stock Price Activity: Moderna shares were down 1.34% at $47.47 at the time of publication on Thursday, according to Benzinga Pro data.

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