MRNA Stock Slips: FDA Slates Advisory Hearing On Experimental Flu Shot

• The open-session hearing comes just weeks ahead of the agency’s Aug. 5 target date to decide on the vaccine’s approval. 
• In February, the FDA rejected Moderna’s application for the vaccine, only to reverse its decision a week later. 
• Moderna is eyeing making the vaccine available in time for the 2026-27 flu season for adults 50 and older.
   

Moderna Inc. (MRNA) shares declined over 2% onThursday after U.S. regulators announced plans for a rare public advisory committee meeting next month to debate the company’s experimental mRNA-based seasonal influenza vaccine, adding a new layer of uncertainty to an already turbulent approval process.

The Food and Drug Administration will convene the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 18 to discuss Moderna’s candidate, known as mRNA-1010, according to a federal register notice. The hearing comes just weeks ahead of the agency’s Aug. 5 target date to decide on the vaccine’s approval.

The U.S. Food and Drug Administration convenes advisory committee meetings on an as-needed basis when its reviewers seek independent scientific expertise on novel, complex, or contentious products under consideration for approval. While the committee’s recommendations carry significant weight, the FDA retains final decision-making authority and is not legally required to follow them.

Moderna’s Struggle With the FDA

The move marks the latest setback in Moderna’s multi-year push to bring the first mRNA flu vaccine to market.

In February, the FDA took the rare step of issuing a Refusal-to-File letter, rejecting Moderna’s initial biologics license application. Regulators cited a single issue: the late-stage trial had compared mRNA-1010 against a standard-dose flu vaccine rather than the high-dose or adjuvanted formulations now recommended as the “best available standard of care” for older adults.

One week later, however, the FDA reversed course, accepted a revised filing, and set the Aug. 5 target action date. The company exercised a Priority Review Voucher to accelerate the timeline, with hopes of having the shot available in time for the 2026-27 flu season for adults 50 and older.

How Did MRNA Retail Traders React?

On Stocktwits, retail sentiment around MRNA stock stayed within the ‘bearish’ territory over the past 24 hours, while message volume remained at ‘low’ levels

MRNA stock has gained over 82% over the past 12 months. 

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