Moderna (MRNA) Stock Falls 9% After FDA Rejects Flu Vaccine Application

TLDR

• Moderna (MRNA) stock plummeted 9% in premarket and 14% in Frankfurt after FDA rejected flu vaccine application
• FDA refused to review mRNA-1010 due to trial design concerns, not safety or efficacy issues
• Agency objected to Moderna using standard flu shot as comparator instead of “best available care”
• Trial with 40,000+ participants showed vaccine was 26.6% more effective than approved flu shot
• CEO disputes decision, saying it contradicts prior FDA guidance from 2024 and 2025

Moderna (MRNA) stock tumbled Wednesday morning after receiving an unexpected blow from regulators. The FDA issued a refusal-to-file letter for the company’s seasonal flu vaccine, sending shares down sharply.

Moderna, Inc., MRNA

The stock dropped 9% in U.S. premarket trading and opened 14% lower in Frankfurt. Trading volume remained light in the early European session.

The FDA declined to review Moderna’s application for mRNA-1010, its seasonal flu vaccine. The agency cited problems with the trial design as the reason for rejection.

Dr. Vinay Prasad, the FDA vaccine director, objected to how Moderna structured its clinical study. The agency said using a standard approved flu shot as a comparator doesn’t represent “best available care.”

Trial Design at Center of Controversy

Moderna conducted a trial with more than 40,000 participants comparing mRNA-1010 to Fluarix. Results announced in September 2025 showed the new vaccine was 26.6% more effective than the FDA-approved flu shot.

The company argues FDA regulations don’t mandate using the most advanced vaccine as a comparator. Moderna maintains it followed agency guidance provided in previous discussions.

CEO Stéphane Bancel criticized the decision in a statement. He said the FDA found no safety or efficacy problems with the actual vaccine product.

Bancel questioned why reviewing a study using an FDA-approved comparator should be controversial. The company claims the rejection conflicts with feedback received in 2024 and 2025.

Moderna has requested a meeting with FDA officials to clarify next steps. The company may need to redesign its trial or explore alternative approval routes.

Broader Regulatory Shifts

The rejection comes as U.S. vaccine policy undergoes changes under HHS Secretary Robert F. Kennedy Jr. FDA officials have reduced COVID-19 recommendations and added new warnings to mRNA vaccines.

The agency removed administration critics from advisory panels. HHS announced plans to cancel over $500 million in mRNA vaccine contracts.

A 2025 internal FDA memo from Prasad proposed ending the streamlined approval process for annual flu vaccines. This method traditionally allowed updates based on immune-response data rather than full efficacy trials.

More than a dozen former FDA commissioners criticized the proposal in a published editorial. They argued the change could slow vaccine development.

Stock Performance and Outlook

Despite Wednesday’s drop, Moderna shares remain up 42% year-to-date. The stock closed up 0.1% Tuesday before the news broke.

Analysts maintain mixed views on Moderna. TipRanks shows a Hold consensus rating with one Buy, 16 Holds, and three Sell recommendations.

The average analyst price target sits at $32.67, suggesting potential downside from current levels. The flu vaccine represents a key growth opportunity beyond COVID-19 products.

Moderna must now decide whether to revise its trial approach or pursue different regulatory pathways. The outcome of its requested FDA meeting will be critical for investors.

The company’s Frankfurt shares traded in low volume during the morning session. U.S. markets will provide a fuller picture of investor reaction when trading opens.

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