FDA refuses to review Moderna's mRNA flu vaccine

Source: Ars Technica

FDA refuses to review Moderna’s mRNA flu vaccine

The Food and Drug Administration has refused to review Moderna’s application for an mRNA flu vaccine, the company revealed Tuesday.

Context

The decision follows a series of actions by the agency under the leadership of Robert F. Kennedy Jr. In his first year in office, Kennedy has already:

• dramatically slashed childhood vaccine recommendations
• canceled $500 million in research funding for mRNA vaccines against potential pandemic threats

FDA’s Reason for Refusal

According to a news release, the FDA cited the design of Moderna’s Phase 3 trial for its mRNA flu vaccine, mRNA‑1010, specifically the comparator vaccine used. The agency rejected the application because Moderna compared mRNA‑1010 to licensed standard‑dose influenza vaccines, including Fluarix (GlaxoSmithKline).

Trial Details

• Trial identifier: NCT06602024
• Enrollment: Nearly 41,000 participants
• Cost: Hundreds of millions of dollars
• Findings: mRNA‑1010 was superior to the comparators in safety and efficacy.

Moderna’s Response

Moderna stated that the FDA had reviewed and accepted the trial design on at least two occasions (April 2024 and August 2025) before the approval application was submitted. The company also noted that Fluarix has previously been used as a comparator vaccine in flu vaccine trials that led to approved products.