Federal Vaccine Advisory Panel Grants Approval for Moderna mRNA Flu Vaccine

The FDA has changed course multiple times as to whether or not to let the vaccine candidate continue undergoing trials to get to market.

Matt MacKenzie

June 22, 2026

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Key Highlights

The FDA's VRBPAC panel unanimously recommended approval of Moderna's mRNA-1010 flu vaccine for adults aged 50-64.
The vaccine showed a 27% higher efficacy against flu-like illness compared to standard-dose vaccines in trials.
Moderna will conduct additional post-marketing studies to assess effectiveness in adults aged 65 and older.
The approval process was influenced by data indicating the vaccine's benefits outweigh its risks.
This new mRNA flu vaccine represents a significant advancement in influenza prevention for middle-aged and older adults.

A federal vaccine advisory panel has given its stamp of approval to Moderna’s mRNA influenza vaccine, mRNA-1010. CIDRAP has the news.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to “recommend approval of the investigational vaccine, which will be marketed under the brand name mFlusiva, for the prevention of flu in adults age 50 to 64.” Moderna will be required to conduct a phase 4, post-marketing study to demonstrate effectiveness in adults aged 65 and older.

The FDA changed course in February after agreeing to review Moderna’s application for the vaccine, saying the phase 3 trial for mRNA-1010 was inadequate because it used a “standard-dose seasonal flu vaccine as the comparator vaccine.” A week later, the FDA reversed course once again. Now, it looks like the vaccine candidate will be able to move forward with testing and studies.

The trial reviewed by VRBPAC found that the vaccine “provided significantly better protection against flu-like illness than standard-dose shots, with a relative vaccine efficacy of 27%.” VRBPAC member Flor Munoz-Rivas said the data “support that the benefits of the vaccine in both age groups [aged 50 to 64 and ages 65 and older] outweigh the risks.”