FDA Advisors Unanimously Support Moderna mRNA-1010 Flu Vaccine

FDA Advisory Committee Unanimously Supports mRNA-1010

On June 18, 2026, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9–0 in favor of approving Moderna’s seasonal mRNA flu vaccine, known as mRNA-1010 (branded as mFlusiva). The committee's decision follows a review of Phase 3 clinical data demonstrating that the vaccine is more effective than traditional flu shots and maintains a strong safety profile.

Clinical Efficacy and Trial Results

Data from two Phase 3 trials indicate that mRNA-1010 provides superior immune responses and efficacy compared to existing options:

• General Adult Population: In a trial of over 40,000 adults aged 50 and older, the mRNA vaccine was approximately 27% more effective against seasonal flu than standard flu shots.
• Seniors (65+): A smaller trial of nearly 3,000 individuals aged 65 and older showed that mRNA-1010 produces stronger immune responses than high-dose flu vaccines, which are currently recommended for this demographic.

Committee members highlighted the "robust" nature of these results. Flor Munoz-Rivas, a pediatric infectious disease expert at Baylor College of Medicine, noted that the agile mRNA platform allows for more rapid development in response to seasonal flu activity and better prepares the healthcare system for future pandemic strains.

Resolution of Regulatory Conflict

The unanimous vote resolves a period of significant internal FDA conflict. In February 2026, Vinay Prasad, a Trump appointee overseeing vaccines, rejected Moderna's filing and refused to review the vaccine. Prasad argued that the large trial was not "adequate and well-controlled" because it did not compare efficacy specifically to high-dose vaccines in the 65+ age group, despite the FDA having previously agreed to a plan that used a smaller trial to compare immune responses for that specific group.

This decision was made over the objections of career FDA scientists and officials. Following widespread outcry, the FDA reversed this decision one week later. Vinay Prasad was subsequently removed from the FDA at the end of April 2026 following a series of controversial decisions, including the rejection of a UniQure gene therapy for Huntington’s disease (which was also later overturned).

Path to Market and Remaining Hurdles

While the VRBPAC vote is a critical milestone, final approval rests with the FDA, which has set a decision deadline for August 5, 2026. Moderna aims to release the vaccine later this year if approved.

Even with FDA approval, the vaccine must secure a recommendation from the Centers for Disease Control and Prevention (CDC) via the Advisory Committee on Immunization Practices (ACIP) to ensure coverage by commercial insurance and federal programs. However, the ACIP is currently facing legal instability; a federal judge issued a temporary injunction blocking several anti-vaccine appointees installed by Health Secretary Robert F. Kennedy Jr., ruling they were appointed improperly. The US Department of Health and Human Services is currently appealing this injunction.