FDA VRBPAC Votes to Recommend Influenza Vaccines for 2026-2027 Season

Today, the FDA VRBPAC voted to recommend influenza vaccines for a trivalent composition for protection against 2 influenza A viruses (H1N1 and H3N2), and 1 influenza B virus (Victoria lineage) strain.

The Votes

After a series of presentations throughout the morning and early afternoon, the committee was posed 2 questions to vote on. The voting language and the vote totals were as follows:

1.Does the committee recommend a 2026-2027 formulation for egg-based influenza virus vaccines in the US that contain the following strains:

• A/Missouri/11/2025 (H1N1)pdm09-like virus
• A/Darwin/1454/2025 (H3N2)-like virus
• B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus

The committee voted 7-0 in favor with no one abstaining.

2.Does the committee recommend a 2026-2027 formulation for Cell culture-, recombinant protein-, or nucleic acid-based vaccines in the US that contain the following strains:

• A/Missouri/11/2025 (H1N1)pdm09-like virus
• A/Darwin/1415/2025 (H3N2)-like virus
• B/Pennsylvania/14/2025 (B/Victoria lineage)-like virus

The committee voted 7-0 in favor with no one abstaining.

The Influenza Season Thus Far

Since October 1, 2025, there has been an estimated 24-47 million influenza cases, between 310,000-710,000 hospitalizations, and an estimated 21,0000-72,000 deaths, according to the Centers for Disease Control and Prevention.*¹ Despite the high number of cases, hospitalizations, and deaths that continue, immunization rates continue to drop. The number of vaccines distributed each season has decreased by 23% since the 2019/2020 season.¹

During the VRBPAC meeting, CDC’a Lisa Grohskopf, MD, MPH, presented data around influenza surveillance of the ongoing current season. She mentioned the season peaked in late December, but there has been a relative increase of cases of influenza B and a decrease in cases in influenza A.

Hospitalizations also peaked in late December, which was similar to the previous influenza season. In adults, there were 76 hospitalizations per 100,000 which is the third highest since the 2010-2011 influenza season. And amongst the pediatric population, this was the second highest hospitalization rates during this same period.

In the pediatric population, there have been 90 reported deaths. And of those with known vaccination status, 85% were not fully vaccinated. In the pediatric population, there was between 14-48% vaccine effectiveness (VE) overall. Efficacy was higher with the B strain vs A strains.

In the adult population between the ages of 18-64, this population saw a vaccine effectiveness of between 22-34% overall. The vaccines were also more effective against influenza B compared to influenza A.

In adults that are 65 years of age and older, vaccine effectiveness was between 30%-41% overall.

Grohskopf pointed out the vaccine effectiveness was lower than previous seasons, and it is not known why. She did mention these are preliminary estimates and said there is variability in the surveillance sites where they capture data including the different subset of populations and strains seen, which could be affecting VE.

This meeting is an annual event, but last year this FDA’s advisory committee meeting was canceled, and no reasons were provided.

*This is in-season estimates through February 28, 2026. It is important to note, these statistics will change as the season goes on and more data is collected and finalized later this year.

Reference
1.Preliminary Estimated Flu Disease Burden 2025-2026 Flu Season. CDC Accessed March 12, 2026.
https://www.cdc.gov/flu-burden/php/php/data-vis/2025-2026.html