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Alliance to VRBPAC: Timely Flu Strain Selection Critical to 2026-2027 Season

Published March 12, 2026

Today, Alliance for Aging Research President & CEO Sue Peschin, MHS, delivered public comment at the FDA’s Vaccine and Related Biological Products Committee (VRBPAC) meeting. Her comments highlighted a written comment letter from the Alliance that was also submitted to VRBPAC. 

The comments:

  • Urge the FDA to provide manufacturers with a timely strain recommendation for the 2026-2027 flu season – a step that is critical to ensuring vaccines are produced and distributed before the fall respiratory season.  
  • Call on the committee to reaffirm that approved influenza vaccines and annual strain updates will not be subjected to new randomized placebo-controlled trial requirements, ensure that any forthcoming guidance on clinical data requirements is developed transparently and distinguishes between initial licensure and annual strain updates, and more.  
  • And raise particular concern about declining vaccination rates among older adults in the face of soaring infection rates in certain populations.

The oral comments delivered at the meeting are as follows and a recording is available:

Good morning,

My name is Sue Peschin and I am the President and CEO of the Alliance for Aging Research. Thank you for holding today’s meeting and for the opportunity to provide our comments.  

The Advisory committees, including VRBPAC, play a critical role in strengthening public confidence that the FDA’s regulatory decisions are informed by rigorous analysis and diverse expert perspectives. We thank Commissioner Makary for his leadership, and we encourage the Agency to continue leveraging these venues to support transparent scientific dialogue moving forward.  

Influenza remains a significant cause of severe illness, hospitalization, and death—and older adults, children younger than 2, and individuals with underlying health conditions are at highest risk. In recent years, between 70 to 85 percent of seasonal flu-related deaths and 50-70 percent of hospitalizations were among older adults. At least 90 children have died from seasonal flu this season, and about 85% of those were not fully vaccinated, according to the American Academy of Pediatrics. 

The influenza vaccines authorized and approved by FDA have undergone rigorous evaluation, and their benefit-risk profile across all approved age groups is not in dispute. We are also pleased to see industry pursue and adopt innovations, including newer technologies, with the goals to help develop more precise protection and improved strain matching over time.  

We have 3 requests for you today: 

  1. First, we urge the VRBPAC and the FDA to provide manufacturers with a timely recommendation for the 2026-2027 season, which appears is the goal today—so thank you! Manufacturers begin producing vaccine components as early as February to ensure timely shipping ahead of the fall season. Delays can cause reduced availability and vaccination rates at a time when protection is needed the most. 
  1. Second, we ask VRBPAC and the FDA to reaffirm that currently approved or authorized influenza vaccines—or annual strain updates to those vaccines—should not be subjected to new requirements for randomized clinical trials using inert placebos. The WHO has been consistently clear that withholding an effective existing vaccine from trial participants poses an unacceptable unethical risk. 

    We certainly support continued follow-up on implementation and monitoring for safety. But if revisions to the FDA’s clinical framework for current or future flu vaccines move forward, we ask that they be developed transparently, with appropriate opportunity for stakeholder engagement and public comment, and sufficient implementation lead time to avoid access disruptions. 

    Additionally, to-date the FDA has approved or authorized flu vaccines that provide different options for patients and providers depending on an individual’s age, health status, and preferences and we ask for you to continue that. The CDC and ACIP preferentially recommend the use of higher dose or adjuvanted flu vaccines for people ages 65 years and older, and the VRBPAC and the FDA play an important role in setting the stage for those recommendations.  
  1. Last, influenza poses a year-round risk in long-term care settings, and we need to ensure that vaccine availability and coverage policies reflect that reality. That’s not your role but everything you do sets the stage for what happens after. Thank you for your service!   

Thank you.

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